Posted on EC List 4/28/2007 Msg #90807
Re: Plan B - Pergolide
To stay on pergolide, your vet can apply for a Medically Necessary
Veterinary Drug exception. The details on how to do this are here:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
In fact, that pathway was the initial suggestion we got from the FDA
before they realized the magnitude of the problem and decided they
didn't want to process thousands of these applications but if that's
what it takes to make them move, so be it. Please note that your vet,
or presumably your vet's office at least, has to call to request the
necessary forms. They won't send them out to owners. That document is
worth reading. It states that the FDA recognizes they have a
responsibility to get drugs out to the people or animals that need
them.
This process would allow your vet to import pergolide (e.g. from
Canada) for your horse. Price will be higher than compounded, but
nothing like what one member told she just paid yesterday for generic
pergolide pills that she located at a US pharmacy - ***OVER $6.00 PER
MG*** - more than double what she was paying. At 1 mg/day, at current
pricing, a 30 day supply would run about $60
http://www.seniormedications.com/drug_list/pergolide.htm
Another alternative, although highly experimental at this point,
would be to try cabergoline (brand name Dostinex) instead. You can
legally order this from a Candian pharmacy, generic version, at a
very low cost, possibly as low as $20/month. I apologize for not
sending out those cabergline files to those that requested them yet.
It was sounding so hopeful for an early solution a while back that I
held off, then got caught up in the pergolide problem again. Will do
that as soon as I finish this post. [If you require information on cabergoline
for your equine patients, please enter a comment at the end of this article
and you will be contacted.]
There are other dopamine agonists also, but we have ZERO information
on what dosages might be appropriate, safety, etc.
Vitex agnus-castus/Chastetree berry: Good track record for
symptomatic control (laminitis, coat quality, etc.) but not all
respond, those that do respond may become refractory to it. Also
concerning that the blood work doesn't necessarily reflect the
clinical improvements.
Now, back to plan A! Don't get too discouraged yet. The FDA is
sensitive to its public image. If it wasn't for the controversy over
compounding, they wouldn't be dragging their feet like they are. It's
not over yet.
Eleanor
Sunday, April 29, 2007
Cypro Not a Viable Alternative
Posted on EC List 4/20/2007 Msg #90479
> My vet said that cyproheptadine MIGHT BE an alternative to pergolide
> if we can't get anymore.
Cypro would be 3 steps backwards I'm afraid. Several studies have now
clearly shown that cypro doesn't even come close to having the same
benefits as pergolide.
Eleanor
> My vet said that cyproheptadine MIGHT BE an alternative to pergolide
> if we can't get anymore.
Cypro would be 3 steps backwards I'm afraid. Several studies have now
clearly shown that cypro doesn't even come close to having the same
benefits as pergolide.
Eleanor
April 18, 2007 - Note from Dr. Larkins
Posted to EC List 4/18/2007 Msg #90420
... just in case anyone is afraid we're not
getting their attention...
BTW, the petition is a big part of the "documentation" she refers to.
-----Original Message-----
From: marcia.larkins@fda.hhs.gov
To: drkellon@aol.com
Sent: Wed, 18 Apr 2007 5:25 PM
Subject: RE: Urgent Matter
Dear Dr. Kellon,
Since my previous response, the recent voluntary withdrawal of the
human pergolide product has come under more discussion within the
Center for Veterinary Medicine (CVM). At this time the impact of
that withdrawal on the future availability of the product to
veterinarians for use in the treatment of Equine Cushing's Disease is
under review and consideration by CVM. Thank you for bringing this
issue to the Center's attention and for providing the documentation
to support your concern.
Marcia K. Larkins D.V.M.
Ombudsman
Center for Veterinary Medicine
Tel: 240-276-9015
Fax: 240-276-9060
... just in case anyone is afraid we're not
getting their attention...
BTW, the petition is a big part of the "documentation" she refers to.
-----Original Message-----
From: marcia.larkins@fda.hhs.gov
To: drkellon@aol.com
Sent: Wed, 18 Apr 2007 5:25 PM
Subject: RE: Urgent Matter
Dear Dr. Kellon,
Since my previous response, the recent voluntary withdrawal of the
human pergolide product has come under more discussion within the
Center for Veterinary Medicine (CVM). At this time the impact of
that withdrawal on the future availability of the product to
veterinarians for use in the treatment of Equine Cushing's Disease is
under review and consideration by CVM. Thank you for bringing this
issue to the Center's attention and for providing the documentation
to support your concern.
Marcia K. Larkins D.V.M.
Ombudsman
Center for Veterinary Medicine
Tel: 240-276-9015
Fax: 240-276-9060
April 18, 2007 - AAEP is On Board !!!
Posted to EC List 4/18/2007 Msg #90405
Dear AAEP Members:
As you may be aware, the FDA has withdrawn the drug pergolide from
the market for use in humans. In order for the drug to continue to be
available for use in veterinary medicine, the FDA must approve an
exception for pergolide to be used by veterinarians and to be
compounded in bulk quantities.
The AAEP, through its Drug Compounding Task Force, has been in
contact with the FDA, and they are aware of the significant impact of
pergolide's withdrawal from the market on equine medicine. The FDA
Center for Veterinary Medicine is working with its counterpart for
human medicine, the Center for Drug Evaluation and Research, to allow
importation of pergolide for use by compounding pharmacies. The FDA
expects to have an official announcement by the end of this week.
The AAEP will continue to communicate with the FDA on this issue. For
updates, please visit the AAEP Web site at or call the AAEP office at
(800) 443-0177.
Sincerely,
The AAEP
Dear AAEP Members:
As you may be aware, the FDA has withdrawn the drug pergolide from
the market for use in humans. In order for the drug to continue to be
available for use in veterinary medicine, the FDA must approve an
exception for pergolide to be used by veterinarians and to be
compounded in bulk quantities.
The AAEP, through its Drug Compounding Task Force, has been in
contact with the FDA, and they are aware of the significant impact of
pergolide's withdrawal from the market on equine medicine. The FDA
Center for Veterinary Medicine is working with its counterpart for
human medicine, the Center for Drug Evaluation and Research, to allow
importation of pergolide for use by compounding pharmacies. The FDA
expects to have an official announcement by the end of this week.
The AAEP will continue to communicate with the FDA on this issue. For
updates, please visit the AAEP Web site at or call the AAEP office at
(800) 443-0177.
Sincerely,
The AAEP
April 13, 2007 Clarification of Pergolide Supply
>Do you have email correspondence from these
> wholesalers that you can share, as you have letters from the FDA?
Yes, I do, but they're private e-mails (not government agencies) and
I don't have permission to broadcast them...
Without identifying the sender, here is an excerpt:
"...Here is what we know and/or what we suspect might happen.
- the FDA has not told us we cannot import the material so far
- the FDA issued a Human Compliance Policy Guideline (CPG)
about 4 years ago that specifically identified 20+ chemicals that
were banned or restricted for use in compounding due to safety
reasons. Presumably the withdrawal of pergolide for safety reasons
would fall under this CPG due to precedent.
- the FDA issued at Veterinary CPG shortly after the Human
CPG that stated all compounding from bulk chemicals for vet purposes
was illegal. There was talk at the time that they would issue a
short list of approved chemicals but according to people that saw the
list it was limited to chemicals commonly used to treat poisoning.
The FDA frequently cites AMDUCA as the rational for why bulk
chemicals are illegal.
- the judge in the Midland case did rule that vet compounding
from bulk chemicals is legal with the restriction that it be done for
non-food chain animals. Unfortunately, the way the federal district
courts operate this ruling only applies to the states within that
district.
- the FDA routinely asks us to provide intended use (and
names of likely customers) in writing for chemicals we import before
they will allow the chemical to clear customs. Given the withdrawal
for safety reasons in humans and the ban on the use of bulk chemicals
in vet practice it is entirely possible that they could refuse to let
this material into the country or into our hands."
If there was no issue here, why would the FDA be working on a
solution? You can review some of the controversies here:
http://www.islandpharmacy.com/site/1420401/page/773881
Maybe large pharmacies with big stockpiles are saying no problem,
maybe some pharmacies import drug directly in quantity and haven't
been stopped (yet). Maybe pharmacies are operating under the
impression that they won't be stopped because they haven't been in
the past (as in the link above), but if suppliers don't stock and
ship, there won't be an issue about whether what they are doing is
legal or not. There will be no supply.
We just have to wait and see what the FDA press release says next
week.
Eleanor
> wholesalers that you can share, as you have letters from the FDA?
Yes, I do, but they're private e-mails (not government agencies) and
I don't have permission to broadcast them...
Without identifying the sender, here is an excerpt:
"...Here is what we know and/or what we suspect might happen.
- the FDA has not told us we cannot import the material so far
- the FDA issued a Human Compliance Policy Guideline (CPG)
about 4 years ago that specifically identified 20+ chemicals that
were banned or restricted for use in compounding due to safety
reasons. Presumably the withdrawal of pergolide for safety reasons
would fall under this CPG due to precedent.
- the FDA issued at Veterinary CPG shortly after the Human
CPG that stated all compounding from bulk chemicals for vet purposes
was illegal. There was talk at the time that they would issue a
short list of approved chemicals but according to people that saw the
list it was limited to chemicals commonly used to treat poisoning.
The FDA frequently cites AMDUCA as the rational for why bulk
chemicals are illegal.
- the judge in the Midland case did rule that vet compounding
from bulk chemicals is legal with the restriction that it be done for
non-food chain animals. Unfortunately, the way the federal district
courts operate this ruling only applies to the states within that
district.
- the FDA routinely asks us to provide intended use (and
names of likely customers) in writing for chemicals we import before
they will allow the chemical to clear customs. Given the withdrawal
for safety reasons in humans and the ban on the use of bulk chemicals
in vet practice it is entirely possible that they could refuse to let
this material into the country or into our hands."
If there was no issue here, why would the FDA be working on a
solution? You can review some of the controversies here:
http://www.islandpharmacy.com/site/1420401/page/773881
Maybe large pharmacies with big stockpiles are saying no problem,
maybe some pharmacies import drug directly in quantity and haven't
been stopped (yet). Maybe pharmacies are operating under the
impression that they won't be stopped because they haven't been in
the past (as in the link above), but if suppliers don't stock and
ship, there won't be an issue about whether what they are doing is
legal or not. There will be no supply.
We just have to wait and see what the FDA press release says next
week.
Eleanor
Update April 13, 2007
Posted to EC List 4/13/2007 Msg #90178
--- In EquineCushings@yahoogroups.com, "Ian Hudgings" [of Vet Pet Solutions compounding pharmacy] wrote:
>
>
> The reason the wholesalers can't get Pergolide is because it is on an
> FDA hold and will be seized by customs at the border. Even if I could
> find a source for bulk Pergolide and convince them to ship it to me,
> it would likely get seized and we would still be in the same
> situation.
The last I heard from a wholesaler (and this information is a week old
so maybe things have changed), the FDA has not taken any action to stop
movement of pergolide, and really would have no reason to do that since
the legal demand for the drug is gone. The finished product (pergolide
pills) manufacturers have ceased production.
The FDA theoretically could seize pergolide or ban importation, but as
far as I know that has not occurred. The reason the wholesalers are no
longer wanting to carry it is simply that there is no legal avenue for
them to sell it.
The compounding of veterinary drugs from bulk powder like this is
considered illegal by the FDA. There is one court decision that
disagrees with that stance, two that uphold it. The only reason it's
even a point of contention is that the original legislation permitting
veterinary compounding did not specifically mention compounding from
bulk drugs. However, a later Compliance Guideline policy statement by
the FDA specifically prohibits compounding from bulk drugs. To put it
another way, even if the human manufacturers hadn't withdrawn the drug
from the market, it could still be illegal for compounding pharmacies
to make pergolide for equine use from bulk drugs. The reason for this
policy is that compounded drugs are not checked for potency and purity
the way manufactured drugs are. We've already seen multiple times on
this list how that can cause problems.
The wholesalers are caught in the middle. They can't legally sell bulk
pergolide to compounding pharmacies.
The only way around this would be for the FDA to make an exception in
the case of pergolide for Cushing's horses. They might also decide to
try to encourage one of the previous pill manufacturers to start
production again. Until this is sorted out, the other option you and
your vets all have individually is to submit a MNVD request as I
outlined yesterday. Post 90108.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
The sooner they start getting these requests, the sooner they'll
realize there's a problem.
Eleanor
--- In EquineCushings@yahoogroups.com, "Ian Hudgings"
>
>
> The reason the wholesalers can't get Pergolide is because it is on an
> FDA hold and will be seized by customs at the border. Even if I could
> find a source for bulk Pergolide and convince them to ship it to me,
> it would likely get seized and we would still be in the same
> situation.
The last I heard from a wholesaler (and this information is a week old
so maybe things have changed), the FDA has not taken any action to stop
movement of pergolide, and really would have no reason to do that since
the legal demand for the drug is gone. The finished product (pergolide
pills) manufacturers have ceased production.
The FDA theoretically could seize pergolide or ban importation, but as
far as I know that has not occurred. The reason the wholesalers are no
longer wanting to carry it is simply that there is no legal avenue for
them to sell it.
The compounding of veterinary drugs from bulk powder like this is
considered illegal by the FDA. There is one court decision that
disagrees with that stance, two that uphold it. The only reason it's
even a point of contention is that the original legislation permitting
veterinary compounding did not specifically mention compounding from
bulk drugs. However, a later Compliance Guideline policy statement by
the FDA specifically prohibits compounding from bulk drugs. To put it
another way, even if the human manufacturers hadn't withdrawn the drug
from the market, it could still be illegal for compounding pharmacies
to make pergolide for equine use from bulk drugs. The reason for this
policy is that compounded drugs are not checked for potency and purity
the way manufactured drugs are. We've already seen multiple times on
this list how that can cause problems.
The wholesalers are caught in the middle. They can't legally sell bulk
pergolide to compounding pharmacies.
The only way around this would be for the FDA to make an exception in
the case of pergolide for Cushing's horses. They might also decide to
try to encourage one of the previous pill manufacturers to start
production again. Until this is sorted out, the other option you and
your vets all have individually is to submit a MNVD request as I
outlined yesterday. Post 90108.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
The sooner they start getting these requests, the sooner they'll
realize there's a problem.
Eleanor
Update April 12, 2007 (Includes correspondance with FDA/CVM)
Posted to EC List 4/12/2007 Msg #90108
Below is the early stages of an exchange with the FDA. Bottom line
situation here is that the compounded pergolide most of you rely on
is, according to an FDA policy statement, illegal.
http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html
The FDA cannot police every compounding pharmacy, but they can more
easily target the wholesalers. The wholesalers know this. No
wholesale shipments, no drug available to the compounders.
The FDA has proposed two solutions which appear below. One is to
convince the prior pill manufacturers to produce the drug for
veterinary use. This hasn't happened yet, and if it does it will be
the ONLY legal source of pergolide and your costs will more than
likely go up. Second option is to have your veterinarian petition the
FDA for an urgent need exemption for use of pergolide in your horse:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
Since compounding from bulk is the only available option at the
moment, they would have to grant that permission but so far are
offering it only on a case by case basis. Considering the thousands
of horses that are probably on it, there's a chance that if we get
the ball rolling with these petitions they will quickly see the size
of the need and publish an exemption that allows bulk compounding of
pergolide for horses. This is a link to the process of getting an
exemption for an individual horse:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
Urge your vets to do this.
Third thing is that I have sent a letter and background information
to every state's Board of Pharmacy. The FDA Compliance Guidelines
reference two court decisions that upheld the illegality of
compounding from bulk drugs. However, a recent Federal Court decision
in Texas found that it was legal. We can't wait for the courts to
hash it out, but the differences of opinion do leave the door open
for any individual state to make an exception. Susie Gordon found a
roster of state pharmacy boards yesterday. All the e-mails work. I
just put it up as a .pdf file. Anyone with a horse that needs
pergolide should contact your state board and let them know. Ask your
vets to do the same. If we keep the pressure on, there should be some
resolution of this before supplies disappear.
We need to keep the petition Kellie put up rolling too. It's the
documentation of need. Kellie is adding the FDA Ombudsman and all the
state pharmacy boards to her list of people that get copies of the
signatures every few days. Contact your local horse groups, 4-H
clubs, breed organizations - anyone you can think of. Send them to
the library to sign if you have to, but keep the signatures coming.
We can do this!
OK, below is a mail I put up on a vets' list this morning. It has the
exchange with the FDA in it, and what I wrote on that list.
Eleanor
Below is a copy of the first stages of an exchange with the FDA
regarding pergolide. It is important to remember that the pergolide
compounded from bulk drug that most are using is actually an illegal
product. The FDA does not have the manpower to police every
compounding pharmacy, but they can keep track of what goes into and
out of a handful of wholesale supply houses. Now that there is no
longer any legal market for the drug, the supply will dry up.
The first option the FDA suggested was to convince manufacturers of
the pills to resume production. So far, they're not interested in
doing that. Maybe with FDA intervention they will. However, in that
case the only option will be the manufactured pills, likely to
considerably increase the cost to owners.
Their second suggestion was for individual veterinarians to petition
for a medically necessary veterinary drug exemption which, if I am
understanding her correctly, would need to be done on a case by case
basis. This could be an agonizingly slow and laborious process but
if it comes to that I wanted all of you to know there may be hoops to
jump through before you can get pergolide to your clients. Since
there aren't any other options, you could be granted permission to
use bulk compounded pergolide - assuming your compounder could get
it.
I'm hoping that the sheer magnitude of the need will lead to the FDA
publishing a specific exemption for compounding of pergolide from
bulk sources for use in horses with PPID, although that's probably
the last thing they want to do.
Letters and background information have also been sent to each
state's board of pharmacy, to hopefully open the door for exemptions
on a state by state basis. The 1994 AMDUCA legislation permitting
compounding did not specifically mention compounding from bulk drug
one way or the other. The compliance guidelines are FDA policy
statements, not law. They reference two court decisions that upheld
the ban on compounding from bulk drug, but a recent decision in a
Texas federal court ruled that veterinary compounding from bulk drug
was not illegal.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
-----Original Message-----
From: drkellon@aol.com
To: marcia.larkins@fda.hhs.gov
Sent: Thu, 12 Apr 2007 8:35 AM
Subject: Re: Urgent Matter
Dear Dr. Larkins,
Thank you for your reply.
To date, none of the previous manufacturers of pergolide mesylate
tablets has expressed an interest in continued production of the drug
for veterinary use. One of the reasons for the petition at
http://www.ipetitions.com/petition/savepergolide/index.html
which currently has almost 1400 signatures from both owners and
veterinarians, was to document that there is, indeed, a sizeable
market and need. We are periodically sending the previous
manufacturers spread sheet copies of the signatures. That option has
not opened up to us so far, but we will keep trying.
As for your second option, I will notify owners and veterinarians of
this pathway. However, given the number of horses involved and their
need to continue medication without interruption, I have a few
questions.
How long does the case review process take? That is, if veterinarians
were to wait until they actually had no other options, how long could
they expect to be without medication until a solution is achieved?
In the event manufacturers continue to express no interest in
resuming production, there would be no legal options available
according to Sec 608.400, CPG 7125.40 which specifically prohibits
compounding from bulk drug substances. Am I correct in assuming that
if the pharmaceutical industry continues to have no interest that
permission to use pergolide compounded from bulk drug may be granted
on a case by case basis, or does "case by case" actually mean for a
particular drug rather than each individual animal? Is there a way
the veterinary community at large could help expedite this process
for all horses with the need, rather than on an individual basis?
Would publishing a specific exemption for compounding of pergolide
from bulk drug for use in horses with PPID/Cushing's disease be a
viable option?
Use of pergolide in horses, a nonfood animal, poses no threat to
human health, and is of no environmental concern. We feel the
petition, which represents only a fraction of the horses impacted,
establishes the need and with voluntary withdrawal of the drug by
prior manufacturers we have a de facto loss of availability and no
approved avenues for obtaining it. Please advise whether individual
veterinarians/practices should begin the MNVP process for their
patients, or if there is a way this can be resolved on a larger scale.
Thank you.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
-----Original Message-----
From: marcia.larkins@fda.hhs.gov
To: drkellon@aol.com
Sent: Wed, 11 Apr 2007 7:01 PM
Subject: RE: Urgent Matter
Dear Dr. Kellon,
I have spoken with a staff member in the Division of Compliance
concerning the withdrawal of pergolide mesylate from the human market
and your request for clarification of the Center for Veterinary
Medicine's (CVM) position on this product for veterinary use. There
are two options to consider. The first option is for you to contact
(one or all of) the companies that were marketing the drug and ask
them to consider making it available with a label for veterinary
use. They should then contact CVM to find out what information/data
would need to be submitted for review and consideration.
The second option would involve you finding an alternate source for
the drug and requesting that CVM grant you permission to use it under
the Medically Necessary Veterinary Drug Product Shortage Management
policy (see http://www.fda.gov/cvm/Policy_Procedures/4170.pdf).
There is specific information required that can only be provided by
the requesting veterinarian and each request is considered on a case-
by-case basis. You should contact CVM before submitting a request
under this policy.
I hope this information is helpful. If I can be of any further
assistance please contact me by email or by phone.
Marcia K. Larkins D.V.M.
Ombudsman
Center for Veterinary Medicine
Tel: 240-276-9015
Fax: 240-276-9060
----------------------------------------------------------------------
----------
From: drkellon@aol.com [mailto:drkellon@aol.com]
Sent: Tuesday, April 10, 2007 10:12 AM
To: Larkins, Marcia K
Subject: Urgent Matter
Dear Dr. Larkins,
I apologize in advance if your office is not the proper place for
this issue, but since it involves the FDA proper and CVM on several
levels I am not sure where to turn. Please see the attached file. In
brief, the voluntary withdrawal of pergolide mesylate from the human
market is poised to have a disastrous impact on the health, even
survival, of many horses with pituitary dysfunction (pituitar pars
intermedia dysfunction, aka Equine Cushing's Diease). Owners of
horses that were relying on Permax or the generic tablets are already
having difficulty sourcing the drug from remaining supplies on the
market. Wholesalers supplying veterinary compounding pharmacies have
either decided to no longer stock it or are concerned/confused about
legality.
We are in desperate need of a clarification.
Thank you.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Below is the early stages of an exchange with the FDA. Bottom line
situation here is that the compounded pergolide most of you rely on
is, according to an FDA policy statement, illegal.
http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html
The FDA cannot police every compounding pharmacy, but they can more
easily target the wholesalers. The wholesalers know this. No
wholesale shipments, no drug available to the compounders.
The FDA has proposed two solutions which appear below. One is to
convince the prior pill manufacturers to produce the drug for
veterinary use. This hasn't happened yet, and if it does it will be
the ONLY legal source of pergolide and your costs will more than
likely go up. Second option is to have your veterinarian petition the
FDA for an urgent need exemption for use of pergolide in your horse:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
Since compounding from bulk is the only available option at the
moment, they would have to grant that permission but so far are
offering it only on a case by case basis. Considering the thousands
of horses that are probably on it, there's a chance that if we get
the ball rolling with these petitions they will quickly see the size
of the need and publish an exemption that allows bulk compounding of
pergolide for horses. This is a link to the process of getting an
exemption for an individual horse:
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
Urge your vets to do this.
Third thing is that I have sent a letter and background information
to every state's Board of Pharmacy. The FDA Compliance Guidelines
reference two court decisions that upheld the illegality of
compounding from bulk drugs. However, a recent Federal Court decision
in Texas found that it was legal. We can't wait for the courts to
hash it out, but the differences of opinion do leave the door open
for any individual state to make an exception. Susie Gordon found a
roster of state pharmacy boards yesterday. All the e-mails work. I
just put it up as a .pdf file. Anyone with a horse that needs
pergolide should contact your state board and let them know. Ask your
vets to do the same. If we keep the pressure on, there should be some
resolution of this before supplies disappear.
We need to keep the petition Kellie put up rolling too. It's the
documentation of need. Kellie is adding the FDA Ombudsman and all the
state pharmacy boards to her list of people that get copies of the
signatures every few days. Contact your local horse groups, 4-H
clubs, breed organizations - anyone you can think of. Send them to
the library to sign if you have to, but keep the signatures coming.
We can do this!
OK, below is a mail I put up on a vets' list this morning. It has the
exchange with the FDA in it, and what I wrote on that list.
Eleanor
Below is a copy of the first stages of an exchange with the FDA
regarding pergolide. It is important to remember that the pergolide
compounded from bulk drug that most are using is actually an illegal
product. The FDA does not have the manpower to police every
compounding pharmacy, but they can keep track of what goes into and
out of a handful of wholesale supply houses. Now that there is no
longer any legal market for the drug, the supply will dry up.
The first option the FDA suggested was to convince manufacturers of
the pills to resume production. So far, they're not interested in
doing that. Maybe with FDA intervention they will. However, in that
case the only option will be the manufactured pills, likely to
considerably increase the cost to owners.
Their second suggestion was for individual veterinarians to petition
for a medically necessary veterinary drug exemption which, if I am
understanding her correctly, would need to be done on a case by case
basis. This could be an agonizingly slow and laborious process but
if it comes to that I wanted all of you to know there may be hoops to
jump through before you can get pergolide to your clients. Since
there aren't any other options, you could be granted permission to
use bulk compounded pergolide - assuming your compounder could get
it.
I'm hoping that the sheer magnitude of the need will lead to the FDA
publishing a specific exemption for compounding of pergolide from
bulk sources for use in horses with PPID, although that's probably
the last thing they want to do.
Letters and background information have also been sent to each
state's board of pharmacy, to hopefully open the door for exemptions
on a state by state basis. The 1994 AMDUCA legislation permitting
compounding did not specifically mention compounding from bulk drug
one way or the other. The compliance guidelines are FDA policy
statements, not law. They reference two court decisions that upheld
the ban on compounding from bulk drug, but a recent decision in a
Texas federal court ruled that veterinary compounding from bulk drug
was not illegal.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
-----Original Message-----
From: drkellon@aol.com
To: marcia.larkins@fda.hhs.gov
Sent: Thu, 12 Apr 2007 8:35 AM
Subject: Re: Urgent Matter
Dear Dr. Larkins,
Thank you for your reply.
To date, none of the previous manufacturers of pergolide mesylate
tablets has expressed an interest in continued production of the drug
for veterinary use. One of the reasons for the petition at
http://www.ipetitions.com/petition/savepergolide/index.html
which currently has almost 1400 signatures from both owners and
veterinarians, was to document that there is, indeed, a sizeable
market and need. We are periodically sending the previous
manufacturers spread sheet copies of the signatures. That option has
not opened up to us so far, but we will keep trying.
As for your second option, I will notify owners and veterinarians of
this pathway. However, given the number of horses involved and their
need to continue medication without interruption, I have a few
questions.
How long does the case review process take? That is, if veterinarians
were to wait until they actually had no other options, how long could
they expect to be without medication until a solution is achieved?
In the event manufacturers continue to express no interest in
resuming production, there would be no legal options available
according to Sec 608.400, CPG 7125.40 which specifically prohibits
compounding from bulk drug substances. Am I correct in assuming that
if the pharmaceutical industry continues to have no interest that
permission to use pergolide compounded from bulk drug may be granted
on a case by case basis, or does "case by case" actually mean for a
particular drug rather than each individual animal? Is there a way
the veterinary community at large could help expedite this process
for all horses with the need, rather than on an individual basis?
Would publishing a specific exemption for compounding of pergolide
from bulk drug for use in horses with PPID/Cushing's disease be a
viable option?
Use of pergolide in horses, a nonfood animal, poses no threat to
human health, and is of no environmental concern. We feel the
petition, which represents only a fraction of the horses impacted,
establishes the need and with voluntary withdrawal of the drug by
prior manufacturers we have a de facto loss of availability and no
approved avenues for obtaining it. Please advise whether individual
veterinarians/practices should begin the MNVP process for their
patients, or if there is a way this can be resolved on a larger scale.
Thank you.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
-----Original Message-----
From: marcia.larkins@fda.hhs.gov
To: drkellon@aol.com
Sent: Wed, 11 Apr 2007 7:01 PM
Subject: RE: Urgent Matter
Dear Dr. Kellon,
I have spoken with a staff member in the Division of Compliance
concerning the withdrawal of pergolide mesylate from the human market
and your request for clarification of the Center for Veterinary
Medicine's (CVM) position on this product for veterinary use. There
are two options to consider. The first option is for you to contact
(one or all of) the companies that were marketing the drug and ask
them to consider making it available with a label for veterinary
use. They should then contact CVM to find out what information/data
would need to be submitted for review and consideration.
The second option would involve you finding an alternate source for
the drug and requesting that CVM grant you permission to use it under
the Medically Necessary Veterinary Drug Product Shortage Management
policy (see http://www.fda.gov/cvm/Policy_Procedures/4170.pdf).
There is specific information required that can only be provided by
the requesting veterinarian and each request is considered on a case-
by-case basis. You should contact CVM before submitting a request
under this policy.
I hope this information is helpful. If I can be of any further
assistance please contact me by email or by phone.
Marcia K. Larkins D.V.M.
Ombudsman
Center for Veterinary Medicine
Tel: 240-276-9015
Fax: 240-276-9060
----------------------------------------------------------------------
----------
From: drkellon@aol.com [mailto:drkellon@aol.com]
Sent: Tuesday, April 10, 2007 10:12 AM
To: Larkins, Marcia K
Subject: Urgent Matter
Dear Dr. Larkins,
I apologize in advance if your office is not the proper place for
this issue, but since it involves the FDA proper and CVM on several
levels I am not sure where to turn. Please see the attached file. In
brief, the voluntary withdrawal of pergolide mesylate from the human
market is poised to have a disastrous impact on the health, even
survival, of many horses with pituitary dysfunction (pituitar pars
intermedia dysfunction, aka Equine Cushing's Diease). Owners of
horses that were relying on Permax or the generic tablets are already
having difficulty sourcing the drug from remaining supplies on the
market. Wholesalers supplying veterinary compounding pharmacies have
either decided to no longer stock it or are concerned/confused about
legality.
We are in desperate need of a clarification.
Thank you.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Update April 10, 2007
Posted on EC List 4/10/2007 Msg #90005
In speaking with some upper level management at drug wholesalers
yesterday, they came up with a variety of reasons for not stocking,
or considering not stocking, pergolide. Some of them were flat out
incorrect. Most, however, centered over concern about what the FDA
would do. They are saying they wouldn't be surprised if a prohibition
was put on the importation of pergolide (not there yet), and also
concerned for their own liability if they sell pergolide in bulk to a
compounding pharmacy (although obviously they've been doing this for
years). Problem is the FDA has been increasingly vigilant about
asking the wholesalers to identify where the drugs are going. With
the human market shut down, it would be obvious it's going to
veterinary compounders. Problem is, according to a Compliance
Guideline Document (this is *not* a law, it's a statement of action
the FDA might be inclined to take under a given set of
circumstances), compounding of veterinary prescriptions from bulk
drugs is a violation.
Here's where it gets sticky. A federal court decision in a Texas
district found that compounding of veterinary prescriptions from bulk
drug was not illegal. The official law on compounding of drugs for
nonfood animals, the 1994 AMDUCA (Animal Medicinal Drug Use
Clarification Act) permits compounding of drugs within the framework
of a valid veterinarian-client-patient relationship, i.e. your horse
is sick, your vet prescribes something for you, his/her client, to
give. AMDUCA doesn't mention compounding from bulk drug ingredients.
So, bottom line is that while we have to keep informing drug
wholesalers and generic pill manufacturers of the size of the market,
we also need to make the FDA very much aware of the need. Wholesalers
that fear prosecution are not going to stock this drug. That's why we
have moved the FDA to the top of the contact list on the petition.
Kellie is going to send copies of the petition response to everyone
on the petition list every few days. Wouldn't hurt one bit for anyone
who is so inclined to also send a personal e-mail to the FDA, or a
fax. The information is on the petition. Regulation of equine issues
really isn't usually very high on the FDAs list of priorities and in
issues like this they are usually very responsive to public feedback.
A good example of this is the threat to pull supplements like
glucosamine off the market a few years back.
I haven't gotten any feedback from the FDA yet. Will let everyone
know as soon as I do. In the meantime, keep the pressure on. E-MAIL
THE FDA!
Eleanor
In speaking with some upper level management at drug wholesalers
yesterday, they came up with a variety of reasons for not stocking,
or considering not stocking, pergolide. Some of them were flat out
incorrect. Most, however, centered over concern about what the FDA
would do. They are saying they wouldn't be surprised if a prohibition
was put on the importation of pergolide (not there yet), and also
concerned for their own liability if they sell pergolide in bulk to a
compounding pharmacy (although obviously they've been doing this for
years). Problem is the FDA has been increasingly vigilant about
asking the wholesalers to identify where the drugs are going. With
the human market shut down, it would be obvious it's going to
veterinary compounders. Problem is, according to a Compliance
Guideline Document (this is *not* a law, it's a statement of action
the FDA might be inclined to take under a given set of
circumstances), compounding of veterinary prescriptions from bulk
drugs is a violation.
Here's where it gets sticky. A federal court decision in a Texas
district found that compounding of veterinary prescriptions from bulk
drug was not illegal. The official law on compounding of drugs for
nonfood animals, the 1994 AMDUCA (Animal Medicinal Drug Use
Clarification Act) permits compounding of drugs within the framework
of a valid veterinarian-client-patient relationship, i.e. your horse
is sick, your vet prescribes something for you, his/her client, to
give. AMDUCA doesn't mention compounding from bulk drug ingredients.
So, bottom line is that while we have to keep informing drug
wholesalers and generic pill manufacturers of the size of the market,
we also need to make the FDA very much aware of the need. Wholesalers
that fear prosecution are not going to stock this drug. That's why we
have moved the FDA to the top of the contact list on the petition.
Kellie is going to send copies of the petition response to everyone
on the petition list every few days. Wouldn't hurt one bit for anyone
who is so inclined to also send a personal e-mail to the FDA, or a
fax. The information is on the petition. Regulation of equine issues
really isn't usually very high on the FDAs list of priorities and in
issues like this they are usually very responsive to public feedback.
A good example of this is the threat to pull supplements like
glucosamine off the market a few years back.
I haven't gotten any feedback from the FDA yet. Will let everyone
know as soon as I do. In the meantime, keep the pressure on. E-MAIL
THE FDA!
Eleanor
Update April 9, 2007 (Includes letter to Wholesalers)
Posted to EC List 4/9/2007 Msg #89950
I'm already starting to get mails from people using the human generics
and Permax saying that their pharmacies are out. All three pill
producers have stopped manufacturing. It appears that the only way the
pills will be produced again is if one of the 3 manufacturers appeals
to the USDA for a special permit. If that happens, that single
manufacturer will be the only source of pill form pergolide. Anyone
currently using pills would be wise to switch to compounded.
*The most accurate way to dose compounded pergolide is in capsule form.
In addition, anyone making a switch to a compounder should make sure
that:
1. The compounder is fully licensed.
2. The compounder only uses bulk drugs that come from FDA approved drug
wholesalers. Ask for the name of their pergolide bulk drug wholesaler.
If it's not on the list below, don't use that compounder.
The petition is going strong, creeping up on 700 signatures
representing thousands of horses. In addition to signing the petition,
I would encourage anyone who feels so inclined to contact the
wholesalers directly by phone, fax or e-mail. When you do, be sure to
mention the name of your compounding pharmacy. One or more of the
wholesalers will recognize them as their clients and will be able to
check their sales records. As soon as a wholesaler confirms they will
continue to stock pergolide and keep the supply uninterrupted, we'll
take them off our contacts list. Also provide a link to the petition
when you contact them. This will be the quickest way to let them know
we have a need - a BIG need! Remember, the drug is out there. The human
market in the USA was very small compared to the rest of the world.
This is what I sent the wholesalers over the weekend and this morning.
Directly below that is a list of the FDA approved wholesalers who were
stocking pergolide and all the contact info I currently have.
Make your voice heard!
-------------------------------
I am a veterinarian and co-owner of the over 5000 member Yahoo Equine
Cushing's group. As you know, at the FDA's urging pergolide mesylate
has been removed from the human market. The three US suppliers of
pergolide tablets are no longer producing the drug. What you may not
realize is that bulk sales of pergolide to compounders are largely
going to the veterinary market.
Pergolide is the only effective pharmacological therapy for horses with
Cushing's Disease, pituitary pars intermedia dysfunction. I believe
that drug wholesalers are unaware of the size of the veterinary market.
It is critically important to keep pergolide available for veterinary
use. The FDA action does not impact off-label use in horses.
A web petition has been put up to collect signatures and comments
regarding the use of pergolide in horses:
http://www.ipetitions.com/petition/savepergolide/index.html
The petition was put up noon on April 6. Despite the holiday weekend,
there are already 14 pages of signatures, reflecting the needs of
thousands of horses. This is only the tip of the iceberg. There are
currently 10 to 12 million horses in the United States, of which
approximately 10% are age 20 or older. It has been estimated that
virtually any equine that lives long enough will develop the
degenerative changes of dopaminergic neurons that leads to pituitary
dysfunction and Cushing's disease. This disease may begin much earlier
in some horses, in their teens. Pergolide is needed by these animals
for the remainder of their life.
We urge you to continue to stock pergolide mesylate. There is a market.
Owners that had been relying on Permax or generic human tablets are
already encountering shortages. There is an urgent need to keep an
uninterrupted flow of pergolide mesylate to compounders.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Co-Owner, Yahoo Equine Cushings
http://pets.groups.yahoo.com/group/EquineCushings/
I'm already starting to get mails from people using the human generics
and Permax saying that their pharmacies are out. All three pill
producers have stopped manufacturing. It appears that the only way the
pills will be produced again is if one of the 3 manufacturers appeals
to the USDA for a special permit. If that happens, that single
manufacturer will be the only source of pill form pergolide. Anyone
currently using pills would be wise to switch to compounded.
*The most accurate way to dose compounded pergolide is in capsule form.
In addition, anyone making a switch to a compounder should make sure
that:
1. The compounder is fully licensed.
2. The compounder only uses bulk drugs that come from FDA approved drug
wholesalers. Ask for the name of their pergolide bulk drug wholesaler.
If it's not on the list below, don't use that compounder.
The petition is going strong, creeping up on 700 signatures
representing thousands of horses. In addition to signing the petition,
I would encourage anyone who feels so inclined to contact the
wholesalers directly by phone, fax or e-mail. When you do, be sure to
mention the name of your compounding pharmacy. One or more of the
wholesalers will recognize them as their clients and will be able to
check their sales records. As soon as a wholesaler confirms they will
continue to stock pergolide and keep the supply uninterrupted, we'll
take them off our contacts list. Also provide a link to the petition
when you contact them. This will be the quickest way to let them know
we have a need - a BIG need! Remember, the drug is out there. The human
market in the USA was very small compared to the rest of the world.
This is what I sent the wholesalers over the weekend and this morning.
Directly below that is a list of the FDA approved wholesalers who were
stocking pergolide and all the contact info I currently have.
Make your voice heard!
-------------------------------
I am a veterinarian and co-owner of the over 5000 member Yahoo Equine
Cushing's group. As you know, at the FDA's urging pergolide mesylate
has been removed from the human market. The three US suppliers of
pergolide tablets are no longer producing the drug. What you may not
realize is that bulk sales of pergolide to compounders are largely
going to the veterinary market.
Pergolide is the only effective pharmacological therapy for horses with
Cushing's Disease, pituitary pars intermedia dysfunction. I believe
that drug wholesalers are unaware of the size of the veterinary market.
It is critically important to keep pergolide available for veterinary
use. The FDA action does not impact off-label use in horses.
A web petition has been put up to collect signatures and comments
regarding the use of pergolide in horses:
http://www.ipetitions.com/petition/savepergolide/index.html
The petition was put up noon on April 6. Despite the holiday weekend,
there are already 14 pages of signatures, reflecting the needs of
thousands of horses. This is only the tip of the iceberg. There are
currently 10 to 12 million horses in the United States, of which
approximately 10% are age 20 or older. It has been estimated that
virtually any equine that lives long enough will develop the
degenerative changes of dopaminergic neurons that leads to pituitary
dysfunction and Cushing's disease. This disease may begin much earlier
in some horses, in their teens. Pergolide is needed by these animals
for the remainder of their life.
We urge you to continue to stock pergolide mesylate. There is a market.
Owners that had been relying on Permax or generic human tablets are
already encountering shortages. There is an urgent need to keep an
uninterrupted flow of pergolide mesylate to compounders.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Co-Owner, Yahoo Equine Cushings
http://pets.groups.yahoo.com/group/EquineCushings/
FDA and CVM Contact Detail
FDA (Food and Drug Administration)
Virginia Behr
CDER Ombudsman
FDA Center for Drug Evaluation and Research
White Oak CDER Office Building 22, Rm 6322
10903 New Hampshire Avenue
Silver Spring MD 20993
301-796-0675 Phone
301-796-9883 Fax
virginia.behr@fda.hhs.gov
Andrew von Eschenbach
Commissioner
Food and Drug Administration
Parklawn Bldg, Rm 1471
5600 Fishers Lane
Rockville MD 20857
301-827-2410 phone
301-443-3100 fax
andrew.voneschenbach@fda.hhs.gov
David J. Horowitz, Esq.
Director, Office of Compliance
FDA Center for Drug Evaluation and Research
Parklawn Bldg, Rm 405
5600 Fishers Lane
Rockville, MD 20857
301-827-4225 - phone
301-443-6591 - fax
david.horowitz@fda.hhs.gov
Stephen K. Galson, M.D.
Director
FDA Center for Drug Evaluation and Research
Rockwall II Bldg, Rm 7100
5515 Security Ln.
Rockville, MD 20852
301-594-5400 - phone
mailto:steven.galson@fda.hhs.gov
CVM (Center for Veterinary Medicine)
Stephen Sundlof, D.V.M.
Director
FDA Center for Veterinary Medicine
Metro Park North 4, Rm 181
7519 Standish Place
Rockville MD 20855
240-276-9000 - phone
240-276-9060 - fax
stephen.sundlof@fda.hhs.gov
Marcia Larkins, D.V.M.
Ombudsman
FDA Center for Veterinary Medicine
Metro Park North 4, Rm 165
7519 Standish Place
Rockville, MD 20855
240-276-9015 - phone
240-276-9060 - fax
marcia.larkins@fda.hhs.gov
Virginia Behr
CDER Ombudsman
FDA Center for Drug Evaluation and Research
White Oak CDER Office Building 22, Rm 6322
10903 New Hampshire Avenue
Silver Spring MD 20993
301-796-0675 Phone
301-796-9883 Fax
virginia.behr@fda.hhs.gov
Andrew von Eschenbach
Commissioner
Food and Drug Administration
Parklawn Bldg, Rm 1471
5600 Fishers Lane
Rockville MD 20857
301-827-2410 phone
301-443-3100 fax
andrew.voneschenbach@fda.hhs.gov
David J. Horowitz, Esq.
Director, Office of Compliance
FDA Center for Drug Evaluation and Research
Parklawn Bldg, Rm 405
5600 Fishers Lane
Rockville, MD 20857
301-827-4225 - phone
301-443-6591 - fax
david.horowitz@fda.hhs.gov
Stephen K. Galson, M.D.
Director
FDA Center for Drug Evaluation and Research
Rockwall II Bldg, Rm 7100
5515 Security Ln.
Rockville, MD 20852
301-594-5400 - phone
mailto:steven.galson@fda.hhs.gov
CVM (Center for Veterinary Medicine)
Stephen Sundlof, D.V.M.
Director
FDA Center for Veterinary Medicine
Metro Park North 4, Rm 181
7519 Standish Place
Rockville MD 20855
240-276-9000 - phone
240-276-9060 - fax
stephen.sundlof@fda.hhs.gov
Marcia Larkins, D.V.M.
Ombudsman
FDA Center for Veterinary Medicine
Metro Park North 4, Rm 165
7519 Standish Place
Rockville, MD 20855
240-276-9015 - phone
240-276-9060 - fax
marcia.larkins@fda.hhs.gov
New Media Contact Links Added
Check the Media Links for new contacts added.
If you know of others that should be added, let us know in a comment here.
If you know of others that should be added, let us know in a comment here.
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