Category Archives: FDA

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) 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. On September 27, 2005, FDA issued proposed regulations to implement the act. These regulations propose procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act.

In the September 12 Federal Register, the US Food and Drug Administration (FDA) announced publication of information designed to provide guidance on the recordkeeping requirements associated with the Bioterrorism Act of 2002 and subsequent FDA Final Rule published in December, 2004. This Act requires persons that “manufacture, process, pack, transport, distribute, receive, hold, or import food,” register their establishment and maintain records allowing “for the identification of the immediate previous sources and the immediate subsequent recipients of food.” “Food” as defined by the Act includes animal feed. This Guidance Document should help clarify the requirements and reinforce the list of exempt entities.

According to an August 23rd press release, US Food and Drug Administration (FDA) Commissioner Dr. Lester Crawford has appointed Rear Admiral Linda Tollefson, DVM to the position of Assistant Commissioner for Science. Dr. Tollefson has been with FDA for 21 years, most recently serving as deputy director of FDA’s Center for Veterinary Medicine (FDA-CVM). She has been actively involved in antimicrobial resistance issues and was instrumental in founding the National Antimicrobial Resistance Monitoring System (NARMS). Her new duties will include serving as Coordinator of Commissioned Corps Affairs at FDA and directing FDA’s Offices of Women’s Health and Orphan Products Development.

In a speech to the International Congress on Meat Science and Technology on August 8th, FDA Commissioner Dr. Lester Crawford indicated that the ban on Specific Risk Materials (SRM) proposed in July, 2004 was still under development. This rule prohibiting the use of SRMs in all animal feeds is an expansion of the current rule banning these materials in ruminant feeds to minimize the spread of the agent (prions) which causes BSE, or Mad Cow Disease, in cattle.

Late Monday, the Senate voted 78-16 to confirm Dr. Lester Crawford as commissioner of the Food & Drug Administration. Crawford, who has a doctorate in pharmacology, is the first veterinarian to be named as head of the nation’s drug regulatory agency. Crawford has been serving as acting FDA commissioner. A worldwide authority on food safety, Crawford has served as an adviser to the U.N.’s World Health Organization for nearly 20 years. He is a member of the National Academy of Sciences’ Institute of Medicine and is a Fellow of the Royal Society of Medicine in the U.K. Earlier in his career, he was administrator of the U.S. Department of Agriculture’s Food Safety & Inspection Service.