Animal & Veterinary
FDA PERMITS IMPORTATION OF DRUGS TO TREAT EPM
by Tania D. Woerner, V.M.D.
FDA Veterinarian Newsletter November/December 1998 Volume XIII, No VI
The Federal Food, Drug, and Cosmetic Act (FFDCA), Sec. 801 (a)(3), states that importation of a new animal drug that is not the subject of an approval in the United States is forbidden. However, the FDA’s Center for Veterinary Medicine recognizes that the lack of certain drugs could result in undue animal suffering. To address this situation, CVM has chosen to exercise regulatory discretion with respect to the personal importation of FDA-regulated new animal drugs providing the following conditions apply:
- the drug does not pose a significant risk to animal or human health
- the drug is used to treat or prevent a serious disease or condition in an animal
- there is no other available source of that drug or alternative drug(s) that is judged by CVM’s veterinary staff to be an adequate substitute
- the request for importation is made by a licensed veterinarian within the context of a valid veterinarian-client-patient relationship
- a relatively small amount of drug is requested for import
- there is no active promotion or marketing of the drug in U.S. markets for the intended use of the product
FDA is committed to working with veterinarians to supply drugs for legitimate medical needs; however, we also caution that drugs purchased outside the U.S. have not been subjected to our high standards for drug manufacturing and quality control, and that drug labeling may not be as detailed and/or comprehensive as U.S. approved products. In addition, the drugs have not been shown to be safe or effective for the intended purpose.
FDA considers equine protozoal myeloencephalitis (EPM) a serious disease; however, we recognize that there are treatments available in the U.S. which have been the standard treatment for the disease, i.e., sulfonamides and pyrimethamine. We also recognize that some horses do not respond to the conventional treatment, thus requiring alternative therapy, often times not available in the U.S. Veterinarians who wish to utilize the Personal Importation Policy for the treatment of EPM should contact Toni Wooten in the Center for Veterinary Medicine’s Division of Compliance at 301 -594-1785. For further information, please contact Dr. Tania D. Woerner, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855, telephone 301-827-0129.
Note: The veterinarian should be prepared to supply such information as drug name, drug class, name and address of supplier, amount of the drug to be imported and the reason why an approved human or animal drug will not treat the disease condition.