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.
Wednesday, May 16, 2007
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
Subscribe to:
Posts (Atom)