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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

Cushings Crisis
April 2007

URGENT NEW INFORMATION
concerning the availability of pergolide for equine Cushing's Disease

4/27/07 Dr. Kellon via email from Susie Gordon, M.D.

First, please let me state that I am well of the current controversy regarding compounders' activities and that Sec. 608.400 - Compounding of Drugs for Use in Animals (CPG 7125.40), quite clearly states the FDA's position with regard to compounding from bulk drug. I am also aware that there are conflicting court opinions on this issue.

However, at this stage of your investigation into the pergolide availability problem I am also quite sure that everyone realizes by now that a very high percentage of horses being treated with pergolide were using bulk compounded drug. In fact, I would venture to say it is well over 90%. Below is an excerpt from a message I received yesterday from a large veterinary compounder. This one pharmacy alone was likely supplying as many horses as the low end estimate of PPID cases I had sent previously. If his estimation of the time line is correct, it is now critically import to avoid any further delay in finding an interim solution for these horses.

Policy issues involving compounding from bulk are peripheral to the problem facing these horses in my opinion, although I also appreciate that concerns regarding potency and purity are inherent to those policies. Even if the three prior human manufacturers were to agree to resume production, which I assume has not been the case or we would have heard about it, there still is the issue of the bulk drug no longer being available. Could they procure drug and resume production of a sufficient amount to prevent widespread shortages in the interim? Importation of finished product from other countries does not sound desirable, nor feasible, either.

On behalf of the owners of all these horses, allow me to strongly urge you to consider publishing an exemption to the prohibition for bulk compounding specifically for pergolide use in horses with PPID, at least as a interim measure until a long term satisfactory solution can be reached. We are running out of time here and it's the animals that are going to pay the price. There is a precedent to an exemption as several chemicals are already exempt.

Eleanor M. Kellon, V.M.D. co-owner Equine Cushing's and Insulin Resistance

http://pets.groups.yahoo.com/group/EquineCushings/

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