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 She refered to the withdrawn Pergolide as the "human" version, and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
Monday, April 30, 2007
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
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