Sunday, April 29, 2007

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


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