Our horses face a crisis in health care. The issue' The potential loss of pergolide, the remedy of choice in combatting Cushing’s disease. The drug is being withdrawn from human use, which is certain to limit its availability for equine use and will make it impossible to import (see story on page 9).
Only the FDA can correct this problem, as no drug manufacturer seems to be interested in resuming production of pergolide for veterinary use only. However, the remaining supply of pergolide is so low, the drug is likely to disappear at least for a while anyway. It doesn’t have to happen, though, as there are several avenues open to the FDA to correct the problem:
• 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 free drug wholesalers to import bulk drug and supply compounders. This would be 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.
• Former U.S. manufacturers of the human pill form could resume production.
• The FDA could allow importation of pergolide pills produced in other countries.
• A drug company could begin the drug-approval process for pergolide as a treatment for Cushing’s. Preliminary communications with the FDA staff in the division of MUMS (Minor Uses and Minor Species) indicates they may be able to help. This division was created to 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.
In the event the FDA doesn’t offer a short-term solution quickly enough, and owners and vets are unable to find a source for the drug, the veterinarian can apply for a Medically Necessary Veterinary Drug exception. See http://www.fda.gov/cvm/Policy_Procedures/4170.pdf.
This would enable the veterinarian to import drugs to treat his/her patient(s). Because of inherent delays in processing, and a likely large volume of petitions, don’t wait until the last minute.
Why is the FDA balking on helping these horses and owners' Because neither allowing compounding from bulk or allowing owners to import from other countries is something the FDA wants to do.
This is a crisis. The FDA’s own guidelines allow for exercising ”regulatory discretion” in the case of drug shortages caused by FDA actions when there’s no other option. Public outcry helped save our nutraceutical supplements. It can help now, too. See page 9 for information on how to make your voice heard.