September 27, 2005
CVM Update - FDA Issues Proposed Regulations for MUMS Designation
The Minor Use and Minor Species (MUMS) Animal Health Act of 2004 amended the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration (FDA) to establish new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species as well as uncommon diseases in major animal species. FDA is issuing proposed regulations to implement the “Designation” provisions of 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 “Designation” section of the MUMS Act has been incorporated into the Federal Food, Drug, and Cosmetic Act (the Act) as Section 573. This Section of the Act is similar to the “Orphan Drug Act” for humans, which provides incentives to pharmaceutical firms that develop drugs for rare diseases or conditions. 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.
The proposed rule was published in the September 27, 2005, Federal Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19196.htm) Written comments on the proposed rule may be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may be faxed to 301-827-6870. Electronic comments may be submitted to the Federal eRulemaking Portal http://www.regulations.gov/ or the FDA web site at http://www.fda.gov/dockets/ecomments. All comments on the draft rules should be submitted by December 12, 2005 and should be identified with the full title of the guidance, the Agency name (FDA), and Docket Number 2005N-0329.
Additional information is included in the September 27, Federal Register. Questions may be directed to Dr. Andrew Beaulieu, Center for Veterinary Medicine (HFV-50), 7519 Standish Place, Rockville, MD 20855, 240-276-9090, e-mail Andrew.Beaulieu@fda.gov
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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