July 27, 2007

FDA Publishes Final Rule on Designation of New Animal Drugs for Minor Uses or Minor Species

The Food and Drug Administration (FDA) issued final regulations July 26, 2007 in response to the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act). The MUMS act amended the Federal Food, Drug, and Cosmetic Act by, among other things, establishing section 573 to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. This act parallels similar legislation passed under the Orphan Drug Act http://www.fda.gov/orphan/oda.htm for humans. FDA published a proposed rule in the Federal Register of December 28, 2005 (70 FR 76732) to implement these new procedures. FDA has evaluated all public comments received in response to the proposed rule and is issuing final regulations to implement the act.

The final rule implements section 573 of the MUMS act and describes the procedure for designating a new animal drug as a minor use or minor species drug. MUMS designation of a new animal drug will allow drug sponsors to be granted seven years of exclusive marketing rights for these limited demand new animal drugs to encourage the development of drugs for minor uses or in minor animal species.

This regulation will define content and format requirements for designation requests as well as provisions for amending requests changing designation ownership, and annual reporting requirements. This rule will also describe the criteria the Center for Veterinary Medicine (CVM) will use for granting or denying these requests. Specific sections of the rule will be dedicated to verification of MUMS status in a request, granting MUMS designation, and revocation of MUMS designation.

The final rule was published in the July 26, 2007, Federal Register http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-14444.htm. It will become effective on October 9, 2007.

Additional information about the final rule is included in the July 26, 2007, Federal Register. Questions may be directed to Dr. Bernadette Dunham, CVM, FDA, 7519 Standish Pl., Rockville, MD 20855, 240-276-9090, Bernadette.Dunham@fda.hhs.gov.



For additional information on animal drugs for minor uses and minor species, please see http://www.fda.gov/cvm/minortoc.htm