Abstract

The Minor Use & Minor Species Animal Health Act of 2004 (the MUMS Act) was made law in August of that year. It was the culmination of years of effort on the part of a coalition made up of professional societies, producer groups, and representatives from the regulated industry, as well as those providing technical assistance within the FDA, and members of the US Congress. The purpose of the law is to increase the legal availability of new animal drugs for use in minor species (all species other than horses, dogs, cats, cattle, swine, chickens, and turkeys) and for minor uses in the major species (uses that are for diseases that occur infrequently or in limited geographic areas and in small numbers of animals annually). To achieve these ends, the law provides new incentives to drug sponsors and new processes to facilitate drug availability.

The MUMS Act establishes three new programs: (1) Conditional Approval, (2) the Index of Legally-Marketed Unapproved New Animal Drugs (the Index), and (3) Designation. Conditional approval is an option for sponsors to get their drug to market early after completing all manufacturing and safety information required for FDA approval, but prior to completing the effectiveness component. Conditional approval must be renewed annually and may be in effect for a maximum of 5 yr, during which time the effectiveness component must be completed to full FDA standards. Indexing is limited to minor species and is intended to make available drugs for claims that cannot reasonably be approved by the standard process. This includes zoo animals, aquarium fish, pocket pets, exotic birds, and other similar groups. The FDA will allow legal marketing of these drugs based largely on the report of expert panels. (This presentation will focus on this process since this is most likely to be of interest to zoo and wildlife professionals). Designation is the veterinary equivalent of orphan drug status in human medicine. A drug claim that is designated will be eligible for grants to support studies needed to demonstrate safety and effectiveness of the drug. It will also be eligible for 7 yr of exclusivity (protection from competition) beginning on the date of approval or conditional approval.

The law specifies that Conditional Approval and Designation go into effect immediately. However, the grants program must wait until publication of final regulations in August of 2006. Indexing may not be implemented until final regulations are published in August of 2007.

The MUMS Act also established a new Office of Minor Use and Minor Species at FDA’s Center for Veterinary Medicine to implement and manage some of these new processes and to continue liaison work with existing programs and minor use/minor species stakeholders. Specific questions can be addressed to the Office Director, Dr. Andrew Beaulieu (abeaulie@cvm.fda.gov) or Dr. Meg Oeller (moeller@cvm.fda.gov).