The Food and Drug Administration has proposed amending regulations relevant to the development of drugs for minor uses in major species to specify what constitutes a "small number of animals" needing a drug. Sponsors who develop such drugs qualify for incentives under the Minor Use and Minor Species Animal Health Act.
The purpose of the MUMS Act is to encourage the development of drugs for minor species as well as for minor uses in major species. The major species are cattle, horses, swine, chickens, turkeys, dogs, and cats.
In its March 18 proposal, the FDA presented an analysis of the threshold number of animals for each major species that represent a drug market value insufficient to prompt a sponsor to develop the drug in the absence of the MUMS Act incentives. The agency evaluated food-producing animals separately from nonfood-producing animals.
In the context of a "minor use" drug, the FDA proposes the following as constituting small numbers of animals for each major species:
- Pigs—1.45 million
- Turkeys—14 million
- Chickens—72 million
The AVMA was a key member of the coalition that helped frame the MUMS Act and urged Congress to pass the legislation. The AVMA also actively comments on regulatory proposals on behalf of AVMA members—and will analyze and comment on this proposal.
The complete text of the proposal is available in the March 18 edition of the Federal Register, available at www.gpoaccess.gov/fr/browse.html. The deadline for comments is July 16. Parties may submit comments electronically at www.regulations.gov, by fax at (301) 827-6870, or by mail at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should include the identification Docket No. 2008N-0011 and RIN 0910-AG03.
Additional information is available from Dr. Margaret Oeller at the Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855; phone, (240) 276-9005; e-mail, Margaret.Oeller@fda.hhs.gov.