On August 16, 2007 Health Canada issued a public communication concerning the end of Permax sales in Canada as of August 30.
As this action was anticipated, Canadian Equine Cushings Group members and Dr. Eleanor Kellon have been engaged in an ongoing proactive approach to ensure the continuation of pergolide availability for equine use has been ongoing.
The following is an excerpt from a communication received by this group from the Veterinary Drugs Directorate - Health Canada:
Secondly, the compounding of drugs is not something that we here at the Vet Drugs Directorate regulate and compounding is dealt with differently in Canada than it is in the United States. It is regulated provincially for Canadian vets and the Canadian Veterinary Medical Association also has guidelines for the use of compounded drugs in veterinary medicine. Pharmacists have their own associations which govern how their compounding practices and they can order Active Pharmaceutical Ingredients from the chemical companies that produce them even if a brand name drug is not labelled for animals. They do not need to use a brand name drug and they do not have to come through the Vet Drugs Directorate for authorization or access to the active ingredient.
As far as we know, the access that pharmacists have to the active pharmaceutical ingredient should not be affected by this recall in Canada. They should still be able to purchase the active ingredient from the chemical companies that make pergolide mesylate (that may be anywhere in the world). But only a pharmacist would be able to find out how easy or how expensive it would be for them to get the ingredient for compounding.
Updates will be provided as they become available.
Saturday, August 25, 2007
Wednesday, May 16, 2007
Cushing's horse places second in equitation class after treatment
THIS IS WHAT EVERYONE'S HARD WORK ON THE PERGOLIDE ISSUE WAS ALL ABOUT!!
Posted to EC List May 16, 2007
My daughter's horse, Secret, started with an early case of
founder/laminitis. He was walking very stiff legged on front legs. We
called the vet. After testing, it was confirmed that he has Cushing's
disease. He is approximately 19 years old.
That was five months ago, in January. He has been on Pergolide since
then. His diet has also been changed to a very low carb diet. His
turn out is limited to about 3 hours a day.
My daughter recently took him to an "A" show locally. Together, they
placed Second in a class of about 15, age group 14 & under, in a 2'6"
equitation class.
The vet told us that after he has been on the treatment, we would
notice that it will be as if he were 5 years younger.
So far, this is true.
Posted to EC List May 16, 2007
My daughter's horse, Secret, started with an early case of
founder/laminitis. He was walking very stiff legged on front legs. We
called the vet. After testing, it was confirmed that he has Cushing's
disease. He is approximately 19 years old.
That was five months ago, in January. He has been on Pergolide since
then. His diet has also been changed to a very low carb diet. His
turn out is limited to about 3 hours a day.
My daughter recently took him to an "A" show locally. Together, they
placed Second in a class of about 15, age group 14 & under, in a 2'6"
equitation class.
The vet told us that after he has been on the treatment, we would
notice that it will be as if he were 5 years younger.
So far, this is true.
FDA Statement - Nuances
Posted on EC List May 15, 2007 Msg #91664
In case anyone is wondering about nuances in the FDA statement, what we
had requested was an exemption from the prohibition on compounding from
bulk drug. What we got was "regulatory discretion". The exemption would
have been a statement that they are allowing it, not considering it
illegal. The regulatory discretion basically means they'll look the
other way but technically they still consider it illegal. Either one
works for us; either one keeps the flow of drug to the compounders.
Only difference is the FDA saves face a bit more with regulatory
discretion. It's purely a matter of semantics. By either publishing an
exemption or making a public statement to the effect they will exercise
regulatory discretion in the framework of a valid prescription, they
are saying they won't move against the compounders or wholesalers. One
statement isn't any stronger than the other. Neither one actually
involves a change in law, and either one can be reversed just as
quickly as it was issued. However, until (and unless) an FDA approved
option comes along (see below), compounding will continue to be your
source of pergolide.
Also, "sponsors of approved product" refers to the 3 companies that
were making the pills before the recall; the only 3 companies that had
applied for and gotten FDA approval to market the drug. A "sponsor" is
a company that seeks FDA approval for a drug. An "approved product" is
a drug that has cleared the FDA approval process for a specific use(s).
So, the rest of the statement, beyond talking about compounding, was to
the effect that they are still trying to encourage the original pill
manufacturers to resume production, and are welcoming any new
sponsors/companies interested in picking it up specifically for equine
use.
Eleanor
In case anyone is wondering about nuances in the FDA statement, what we
had requested was an exemption from the prohibition on compounding from
bulk drug. What we got was "regulatory discretion". The exemption would
have been a statement that they are allowing it, not considering it
illegal. The regulatory discretion basically means they'll look the
other way but technically they still consider it illegal. Either one
works for us; either one keeps the flow of drug to the compounders.
Only difference is the FDA saves face a bit more with regulatory
discretion. It's purely a matter of semantics. By either publishing an
exemption or making a public statement to the effect they will exercise
regulatory discretion in the framework of a valid prescription, they
are saying they won't move against the compounders or wholesalers. One
statement isn't any stronger than the other. Neither one actually
involves a change in law, and either one can be reversed just as
quickly as it was issued. However, until (and unless) an FDA approved
option comes along (see below), compounding will continue to be your
source of pergolide.
Also, "sponsors of approved product" refers to the 3 companies that
were making the pills before the recall; the only 3 companies that had
applied for and gotten FDA approval to market the drug. A "sponsor" is
a company that seeks FDA approval for a drug. An "approved product" is
a drug that has cleared the FDA approval process for a specific use(s).
So, the rest of the statement, beyond talking about compounding, was to
the effect that they are still trying to encourage the original pill
manufacturers to resume production, and are welcoming any new
sponsors/companies interested in picking it up specifically for equine
use.
Eleanor
Horse.com - Pergolide: FDA to Allow Compounding From Bulk
The Food and Drug Administration's (FDA) Center for Veterinary Medicine announced on May 11 it will allow bulk pergolide to be used in compounding pergolide for use in horses.
"A lot of hard work by a large number of people went into getting this resolution," Kellon [Eleanor Kellon, V.M.D.] said. "We've been working on it since the week after the announcement of the drug's withdrawal. It's been a long six weeks, but we're all pleased that the FDA acted in time to prevent any horses having to go without treatment."
Read more...
"A lot of hard work by a large number of people went into getting this resolution," Kellon [Eleanor Kellon, V.M.D.] said. "We've been working on it since the week after the announcement of the drug's withdrawal. It's been a long six weeks, but we're all pleased that the FDA acted in time to prevent any horses having to go without treatment."
Read more...
EquiSearch: FDA Clears Way for Compounding of Pergolide for Horses
A May 11 FDA announcement has cleared the way for compounding of pergolide for horses, but what does the fine print mean? Find out in this special bulletin from EQUUS magazine.
"What it boils down to is that they are allowing it for now," says Kellon [Eleanor Kellon, V.M.D.] "but if an actual drug company decides to start up manufacturing the pill form again or if a drug company wants to go down an official pathway to get it approved for equine use, the bulk compounding will again be considered illegal as soon as that source is up and running."
Read more...
"What it boils down to is that they are allowing it for now," says Kellon [Eleanor Kellon, V.M.D.] "but if an actual drug company decides to start up manufacturing the pill form again or if a drug company wants to go down an official pathway to get it approved for equine use, the bulk compounding will again be considered illegal as soon as that source is up and running."
Read more...
Friday, May 11, 2007
It's Official - WE WON !!!
Statement just issued by FDA, Center for Veterinary Medicine
http://www.fda.gov/cvm/pergolide.htm
"CVM recognizes that veterinarians are prescribing pergolide for the treatment of Cushing’s Syndrome in horses. Veterinarians have been prescribing the drug under the provisions of the Animal Medicinal Drug Use Clarification Act which allows veterinary practitioners to prescribe approved human drugs for “extralabel” use in animals.
"FDA is working with the sponsors of the approved products and all other interested parties to ensure that pergolide remains available to treat Cushing’s Syndrome in horses until a new animal drug application is approved for that use. This includes trying to make the approved product available through veterinary distribution channels and exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide. Bulk substance used for pharmacy compounding should be labeled for “animal use only.” All pharmacy compounding must be done under a valid veterinary prescription to treat an affected horse."
http://www.fda.gov/cvm/pergolide.htm
"CVM recognizes that veterinarians are prescribing pergolide for the treatment of Cushing’s Syndrome in horses. Veterinarians have been prescribing the drug under the provisions of the Animal Medicinal Drug Use Clarification Act which allows veterinary practitioners to prescribe approved human drugs for “extralabel” use in animals.
"FDA is working with the sponsors of the approved products and all other interested parties to ensure that pergolide remains available to treat Cushing’s Syndrome in horses until a new animal drug application is approved for that use. This includes trying to make the approved product available through veterinary distribution channels and exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide. Bulk substance used for pharmacy compounding should be labeled for “animal use only.” All pharmacy compounding must be done under a valid veterinary prescription to treat an affected horse."
Letter to Congressional Horse Caucus
This letter was sent to the Co-Chairs of the Congressional Horse Caucus on behalf of the over 5000 members of the Equine Cushings list and all owners of horses afflicted with Cushing's disease.
FDA Action Causes Horse Health Crisis
Dear Congressmen Stearns and Chandler,
As co-chairmen of the Congressional Horse Caucus, we are writing to ask for your urgent help in requesting the FDA to act upon the drug crisis now facing approximately 75,000 horses in the United States afflicted with Cushing’s Disease or Pituitary Pars Intermedia Dysfunction (PPID).
As you know, on March 29,2007, the FDA asked for voluntary withdrawal of the drug pergolide used in the treatment of Parkinson’s disease secondary to studies confirming cardiac valvular dysfunction in a small subset of human patients. The FDA was apparently not aware of the impact withdrawal of this drug posed to horses diagnosed with Cushing’s Disease. For the past 10 years, pergolide has been the Gold Standard treatment for this disease. While pergolide does not cure PPID, it allows for equines to maintain an excellent quality of life and function. At present, there are no viable drug therapy substitutes for pergolide.
Our group is led by the nationally known and published equine veterinarian; Eleanor Kellon, VMD.[i] Dr. Kellon is co-owner and veterinary advisor of the Equine Cushing’s List (http://groups.yahoo.com/group/EquineCushings). We are over 5,000 members strong (including international members) and we are fighting to ask the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID.
Dr. Kellon has conservatively estimated that of the 10 million horses in the United States, approximately 75,000 are afflicted with PPID.[ii] As of the week of May 2nd, our group has confirmed from ALL compounding wholesalers that NONE have ordered pergolide and NONE will do so until the FDA gives the green light. Additionally, we now estimate that there is only a six week supply of the drug in the United States as of May 9th.[iii]
Without this drug, these horses face certain euthanasia. The primary cause of death will be laminitis secondary to their uncontrolled disease; the very same laminitis that took the lives of Barbaro and Secretariat.
Congressmen, you are both from states with large equine populations. You understand that the equine industry is a vital part of our economy. Both of you and the members of your caucus have already demonstrated your commitment to the equine population by your exceptional work on the Horse Protection Act.
We have contacted the FDA to no avail. Since the March 29th FDA announcement, Dr. Kellon and many of our members have had direct contact (phone, fax, and e-mail) with the appropriate individuals at the FDA. There is still NO definitive plan in place to resolve this crisis. We strongly feel that it will take the voice of Congress to alert the FDA to the consequences of their inaction. By asking the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID you and the members of the Congressional Horse Caucus will save the lives of thousand of horses.
Thank you for considering these horses as constituents of your respective states. Thank you for helping us save the lives of these horses and for ensuring that their devoted owners will have the medication they need for their equine companions.
Sincerely,
Susanna R. Gordon, MD
List Moderator, Equine Cushing’s Group
Kathleen Gustafson, PhD
List Moderator, Equine Cushing’s Group
________________________________________
[i] For further information, Dr. Kellon may be contacted at:
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
drkellon@aol.com
[ii] Canvass of Equine Veterinarian Practices, May 2007
[iii] Communication between Eleanor Kellon, V.M.D. and suppliers, April and May, 2007
For background summary, please see articles at:
http://www.thehorse.com/ViewArticle.aspx?ID=9526&nID=7
http://www.thehorse.com/ViewArticle.aspx?ID=9405&kw=pergolide
Current petition signatures as of 10 May 2007:
http://www.ipetitions.com/petition/savepergolide/signatures.html
FDA Action Causes Horse Health Crisis
Dear Congressmen Stearns and Chandler,
As co-chairmen of the Congressional Horse Caucus, we are writing to ask for your urgent help in requesting the FDA to act upon the drug crisis now facing approximately 75,000 horses in the United States afflicted with Cushing’s Disease or Pituitary Pars Intermedia Dysfunction (PPID).
As you know, on March 29,2007, the FDA asked for voluntary withdrawal of the drug pergolide used in the treatment of Parkinson’s disease secondary to studies confirming cardiac valvular dysfunction in a small subset of human patients. The FDA was apparently not aware of the impact withdrawal of this drug posed to horses diagnosed with Cushing’s Disease. For the past 10 years, pergolide has been the Gold Standard treatment for this disease. While pergolide does not cure PPID, it allows for equines to maintain an excellent quality of life and function. At present, there are no viable drug therapy substitutes for pergolide.
Our group is led by the nationally known and published equine veterinarian; Eleanor Kellon, VMD.[i] Dr. Kellon is co-owner and veterinary advisor of the Equine Cushing’s List (http://groups.yahoo.com/group/EquineCushings). We are over 5,000 members strong (including international members) and we are fighting to ask the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID.
Dr. Kellon has conservatively estimated that of the 10 million horses in the United States, approximately 75,000 are afflicted with PPID.[ii] As of the week of May 2nd, our group has confirmed from ALL compounding wholesalers that NONE have ordered pergolide and NONE will do so until the FDA gives the green light. Additionally, we now estimate that there is only a six week supply of the drug in the United States as of May 9th.[iii]
Without this drug, these horses face certain euthanasia. The primary cause of death will be laminitis secondary to their uncontrolled disease; the very same laminitis that took the lives of Barbaro and Secretariat.
Congressmen, you are both from states with large equine populations. You understand that the equine industry is a vital part of our economy. Both of you and the members of your caucus have already demonstrated your commitment to the equine population by your exceptional work on the Horse Protection Act.
We have contacted the FDA to no avail. Since the March 29th FDA announcement, Dr. Kellon and many of our members have had direct contact (phone, fax, and e-mail) with the appropriate individuals at the FDA. There is still NO definitive plan in place to resolve this crisis. We strongly feel that it will take the voice of Congress to alert the FDA to the consequences of their inaction. By asking the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID you and the members of the Congressional Horse Caucus will save the lives of thousand of horses.
Thank you for considering these horses as constituents of your respective states. Thank you for helping us save the lives of these horses and for ensuring that their devoted owners will have the medication they need for their equine companions.
Sincerely,
Susanna R. Gordon, MD
List Moderator, Equine Cushing’s Group
Kathleen Gustafson, PhD
List Moderator, Equine Cushing’s Group
________________________________________
[i] For further information, Dr. Kellon may be contacted at:
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
drkellon@aol.com
[ii] Canvass of Equine Veterinarian Practices, May 2007
[iii] Communication between Eleanor Kellon, V.M.D. and suppliers, April and May, 2007
For background summary, please see articles at:
http://www.thehorse.com/ViewArticle.aspx?ID=9526&nID=7
http://www.thehorse.com/ViewArticle.aspx?ID=9405&kw=pergolide
Current petition signatures as of 10 May 2007:
http://www.ipetitions.com/petition/savepergolide/signatures.html
Thursday, May 10, 2007
Thanks to Our Supporters
Thanks to all of you who are helping spread the word by linking here from your blogs and web sites. Check out these articles!
The Jurga Report: Horse Health Headlines
Fran Jurga keeps you up-to-date on EquiSearch.com on news about horse health, care, equine science and research that affects horses.
Fran Jurga's "HoofBlog": Up-to-the Minute News from Hoofcare & Lameness Journal
A Georgia Lawyer
Karen's EasyCare & Endurance Musings
Dressage unLtd.
The Jurga Report: Horse Health Headlines
Fran Jurga keeps you up-to-date on EquiSearch.com on news about horse health, care, equine science and research that affects horses.
Fran Jurga's "HoofBlog": Up-to-the Minute News from Hoofcare & Lameness Journal
A Georgia Lawyer
Karen's EasyCare & Endurance Musings
Dressage unLtd.
Wednesday, May 9, 2007
Canadians Lend Their Support
Bridie before being started on Pergolide showing many of the "typical" signs of Cushing's disease
After a year on Pergolide, you can see how much healthier and perkier Bridie appears.
Excerpts from Angela's letter to Canadian publicatons -
I am writing this letter to inform you of the plight of many thousands of Cushing's Equines in the USA - and quite possibly in Canada in the near future - if the issue with Pergolide withdrawal by the FDA (due to side effects in humans but never documented in equines) is not resolved quickly. The drug Pergolide is the treatment of choice for Equine Cushing's or PPID. My Shetland pony of 20 years is on Pergolide for Cushing's and she is healthy and happy. Not so prior to the diagnosis and drug intervention. Bridie had laminitis and founder with rotation in all four hooves and was in considerable pain. With “DDT”- diagnosis, diet and trim with keen hoof management, it took 12 months of rehabilitation to return to health and she is NOW pain free. Without the medication Pergolide to control her symptoms I would have no choice but to have her humanely put to sleep. This is the dilemma.
The U.S. FDA, which on March 29 2007 withdrew the drug Pergolide, still has not brought forth any resolution to the predicament they put us in. As a consequence of this, thousands of horses are at risk to be euthanized due to uncontrolled symptoms of Cushing's - the most common and severe symptoms being crippling laminitis and founder. The reserve drug supplies are almost gone and production has been halted. We have asked the FDA to amend this desperate situation with an EXEMPTION FOR COMPOUNDING PERGOLIDE for special veterinary use.
At present news stations and horse publications are now addressing this issue with editorials and news spots highlighting this horrendous situation. Yet, many vets and caregivers are still not current on the situation. Without Pergolide to control the symptoms they can progress to laminitis and founder within two to three weeks. Time is running out for these equines as Pergolide production has been halted in the U.S.A. An online petition has over 4,500 signatures to date and this number grows every day. We are requesting all venues to provide public information on the desperate plight of these equines and beseech the FDA to address this issue IMMEDIATELY!
New Jersey Readers Get the Pergolide Message!
Hunterdon County Democrat story features Kellie and her TB eventing horse Kelton.
"Horse owners are hoping they can convince both the FDA and the manufacturers to keep the drug available to veterinarians, too. It was not known how many horses are being treated with pergolide, but it is possible that more horses use it than people."
Read the story and see Kellie and Kelton here:
http://www.print2webcorp.com/news/njcom/hunterdon/horsenews/20070501/p16.asp?st=p16_s1.htm
5 O'Clock News Spot on WJACTV - NBC Affiliate Station
"The drug Pergolide, although unsafe for humans treating Parkinson's, was used to treat horses with Cushing's Syndrome."
"A drug used to treat humans with Parkinson's Disease has been pulled off of the market by the U.S. Food and Drug Administration. Now, horse owners who use the drug Pergolide say that it will leave them unable to treat their horses suffering from Cushing's Syndrome."
See the story and news clip here:
http://www.wjactv.com/news/13288711/detail.html
"A drug used to treat humans with Parkinson's Disease has been pulled off of the market by the U.S. Food and Drug Administration. Now, horse owners who use the drug Pergolide say that it will leave them unable to treat their horses suffering from Cushing's Syndrome."
See the story and news clip here:
http://www.wjactv.com/news/13288711/detail.html
Tuesday, May 8, 2007
Canadian Media Contacts
The Canadian Press
You can submit story idea, photos or video (keep short)
info@cp.org
CBC Radio
Ontario Today
http://www.cbc.ca/local_includes/ottawa_contacts/ontariotoday.html
The Current
http://www.cbc.ca/thecurrent/contact.html
The World Report
http://www.cbc.ca/worldreport/contactus.html
The World this Hour http://www.cbc.ca/worldthishour/contactus.html
The World at Six
http://www.cbc.ca/w6/contact.html
As It Happens
http://www.cbc.ca/aih/contactus.html
CBC Radio Over Night
http://www.cbc.ca/overnight/contactus.html
CBC TV
CBC Newsworld
http://www.cbc.ca/includes/newsworld/contacts/cbcmorning_story_idea.html
The National
http://www.cbc.ca/national/yourturn/index.html
You can submit story idea, photos or video (keep short)
info@cp.org
CBC Radio
Ontario Today
http://www.cbc.ca/local_includes/ottawa_contacts/ontariotoday.html
The Current
http://www.cbc.ca/thecurrent/contact.html
The World Report
http://www.cbc.ca/worldreport/contactus.html
The World this Hour http://www.cbc.ca/worldthishour/contactus.html
The World at Six
http://www.cbc.ca/w6/contact.html
As It Happens
http://www.cbc.ca/aih/contactus.html
CBC Radio Over Night
http://www.cbc.ca/overnight/contactus.html
CBC TV
CBC Newsworld
http://www.cbc.ca/includes/newsworld/contacts/cbcmorning_story_idea.html
The National
http://www.cbc.ca/national/yourturn/index.html
Canadian Horse Publications
Horse Publications Group
Box 670
Aurora, ON.
L4G 4J9
Canada
Toll Free: 1-800-505-7428
Local Calls: 905-727-0107
Fax: 905-841-1530
Jennifer Anstey - Publisher
janstey@horse-canada.com
Amy Harris - Managing Editor of Horse Sport
editor@horse-canada.com
Lee Benson - Managing Editor of Horse-Canada & Canadian Thoroughbred
info@horse-canada.com
Susan Stafford - Managing Editor of Horsepower
fearless.editor@sympatico.ca
Equine Lifestyle Magazine
Laura Ireland
l.ireland@equine-lifestyle.com
Staff Writers and submissions
writers@equine-lifestyle.com
administration@equine-lifestyle.com
Canadian Mailing Address
Equine Lifestyle Magazine
P.O. Box 385
Lambeth Stn.,London, Ontario
Canada N6P 1R1
US Mailing Address
Equine Lifestyle Magazine
P.O. Box 201
Belford, New Jersey
U.S.A. 07718
Box 670
Aurora, ON.
L4G 4J9
Canada
Toll Free: 1-800-505-7428
Local Calls: 905-727-0107
Fax: 905-841-1530
Jennifer Anstey - Publisher
janstey@horse-canada.com
Amy Harris - Managing Editor of Horse Sport
editor@horse-canada.com
Lee Benson - Managing Editor of Horse-Canada & Canadian Thoroughbred
info@horse-canada.com
Susan Stafford - Managing Editor of Horsepower
fearless.editor@sympatico.ca
Equine Lifestyle Magazine
Laura Ireland
l.ireland@equine-lifestyle.com
Staff Writers and submissions
writers@equine-lifestyle.com
administration@equine-lifestyle.com
Canadian Mailing Address
Equine Lifestyle Magazine
P.O. Box 385
Lambeth Stn.,London, Ontario
Canada N6P 1R1
US Mailing Address
Equine Lifestyle Magazine
P.O. Box 201
Belford, New Jersey
U.S.A. 07718
Monday, May 7, 2007
Pergolide Supply Dwindling
Re: I wonder if anyone else is having this problem [veterinarians being told by pharmacies that there is adequate stock of pergolide]
Posted by Dr. Kellon on EC List May 7, 2007 Msg #91278
The big compounders were saying "no problem" initially too - until
they tried to place an order for bulk drug.
- pills are gone
- legitimate drug wholesalers (who supply compounding pharmacies)
have no drug
- Customs is *allegedly* (haven't confirmed this) stopping drug at
the border
There are US manufacturers who make bulk pergolide that *might* (this
isn't confirmed either) be able to supply compounders under a
veterinary use only order, but the rock bottom lowest price I've
found from the US companies is over $1 per mg, so the compounded
product would be at least $2/mg, probably more.
A compounder still selling the drug without a price mark up and
saying "no problem" is either selling VERY old stock, or is getting
it black market. Tell any vets claiming this isn't an issue to ask
the compounder where their drug is coming from and when did they last
check with their supplier about availability.
Make no mistake about this. There definitely is a crisis.
Eleanor
Posted by Dr. Kellon on EC List May 7, 2007 Msg #91278
The big compounders were saying "no problem" initially too - until
they tried to place an order for bulk drug.
- pills are gone
- legitimate drug wholesalers (who supply compounding pharmacies)
have no drug
- Customs is *allegedly* (haven't confirmed this) stopping drug at
the border
There are US manufacturers who make bulk pergolide that *might* (this
isn't confirmed either) be able to supply compounders under a
veterinary use only order, but the rock bottom lowest price I've
found from the US companies is over $1 per mg, so the compounded
product would be at least $2/mg, probably more.
A compounder still selling the drug without a price mark up and
saying "no problem" is either selling VERY old stock, or is getting
it black market. Tell any vets claiming this isn't an issue to ask
the compounder where their drug is coming from and when did they last
check with their supplier about availability.
Make no mistake about this. There definitely is a crisis.
Eleanor
Congressional Horse Caucus
The Congressional Horse Caucus is a bipartisan group of Representatives who have an interest in the equine industry and want to support the issues important to it.
The Caucus Co-chairs for the 110th Congress (convened January 4, 2007) are Congressmen Cliff Stearns (R-FL) and Ben Chandler (D-KY).
Caucus Members
Stearns, Cliff (R-FL)
Chandler, Ben (D-KY)
Blackburn, Marsha (R-TN)
Boucher, Rick (D-VA)
Burgess, Mike (R-TX)
Capito, Shelly Moore (R-WV)
Cardoza, Dennis (D-CA)
Carter, John (R-TX)
Cole, Tom (R-OK)
Costello, Jerry (D-IL)
Crowley, Joseph (D-NY)
Davis, Geoff (R-KY)
Davis, Jo Ann (R-VA)
Davis, Lincoln (D-TN)
Duncan, John (R-TN)
Feeney, Tom (R-FL)
Gillmor, Paul (R-OH)
Gordon, Bart (D-TN)
Hefley, Joel (R-CO)
Herger, Wally (R-CA)
Hinojosa, Ruben (D-TX)
Issa, Darrell (R-CA)
Jenkins, William (R-TN)
Jones, Walter (R-NC)
Keller, Ric (R-FL)
Kirk, Mark (R-IL)
Kline, John (R-MN)
LaHood, Ray (R-IL)
Lewis, Ron (R-KY)
McCotter, Thaddeus (R-MI)
McCarthy, Carolyn (D-NY)
McCrery, Jim (R-LA)
McKeon, Buck (R-CA)
Meek, Kendrick (D-FL)
Millender-McDonald, J. (D-CA)
Mollohan, Alan (D-WV)
Osborne, Tom (R-NE)
Pallone, Frank (D-NJ)
Pascrell, Bill (D-NJ)
Payne, Donald (D-NJ)
Peterson, Colin (D-MN)
Putnam, Adam (R-FL)
Radanovich, George (R-CA)
Rahall, Nick (D-WV)
Rodgers, Hal (R-KY)
Ros-Lehithen, Ileana (R-FL)
Ross, Mike (D-AR)
Ruppersberger, C.A. (D-MD)
Smith, Adam (D-WA)
Spratt, John (D-SC)
Thornberry, Mac (R-TX)
Tiberi, Pat (R-OH)
Wamp, Zack (R-TN)
Weller, Jerry (R-IL)
Whitfield, Ed (R-KY)
Wilson, Joe (R-SC)
The Caucus Co-chairs for the 110th Congress (convened January 4, 2007) are Congressmen Cliff Stearns (R-FL) and Ben Chandler (D-KY).
Caucus Members
Stearns, Cliff (R-FL)
Chandler, Ben (D-KY)
Blackburn, Marsha (R-TN)
Boucher, Rick (D-VA)
Burgess, Mike (R-TX)
Capito, Shelly Moore (R-WV)
Cardoza, Dennis (D-CA)
Carter, John (R-TX)
Cole, Tom (R-OK)
Costello, Jerry (D-IL)
Crowley, Joseph (D-NY)
Davis, Geoff (R-KY)
Davis, Jo Ann (R-VA)
Davis, Lincoln (D-TN)
Duncan, John (R-TN)
Feeney, Tom (R-FL)
Gillmor, Paul (R-OH)
Gordon, Bart (D-TN)
Hefley, Joel (R-CO)
Herger, Wally (R-CA)
Hinojosa, Ruben (D-TX)
Issa, Darrell (R-CA)
Jenkins, William (R-TN)
Jones, Walter (R-NC)
Keller, Ric (R-FL)
Kirk, Mark (R-IL)
Kline, John (R-MN)
LaHood, Ray (R-IL)
Lewis, Ron (R-KY)
McCotter, Thaddeus (R-MI)
McCarthy, Carolyn (D-NY)
McCrery, Jim (R-LA)
McKeon, Buck (R-CA)
Meek, Kendrick (D-FL)
Millender-McDonald, J. (D-CA)
Mollohan, Alan (D-WV)
Osborne, Tom (R-NE)
Pallone, Frank (D-NJ)
Pascrell, Bill (D-NJ)
Payne, Donald (D-NJ)
Peterson, Colin (D-MN)
Putnam, Adam (R-FL)
Radanovich, George (R-CA)
Rahall, Nick (D-WV)
Rodgers, Hal (R-KY)
Ros-Lehithen, Ileana (R-FL)
Ross, Mike (D-AR)
Ruppersberger, C.A. (D-MD)
Smith, Adam (D-WA)
Spratt, John (D-SC)
Thornberry, Mac (R-TX)
Tiberi, Pat (R-OH)
Wamp, Zack (R-TN)
Weller, Jerry (R-IL)
Whitfield, Ed (R-KY)
Wilson, Joe (R-SC)
Sunday, May 6, 2007
Horse Owner's Response to Generic FDA Reply
I am glad to hear that the FDA is apparently working on a solution to the
pergolide crisis.
However, if you will forgive me, I am having a hard time believing that your
agency really understands the urgency of the pergolide situation. Because, in my opinion, if you really got it, the FDA would have solved the problem by now.
Please understand that every day the FDA drags its feet and does not resolve
this crisis is a precious day that is wasted, where our horses are closer to not having the life saving drug that they need. Horses that die due to a pergolide shortage will have died needless and premature deaths. We should not have to lose a single horse before the FDA acts.
There are no more pergolide pills available in the pharmacies, the only "legal"
source of the drug, according to your agency. Supplies of the bulk drug for compounding are quickly dwindling. We do not have the luxury of time waiting for the FDA to get around to a solution. PLEASE RESOLVE THIS NOW.
"The lives of our horses are in your hands and, if you were in our place, you
would realize that waiting is not an option.
Sincerely,
[Horse Owner and Horse]
pergolide crisis.
However, if you will forgive me, I am having a hard time believing that your
agency really understands the urgency of the pergolide situation. Because, in my opinion, if you really got it, the FDA would have solved the problem by now.
Please understand that every day the FDA drags its feet and does not resolve
this crisis is a precious day that is wasted, where our horses are closer to not having the life saving drug that they need. Horses that die due to a pergolide shortage will have died needless and premature deaths. We should not have to lose a single horse before the FDA acts.
There are no more pergolide pills available in the pharmacies, the only "legal"
source of the drug, according to your agency. Supplies of the bulk drug for compounding are quickly dwindling. We do not have the luxury of time waiting for the FDA to get around to a solution. PLEASE RESOLVE THIS NOW.
"The lives of our horses are in your hands and, if you were in our place, you
would realize that waiting is not an option.
Sincerely,
[Horse Owner and Horse]
Generic CVM Response to Letters
This is representative of the fairly generic responses to their letters being received by horse owners from CVM Ombudsman Marcia Larkins, V.M.D.
"Review and consideration" can take a long time.
"Your email messages to Dr. Sundlof and to the CDER Ombudsman were forwarded to me. Thank you for sharing your story about your horse. The Center for Veterinary Medicine (CVM) is sensitive to your concerns about [horse's name] health and well being. As stated in my previous response to you CVM is very aware of the impact of the withdrawal of the human pergolide product. The future availability of the product to veterinarians for use in the treatment of Equine Cushing's Disease is currently under review and consideration by CVM. The Center understands the importance and sense of urgency among horse owners about this product and is actively working on finding a resolution as soon as possible."
"Review and consideration" can take a long time.
"Your email messages to Dr. Sundlof and to the CDER Ombudsman were forwarded to me. Thank you for sharing your story about your horse. The Center for Veterinary Medicine (CVM) is sensitive to your concerns about [horse's name] health and well being. As stated in my previous response to you CVM is very aware of the impact of the withdrawal of the human pergolide product. The future availability of the product to veterinarians for use in the treatment of Equine Cushing's Disease is currently under review and consideration by CVM. The Center understands the importance and sense of urgency among horse owners about this product and is actively working on finding a resolution as soon as possible."
Friday, May 4, 2007
Sherri's Letter (with pictures of Aletheia)
Dear Governor Bredesen,
While I realize my concern may not be top of your list of priorities, IT IS THE TOP OF MY LIST and tens of thousands of other horse owners. I am including a few photos of my mare to try to put this all in perspective for you.
This is my mare and her last foal..... before Cushings and the resultant Founder.
I am writing you about the recent recall of the drug Pergolide from the market. This move by the FDA has created an urgent and disastrous situation for not only my horse but thousands of horses with Equine Cushing's disease (PPID).
Hopefully, you and others are aware or being made aware that Pergolide is the only viable treatment for these horses and that it is a very common and debilitating disease.
A study by Dr. Frank Andrews DVM, MS, ACVIM, at the University of Tennessee, found that 56% of horses 13 years of age and over are affected by this disease. (See The Horse, March 2006.). Needless to say, not all of these horses are being properly diagnosed, but many are.
The Michigan Cushing's Project, a landmark study by Dr. Harold Schott at MSU established Pergolide saves lives of these horses.
My foundation mare, Aletheia – the love of my life, suffers from Equine Cushings disease and foundered severely (20+ degrees of rotation several years ago). I have spent tens of thousands of dollars on Vets and Farriers, Sterile Maggots for her feet, consultations with experts, diet balancing and Pergolide to make my mare stable and reasonably sound with a good quality of life.
This is Aletheia the first month she was on Pergolide, a special diet,
and a special area constructed to allow her to be with the herd, yet safe.
Had I not found a group on the internet four years ago (with upwards of 5,000 members) that understands and is on the cutting edge of this disease, my mare would not be alive today. She is on a special diet – I drive 6.5 hours every 90 days to get her Plain Beet Pulp. I have constructed a special paddock for her to have close contact with her friends (my other horses) while keeping her safe with 24 hour access to her oversized stall and outdoor paddock. In addition to her special diet and living arrangements she is provide 1.5 milligrams of PERGOLIDE (compounded) per day (2 mg during the fall seasonal rise). WITHOUT THE PERGOLIDE SHE WILL DECLINE RAPIDLY FORCING ME TO EUTHANIZE HER DUE TO THE INCREASE IN FOOT PAIN, MUSCLE WASTING, LETHARGY, DEPRESSION, FATIGUE AND IMPAIRED IMMUNITY.
Aletheia after 6 months on Pergolide, diet and yet another special area
constructed for her health, safety and pleasure !
I was first told by my supplier of Pergolide that access to the drug would not be an issue for at least the foreseeable future. I am now being told that there will be none available within the next 30 – 60 days! I would stockpile it if that were possible, however the drug has a shelf-life of somewhere less than 6 months. UNLESS SOMETHING IS DONE QUICKLY……… THOUSANDS OF HORSES – INCLUDING MINE WILL SUFFER OR DIE NEEDLESSLY AND PREMATURELY…..
I urge the FDA to immediately institute the provision for regulatory discretion as detailed in CVM Program Policy and Guidelines Manual, Guide 1240-4170, by publishing an exemption from the prohibition on compounding from bulk drug with specific reference to horses with Cushing's disease, as at least an interim solution. The FDA had been supplied with documentation of the impending shortage, documentation of need, and absence of alternatives for horses. To allow even one horse to suffer needlessly is an outrage.
PLEASE, make this simple solution a priority for the tens of thousands of horses in need a reality before it is too late…….
Sincerely,
Sherri Soper
Moscow, Tennessee
While I realize my concern may not be top of your list of priorities, IT IS THE TOP OF MY LIST and tens of thousands of other horse owners. I am including a few photos of my mare to try to put this all in perspective for you.
This is my mare and her last foal..... before Cushings and the resultant Founder.
I am writing you about the recent recall of the drug Pergolide from the market. This move by the FDA has created an urgent and disastrous situation for not only my horse but thousands of horses with Equine Cushing's disease (PPID).
Hopefully, you and others are aware or being made aware that Pergolide is the only viable treatment for these horses and that it is a very common and debilitating disease.
A study by Dr. Frank Andrews DVM, MS, ACVIM, at the University of Tennessee, found that 56% of horses 13 years of age and over are affected by this disease. (See The Horse, March 2006.). Needless to say, not all of these horses are being properly diagnosed, but many are.
The Michigan Cushing's Project, a landmark study by Dr. Harold Schott at MSU established Pergolide saves lives of these horses.
My foundation mare, Aletheia – the love of my life, suffers from Equine Cushings disease and foundered severely (20+ degrees of rotation several years ago). I have spent tens of thousands of dollars on Vets and Farriers, Sterile Maggots for her feet, consultations with experts, diet balancing and Pergolide to make my mare stable and reasonably sound with a good quality of life.
This is Aletheia the first month she was on Pergolide, a special diet,
and a special area constructed to allow her to be with the herd, yet safe.
Had I not found a group on the internet four years ago (with upwards of 5,000 members) that understands and is on the cutting edge of this disease, my mare would not be alive today. She is on a special diet – I drive 6.5 hours every 90 days to get her Plain Beet Pulp. I have constructed a special paddock for her to have close contact with her friends (my other horses) while keeping her safe with 24 hour access to her oversized stall and outdoor paddock. In addition to her special diet and living arrangements she is provide 1.5 milligrams of PERGOLIDE (compounded) per day (2 mg during the fall seasonal rise). WITHOUT THE PERGOLIDE SHE WILL DECLINE RAPIDLY FORCING ME TO EUTHANIZE HER DUE TO THE INCREASE IN FOOT PAIN, MUSCLE WASTING, LETHARGY, DEPRESSION, FATIGUE AND IMPAIRED IMMUNITY.
Aletheia after 6 months on Pergolide, diet and yet another special area
constructed for her health, safety and pleasure !
I was first told by my supplier of Pergolide that access to the drug would not be an issue for at least the foreseeable future. I am now being told that there will be none available within the next 30 – 60 days! I would stockpile it if that were possible, however the drug has a shelf-life of somewhere less than 6 months. UNLESS SOMETHING IS DONE QUICKLY……… THOUSANDS OF HORSES – INCLUDING MINE WILL SUFFER OR DIE NEEDLESSLY AND PREMATURELY…..
I urge the FDA to immediately institute the provision for regulatory discretion as detailed in CVM Program Policy and Guidelines Manual, Guide 1240-4170, by publishing an exemption from the prohibition on compounding from bulk drug with specific reference to horses with Cushing's disease, as at least an interim solution. The FDA had been supplied with documentation of the impending shortage, documentation of need, and absence of alternatives for horses. To allow even one horse to suffer needlessly is an outrage.
PLEASE, make this simple solution a priority for the tens of thousands of horses in need a reality before it is too late…….
Sincerely,
Sherri Soper
Moscow, Tennessee
New Horse.com Article on Pergolide Crisis!
Updated information and interview with Eleanor Kellon, VMD
Pergolide Availability: No FDA Announcement, Supplies Running Low
by: Erin Ryder, News Editor
May 04 2007 Article # 9526
"More than a month since pergolide mesylate, a drug commonly used to treat pituitary pars intermedia dysfunction (PPID), also known as equine Cushing's disease, was withdrawn for human use, the FDA has yet to make an announcement on whether it will allow bulk shipments of the drug to be imported for veterinary use."
(read the complete article)
Pergolide Availability: No FDA Announcement, Supplies Running Low
by: Erin Ryder, News Editor
May 04 2007 Article # 9526
"More than a month since pergolide mesylate, a drug commonly used to treat pituitary pars intermedia dysfunction (PPID), also known as equine Cushing's disease, was withdrawn for human use, the FDA has yet to make an announcement on whether it will allow bulk shipments of the drug to be imported for veterinary use."
(read the complete article)
Import Requests - Don't Delay Filing
Posted to EC List May 3, 2007 Msg #91059
I just want to emphasize as strongly as I can how important it is for
each and every owner of a Cushing's horse on pergolide to file one of
these applications to import drug.
**Note that the last line on the instructions says to allow 3 to 4
weeks for processing**
"Processing" isn't the same thing as actually getting permission either.
You have to get this information into the FDA well in advance of your
supply disappearing. Don't count on this getting resolved in time.
Don't rely on what your supplier is telling you. Don't wait because
you're not sure if you can afford imported drug. Definitely don't wait
until you run out. If they come up with a solution before you have to
use this option, great. If they don't, or if there is one in the works
but not up and runnning in time, your horse will be caught high and dry.
Print the file and get it to your vet NOW. Also let your vet know that
they will have to file one for each and every individual horse being
treated with pergolide.
Would also strongly suggest that it be sent with delivery confirmation
or signature required.
This is your safety net. Use it.
Eleanor
I just want to emphasize as strongly as I can how important it is for
each and every owner of a Cushing's horse on pergolide to file one of
these applications to import drug.
**Note that the last line on the instructions says to allow 3 to 4
weeks for processing**
"Processing" isn't the same thing as actually getting permission either.
You have to get this information into the FDA well in advance of your
supply disappearing. Don't count on this getting resolved in time.
Don't rely on what your supplier is telling you. Don't wait because
you're not sure if you can afford imported drug. Definitely don't wait
until you run out. If they come up with a solution before you have to
use this option, great. If they don't, or if there is one in the works
but not up and runnning in time, your horse will be caught high and dry.
Print the file and get it to your vet NOW. Also let your vet know that
they will have to file one for each and every individual horse being
treated with pergolide.
Would also strongly suggest that it be sent with delivery confirmation
or signature required.
This is your safety net. Use it.
Eleanor
Thursday, May 3, 2007
Medically Necessary Veterinary Imports Request II
Posted to EC List by Dr. Kellon May 3, 2007 Msg #91069
Answers for the "13 Questions" in the request letter.
Answers in [brackets]. You can cut/paste this into a word file so most of the information does not need to be retyped for printing on letterhead.
To:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary Division of Compliance, HFV-235
7519 Standish Place
Rockville, MD 20855
Fax: (240)276-9241
Re: Medically Necessary Personal Veterinary Imports
Please determine the following in the initial contact:
How did the veterinarian learn of this product?
[Pergolide has been the drug of choice for Cushing's in equines at least 10 years.]
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
[1-5 are obvious]
5. Name of drug
[Pergolide]
6. Drug family or class
[Dopamine agonist]
7. Name and address of drug supplier
[You will have to have picked out a pharmacy in another country
before this question can be answered and the application submitted.
Fairly easy to do on line. You don't have to actually place an order
or open an account, etc. They just need to know where it will be
coming from. Be prepared to be shocked at these prices.
See list below for suppliers.]
8. Legal status of the drug in the foreign country
[Legal]
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
[Need to specify the strength of the pills you are importing and
how many pills each time - e.g. a 100 count bottle of 0.5 mg generic
pergolide pills.]
10. Disease condition to be treated
[PPID/Cushings]
11. Reason why an approved human or animal drug will not treat the
disease condition
[There are no approved human or animal drugs other than pergolide
which are known to adequately treat the condition.]
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
[Veterinarian needs to answer "yes" to all three questions.]
13. Please include your email address.
[Veterinarian's email address]
Example Suppliers for Question 7:
http://www.rxcarecanada.com/Permax.asp?prodid=1348
http://www.smartmed.ca/canada_drugs/buy_pergolide_canada.asp
http://www.1drugstore-online.com/showprice.asp?name=pergolide&bysearch=ok
http://goldpharma.com/?show=search&search_srt=Parkotil&affiliate=1629522380&ref=search
Answers for the "13 Questions" in the request letter.
Answers in [brackets]. You can cut/paste this into a word file so most of the information does not need to be retyped for printing on letterhead.
To:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary Division of Compliance, HFV-235
7519 Standish Place
Rockville, MD 20855
Fax: (240)276-9241
Re: Medically Necessary Personal Veterinary Imports
Please determine the following in the initial contact:
How did the veterinarian learn of this product?
[Pergolide has been the drug of choice for Cushing's in equines at least 10 years.]
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
[1-5 are obvious]
5. Name of drug
[Pergolide]
6. Drug family or class
[Dopamine agonist]
7. Name and address of drug supplier
[You will have to have picked out a pharmacy in another country
before this question can be answered and the application submitted.
Fairly easy to do on line. You don't have to actually place an order
or open an account, etc. They just need to know where it will be
coming from. Be prepared to be shocked at these prices.
See list below for suppliers.]
8. Legal status of the drug in the foreign country
[Legal]
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
[Need to specify the strength of the pills you are importing and
how many pills each time - e.g. a 100 count bottle of 0.5 mg generic
pergolide pills.]
10. Disease condition to be treated
[PPID/Cushings]
11. Reason why an approved human or animal drug will not treat the
disease condition
[There are no approved human or animal drugs other than pergolide
which are known to adequately treat the condition.]
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
[Veterinarian needs to answer "yes" to all three questions.]
13. Please include your email address.
[Veterinarian's email address]
Example Suppliers for Question 7:
http://www.rxcarecanada.com/Permax.asp?prodid=1348
http://www.smartmed.ca/canada_drugs/buy_pergolide_canada.asp
http://www.1drugstore-online.com/showprice.asp?name=pergolide&bysearch=ok
http://goldpharma.com/?show=search&search_srt=Parkotil&affiliate=1629522380&ref=search
Medically Necessary Veterinary Imports Request
Summary of Fax Cover Sheet:
From: Michael Zimmerman; (michael.zimmerman@fda.hhs.gov)
Re: Request Import Drug
Notes: Attached is a copy of the 13 questions that must be answered to consider your request to import medication for your patient(s). Please answer each question as thoroughly as possible and fax your completed request back to our office. Please call if you have any questions. Thank you.
Address and Question Sheet:
Please submit letter to:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary
Division of Compliance, HFV-235
7519 Standish Place
Rockville, Maryland 20855
Or fax to 240-276-9241
Questions: (240)276-9202
Please determine the following in the initial contact:
How did the veterinarian learn of this product? If there is
any indication the product has been actively promoted in
U.S. markets it will be refused entry and an import alert will
be issued.
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
5. Name of drug
6. Drug family or class
7. Name and address of drug supplier
8. Legal status of the drug in the foreign country
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
10. Disease condition to be treated
11. Reason why an approved human or animal drug will not treat the
disease condition
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
13. Please inlude your email address.
ALL REQUESTS MUST BE SIGNED BY THE VETERINARIAN AND BE ON LETTERHEAD
Please allow 3-4 weeks for processing.
Revised February 1, 2007
[Go to version formatted as letter]
From: Michael Zimmerman; (michael.zimmerman@fda.hhs.gov)
Re: Request Import Drug
Notes: Attached is a copy of the 13 questions that must be answered to consider your request to import medication for your patient(s). Please answer each question as thoroughly as possible and fax your completed request back to our office. Please call if you have any questions. Thank you.
Address and Question Sheet:
Please submit letter to:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary
Division of Compliance, HFV-235
7519 Standish Place
Rockville, Maryland 20855
Or fax to 240-276-9241
Questions: (240)276-9202
Please determine the following in the initial contact:
How did the veterinarian learn of this product? If there is
any indication the product has been actively promoted in
U.S. markets it will be refused entry and an import alert will
be issued.
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
5. Name of drug
6. Drug family or class
7. Name and address of drug supplier
8. Legal status of the drug in the foreign country
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
10. Disease condition to be treated
11. Reason why an approved human or animal drug will not treat the
disease condition
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
13. Please inlude your email address.
ALL REQUESTS MUST BE SIGNED BY THE VETERINARIAN AND BE ON LETTERHEAD
Please allow 3-4 weeks for processing.
Revised February 1, 2007
[Go to version formatted as letter]
FDA and CVM Q/A
Q - What is MNVD (or MNVP)?
A - MNVD stands for Medically Necessary Veterinary Drug
CVM Policy Guide 1240-4170 outlines the policy for MNVD Product Shortage Management.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
"Medically Necessary Veterinary Product (MNVP): A product is considered to be an MNVP if it is used to treat or prevent a serious disease or condition, or needed to assurethe availability of safe food products of animal origin and there is no other available source of that product of alternative drug that is judged by CVM's veterinary staff to be an adequate substitute. Inconvenience and non-therapeutic uses are insufficient basis to classify a product as an MNVP."
"It is Agency policy to attempt to prevent or alleviate shortages of MNVPs. An MNVP shortage may involve an actual or potential shortage of a drug product."
The document goes on to outline Responsibilities and Procedures.
Q - What is the MNVD form?
A - There is currently a shortage of the legal generic pergolide tablets in the United States. There is a rapidly dimishing supply of bulk pergolide available for compounding, which is actually not legal under current policies. In order to ensure that an equine patient's medication (pergolide) continues uninterrupted, it may be necessary to import generic pergolide tablets from non-US sources.
This is not actually a "form" but
a) a fax cover sheet referring to "Request to Import Drug" and
b) a second sheet, "Medically Necessary Personal Veterinary Imports", listing the 13 questions that must be answered by the attending veterinarian on letterhead with the veterinarian's signature. A separate request must be made for each equine.
In separate articles you will find:
- The list of questions
- "Standard" answers to the 13 questions
- A list of non-US suppliers of generic pergolide tablets (for question #7)
These are also available in PDF either at the Equine Cushings List files
http://pets.groups.yahoo.com/group/EquineCushings/files
or by requesting copies by entering a comment at the end of this article.
A - MNVD stands for Medically Necessary Veterinary Drug
CVM Policy Guide 1240-4170 outlines the policy for MNVD Product Shortage Management.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
"Medically Necessary Veterinary Product (MNVP): A product is considered to be an MNVP if it is used to treat or prevent a serious disease or condition, or needed to assurethe availability of safe food products of animal origin and there is no other available source of that product of alternative drug that is judged by CVM's veterinary staff to be an adequate substitute. Inconvenience and non-therapeutic uses are insufficient basis to classify a product as an MNVP."
"It is Agency policy to attempt to prevent or alleviate shortages of MNVPs. An MNVP shortage may involve an actual or potential shortage of a drug product."
The document goes on to outline Responsibilities and Procedures.
Q - What is the MNVD form?
A - There is currently a shortage of the legal generic pergolide tablets in the United States. There is a rapidly dimishing supply of bulk pergolide available for compounding, which is actually not legal under current policies. In order to ensure that an equine patient's medication (pergolide) continues uninterrupted, it may be necessary to import generic pergolide tablets from non-US sources.
This is not actually a "form" but
a) a fax cover sheet referring to "Request to Import Drug" and
b) a second sheet, "Medically Necessary Personal Veterinary Imports", listing the 13 questions that must be answered by the attending veterinarian on letterhead with the veterinarian's signature. A separate request must be made for each equine.
In separate articles you will find:
- The list of questions
- "Standard" answers to the 13 questions
- A list of non-US suppliers of generic pergolide tablets (for question #7)
These are also available in PDF either at the Equine Cushings List files
http://pets.groups.yahoo.com/group/EquineCushings/files
or by requesting copies by entering a comment at the end of this article.
PERGOLIDE CRISIS - STATUS
Posted to EC List May 2, 2007 Msg #91035
A member ... got a copy of the instructions for filing a
medically necessary veterinary drug application today. I just put it
in the files and a notice should have gone out to everyone.
[Note - if you are not an EC List member and would like to request a copy
of this please enter a comment at the end of this article.]
This is the "safety net" pathway we've been talking about that lets
individuals get permission to import the drug until (if) the FDA
finds a solution to the shortage. Gotta tell you the fact they've
made a policy reversal on accepting these could be a bad sign. It
might mean they're hopelessly deadlocked on what to do about our
problem.
The application process isn't terribly long or complicated and I'll
post the answer to all the questions on there so your vets can
complete it in no time flat. Even if you still have some left, or
think you could get some (illegal) compounded drug, **ASK YOUR VET TO
FILE THE APPLICATION NOW**. Lord only knows what the "normal"
turnaround time is, and if it comes to hundreds or thousands of these
applications - well, you can imagine...
There was a "grapevine" rumor that today was to be the day for the
FDA announcement. In view of that, I waited to call the FDA again.
Not too surprisingly, no announcement. We have updates on adding
hydrogen peroxide added to fish water, but nothing on our horses.
They haven't even officially issued a press statement to the effect
that they are working on the problem.
Will let you know what, if anything, I can find out from the FDA
tomorrow.
Otherwise, we must step up the pressure. Keep going with the media
contacts, organizations, etc. but bear in mind no one, including the
government, can make them do anything. Public pressure and bad press
can. Don't waste too much time on special interest groups except to
send an alert and request for signatures on the petition. Don't do
anything that takes your time and energy away from directly
contacting the FDA by phone, fax, snail mail, e-mail. The news media
campaign is worthwhile, but they'll be slow to act. They have to
research it first. First reaction is likely to be to toss it into the
trash can so volume of requests will be important to even start that
process. Don't let a day go by without contacting the FDA and PLEASE
we need more regional pergolide pill in pharmacies information. It
doesn't matter if your horse actually has Cushing's or not. It
doesn't matter if you have a stash of compounded pergolide or your
compounder says they do. The FDA is supposed to be concerned with
**legally available** drug. Document that you have no legally
available source.
They're stalling on this, trying to get a feel for how
genuinely "urgent" the situation is, hoping for some company to step
up to the plate to resume manufacturing so they can avoid having to
issue an importation or compounding exemption, but in the process
they're putting our horses in a very real danger of having a gap in
their treatment at the highest risk time of the year.
Priorities right now are:
- Document there is no legal available source in your area
- Encourage your vets to submit the medically necessary veterinary
drug information for your horse
- Continue to pressure, DAILY, the FDA and news media
Eleanor
A member ... got a copy of the instructions for filing a
medically necessary veterinary drug application today. I just put it
in the files and a notice should have gone out to everyone.
[Note - if you are not an EC List member and would like to request a copy
of this please enter a comment at the end of this article.]
This is the "safety net" pathway we've been talking about that lets
individuals get permission to import the drug until (if) the FDA
finds a solution to the shortage. Gotta tell you the fact they've
made a policy reversal on accepting these could be a bad sign. It
might mean they're hopelessly deadlocked on what to do about our
problem.
The application process isn't terribly long or complicated and I'll
post the answer to all the questions on there so your vets can
complete it in no time flat. Even if you still have some left, or
think you could get some (illegal) compounded drug, **ASK YOUR VET TO
FILE THE APPLICATION NOW**. Lord only knows what the "normal"
turnaround time is, and if it comes to hundreds or thousands of these
applications - well, you can imagine...
There was a "grapevine" rumor that today was to be the day for the
FDA announcement. In view of that, I waited to call the FDA again.
Not too surprisingly, no announcement. We have updates on adding
hydrogen peroxide added to fish water, but nothing on our horses.
They haven't even officially issued a press statement to the effect
that they are working on the problem.
Will let you know what, if anything, I can find out from the FDA
tomorrow.
Otherwise, we must step up the pressure. Keep going with the media
contacts, organizations, etc. but bear in mind no one, including the
government, can make them do anything. Public pressure and bad press
can. Don't waste too much time on special interest groups except to
send an alert and request for signatures on the petition. Don't do
anything that takes your time and energy away from directly
contacting the FDA by phone, fax, snail mail, e-mail. The news media
campaign is worthwhile, but they'll be slow to act. They have to
research it first. First reaction is likely to be to toss it into the
trash can so volume of requests will be important to even start that
process. Don't let a day go by without contacting the FDA and PLEASE
we need more regional pergolide pill in pharmacies information. It
doesn't matter if your horse actually has Cushing's or not. It
doesn't matter if you have a stash of compounded pergolide or your
compounder says they do. The FDA is supposed to be concerned with
**legally available** drug. Document that you have no legally
available source.
They're stalling on this, trying to get a feel for how
genuinely "urgent" the situation is, hoping for some company to step
up to the plate to resume manufacturing so they can avoid having to
issue an importation or compounding exemption, but in the process
they're putting our horses in a very real danger of having a gap in
their treatment at the highest risk time of the year.
Priorities right now are:
- Document there is no legal available source in your area
- Encourage your vets to submit the medically necessary veterinary
drug information for your horse
- Continue to pressure, DAILY, the FDA and news media
Eleanor
Wednesday, May 2, 2007
Supply at Wholesalers
Posted to EC List May 1, 2007 Msg #90977
It has been a while since I posted so I have some catching up to do...
Availability of Pergolide Mesylate and Permax tablets in Denver, CO:
Cardinal, a multi-billion dollar pharmacy wholesaler has been stocked
out of Permax and Pergolide Mesylate tablets since May 3, 2007.
How to contact the media: There is an excellent website that makes it
easy to send messages and advisories to media outlets. You can enter
your zipcode and select up to 5 media outlets at a time to email.
Here's the web address:
http://capwiz.com/wa/dbq/media/
Availability of Pergolide for compounding: I have checked with all the
compounding wholesalers over the past week and none of them have
ordered any Pergolide nor do they plan to order any until the FDA
gives them the green light.
Ian Hudgings
Vet Pet Solutions
It has been a while since I posted so I have some catching up to do...
Availability of Pergolide Mesylate and Permax tablets in Denver, CO:
Cardinal, a multi-billion dollar pharmacy wholesaler has been stocked
out of Permax and Pergolide Mesylate tablets since May 3, 2007.
How to contact the media: There is an excellent website that makes it
easy to send messages and advisories to media outlets. You can enter
your zipcode and select up to 5 media outlets at a time to email.
Here's the web address:
http://capwiz.com/wa/dbq/media/
Availability of Pergolide for compounding: I have checked with all the
compounding wholesalers over the past week and none of them have
ordered any Pergolide nor do they plan to order any until the FDA
gives them the green light.
Ian Hudgings
Vet Pet Solutions
Network Contacts
Use the subject line FDA ACTION CAUSES HORSE HEALTH CRISIS when ever possible.
ABC News
http://abcnews.go.com/Site/page?id=3068843
to contact:
Good Morning America
World News Tonight
Nightline
Primetime
20/20
Weekend News
This Week
NBC - NBC Nightly News
nightly@nbc.com
CBS News
Need to click on "contact us" at bottom of page - brings up form with drop down list of shows (including CBS Evening News w/Katie Couric).
http://www.cbsnews.com/
Fox News
Listing of all contact email addresses
http://www.foxnews.com/story/0,2933,77538,00.html
Geraldo at Large — Atlarge@foxnews.com
CNN
http://www.cnn.com/feedback/forms/form11b.html?2
ABC News
http://abcnews.go.com/Site/page?id=3068843
to contact:
Good Morning America
World News Tonight
Nightline
Primetime
20/20
Weekend News
This Week
NBC - NBC Nightly News
nightly@nbc.com
CBS News
Need to click on "contact us" at bottom of page - brings up form with drop down list of shows (including CBS Evening News w/Katie Couric).
http://www.cbsnews.com/
Fox News
Listing of all contact email addresses
http://www.foxnews.com/story/0,2933,77538,00.html
Geraldo at Large — Atlarge@foxnews.com
CNN
http://www.cnn.com/feedback/forms/form11b.html?2
Contacting NPR (National Public Radio)
Use subject line FDA ACTION CAUSES HORSE HEALTH CRISIS for media contacts
The crisis has several components - it's not just a "human interest" story
Animal health/welfare
Science
Political (David and Goliath big government - FDA vs horseowners, vets, etc, and interagency cooperation(or lack of)
NPR (National Public Radio)
http://www.npr.org/about/pitch/story.html
(This should reach Morning Edition, Weekend Edition, Science Friday)
NPR Affiliate Network shows
Diane Rehm (Diane Rehm Show)
http://www.wamu.org/contact/
Justice Talking
http://www.justicetalking.org/aboutus.asp
Weekend America
http://weekendamerica.publicradio.org/pitchastory/
The crisis has several components - it's not just a "human interest" story
Animal health/welfare
Science
Political (David and Goliath big government - FDA vs horseowners, vets, etc, and interagency cooperation(or lack of)
NPR (National Public Radio)
http://www.npr.org/about/pitch/story.html
(This should reach Morning Edition, Weekend Edition, Science Friday)
NPR Affiliate Network shows
Diane Rehm (Diane Rehm Show)
http://www.wamu.org/contact/
Justice Talking
http://www.justicetalking.org/aboutus.asp
Weekend America
http://weekendamerica.publicradio.org/pitchastory/
Tuesday, May 1, 2007
Using Same Subject Line for Emails
Posted to EC List May 1, 2007 Msg #90952
> > ABC News web site and go to "Prime Time", or "20:20", or "Contact
> Us" and leave
> > comments or emails--maybe to all places. > Can't hurt of they hear
> from a bunch of us!
Know what? You really have a point there.
I'm sure the volume is high so let's all use the same subject line so
that hopefully somebody notices. How about:
FDA ACTION CAUSES HORSE HEALTH CRISIS
Write whatever you want to write, but everybody use the same subject
line.
Eleanor
> > ABC News web site and go to "Prime Time", or "20:20", or "Contact
> Us" and leave
> > comments or emails--maybe to all places. > Can't hurt of they hear
> from a bunch of us!
Know what? You really have a point there.
I'm sure the volume is high so let's all use the same subject line so
that hopefully somebody notices. How about:
FDA ACTION CAUSES HORSE HEALTH CRISIS
Write whatever you want to write, but everybody use the same subject
line.
Eleanor
Monday, April 30, 2007
Pharmacy claiming to have no problem getting Pergolide?
Posted to EC List 4/30.2007 Msg # 90916
Re: Urgent! Pharmacy claiming to have no problem getting Pergolide!!!
> She refered to the withdrawn Pergolide as the "human" version, and
> compounded pergolide as the "animal version". She said that they
> get pergolide in a raw state from a chemical company, not a
> manufacturer. This company they get it from is in the US.
>
> They then compound it and are selling it to vets. She said the
> company they are getting it from is having no problem w/ obtaining
> it and therefore neither are they because it is the "animal" version.
She's wrong.
These little companies haven't tried to reorder any yet.
Facts:
- Unless they have some really shady black market source (not good),
the pharmacies order "raw" (bulk) from drug wholesalers. Drug
wholesalers order from foreign chemical manufacturers (there actually
are some in the US too - for $2 to $3 PER MG - so you know it's not
coming from there!).
- THERE IS NO DRUG AVAILABLE FROM THE LEGITIMATE WHOLESALERS. NADA, NONE, ZILCH - IT'S GONE.
- There is no such thing as the "animal version" of a bulk drug. Both
the compounded versions and the human pills were being made from the
same "raw"/bulk drug.
Even the big compounders that were initially saying they had large
supplies and didn't expect any problems with getting the bulk drug
are panicing now.
For your own (or rather, your horse's) safety, if you run into a
pharmacy that says "no problem", ask them who their supplier is. If
they won't tell you, run.
Eleanor
Re: Urgent! Pharmacy claiming to have no problem getting Pergolide!!!
> She refered to the withdrawn Pergolide as the "human" version, and
> compounded pergolide as the "animal version". She said that they
> get pergolide in a raw state from a chemical company, not a
> manufacturer. This company they get it from is in the US.
>
> They then compound it and are selling it to vets. She said the
> company they are getting it from is having no problem w/ obtaining
> it and therefore neither are they because it is the "animal" version.
She's wrong.
These little companies haven't tried to reorder any yet.
Facts:
- Unless they have some really shady black market source (not good),
the pharmacies order "raw" (bulk) from drug wholesalers. Drug
wholesalers order from foreign chemical manufacturers (there actually
are some in the US too - for $2 to $3 PER MG - so you know it's not
coming from there!).
- THERE IS NO DRUG AVAILABLE FROM THE LEGITIMATE WHOLESALERS. NADA, NONE, ZILCH - IT'S GONE.
- There is no such thing as the "animal version" of a bulk drug. Both
the compounded versions and the human pills were being made from the
same "raw"/bulk drug.
Even the big compounders that were initially saying they had large
supplies and didn't expect any problems with getting the bulk drug
are panicing now.
For your own (or rather, your horse's) safety, if you run into a
pharmacy that says "no problem", ask them who their supplier is. If
they won't tell you, run.
Eleanor
Great Personalized Letter
My letter to Senator McCain
I worked on McCain's first bid for US Senate - though I no longer live in AZ,
thought maybe this might help...
Kirsten
______________________
Dear Senator McCain,
Think way back to 1986 - I was that cute redhead at your headquarters in
Phoenix with whom you would flirt on occasion. (All in good fun, and even with
your wife present.) Anyway, I've been telling people for years that I hoped you
would be elected to the highest office so that I could say the President used to
flirt with me. (And of course that meant something before Clinton.)
At any rate, 20 years later and not nearly as cute (and now married to soon to
be retired Lt. Colonel Karl W******), I am writing to ask a favor...
I know you are very very busy, but...
We horse owners are facing a crisis. Pergolide, the only drug that manages
Equine Cushing's disease, has been pulled from the market. For people, there
are other alternatives, but for the horses there are none. A group of over
3,000 of us have signed a petition and sent it to the FDA without satisfactory
response to date. Thousands of horses' lives depend on this drug.
Below is the letter that has been sent along with the contact information; I
am hoping that you can do something to help usher a life-saving response soon.
Thank you,
And best of everything to you.
Kirsten (B***) W********
Contact at FDA:
David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov
"Time is running out for these horses. We urge the FDA to immediately
institute the provision for regulatory discretion as detailed in CVM
Program Policy and Guidelines Manual, Guide 1240.4170 by publishing
an exception from the prohibition on compounding from bulk drug with
specific reference to horses with Cushing's Disease as at least an
interim solution. We have fulfilled the requirements for
documentation of impending shortage, documentation of need and
absence of alternatives for horses. To allow even one horse to suffer
needlessly is an outrage. Human pharmacies with generic pills - those
that even have any - are price gouging. An owner informed me
yesterday her cost went up over 100%. These horses desperately need
an affordable solution."
I worked on McCain's first bid for US Senate - though I no longer live in AZ,
thought maybe this might help...
Kirsten
______________________
Dear Senator McCain,
Think way back to 1986 - I was that cute redhead at your headquarters in
Phoenix with whom you would flirt on occasion. (All in good fun, and even with
your wife present.) Anyway, I've been telling people for years that I hoped you
would be elected to the highest office so that I could say the President used to
flirt with me. (And of course that meant something before Clinton.)
At any rate, 20 years later and not nearly as cute (and now married to soon to
be retired Lt. Colonel Karl W******), I am writing to ask a favor...
I know you are very very busy, but...
We horse owners are facing a crisis. Pergolide, the only drug that manages
Equine Cushing's disease, has been pulled from the market. For people, there
are other alternatives, but for the horses there are none. A group of over
3,000 of us have signed a petition and sent it to the FDA without satisfactory
response to date. Thousands of horses' lives depend on this drug.
Below is the letter that has been sent along with the contact information; I
am hoping that you can do something to help usher a life-saving response soon.
Thank you,
And best of everything to you.
Kirsten (B***) W********
Contact at FDA:
David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov
"Time is running out for these horses. We urge the FDA to immediately
institute the provision for regulatory discretion as detailed in CVM
Program Policy and Guidelines Manual, Guide 1240.4170 by publishing
an exception from the prohibition on compounding from bulk drug with
specific reference to horses with Cushing's Disease as at least an
interim solution. We have fulfilled the requirements for
documentation of impending shortage, documentation of need and
absence of alternatives for horses. To allow even one horse to suffer
needlessly is an outrage. Human pharmacies with generic pills - those
that even have any - are price gouging. An owner informed me
yesterday her cost went up over 100%. These horses desperately need
an affordable solution."
Can I Bring Pergolide into the US from Another Country?
Posted on EC List 4/29/2007 Msg #90865
> Can a person physically go to another country and
> bring pergolide into the USA?
No, because to be eligible for importation (even if you go yourself
and get it, it's still importation) it has to be an approved drug
that is identical in every way, including product labelling and
language, to the US form of the drug and has to be manufactured
according to US standards. Because there is no longer an "approved"
form of pergolide, you can't bring it into the country without a
permit.
What's interesting though is that all the importation rules apply to
**HUMAN** use. Not a peep about drugs for veterinary use. When
omissions in legislation and guidance documents like this occur, the
FDA will typically make a statement either way depending on what they
favor, rather than any legal basis. For example, the DSHEA (Dietary
Supplements Health and Education Act) protected human access to
things like glucosamine, but because it didn't specifically mention
animals there was a push a few years back to ban these things for
animals. In the case of the drug importation laws, odds are they
would declare the opposite - that they really did mean to include
animal drugs in all the importation restrictions.
By not specifically including animals, any action they might take to
stop your husband bringing it in would be subject to legal
questioning in court - but who has the time or money for that! It
might be an interesting test of the system for him to try it though.
Take your vet's prescription with you, marked clearly "for equine
use", buy just a very small amount and see what happens at customs.
Eleanor
> Can a person physically go to another country and
> bring pergolide into the USA?
No, because to be eligible for importation (even if you go yourself
and get it, it's still importation) it has to be an approved drug
that is identical in every way, including product labelling and
language, to the US form of the drug and has to be manufactured
according to US standards. Because there is no longer an "approved"
form of pergolide, you can't bring it into the country without a
permit.
What's interesting though is that all the importation rules apply to
**HUMAN** use. Not a peep about drugs for veterinary use. When
omissions in legislation and guidance documents like this occur, the
FDA will typically make a statement either way depending on what they
favor, rather than any legal basis. For example, the DSHEA (Dietary
Supplements Health and Education Act) protected human access to
things like glucosamine, but because it didn't specifically mention
animals there was a push a few years back to ban these things for
animals. In the case of the drug importation laws, odds are they
would declare the opposite - that they really did mean to include
animal drugs in all the importation restrictions.
By not specifically including animals, any action they might take to
stop your husband bringing it in would be subject to legal
questioning in court - but who has the time or money for that! It
might be an interesting test of the system for him to try it though.
Take your vet's prescription with you, marked clearly "for equine
use", buy just a very small amount and see what happens at customs.
Eleanor
Who Still Has Supplies?
Posted to EC List 4/29/2007 Msg #90861
>Do you know if any of the sources are still selling the compounded
>mix? I cannot even stomach being without it.
Danielle,
Most of the compounders still have a few weeks or months worth left but
it's not going to last long. Do a Google search for the terms
veterinary, compounding and pergolide.
Eleanor
>Do you know if any of the sources are still selling the compounded
>mix? I cannot even stomach being without it.
Danielle,
Most of the compounders still have a few weeks or months worth left but
it's not going to last long. Do a Google search for the terms
veterinary, compounding and pergolide.
Eleanor
Pergolide Action!
Posted by Dr. Kellon to EC List 4/29/2007 Msg #90858
Since the FDA apparently isn't doing it's homework on how much pergolide is out there in any form, I'd like as many people as possible to call 5, 10 or more pharmacies in your local area, ask them if they have any pergolide pills and if they do, how many, what strength. Jot down the date, pharmacy name and how much, if any, they have. Send that information to the "big 5" below, with a cc to me. If you are uncomfortable doing that, please send it to me and I'll forward it identified only by your city/town. [You can enter your results in a comment at the end of this article and it will be forwarded to Dr. Kellon.]
The only legal source in the FDA's eyes is the pills. The sooner we can document they are gone, or about to be, the better.
David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov
Stephen F Sundlof, D.V.M., Ph.D.
Director of the Center for Veterinary Medicine
Food and Drug Administration
240-276-9000 phone
240-276-9001 fax
stephen.sundlof@fda.hhs.gov
Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 phone
240-276-9060 fax
marcia.larkins@fda.hhs.gov
Virginia Behr
FDA - Ombudsman
Phone 301-796-0675
Fax 301-796-9883
virginia.behr@fda.hhs.gov
Andrew von Eschenbach
FDA Commissioner
phone 301-827-2410
Fax 301-443-3100
andrew.voneschenbach@fda.hhs.gov
Since the FDA apparently isn't doing it's homework on how much pergolide is out there in any form, I'd like as many people as possible to call 5, 10 or more pharmacies in your local area, ask them if they have any pergolide pills and if they do, how many, what strength. Jot down the date, pharmacy name and how much, if any, they have. Send that information to the "big 5" below, with a cc to me. If you are uncomfortable doing that, please send it to me and I'll forward it identified only by your city/town. [You can enter your results in a comment at the end of this article and it will be forwarded to Dr. Kellon.]
The only legal source in the FDA's eyes is the pills. The sooner we can document they are gone, or about to be, the better.
David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov
Stephen F Sundlof, D.V.M., Ph.D.
Director of the Center for Veterinary Medicine
Food and Drug Administration
240-276-9000 phone
240-276-9001 fax
stephen.sundlof@fda.hhs.gov
Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 phone
240-276-9060 fax
marcia.larkins@fda.hhs.gov
Virginia Behr
FDA - Ombudsman
Phone 301-796-0675
Fax 301-796-9883
virginia.behr@fda.hhs.gov
Andrew von Eschenbach
FDA Commissioner
phone 301-827-2410
Fax 301-443-3100
andrew.voneschenbach@fda.hhs.gov
Update April 26, 2007
Posted to EC List 4/26/2007 Msg #90692
Such as it is, here goes.
The Veterinary side of the FDA (CVM - Center for Veterinary Medicine), did prepare a proposal for an interim solution. I spoke to the officer (that's what they call them at the FDA, "officer") in charge of that. He would not tell me what was in it but did tell me that he had sent it over to FDA "main" for approval. The approval was expected to have occurred by last Friday at the latest (that was the announcement we were expecting) but never appeared. On Tuesday, he said he was hoping to see it "soon".
Part of the problem is priority. They're a tad distracted by the contaminated pet food fiasco ... but even more important is that none of the immediate available options are very appealing to the FDA. Below is a list of the possible solutions that I just put together for a Horse Journal article:
1. The FDA could publish a specific exemption from the prohibition on compounding from bulk drugs with regard to pergolide and horses with Cushing's Disease. This would immediately free drug wholesalers to supply compounders. Drug should still only be produced upon receipt of a prescription from the treating veterinarian. This would be entirely legal and there are precedents for issuing exceptions. Certain chemicals used in treatments of poisonings have already been granted exceptions. We favor this as a short term solution.
2. The former USA manufacturers of pergolide pills in this country could be encouraged to resume production specifically for veterinary use.
3. The FDA could allow importation of pergolide pills produced in other countries.
4. A drug company could begin the drug approval process for pergolide as a treatment for equine PPID. This is time consuming and expensive, but preliminary communications with the FDA CVM staff in the division of MUMS – Minor Uses and Minor Species – indicates they may be able to help. This division was created to help fill the special needs of relatively uncommon species, or uncommon diseases. While the number of horses with Cushing's Disease is certainly not small, the market size can't compare to the need for things like dewormers and antibiotics. The program provides financial incentives and allows for sales of the drug before the entire approval process has been completed.
5. In the event the FDA does not offer even a short term solution
quick enough, and an owner/vet find themselves unable to source the
drug, the veterinarian can apply for a Medically Necessary Veterinary
Drug exception. Details for this application can be found at:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf/ Once approved, this would enable the veterinarian to import drug to treat his or her patient(s). Because of inherent delays in petitions being approved, and a likely large volume of petitions once the supply begins to dry
up, you shouldn't wait until the last minute to get started on this.
===================
In speaking with the FDA on Tuesday, it was abundantly clear that
granting an exception for bulk compounding was the last thing they
wanted to do. The current compounding furor, with abuses on both
human and veterinary ends, haven't helped us any. Still, this would
be the quickest solution. The FDA would prefer to see 2. happen, but
no interest from that sector so far. Number 3. is probably the
solution that CVM proposed (I'm guessing at that), but FDA main
wouldn't be wild about that idea either.
Number 4. is something I'm actively working on, identifying companies that are already making "specialty" drugs (smaller market than big sellers like dewormers or antibiotics), small companies, companies with experience producing drugs that are potent in small doses in a loose powder form.
Number 5. is your safety net. There's no way to tell how much
pergolide is still out there, or how long it will last. Pharmacies
that seem to have a good supply now could find it disappearing
quickly as other pharmacies run out. If this drags on too long, you
could also easily be looking at a problem with black market drug of
god knows what quality and coming from god knows where. If the
availability of drug through approved suppliers doesn't change,
sooner or later you're going to have be highly suspicious of anyone
who claims they have no problem getting the drug. The FDA is not
interested in having to process a huge volume of these applications,
but may try to stall on doing anything until they actually start to
get them.
==========================
Until they have a solution in front of them that they like, the FDA is going to drag its feet. We need to keep putting pressure on them. All of you who cross-post and generate new signatures on the petition are helping. Several members are also getting breed associations involved and/or getting articles in magazines. I've been interviewed by The Horse, Equus and got a request late yesterday from Horse Illustrated. There will be an article in the next issue of Horse Journal. Also trying to get a national news service to pick it up.
You can all also help by sending individual e-mails, faxes or phone
calls to these 3 people:
Food and Drug Administration
1-888-463-6332 – phone
cderombudsman@fda.hhs.gov
Dr. Stephen Sundlof
Director of the Center for Veterinary Medicine
240-276-9000 – phone
240-276-9001 - fax
stephen.sundlof@fda.hhs.gov
Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 – phone
240-276-9060 – fx
marcia.larkins@fda.hhs.gov
Phone, fax, e-mail or all three as often as you like.
[4/20/07 - additional contact added]
David J. Horowitz
Deputy Director, Office of Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov
By the way, in response to the reply from the FDA that some of you
got, basically saying it's not their problem and it's up to the
manufacturers to supply the drug, that's not true. No manufacturer is
obligated to make any drug. Few firms would be interested in
this "small" a market, compared to something that the entire equine
population uses on a regular basis.
The FDA does acknowledge that it has the responsibility to prevent or alleviate both real and potential shortages of essential drugs. Read:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
This *is* their problem, but it's up to us to see that they deal with
it before even one horse runs out of pergolide.
Eleanor
Such as it is, here goes.
The Veterinary side of the FDA (CVM - Center for Veterinary Medicine), did prepare a proposal for an interim solution. I spoke to the officer (that's what they call them at the FDA, "officer") in charge of that. He would not tell me what was in it but did tell me that he had sent it over to FDA "main" for approval. The approval was expected to have occurred by last Friday at the latest (that was the announcement we were expecting) but never appeared. On Tuesday, he said he was hoping to see it "soon".
Part of the problem is priority. They're a tad distracted by the contaminated pet food fiasco ... but even more important is that none of the immediate available options are very appealing to the FDA. Below is a list of the possible solutions that I just put together for a Horse Journal article:
1. The FDA could publish a specific exemption from the prohibition on compounding from bulk drugs with regard to pergolide and horses with Cushing's Disease. This would immediately free drug wholesalers to supply compounders. Drug should still only be produced upon receipt of a prescription from the treating veterinarian. This would be entirely legal and there are precedents for issuing exceptions. Certain chemicals used in treatments of poisonings have already been granted exceptions. We favor this as a short term solution.
2. The former USA manufacturers of pergolide pills in this country could be encouraged to resume production specifically for veterinary use.
3. The FDA could allow importation of pergolide pills produced in other countries.
4. A drug company could begin the drug approval process for pergolide as a treatment for equine PPID. This is time consuming and expensive, but preliminary communications with the FDA CVM staff in the division of MUMS – Minor Uses and Minor Species – indicates they may be able to help. This division was created to help fill the special needs of relatively uncommon species, or uncommon diseases. While the number of horses with Cushing's Disease is certainly not small, the market size can't compare to the need for things like dewormers and antibiotics. The program provides financial incentives and allows for sales of the drug before the entire approval process has been completed.
5. In the event the FDA does not offer even a short term solution
quick enough, and an owner/vet find themselves unable to source the
drug, the veterinarian can apply for a Medically Necessary Veterinary
Drug exception. Details for this application can be found at:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf/ Once approved, this would enable the veterinarian to import drug to treat his or her patient(s). Because of inherent delays in petitions being approved, and a likely large volume of petitions once the supply begins to dry
up, you shouldn't wait until the last minute to get started on this.
===================
In speaking with the FDA on Tuesday, it was abundantly clear that
granting an exception for bulk compounding was the last thing they
wanted to do. The current compounding furor, with abuses on both
human and veterinary ends, haven't helped us any. Still, this would
be the quickest solution. The FDA would prefer to see 2. happen, but
no interest from that sector so far. Number 3. is probably the
solution that CVM proposed (I'm guessing at that), but FDA main
wouldn't be wild about that idea either.
Number 4. is something I'm actively working on, identifying companies that are already making "specialty" drugs (smaller market than big sellers like dewormers or antibiotics), small companies, companies with experience producing drugs that are potent in small doses in a loose powder form.
Number 5. is your safety net. There's no way to tell how much
pergolide is still out there, or how long it will last. Pharmacies
that seem to have a good supply now could find it disappearing
quickly as other pharmacies run out. If this drags on too long, you
could also easily be looking at a problem with black market drug of
god knows what quality and coming from god knows where. If the
availability of drug through approved suppliers doesn't change,
sooner or later you're going to have be highly suspicious of anyone
who claims they have no problem getting the drug. The FDA is not
interested in having to process a huge volume of these applications,
but may try to stall on doing anything until they actually start to
get them.
==========================
Until they have a solution in front of them that they like, the FDA is going to drag its feet. We need to keep putting pressure on them. All of you who cross-post and generate new signatures on the petition are helping. Several members are also getting breed associations involved and/or getting articles in magazines. I've been interviewed by The Horse, Equus and got a request late yesterday from Horse Illustrated. There will be an article in the next issue of Horse Journal. Also trying to get a national news service to pick it up.
You can all also help by sending individual e-mails, faxes or phone
calls to these 3 people:
Food and Drug Administration
1-888-463-6332 – phone
cderombudsman@fda.hhs.gov
Dr. Stephen Sundlof
Director of the Center for Veterinary Medicine
240-276-9000 – phone
240-276-9001 - fax
stephen.sundlof@fda.hhs.gov
Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 – phone
240-276-9060 – fx
marcia.larkins@fda.hhs.gov
Phone, fax, e-mail or all three as often as you like.
[4/20/07 - additional contact added]
David J. Horowitz
Deputy Director, Office of Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov
By the way, in response to the reply from the FDA that some of you
got, basically saying it's not their problem and it's up to the
manufacturers to supply the drug, that's not true. No manufacturer is
obligated to make any drug. Few firms would be interested in
this "small" a market, compared to something that the entire equine
population uses on a regular basis.
The FDA does acknowledge that it has the responsibility to prevent or alleviate both real and potential shortages of essential drugs. Read:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
This *is* their problem, but it's up to us to see that they deal with
it before even one horse runs out of pergolide.
Eleanor
Sunday, April 29, 2007
Plan "B" if US Supply Dries Up (plan ahead)
Posted on EC List 4/28/2007 Msg #90807
Re: Plan B - Pergolide
To stay on pergolide, your vet can apply for a Medically Necessary
Veterinary Drug exception. The details on how to do this are here:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
In fact, that pathway was the initial suggestion we got from the FDA
before they realized the magnitude of the problem and decided they
didn't want to process thousands of these applications but if that's
what it takes to make them move, so be it. Please note that your vet,
or presumably your vet's office at least, has to call to request the
necessary forms. They won't send them out to owners. That document is
worth reading. It states that the FDA recognizes they have a
responsibility to get drugs out to the people or animals that need
them.
This process would allow your vet to import pergolide (e.g. from
Canada) for your horse. Price will be higher than compounded, but
nothing like what one member told she just paid yesterday for generic
pergolide pills that she located at a US pharmacy - ***OVER $6.00 PER
MG*** - more than double what she was paying. At 1 mg/day, at current
pricing, a 30 day supply would run about $60
http://www.seniormedications.com/drug_list/pergolide.htm
Another alternative, although highly experimental at this point,
would be to try cabergoline (brand name Dostinex) instead. You can
legally order this from a Candian pharmacy, generic version, at a
very low cost, possibly as low as $20/month. I apologize for not
sending out those cabergline files to those that requested them yet.
It was sounding so hopeful for an early solution a while back that I
held off, then got caught up in the pergolide problem again. Will do
that as soon as I finish this post. [If you require information on cabergoline
for your equine patients, please enter a comment at the end of this article
and you will be contacted.]
There are other dopamine agonists also, but we have ZERO information
on what dosages might be appropriate, safety, etc.
Vitex agnus-castus/Chastetree berry: Good track record for
symptomatic control (laminitis, coat quality, etc.) but not all
respond, those that do respond may become refractory to it. Also
concerning that the blood work doesn't necessarily reflect the
clinical improvements.
Now, back to plan A! Don't get too discouraged yet. The FDA is
sensitive to its public image. If it wasn't for the controversy over
compounding, they wouldn't be dragging their feet like they are. It's
not over yet.
Eleanor
Re: Plan B - Pergolide
To stay on pergolide, your vet can apply for a Medically Necessary
Veterinary Drug exception. The details on how to do this are here:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
In fact, that pathway was the initial suggestion we got from the FDA
before they realized the magnitude of the problem and decided they
didn't want to process thousands of these applications but if that's
what it takes to make them move, so be it. Please note that your vet,
or presumably your vet's office at least, has to call to request the
necessary forms. They won't send them out to owners. That document is
worth reading. It states that the FDA recognizes they have a
responsibility to get drugs out to the people or animals that need
them.
This process would allow your vet to import pergolide (e.g. from
Canada) for your horse. Price will be higher than compounded, but
nothing like what one member told she just paid yesterday for generic
pergolide pills that she located at a US pharmacy - ***OVER $6.00 PER
MG*** - more than double what she was paying. At 1 mg/day, at current
pricing, a 30 day supply would run about $60
http://www.seniormedications.com/drug_list/pergolide.htm
Another alternative, although highly experimental at this point,
would be to try cabergoline (brand name Dostinex) instead. You can
legally order this from a Candian pharmacy, generic version, at a
very low cost, possibly as low as $20/month. I apologize for not
sending out those cabergline files to those that requested them yet.
It was sounding so hopeful for an early solution a while back that I
held off, then got caught up in the pergolide problem again. Will do
that as soon as I finish this post. [If you require information on cabergoline
for your equine patients, please enter a comment at the end of this article
and you will be contacted.]
There are other dopamine agonists also, but we have ZERO information
on what dosages might be appropriate, safety, etc.
Vitex agnus-castus/Chastetree berry: Good track record for
symptomatic control (laminitis, coat quality, etc.) but not all
respond, those that do respond may become refractory to it. Also
concerning that the blood work doesn't necessarily reflect the
clinical improvements.
Now, back to plan A! Don't get too discouraged yet. The FDA is
sensitive to its public image. If it wasn't for the controversy over
compounding, they wouldn't be dragging their feet like they are. It's
not over yet.
Eleanor
Cypro Not a Viable Alternative
Posted on EC List 4/20/2007 Msg #90479
> My vet said that cyproheptadine MIGHT BE an alternative to pergolide
> if we can't get anymore.
Cypro would be 3 steps backwards I'm afraid. Several studies have now
clearly shown that cypro doesn't even come close to having the same
benefits as pergolide.
Eleanor
> My vet said that cyproheptadine MIGHT BE an alternative to pergolide
> if we can't get anymore.
Cypro would be 3 steps backwards I'm afraid. Several studies have now
clearly shown that cypro doesn't even come close to having the same
benefits as pergolide.
Eleanor
April 18, 2007 - Note from Dr. Larkins
Posted to EC List 4/18/2007 Msg #90420
... just in case anyone is afraid we're not
getting their attention...
BTW, the petition is a big part of the "documentation" she refers to.
-----Original Message-----
From: marcia.larkins@fda.hhs.gov
To: drkellon@aol.com
Sent: Wed, 18 Apr 2007 5:25 PM
Subject: RE: Urgent Matter
Dear Dr. Kellon,
Since my previous response, the recent voluntary withdrawal of the
human pergolide product has come under more discussion within the
Center for Veterinary Medicine (CVM). At this time the impact of
that withdrawal on the future availability of the product to
veterinarians for use in the treatment of Equine Cushing's Disease is
under review and consideration by CVM. Thank you for bringing this
issue to the Center's attention and for providing the documentation
to support your concern.
Marcia K. Larkins D.V.M.
Ombudsman
Center for Veterinary Medicine
Tel: 240-276-9015
Fax: 240-276-9060
... just in case anyone is afraid we're not
getting their attention...
BTW, the petition is a big part of the "documentation" she refers to.
-----Original Message-----
From: marcia.larkins@fda.hhs.gov
To: drkellon@aol.com
Sent: Wed, 18 Apr 2007 5:25 PM
Subject: RE: Urgent Matter
Dear Dr. Kellon,
Since my previous response, the recent voluntary withdrawal of the
human pergolide product has come under more discussion within the
Center for Veterinary Medicine (CVM). At this time the impact of
that withdrawal on the future availability of the product to
veterinarians for use in the treatment of Equine Cushing's Disease is
under review and consideration by CVM. Thank you for bringing this
issue to the Center's attention and for providing the documentation
to support your concern.
Marcia K. Larkins D.V.M.
Ombudsman
Center for Veterinary Medicine
Tel: 240-276-9015
Fax: 240-276-9060
April 18, 2007 - AAEP is On Board !!!
Posted to EC List 4/18/2007 Msg #90405
Dear AAEP Members:
As you may be aware, the FDA has withdrawn the drug pergolide from
the market for use in humans. In order for the drug to continue to be
available for use in veterinary medicine, the FDA must approve an
exception for pergolide to be used by veterinarians and to be
compounded in bulk quantities.
The AAEP, through its Drug Compounding Task Force, has been in
contact with the FDA, and they are aware of the significant impact of
pergolide's withdrawal from the market on equine medicine. The FDA
Center for Veterinary Medicine is working with its counterpart for
human medicine, the Center for Drug Evaluation and Research, to allow
importation of pergolide for use by compounding pharmacies. The FDA
expects to have an official announcement by the end of this week.
The AAEP will continue to communicate with the FDA on this issue. For
updates, please visit the AAEP Web site at or call the AAEP office at
(800) 443-0177.
Sincerely,
The AAEP
Dear AAEP Members:
As you may be aware, the FDA has withdrawn the drug pergolide from
the market for use in humans. In order for the drug to continue to be
available for use in veterinary medicine, the FDA must approve an
exception for pergolide to be used by veterinarians and to be
compounded in bulk quantities.
The AAEP, through its Drug Compounding Task Force, has been in
contact with the FDA, and they are aware of the significant impact of
pergolide's withdrawal from the market on equine medicine. The FDA
Center for Veterinary Medicine is working with its counterpart for
human medicine, the Center for Drug Evaluation and Research, to allow
importation of pergolide for use by compounding pharmacies. The FDA
expects to have an official announcement by the end of this week.
The AAEP will continue to communicate with the FDA on this issue. For
updates, please visit the AAEP Web site at or call the AAEP office at
(800) 443-0177.
Sincerely,
The AAEP
April 13, 2007 Clarification of Pergolide Supply
>Do you have email correspondence from these
> wholesalers that you can share, as you have letters from the FDA?
Yes, I do, but they're private e-mails (not government agencies) and
I don't have permission to broadcast them...
Without identifying the sender, here is an excerpt:
"...Here is what we know and/or what we suspect might happen.
- the FDA has not told us we cannot import the material so far
- the FDA issued a Human Compliance Policy Guideline (CPG)
about 4 years ago that specifically identified 20+ chemicals that
were banned or restricted for use in compounding due to safety
reasons. Presumably the withdrawal of pergolide for safety reasons
would fall under this CPG due to precedent.
- the FDA issued at Veterinary CPG shortly after the Human
CPG that stated all compounding from bulk chemicals for vet purposes
was illegal. There was talk at the time that they would issue a
short list of approved chemicals but according to people that saw the
list it was limited to chemicals commonly used to treat poisoning.
The FDA frequently cites AMDUCA as the rational for why bulk
chemicals are illegal.
- the judge in the Midland case did rule that vet compounding
from bulk chemicals is legal with the restriction that it be done for
non-food chain animals. Unfortunately, the way the federal district
courts operate this ruling only applies to the states within that
district.
- the FDA routinely asks us to provide intended use (and
names of likely customers) in writing for chemicals we import before
they will allow the chemical to clear customs. Given the withdrawal
for safety reasons in humans and the ban on the use of bulk chemicals
in vet practice it is entirely possible that they could refuse to let
this material into the country or into our hands."
If there was no issue here, why would the FDA be working on a
solution? You can review some of the controversies here:
http://www.islandpharmacy.com/site/1420401/page/773881
Maybe large pharmacies with big stockpiles are saying no problem,
maybe some pharmacies import drug directly in quantity and haven't
been stopped (yet). Maybe pharmacies are operating under the
impression that they won't be stopped because they haven't been in
the past (as in the link above), but if suppliers don't stock and
ship, there won't be an issue about whether what they are doing is
legal or not. There will be no supply.
We just have to wait and see what the FDA press release says next
week.
Eleanor
> wholesalers that you can share, as you have letters from the FDA?
Yes, I do, but they're private e-mails (not government agencies) and
I don't have permission to broadcast them...
Without identifying the sender, here is an excerpt:
"...Here is what we know and/or what we suspect might happen.
- the FDA has not told us we cannot import the material so far
- the FDA issued a Human Compliance Policy Guideline (CPG)
about 4 years ago that specifically identified 20+ chemicals that
were banned or restricted for use in compounding due to safety
reasons. Presumably the withdrawal of pergolide for safety reasons
would fall under this CPG due to precedent.
- the FDA issued at Veterinary CPG shortly after the Human
CPG that stated all compounding from bulk chemicals for vet purposes
was illegal. There was talk at the time that they would issue a
short list of approved chemicals but according to people that saw the
list it was limited to chemicals commonly used to treat poisoning.
The FDA frequently cites AMDUCA as the rational for why bulk
chemicals are illegal.
- the judge in the Midland case did rule that vet compounding
from bulk chemicals is legal with the restriction that it be done for
non-food chain animals. Unfortunately, the way the federal district
courts operate this ruling only applies to the states within that
district.
- the FDA routinely asks us to provide intended use (and
names of likely customers) in writing for chemicals we import before
they will allow the chemical to clear customs. Given the withdrawal
for safety reasons in humans and the ban on the use of bulk chemicals
in vet practice it is entirely possible that they could refuse to let
this material into the country or into our hands."
If there was no issue here, why would the FDA be working on a
solution? You can review some of the controversies here:
http://www.islandpharmacy.com/site/1420401/page/773881
Maybe large pharmacies with big stockpiles are saying no problem,
maybe some pharmacies import drug directly in quantity and haven't
been stopped (yet). Maybe pharmacies are operating under the
impression that they won't be stopped because they haven't been in
the past (as in the link above), but if suppliers don't stock and
ship, there won't be an issue about whether what they are doing is
legal or not. There will be no supply.
We just have to wait and see what the FDA press release says next
week.
Eleanor
Update April 13, 2007
Posted to EC List 4/13/2007 Msg #90178
--- In EquineCushings@yahoogroups.com, "Ian Hudgings" [of Vet Pet Solutions compounding pharmacy] wrote:
>
>
> The reason the wholesalers can't get Pergolide is because it is on an
> FDA hold and will be seized by customs at the border. Even if I could
> find a source for bulk Pergolide and convince them to ship it to me,
> it would likely get seized and we would still be in the same
> situation.
The last I heard from a wholesaler (and this information is a week old
so maybe things have changed), the FDA has not taken any action to stop
movement of pergolide, and really would have no reason to do that since
the legal demand for the drug is gone. The finished product (pergolide
pills) manufacturers have ceased production.
The FDA theoretically could seize pergolide or ban importation, but as
far as I know that has not occurred. The reason the wholesalers are no
longer wanting to carry it is simply that there is no legal avenue for
them to sell it.
The compounding of veterinary drugs from bulk powder like this is
considered illegal by the FDA. There is one court decision that
disagrees with that stance, two that uphold it. The only reason it's
even a point of contention is that the original legislation permitting
veterinary compounding did not specifically mention compounding from
bulk drugs. However, a later Compliance Guideline policy statement by
the FDA specifically prohibits compounding from bulk drugs. To put it
another way, even if the human manufacturers hadn't withdrawn the drug
from the market, it could still be illegal for compounding pharmacies
to make pergolide for equine use from bulk drugs. The reason for this
policy is that compounded drugs are not checked for potency and purity
the way manufactured drugs are. We've already seen multiple times on
this list how that can cause problems.
The wholesalers are caught in the middle. They can't legally sell bulk
pergolide to compounding pharmacies.
The only way around this would be for the FDA to make an exception in
the case of pergolide for Cushing's horses. They might also decide to
try to encourage one of the previous pill manufacturers to start
production again. Until this is sorted out, the other option you and
your vets all have individually is to submit a MNVD request as I
outlined yesterday. Post 90108.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
The sooner they start getting these requests, the sooner they'll
realize there's a problem.
Eleanor
--- In EquineCushings@yahoogroups.com, "Ian Hudgings"
>
>
> The reason the wholesalers can't get Pergolide is because it is on an
> FDA hold and will be seized by customs at the border. Even if I could
> find a source for bulk Pergolide and convince them to ship it to me,
> it would likely get seized and we would still be in the same
> situation.
The last I heard from a wholesaler (and this information is a week old
so maybe things have changed), the FDA has not taken any action to stop
movement of pergolide, and really would have no reason to do that since
the legal demand for the drug is gone. The finished product (pergolide
pills) manufacturers have ceased production.
The FDA theoretically could seize pergolide or ban importation, but as
far as I know that has not occurred. The reason the wholesalers are no
longer wanting to carry it is simply that there is no legal avenue for
them to sell it.
The compounding of veterinary drugs from bulk powder like this is
considered illegal by the FDA. There is one court decision that
disagrees with that stance, two that uphold it. The only reason it's
even a point of contention is that the original legislation permitting
veterinary compounding did not specifically mention compounding from
bulk drugs. However, a later Compliance Guideline policy statement by
the FDA specifically prohibits compounding from bulk drugs. To put it
another way, even if the human manufacturers hadn't withdrawn the drug
from the market, it could still be illegal for compounding pharmacies
to make pergolide for equine use from bulk drugs. The reason for this
policy is that compounded drugs are not checked for potency and purity
the way manufactured drugs are. We've already seen multiple times on
this list how that can cause problems.
The wholesalers are caught in the middle. They can't legally sell bulk
pergolide to compounding pharmacies.
The only way around this would be for the FDA to make an exception in
the case of pergolide for Cushing's horses. They might also decide to
try to encourage one of the previous pill manufacturers to start
production again. Until this is sorted out, the other option you and
your vets all have individually is to submit a MNVD request as I
outlined yesterday. Post 90108.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
The sooner they start getting these requests, the sooner they'll
realize there's a problem.
Eleanor
Update April 12, 2007 (Includes correspondance with FDA/CVM)
Posted to EC List 4/12/2007 Msg #90108
Below is the early stages of an exchange with the FDA. Bottom line
situation here is that the compounded pergolide most of you rely on
is, according to an FDA policy statement, illegal.
http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html
The FDA cannot police every compounding pharmacy, but they can more
easily target the wholesalers. The wholesalers know this. No
wholesale shipments, no drug available to the compounders.
The FDA has proposed two solutions which appear below. One is to
convince the prior pill manufacturers to produce the drug for
veterinary use. This hasn't happened yet, and if it does it will be
the ONLY legal source of pergolide and your costs will more than
likely go up. Second option is to have your veterinarian petition the
FDA for an urgent need exemption for use of pergolide in your horse:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
Since compounding from bulk is the only available option at the
moment, they would have to grant that permission but so far are
offering it only on a case by case basis. Considering the thousands
of horses that are probably on it, there's a chance that if we get
the ball rolling with these petitions they will quickly see the size
of the need and publish an exemption that allows bulk compounding of
pergolide for horses. This is a link to the process of getting an
exemption for an individual horse:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
Urge your vets to do this.
Third thing is that I have sent a letter and background information
to every state's Board of Pharmacy. The FDA Compliance Guidelines
reference two court decisions that upheld the illegality of
compounding from bulk drugs. However, a recent Federal Court decision
in Texas found that it was legal. We can't wait for the courts to
hash it out, but the differences of opinion do leave the door open
for any individual state to make an exception. Susie Gordon found a
roster of state pharmacy boards yesterday. All the e-mails work. I
just put it up as a .pdf file. Anyone with a horse that needs
pergolide should contact your state board and let them know. Ask your
vets to do the same. If we keep the pressure on, there should be some
resolution of this before supplies disappear.
We need to keep the petition Kellie put up rolling too. It's the
documentation of need. Kellie is adding the FDA Ombudsman and all the
state pharmacy boards to her list of people that get copies of the
signatures every few days. Contact your local horse groups, 4-H
clubs, breed organizations - anyone you can think of. Send them to
the library to sign if you have to, but keep the signatures coming.
We can do this!
OK, below is a mail I put up on a vets' list this morning. It has the
exchange with the FDA in it, and what I wrote on that list.
Eleanor
Below is a copy of the first stages of an exchange with the FDA
regarding pergolide. It is important to remember that the pergolide
compounded from bulk drug that most are using is actually an illegal
product. The FDA does not have the manpower to police every
compounding pharmacy, but they can keep track of what goes into and
out of a handful of wholesale supply houses. Now that there is no
longer any legal market for the drug, the supply will dry up.
The first option the FDA suggested was to convince manufacturers of
the pills to resume production. So far, they're not interested in
doing that. Maybe with FDA intervention they will. However, in that
case the only option will be the manufactured pills, likely to
considerably increase the cost to owners.
Their second suggestion was for individual veterinarians to petition
for a medically necessary veterinary drug exemption which, if I am
understanding her correctly, would need to be done on a case by case
basis. This could be an agonizingly slow and laborious process but
if it comes to that I wanted all of you to know there may be hoops to
jump through before you can get pergolide to your clients. Since
there aren't any other options, you could be granted permission to
use bulk compounded pergolide - assuming your compounder could get
it.
I'm hoping that the sheer magnitude of the need will lead to the FDA
publishing a specific exemption for compounding of pergolide from
bulk sources for use in horses with PPID, although that's probably
the last thing they want to do.
Letters and background information have also been sent to each
state's board of pharmacy, to hopefully open the door for exemptions
on a state by state basis. The 1994 AMDUCA legislation permitting
compounding did not specifically mention compounding from bulk drug
one way or the other. The compliance guidelines are FDA policy
statements, not law. They reference two court decisions that upheld
the ban on compounding from bulk drug, but a recent decision in a
Texas federal court ruled that veterinary compounding from bulk drug
was not illegal.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
-----Original Message-----
From: drkellon@aol.com
To: marcia.larkins@fda.hhs.gov
Sent: Thu, 12 Apr 2007 8:35 AM
Subject: Re: Urgent Matter
Dear Dr. Larkins,
Thank you for your reply.
To date, none of the previous manufacturers of pergolide mesylate
tablets has expressed an interest in continued production of the drug
for veterinary use. One of the reasons for the petition at
http://www.ipetitions.com/petition/savepergolide/index.html
which currently has almost 1400 signatures from both owners and
veterinarians, was to document that there is, indeed, a sizeable
market and need. We are periodically sending the previous
manufacturers spread sheet copies of the signatures. That option has
not opened up to us so far, but we will keep trying.
As for your second option, I will notify owners and veterinarians of
this pathway. However, given the number of horses involved and their
need to continue medication without interruption, I have a few
questions.
How long does the case review process take? That is, if veterinarians
were to wait until they actually had no other options, how long could
they expect to be without medication until a solution is achieved?
In the event manufacturers continue to express no interest in
resuming production, there would be no legal options available
according to Sec 608.400, CPG 7125.40 which specifically prohibits
compounding from bulk drug substances. Am I correct in assuming that
if the pharmaceutical industry continues to have no interest that
permission to use pergolide compounded from bulk drug may be granted
on a case by case basis, or does "case by case" actually mean for a
particular drug rather than each individual animal? Is there a way
the veterinary community at large could help expedite this process
for all horses with the need, rather than on an individual basis?
Would publishing a specific exemption for compounding of pergolide
from bulk drug for use in horses with PPID/Cushing's disease be a
viable option?
Use of pergolide in horses, a nonfood animal, poses no threat to
human health, and is of no environmental concern. We feel the
petition, which represents only a fraction of the horses impacted,
establishes the need and with voluntary withdrawal of the drug by
prior manufacturers we have a de facto loss of availability and no
approved avenues for obtaining it. Please advise whether individual
veterinarians/practices should begin the MNVP process for their
patients, or if there is a way this can be resolved on a larger scale.
Thank you.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
-----Original Message-----
From: marcia.larkins@fda.hhs.gov
To: drkellon@aol.com
Sent: Wed, 11 Apr 2007 7:01 PM
Subject: RE: Urgent Matter
Dear Dr. Kellon,
I have spoken with a staff member in the Division of Compliance
concerning the withdrawal of pergolide mesylate from the human market
and your request for clarification of the Center for Veterinary
Medicine's (CVM) position on this product for veterinary use. There
are two options to consider. The first option is for you to contact
(one or all of) the companies that were marketing the drug and ask
them to consider making it available with a label for veterinary
use. They should then contact CVM to find out what information/data
would need to be submitted for review and consideration.
The second option would involve you finding an alternate source for
the drug and requesting that CVM grant you permission to use it under
the Medically Necessary Veterinary Drug Product Shortage Management
policy (see http://www.fda.gov/cvm/Policy_Procedures/4170.pdf).
There is specific information required that can only be provided by
the requesting veterinarian and each request is considered on a case-
by-case basis. You should contact CVM before submitting a request
under this policy.
I hope this information is helpful. If I can be of any further
assistance please contact me by email or by phone.
Marcia K. Larkins D.V.M.
Ombudsman
Center for Veterinary Medicine
Tel: 240-276-9015
Fax: 240-276-9060
----------------------------------------------------------------------
----------
From: drkellon@aol.com [mailto:drkellon@aol.com]
Sent: Tuesday, April 10, 2007 10:12 AM
To: Larkins, Marcia K
Subject: Urgent Matter
Dear Dr. Larkins,
I apologize in advance if your office is not the proper place for
this issue, but since it involves the FDA proper and CVM on several
levels I am not sure where to turn. Please see the attached file. In
brief, the voluntary withdrawal of pergolide mesylate from the human
market is poised to have a disastrous impact on the health, even
survival, of many horses with pituitary dysfunction (pituitar pars
intermedia dysfunction, aka Equine Cushing's Diease). Owners of
horses that were relying on Permax or the generic tablets are already
having difficulty sourcing the drug from remaining supplies on the
market. Wholesalers supplying veterinary compounding pharmacies have
either decided to no longer stock it or are concerned/confused about
legality.
We are in desperate need of a clarification.
Thank you.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Below is the early stages of an exchange with the FDA. Bottom line
situation here is that the compounded pergolide most of you rely on
is, according to an FDA policy statement, illegal.
http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html
The FDA cannot police every compounding pharmacy, but they can more
easily target the wholesalers. The wholesalers know this. No
wholesale shipments, no drug available to the compounders.
The FDA has proposed two solutions which appear below. One is to
convince the prior pill manufacturers to produce the drug for
veterinary use. This hasn't happened yet, and if it does it will be
the ONLY legal source of pergolide and your costs will more than
likely go up. Second option is to have your veterinarian petition the
FDA for an urgent need exemption for use of pergolide in your horse:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
Since compounding from bulk is the only available option at the
moment, they would have to grant that permission but so far are
offering it only on a case by case basis. Considering the thousands
of horses that are probably on it, there's a chance that if we get
the ball rolling with these petitions they will quickly see the size
of the need and publish an exemption that allows bulk compounding of
pergolide for horses. This is a link to the process of getting an
exemption for an individual horse:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
Urge your vets to do this.
Third thing is that I have sent a letter and background information
to every state's Board of Pharmacy. The FDA Compliance Guidelines
reference two court decisions that upheld the illegality of
compounding from bulk drugs. However, a recent Federal Court decision
in Texas found that it was legal. We can't wait for the courts to
hash it out, but the differences of opinion do leave the door open
for any individual state to make an exception. Susie Gordon found a
roster of state pharmacy boards yesterday. All the e-mails work. I
just put it up as a .pdf file. Anyone with a horse that needs
pergolide should contact your state board and let them know. Ask your
vets to do the same. If we keep the pressure on, there should be some
resolution of this before supplies disappear.
We need to keep the petition Kellie put up rolling too. It's the
documentation of need. Kellie is adding the FDA Ombudsman and all the
state pharmacy boards to her list of people that get copies of the
signatures every few days. Contact your local horse groups, 4-H
clubs, breed organizations - anyone you can think of. Send them to
the library to sign if you have to, but keep the signatures coming.
We can do this!
OK, below is a mail I put up on a vets' list this morning. It has the
exchange with the FDA in it, and what I wrote on that list.
Eleanor
Below is a copy of the first stages of an exchange with the FDA
regarding pergolide. It is important to remember that the pergolide
compounded from bulk drug that most are using is actually an illegal
product. The FDA does not have the manpower to police every
compounding pharmacy, but they can keep track of what goes into and
out of a handful of wholesale supply houses. Now that there is no
longer any legal market for the drug, the supply will dry up.
The first option the FDA suggested was to convince manufacturers of
the pills to resume production. So far, they're not interested in
doing that. Maybe with FDA intervention they will. However, in that
case the only option will be the manufactured pills, likely to
considerably increase the cost to owners.
Their second suggestion was for individual veterinarians to petition
for a medically necessary veterinary drug exemption which, if I am
understanding her correctly, would need to be done on a case by case
basis. This could be an agonizingly slow and laborious process but
if it comes to that I wanted all of you to know there may be hoops to
jump through before you can get pergolide to your clients. Since
there aren't any other options, you could be granted permission to
use bulk compounded pergolide - assuming your compounder could get
it.
I'm hoping that the sheer magnitude of the need will lead to the FDA
publishing a specific exemption for compounding of pergolide from
bulk sources for use in horses with PPID, although that's probably
the last thing they want to do.
Letters and background information have also been sent to each
state's board of pharmacy, to hopefully open the door for exemptions
on a state by state basis. The 1994 AMDUCA legislation permitting
compounding did not specifically mention compounding from bulk drug
one way or the other. The compliance guidelines are FDA policy
statements, not law. They reference two court decisions that upheld
the ban on compounding from bulk drug, but a recent decision in a
Texas federal court ruled that veterinary compounding from bulk drug
was not illegal.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
-----Original Message-----
From: drkellon@aol.com
To: marcia.larkins@fda.hhs.gov
Sent: Thu, 12 Apr 2007 8:35 AM
Subject: Re: Urgent Matter
Dear Dr. Larkins,
Thank you for your reply.
To date, none of the previous manufacturers of pergolide mesylate
tablets has expressed an interest in continued production of the drug
for veterinary use. One of the reasons for the petition at
http://www.ipetitions.com/petition/savepergolide/index.html
which currently has almost 1400 signatures from both owners and
veterinarians, was to document that there is, indeed, a sizeable
market and need. We are periodically sending the previous
manufacturers spread sheet copies of the signatures. That option has
not opened up to us so far, but we will keep trying.
As for your second option, I will notify owners and veterinarians of
this pathway. However, given the number of horses involved and their
need to continue medication without interruption, I have a few
questions.
How long does the case review process take? That is, if veterinarians
were to wait until they actually had no other options, how long could
they expect to be without medication until a solution is achieved?
In the event manufacturers continue to express no interest in
resuming production, there would be no legal options available
according to Sec 608.400, CPG 7125.40 which specifically prohibits
compounding from bulk drug substances. Am I correct in assuming that
if the pharmaceutical industry continues to have no interest that
permission to use pergolide compounded from bulk drug may be granted
on a case by case basis, or does "case by case" actually mean for a
particular drug rather than each individual animal? Is there a way
the veterinary community at large could help expedite this process
for all horses with the need, rather than on an individual basis?
Would publishing a specific exemption for compounding of pergolide
from bulk drug for use in horses with PPID/Cushing's disease be a
viable option?
Use of pergolide in horses, a nonfood animal, poses no threat to
human health, and is of no environmental concern. We feel the
petition, which represents only a fraction of the horses impacted,
establishes the need and with voluntary withdrawal of the drug by
prior manufacturers we have a de facto loss of availability and no
approved avenues for obtaining it. Please advise whether individual
veterinarians/practices should begin the MNVP process for their
patients, or if there is a way this can be resolved on a larger scale.
Thank you.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
-----Original Message-----
From: marcia.larkins@fda.hhs.gov
To: drkellon@aol.com
Sent: Wed, 11 Apr 2007 7:01 PM
Subject: RE: Urgent Matter
Dear Dr. Kellon,
I have spoken with a staff member in the Division of Compliance
concerning the withdrawal of pergolide mesylate from the human market
and your request for clarification of the Center for Veterinary
Medicine's (CVM) position on this product for veterinary use. There
are two options to consider. The first option is for you to contact
(one or all of) the companies that were marketing the drug and ask
them to consider making it available with a label for veterinary
use. They should then contact CVM to find out what information/data
would need to be submitted for review and consideration.
The second option would involve you finding an alternate source for
the drug and requesting that CVM grant you permission to use it under
the Medically Necessary Veterinary Drug Product Shortage Management
policy (see http://www.fda.gov/cvm/Policy_Procedures/4170.pdf).
There is specific information required that can only be provided by
the requesting veterinarian and each request is considered on a case-
by-case basis. You should contact CVM before submitting a request
under this policy.
I hope this information is helpful. If I can be of any further
assistance please contact me by email or by phone.
Marcia K. Larkins D.V.M.
Ombudsman
Center for Veterinary Medicine
Tel: 240-276-9015
Fax: 240-276-9060
----------------------------------------------------------------------
----------
From: drkellon@aol.com [mailto:drkellon@aol.com]
Sent: Tuesday, April 10, 2007 10:12 AM
To: Larkins, Marcia K
Subject: Urgent Matter
Dear Dr. Larkins,
I apologize in advance if your office is not the proper place for
this issue, but since it involves the FDA proper and CVM on several
levels I am not sure where to turn. Please see the attached file. In
brief, the voluntary withdrawal of pergolide mesylate from the human
market is poised to have a disastrous impact on the health, even
survival, of many horses with pituitary dysfunction (pituitar pars
intermedia dysfunction, aka Equine Cushing's Diease). Owners of
horses that were relying on Permax or the generic tablets are already
having difficulty sourcing the drug from remaining supplies on the
market. Wholesalers supplying veterinary compounding pharmacies have
either decided to no longer stock it or are concerned/confused about
legality.
We are in desperate need of a clarification.
Thank you.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Update April 10, 2007
Posted on EC List 4/10/2007 Msg #90005
In speaking with some upper level management at drug wholesalers
yesterday, they came up with a variety of reasons for not stocking,
or considering not stocking, pergolide. Some of them were flat out
incorrect. Most, however, centered over concern about what the FDA
would do. They are saying they wouldn't be surprised if a prohibition
was put on the importation of pergolide (not there yet), and also
concerned for their own liability if they sell pergolide in bulk to a
compounding pharmacy (although obviously they've been doing this for
years). Problem is the FDA has been increasingly vigilant about
asking the wholesalers to identify where the drugs are going. With
the human market shut down, it would be obvious it's going to
veterinary compounders. Problem is, according to a Compliance
Guideline Document (this is *not* a law, it's a statement of action
the FDA might be inclined to take under a given set of
circumstances), compounding of veterinary prescriptions from bulk
drugs is a violation.
Here's where it gets sticky. A federal court decision in a Texas
district found that compounding of veterinary prescriptions from bulk
drug was not illegal. The official law on compounding of drugs for
nonfood animals, the 1994 AMDUCA (Animal Medicinal Drug Use
Clarification Act) permits compounding of drugs within the framework
of a valid veterinarian-client-patient relationship, i.e. your horse
is sick, your vet prescribes something for you, his/her client, to
give. AMDUCA doesn't mention compounding from bulk drug ingredients.
So, bottom line is that while we have to keep informing drug
wholesalers and generic pill manufacturers of the size of the market,
we also need to make the FDA very much aware of the need. Wholesalers
that fear prosecution are not going to stock this drug. That's why we
have moved the FDA to the top of the contact list on the petition.
Kellie is going to send copies of the petition response to everyone
on the petition list every few days. Wouldn't hurt one bit for anyone
who is so inclined to also send a personal e-mail to the FDA, or a
fax. The information is on the petition. Regulation of equine issues
really isn't usually very high on the FDAs list of priorities and in
issues like this they are usually very responsive to public feedback.
A good example of this is the threat to pull supplements like
glucosamine off the market a few years back.
I haven't gotten any feedback from the FDA yet. Will let everyone
know as soon as I do. In the meantime, keep the pressure on. E-MAIL
THE FDA!
Eleanor
In speaking with some upper level management at drug wholesalers
yesterday, they came up with a variety of reasons for not stocking,
or considering not stocking, pergolide. Some of them were flat out
incorrect. Most, however, centered over concern about what the FDA
would do. They are saying they wouldn't be surprised if a prohibition
was put on the importation of pergolide (not there yet), and also
concerned for their own liability if they sell pergolide in bulk to a
compounding pharmacy (although obviously they've been doing this for
years). Problem is the FDA has been increasingly vigilant about
asking the wholesalers to identify where the drugs are going. With
the human market shut down, it would be obvious it's going to
veterinary compounders. Problem is, according to a Compliance
Guideline Document (this is *not* a law, it's a statement of action
the FDA might be inclined to take under a given set of
circumstances), compounding of veterinary prescriptions from bulk
drugs is a violation.
Here's where it gets sticky. A federal court decision in a Texas
district found that compounding of veterinary prescriptions from bulk
drug was not illegal. The official law on compounding of drugs for
nonfood animals, the 1994 AMDUCA (Animal Medicinal Drug Use
Clarification Act) permits compounding of drugs within the framework
of a valid veterinarian-client-patient relationship, i.e. your horse
is sick, your vet prescribes something for you, his/her client, to
give. AMDUCA doesn't mention compounding from bulk drug ingredients.
So, bottom line is that while we have to keep informing drug
wholesalers and generic pill manufacturers of the size of the market,
we also need to make the FDA very much aware of the need. Wholesalers
that fear prosecution are not going to stock this drug. That's why we
have moved the FDA to the top of the contact list on the petition.
Kellie is going to send copies of the petition response to everyone
on the petition list every few days. Wouldn't hurt one bit for anyone
who is so inclined to also send a personal e-mail to the FDA, or a
fax. The information is on the petition. Regulation of equine issues
really isn't usually very high on the FDAs list of priorities and in
issues like this they are usually very responsive to public feedback.
A good example of this is the threat to pull supplements like
glucosamine off the market a few years back.
I haven't gotten any feedback from the FDA yet. Will let everyone
know as soon as I do. In the meantime, keep the pressure on. E-MAIL
THE FDA!
Eleanor
Update April 9, 2007 (Includes letter to Wholesalers)
Posted to EC List 4/9/2007 Msg #89950
I'm already starting to get mails from people using the human generics
and Permax saying that their pharmacies are out. All three pill
producers have stopped manufacturing. It appears that the only way the
pills will be produced again is if one of the 3 manufacturers appeals
to the USDA for a special permit. If that happens, that single
manufacturer will be the only source of pill form pergolide. Anyone
currently using pills would be wise to switch to compounded.
*The most accurate way to dose compounded pergolide is in capsule form.
In addition, anyone making a switch to a compounder should make sure
that:
1. The compounder is fully licensed.
2. The compounder only uses bulk drugs that come from FDA approved drug
wholesalers. Ask for the name of their pergolide bulk drug wholesaler.
If it's not on the list below, don't use that compounder.
The petition is going strong, creeping up on 700 signatures
representing thousands of horses. In addition to signing the petition,
I would encourage anyone who feels so inclined to contact the
wholesalers directly by phone, fax or e-mail. When you do, be sure to
mention the name of your compounding pharmacy. One or more of the
wholesalers will recognize them as their clients and will be able to
check their sales records. As soon as a wholesaler confirms they will
continue to stock pergolide and keep the supply uninterrupted, we'll
take them off our contacts list. Also provide a link to the petition
when you contact them. This will be the quickest way to let them know
we have a need - a BIG need! Remember, the drug is out there. The human
market in the USA was very small compared to the rest of the world.
This is what I sent the wholesalers over the weekend and this morning.
Directly below that is a list of the FDA approved wholesalers who were
stocking pergolide and all the contact info I currently have.
Make your voice heard!
-------------------------------
I am a veterinarian and co-owner of the over 5000 member Yahoo Equine
Cushing's group. As you know, at the FDA's urging pergolide mesylate
has been removed from the human market. The three US suppliers of
pergolide tablets are no longer producing the drug. What you may not
realize is that bulk sales of pergolide to compounders are largely
going to the veterinary market.
Pergolide is the only effective pharmacological therapy for horses with
Cushing's Disease, pituitary pars intermedia dysfunction. I believe
that drug wholesalers are unaware of the size of the veterinary market.
It is critically important to keep pergolide available for veterinary
use. The FDA action does not impact off-label use in horses.
A web petition has been put up to collect signatures and comments
regarding the use of pergolide in horses:
http://www.ipetitions.com/petition/savepergolide/index.html
The petition was put up noon on April 6. Despite the holiday weekend,
there are already 14 pages of signatures, reflecting the needs of
thousands of horses. This is only the tip of the iceberg. There are
currently 10 to 12 million horses in the United States, of which
approximately 10% are age 20 or older. It has been estimated that
virtually any equine that lives long enough will develop the
degenerative changes of dopaminergic neurons that leads to pituitary
dysfunction and Cushing's disease. This disease may begin much earlier
in some horses, in their teens. Pergolide is needed by these animals
for the remainder of their life.
We urge you to continue to stock pergolide mesylate. There is a market.
Owners that had been relying on Permax or generic human tablets are
already encountering shortages. There is an urgent need to keep an
uninterrupted flow of pergolide mesylate to compounders.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Co-Owner, Yahoo Equine Cushings
http://pets.groups.yahoo.com/group/EquineCushings/
I'm already starting to get mails from people using the human generics
and Permax saying that their pharmacies are out. All three pill
producers have stopped manufacturing. It appears that the only way the
pills will be produced again is if one of the 3 manufacturers appeals
to the USDA for a special permit. If that happens, that single
manufacturer will be the only source of pill form pergolide. Anyone
currently using pills would be wise to switch to compounded.
*The most accurate way to dose compounded pergolide is in capsule form.
In addition, anyone making a switch to a compounder should make sure
that:
1. The compounder is fully licensed.
2. The compounder only uses bulk drugs that come from FDA approved drug
wholesalers. Ask for the name of their pergolide bulk drug wholesaler.
If it's not on the list below, don't use that compounder.
The petition is going strong, creeping up on 700 signatures
representing thousands of horses. In addition to signing the petition,
I would encourage anyone who feels so inclined to contact the
wholesalers directly by phone, fax or e-mail. When you do, be sure to
mention the name of your compounding pharmacy. One or more of the
wholesalers will recognize them as their clients and will be able to
check their sales records. As soon as a wholesaler confirms they will
continue to stock pergolide and keep the supply uninterrupted, we'll
take them off our contacts list. Also provide a link to the petition
when you contact them. This will be the quickest way to let them know
we have a need - a BIG need! Remember, the drug is out there. The human
market in the USA was very small compared to the rest of the world.
This is what I sent the wholesalers over the weekend and this morning.
Directly below that is a list of the FDA approved wholesalers who were
stocking pergolide and all the contact info I currently have.
Make your voice heard!
-------------------------------
I am a veterinarian and co-owner of the over 5000 member Yahoo Equine
Cushing's group. As you know, at the FDA's urging pergolide mesylate
has been removed from the human market. The three US suppliers of
pergolide tablets are no longer producing the drug. What you may not
realize is that bulk sales of pergolide to compounders are largely
going to the veterinary market.
Pergolide is the only effective pharmacological therapy for horses with
Cushing's Disease, pituitary pars intermedia dysfunction. I believe
that drug wholesalers are unaware of the size of the veterinary market.
It is critically important to keep pergolide available for veterinary
use. The FDA action does not impact off-label use in horses.
A web petition has been put up to collect signatures and comments
regarding the use of pergolide in horses:
http://www.ipetitions.com/petition/savepergolide/index.html
The petition was put up noon on April 6. Despite the holiday weekend,
there are already 14 pages of signatures, reflecting the needs of
thousands of horses. This is only the tip of the iceberg. There are
currently 10 to 12 million horses in the United States, of which
approximately 10% are age 20 or older. It has been estimated that
virtually any equine that lives long enough will develop the
degenerative changes of dopaminergic neurons that leads to pituitary
dysfunction and Cushing's disease. This disease may begin much earlier
in some horses, in their teens. Pergolide is needed by these animals
for the remainder of their life.
We urge you to continue to stock pergolide mesylate. There is a market.
Owners that had been relying on Permax or generic human tablets are
already encountering shortages. There is an urgent need to keep an
uninterrupted flow of pergolide mesylate to compounders.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Co-Owner, Yahoo Equine Cushings
http://pets.groups.yahoo.com/group/EquineCushings/
FDA and CVM Contact Detail
FDA (Food and Drug Administration)
Virginia Behr
CDER Ombudsman
FDA Center for Drug Evaluation and Research
White Oak CDER Office Building 22, Rm 6322
10903 New Hampshire Avenue
Silver Spring MD 20993
301-796-0675 Phone
301-796-9883 Fax
virginia.behr@fda.hhs.gov
Andrew von Eschenbach
Commissioner
Food and Drug Administration
Parklawn Bldg, Rm 1471
5600 Fishers Lane
Rockville MD 20857
301-827-2410 phone
301-443-3100 fax
andrew.voneschenbach@fda.hhs.gov
David J. Horowitz, Esq.
Director, Office of Compliance
FDA Center for Drug Evaluation and Research
Parklawn Bldg, Rm 405
5600 Fishers Lane
Rockville, MD 20857
301-827-4225 - phone
301-443-6591 - fax
david.horowitz@fda.hhs.gov
Stephen K. Galson, M.D.
Director
FDA Center for Drug Evaluation and Research
Rockwall II Bldg, Rm 7100
5515 Security Ln.
Rockville, MD 20852
301-594-5400 - phone
mailto:steven.galson@fda.hhs.gov
CVM (Center for Veterinary Medicine)
Stephen Sundlof, D.V.M.
Director
FDA Center for Veterinary Medicine
Metro Park North 4, Rm 181
7519 Standish Place
Rockville MD 20855
240-276-9000 - phone
240-276-9060 - fax
stephen.sundlof@fda.hhs.gov
Marcia Larkins, D.V.M.
Ombudsman
FDA Center for Veterinary Medicine
Metro Park North 4, Rm 165
7519 Standish Place
Rockville, MD 20855
240-276-9015 - phone
240-276-9060 - fax
marcia.larkins@fda.hhs.gov
Virginia Behr
CDER Ombudsman
FDA Center for Drug Evaluation and Research
White Oak CDER Office Building 22, Rm 6322
10903 New Hampshire Avenue
Silver Spring MD 20993
301-796-0675 Phone
301-796-9883 Fax
virginia.behr@fda.hhs.gov
Andrew von Eschenbach
Commissioner
Food and Drug Administration
Parklawn Bldg, Rm 1471
5600 Fishers Lane
Rockville MD 20857
301-827-2410 phone
301-443-3100 fax
andrew.voneschenbach@fda.hhs.gov
David J. Horowitz, Esq.
Director, Office of Compliance
FDA Center for Drug Evaluation and Research
Parklawn Bldg, Rm 405
5600 Fishers Lane
Rockville, MD 20857
301-827-4225 - phone
301-443-6591 - fax
david.horowitz@fda.hhs.gov
Stephen K. Galson, M.D.
Director
FDA Center for Drug Evaluation and Research
Rockwall II Bldg, Rm 7100
5515 Security Ln.
Rockville, MD 20852
301-594-5400 - phone
mailto:steven.galson@fda.hhs.gov
CVM (Center for Veterinary Medicine)
Stephen Sundlof, D.V.M.
Director
FDA Center for Veterinary Medicine
Metro Park North 4, Rm 181
7519 Standish Place
Rockville MD 20855
240-276-9000 - phone
240-276-9060 - fax
stephen.sundlof@fda.hhs.gov
Marcia Larkins, D.V.M.
Ombudsman
FDA Center for Veterinary Medicine
Metro Park North 4, Rm 165
7519 Standish Place
Rockville, MD 20855
240-276-9015 - phone
240-276-9060 - fax
marcia.larkins@fda.hhs.gov
New Media Contact Links Added
Check the Media Links for new contacts added.
If you know of others that should be added, let us know in a comment here.
If you know of others that should be added, let us know in a comment here.
Saturday, April 28, 2007
Patti's Letter to Sen McCain
I sent the following to Senator John McCain using the government contacts link .
(Please feel free to cut/paste this if you'd like to use it as a guideline for your own letter to your elected representatives.)
To Senator John McCain 4/25/2007
Re: FDA Pergolide Withdrawal
If the continued availability of pergolide is not ensured, many horses with Cushing's disease (Pituitary Pars Intermedia Dysfunction or PPID) will be at risk to suffer the debilitating side effects of this disease. Cushing's is a "senior" disease - many with younger fit horses might not consider this important right now but any seasoned campaigner can be affected. Pergolide (obtained by veterinary prescription through compounding pharmacies or branded Permax which is no longer manufactured) is currently the only viable (effective and economical) treatment for this condition in horses. There currently are no alternatives.
For background:
Link to FDA notice
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html
Link to article which summarizes the situation
http://www.thehorse.com/ViewArticle.aspx?ID=9405&kw=pergolide
Link to petition
http://www.ipetitions.com/petition/savepergolide?e
This petition currently has over 3400 signatures, including many veterinarians. Eleanor Kellon, VMD, has spearheaded and is devoting countless hours to this effort in behalf of many thousands of Cushing's horses and their owners - contacting federal [FDA and CVM] and state officials, veterinary schools and organizations, writing articles, and working with pharmacists and research veterinarians in the U.S. and abroad.
This is a complex issue mired down in FDA rules and regulations beyond the scope of the average citizen or veterinarian.
Your attention and intervention into this current situation would be greatly appreciated by thousands of horse owners.
Respectfully,
Patti Kuvik
Vail AZ
(Please feel free to cut/paste this if you'd like to use it as a guideline for your own letter to your elected representatives.)
To Senator John McCain 4/25/2007
Re: FDA Pergolide Withdrawal
If the continued availability of pergolide is not ensured, many horses with Cushing's disease (Pituitary Pars Intermedia Dysfunction or PPID) will be at risk to suffer the debilitating side effects of this disease. Cushing's is a "senior" disease - many with younger fit horses might not consider this important right now but any seasoned campaigner can be affected. Pergolide (obtained by veterinary prescription through compounding pharmacies or branded Permax which is no longer manufactured) is currently the only viable (effective and economical) treatment for this condition in horses. There currently are no alternatives.
For background:
Link to FDA notice
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html
Link to article which summarizes the situation
http://www.thehorse.com/ViewArticle.aspx?ID=9405&kw=pergolide
Link to petition
http://www.ipetitions.com/petition/savepergolide?e
This petition currently has over 3400 signatures, including many veterinarians. Eleanor Kellon, VMD, has spearheaded and is devoting countless hours to this effort in behalf of many thousands of Cushing's horses and their owners - contacting federal [FDA and CVM] and state officials, veterinary schools and organizations, writing articles, and working with pharmacists and research veterinarians in the U.S. and abroad.
This is a complex issue mired down in FDA rules and regulations beyond the scope of the average citizen or veterinarian.
Your attention and intervention into this current situation would be greatly appreciated by thousands of horse owners.
Respectfully,
Patti Kuvik
Vail AZ
Claire's Letter to the FDA
Posted to EC Photos, reprinted with permission of author.
Dear Fellow Listers,
At Robin & Dr. Kellon's request I am posting a link to the letter I sent yesterday to Dr. Marcia Larkins and Dr. Stephen Sundlof at the FDA:
marcia.larkins@fda.hhs.gov
stephen.sundlof@fda.hhs.gov
The reason I'm linking to it, rather than pasting it directly into this email is because it contains photos that I think are a very important and integral part of the message. And as you know we can't post photos directly into this list's messsages.
Read Claire's letter to the FDA.
Please understand that this letter is merely a SAMPLE of a personalized FDA plea. Please DO NOT copy my wording as it would really lessen the impact on those at FDA if they get letters that are very similarly worded -- BUT you can certainly use it as a starting point and modify it to fit your personal situation. The more letters they receive from horseowners talking about their specific horses, the more likely they are to view this as a very REAL threat to very REAL horses. Dr. Kellon has hit them with facts and numbers and hopefully educated them as to the value & importance of pergolide for treatment of these horses. You and I can make it real & personal. These are not just numbers, these horses are very real and part of our families.
Please write !! tell them your story...and specifically ask them to make a <<<"specific exemption from compounding from bulk drug for pergolide to be used to treat equine PPID">>>
If we lose just one horse due to the unavailability of pergolide ...it's one too many !!!!! Jump on the band wagon and write to everyone who might have an impact.I have sent everyone in my address book the petition to sign and will continue to write letters until this issue is resolved.
At their request, I even wrote a story for a local AZ publication the "Bridle & Bit"...hope they can get in their next issue.We need to speak out ...loud & clear!!!!For my beloved Tamera and every horse out there that needs pergolide!!!!
Claire from AZ
[Claire's article in Bridle & Bit]
Dear Fellow Listers,
At Robin & Dr. Kellon's request I am posting a link to the letter I sent yesterday to Dr. Marcia Larkins and Dr. Stephen Sundlof at the FDA:
marcia.larkins@fda.hhs.gov
stephen.sundlof@fda.hhs.gov
The reason I'm linking to it, rather than pasting it directly into this email is because it contains photos that I think are a very important and integral part of the message. And as you know we can't post photos directly into this list's messsages.
Read Claire's letter to the FDA.
Please understand that this letter is merely a SAMPLE of a personalized FDA plea. Please DO NOT copy my wording as it would really lessen the impact on those at FDA if they get letters that are very similarly worded -- BUT you can certainly use it as a starting point and modify it to fit your personal situation. The more letters they receive from horseowners talking about their specific horses, the more likely they are to view this as a very REAL threat to very REAL horses. Dr. Kellon has hit them with facts and numbers and hopefully educated them as to the value & importance of pergolide for treatment of these horses. You and I can make it real & personal. These are not just numbers, these horses are very real and part of our families.
Please write !! tell them your story...and specifically ask them to make a <<<"specific exemption from compounding from bulk drug for pergolide to be used to treat equine PPID">>>
If we lose just one horse due to the unavailability of pergolide ...it's one too many !!!!! Jump on the band wagon and write to everyone who might have an impact.I have sent everyone in my address book the petition to sign and will continue to write letters until this issue is resolved.
At their request, I even wrote a story for a local AZ publication the "Bridle & Bit"...hope they can get in their next issue.We need to speak out ...loud & clear!!!!For my beloved Tamera and every horse out there that needs pergolide!!!!
Claire from AZ
[Claire's article in Bridle & Bit]
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