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