Thursday, May 3, 2007


Posted to EC List May 2, 2007 Msg #91035

A member ... got a copy of the instructions for filing a
medically necessary veterinary drug application today. I just put it
in the files and a notice should have gone out to everyone.
[Note - if you are not an EC List member and would like to request a copy
of this please enter a comment at the end of this article.]

This is the "safety net" pathway we've been talking about that lets
individuals get permission to import the drug until (if) the FDA
finds a solution to the shortage. Gotta tell you the fact they've
made a policy reversal on accepting these could be a bad sign. It
might mean they're hopelessly deadlocked on what to do about our

The application process isn't terribly long or complicated and I'll
post the answer to all the questions on there so your vets can
complete it in no time flat. Even if you still have some left, or
think you could get some (illegal) compounded drug, **ASK YOUR VET TO
FILE THE APPLICATION NOW**. Lord only knows what the "normal"
turnaround time is, and if it comes to hundreds or thousands of these
applications - well, you can imagine...

There was a "grapevine" rumor that today was to be the day for the
FDA announcement. In view of that, I waited to call the FDA again.
Not too surprisingly, no announcement. We have updates on adding
hydrogen peroxide added to fish water, but nothing on our horses.
They haven't even officially issued a press statement to the effect
that they are working on the problem.

Will let you know what, if anything, I can find out from the FDA

Otherwise, we must step up the pressure. Keep going with the media
contacts, organizations, etc. but bear in mind no one, including the
government, can make them do anything. Public pressure and bad press
can. Don't waste too much time on special interest groups except to
send an alert and request for signatures on the petition. Don't do
anything that takes your time and energy away from directly
contacting the FDA by phone, fax, snail mail, e-mail. The news media
campaign is worthwhile, but they'll be slow to act. They have to
research it first. First reaction is likely to be to toss it into the
trash can so volume of requests will be important to even start that
process. Don't let a day go by without contacting the FDA and PLEASE
we need more regional pergolide pill in pharmacies information. It
doesn't matter if your horse actually has Cushing's or not. It
doesn't matter if you have a stash of compounded pergolide or your
compounder says they do. The FDA is supposed to be concerned with
**legally available** drug. Document that you have no legally
available source.

They're stalling on this, trying to get a feel for how
genuinely "urgent" the situation is, hoping for some company to step
up to the plate to resume manufacturing so they can avoid having to
issue an importation or compounding exemption, but in the process
they're putting our horses in a very real danger of having a gap in
their treatment at the highest risk time of the year.

Priorities right now are:

- Document there is no legal available source in your area
- Encourage your vets to submit the medically necessary veterinary
drug information for your horse
- Continue to pressure, DAILY, the FDA and news media


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