FDA Issues Proposed Regulations to Implement the Minor Use and Minor Species Act

September 27, 2005 — 

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.

Minor use drugs are drugs for use in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that are needed for diseases that occur in only a small number of animals either because they occur infrequently or in limited geographic areas. Minor species are all animals other than the major species, for example, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include animals such as sheep, goats, catfish, and honey bees.

The proposed rule provides the functional requirements for drug sponsors requesting MUMS designation for proposed new animal drugs. The rule also describes "exclusive marketing rights" which is one of the primary incentives for MUMS designation. Companies who gain approval for designated new animal drugs will be granted seven years of exclusive marketing rights.

Public comments on this document will be accepted if received by December 12, 2005. Comments must be forwarded to the agency as described in the Federal Register.

Sources:
Federal Register
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19196.htm

FDA, CVM website
http://www.fda.gov/cvm/proMumsDes.htm