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U.S. Department of Health and Human Services

Animal & Veterinary

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VETERINARIANS MAY NOT PRESCRIBE THALIDOMIDE

FDA Veterinarian Newsletter 2002 Volume XVI, No VI

In response to inquiries received by CVM concerning thalidomide, the following statements explain in detail the reasons why veterinarians are not able to prescribe thalidomide for use in their animal patients.

Thalidomide is approved as a drug for use in humans for the treatment of skin lesions associated with erythema nodosum leprosum. Because of thalidomide's potential for causing birth defects, FDA invoked unprecedented authority to tightly control the marketing of thalidomide in the United States through the S.T.E.P.S.™ (System for Thalidomide Education and Prescribing Safety) program. Thalidomide was the first drug approved under the provisions of § 314.520 (approval with restrictions to assure safe use). Section 314.520 states that if FDA concludes that a drug product can be safely used only if distribution or use is restricted, FDA will require such post-marketing restrictions as are needed to assure safe use of the product. The restricted distribution program for thalidomide is specifically designed to ensure that no human fetus is exposed to the drug.

Due to the complexities of the S.T.E.P.S.™ program, which was specifically designed for human patients, and the need for careful assessment of all adverse reactions and possible fetal exposure, the manufacturer of the approved product will not knowingly register veterinarians as prescribers. Therefore, veterinarians are unable to prescribe the approved human drug.

FDA recognizes the need for veterinarians to have access to a variety of drug products that are not specifically approved for use in animals and provides several avenues for allowing such use under most circumstances.

Extra-label use of approved human drugs in non-food producing animals is generally permitted under § 530.30(a), except when the public health is threatened. FDA has found that thalidomide poses a threat to public health unless access to the drug and its use are restricted. Thus, it is not available to veterinarians under this regulation because veterinarians cannot register as prescribers under the mandatory restricted distribution program.

FDA may exercise enforcement discretion on a case-by-case basis to allow veterinarians to use unapproved drugs not otherwise provided for by regulation for investigational purposes on an experimental basis in the United States. FDA will not exercise its enforcement discretion for veterinary use of thalidomide because any distribution of thalidomide outside of the S.T.E.P.S.™ program, without the safeguards and monitoring provided by the program, would defeat the Agency's efforts to restrict access to the drug and ensure a zero tolerance for thalidomide exposure of a fetus during human pregnancy. Thalidomide use in such uncontrolled channels could result in human fetal exposure via diversion or accidental exposure.

FDA may also exercise regulatory discretion to permit the importation of unapproved products into the United States for personal use. Before FDA will permit personal importation, it will consider whether importation of the product will represent an unreasonable risk. Due to the serious health risks associated with use of thalidomide in inadequately controlled settings, it is considered inappropriate for release under the personal importation guidance and all imports of thalidomide, whether intended for human or animal use, will be detained.