August 2, 2007

FDA publishes final ruling on new animal drugs

The Food and Drug Administration (FDA) issued final regulations, in response to the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) July 26. 

The MUMS act amended the Federal Food, Drug, and Cosmetic Act by establishing new regulatory procedures that provide incentives to make more drugs available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. 

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 and is issuing final regulations to implement the act.

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 its development.

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. 

The final rule was published in the July 26, 2007, Federal Register and would become effective on October 9, 2007.