The Food and Drug Administration recently issued regulations that may improve availability of drugs for species ranging from parrots and ferrets to zoo animals and ornamental fish.
The final rule implements a provision of the Minor Use and Minor Species Animal Health Act. The MUMS Act established regulatory procedures to increase drug availability for minor species and uncommon diseases in major species. A provision for nonfood-producing minor species will create an index of drugs that companies may market without completing the traditional approval process.
The potential market for these drugs is too small to support the costs of the approval process, though the companies will still need to demonstrate the drugs' safety and effectiveness. The FDA will list drugs in the index on the satisfactory recommendation of external expert panels. The agency will limit the index to nonfood minor species—with an exception for certain early life stages of food animals, such as some fish eggs, that pose no concerns for human food safety.
The regulations that implement the indexing provision establish the procedures and criteria for listing a drug in the index. The regulations describe the process by which the FDA will make decisions regarding the eligibility of a drug for indexing, the selection of an expert panel, and the findings of the panel.
The final rule takes effect Feb. 19. Until then, the FDA cannot accept submissions for indexing. The rule appeared in the Dec. 6 Federal Register, online at www.gpoaccess.gov/fr/. Information also is available from Dr. Bernadette Dunham, Center for Veterinary Medicine, HFV-50, 7519 Standish Place, Rockville, MD 20855; phone, (240) 276-9090; Bernadette.Dunham@fda.hhs.gov.