FDA providing MUMS grants to aid new drug studies
The Food and Drug Administration is providing up to $750,000 for developers of drugs for animals listed as minor species or for minor uses in major species.
The Food and Drug Administration announced recently the funding would be provided under the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. Applications for funding are due July 1.
The grants have to be used to defray costs of safety and effectiveness testing during development of new drugs. The FDA indicated the agency would provide up to $50,000 annually for up to two years for routine studies or up to $100,000 annually for up to two years for unusually complex studies. The FDA indicated a third year of funding could be available for toxicology studies.
Information from the FDA Center for Veterinary Medicine indicates the law is expected to provide benefits to owners of exotic pets, owners of animals with uncommon diseases or diseases confined to limited geographic areas, and zoo veterinarians, as well as to help pharmaceutical companies "overcome the financial roadblocks they face in providing limited-demand animal drugs."
Under the 2004 law, sponsors of drugs marketed under MUMS need to provide annual reports indicating progress toward approval.
In March, a drug used as a spawning aid in ornamental finfish broodstock became the first new animal drug added to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Before they can be marketed, minor species drugs must be approved, conditionally approved, or indexed by the FDA.