Sunday, May 6, 2007

Horse Owner's Response to Generic FDA Reply

I am glad to hear that the FDA is apparently working on a solution to the
pergolide crisis.

However, if you will forgive me, I am having a hard time believing that your
agency really understands the urgency of the pergolide situation. Because, in my opinion, if you really got it, the FDA would have solved the problem by now.

Please understand that every day the FDA drags its feet and does not resolve
this crisis is a precious day that is wasted, where our horses are closer to not having the life saving drug that they need. Horses that die due to a pergolide shortage will have died needless and premature deaths. We should not have to lose a single horse before the FDA acts.

There are no more pergolide pills available in the pharmacies, the only "legal"
source of the drug, according to your agency. Supplies of the bulk drug for compounding are quickly dwindling. We do not have the luxury of time waiting for the FDA to get around to a solution. PLEASE RESOLVE THIS NOW.

"The lives of our horses are in your hands and, if you were in our place, you
would realize that waiting is not an option.


[Horse Owner and Horse]

Generic CVM Response to Letters

This is representative of the fairly generic responses to their letters being received by horse owners from CVM Ombudsman Marcia Larkins, V.M.D.
"Review and consideration" can take a long time.

"Your email messages to Dr. Sundlof and to the CDER Ombudsman were forwarded to me. Thank you for sharing your story about your horse. The Center for Veterinary Medicine (CVM) is sensitive to your concerns about [horse's name] health and well being. As stated in my previous response to you CVM is very aware of the impact of the withdrawal of the human pergolide product. The future availability of the product to veterinarians for use in the treatment of Equine Cushing's Disease is currently under review and consideration by CVM. The Center understands the importance and sense of urgency among horse owners about this product and is actively working on finding a resolution as soon as possible."