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

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

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

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]

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.

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

Plan "B" if US Supply Dries Up (plan ahead)

Posted on EC List 4/28/2007 Msg #90807

Re: Plan B - Pergolide

To stay on pergolide, your vet can apply for a Medically Necessary
Veterinary Drug exception. The details on how to do this are here:

http://www.fda.gov/cvm/Policy_Procedures/4170.pdf

In fact, that pathway was the initial suggestion we got from the FDA
before they realized the magnitude of the problem and decided they
didn't want to process thousands of these applications but if that's
what it takes to make them move, so be it. Please note that your vet,
or presumably your vet's office at least, has to call to request the
necessary forms. They won't send them out to owners. That document is
worth reading. It states that the FDA recognizes they have a
responsibility to get drugs out to the people or animals that need
them.

This process would allow your vet to import pergolide (e.g. from
Canada) for your horse. Price will be higher than compounded, but
nothing like what one member told she just paid yesterday for generic
pergolide pills that she located at a US pharmacy - ***OVER $6.00 PER
MG*** - more than double what she was paying. At 1 mg/day, at current
pricing, a 30 day supply would run about $60

http://www.seniormedications.com/drug_list/pergolide.htm

Another alternative, although highly experimental at this point,
would be to try cabergoline (brand name Dostinex) instead. You can
legally order this from a Candian pharmacy, generic version, at a
very low cost, possibly as low as $20/month. I apologize for not
sending out those cabergline files to those that requested them yet.
It was sounding so hopeful for an early solution a while back that I
held off, then got caught up in the pergolide problem again. Will do
that as soon as I finish this post. [If you require information on cabergoline
for your equine patients, please enter a comment at the end of this article
and you will be contacted.]

There are other dopamine agonists also, but we have ZERO information
on what dosages might be appropriate, safety, etc.

Vitex agnus-castus/Chastetree berry: Good track record for
symptomatic control (laminitis, coat quality, etc.) but not all
respond, those that do respond may become refractory to it. Also
concerning that the blood work doesn't necessarily reflect the
clinical improvements.

Now, back to plan A! Don't get too discouraged yet. The FDA is
sensitive to its public image. If it wasn't for the controversy over
compounding, they wouldn't be dragging their feet like they are. It's
not over yet.

Eleanor

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

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

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



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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