FDA supports animal drug research
The agency said the farmed fish sector is in need of new products that can be used to address fish diseases, said the agency.
The FDA has opened a grant application period to support research for products to address minor uses or minor species (MUMS). Minor uses addresses drugs that are not frequently used.
The application period runs through January 13, the agency reported.
The FDA and Center for Veterinary Medicine have already awarded around $2.8m, through 50 grants, to support the effectiveness or safety of new products designed as animal drugs for aquaculture and other minor species like goats and pheasants, said Anne Norris, health communications specialist with the FDA. “Some of the minor use products involve novel cutting-edge therapeutic techniques that are being, or may be applied to the treatment of humans,” she added.
“The specific purpose of the MUMS Grant program, authorized by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act), is to provide [financial support] to assist in defraying the costs of qualified safety and effectiveness testing that either results in or substantially contributes to FDA approval or conditional approval of a MUMS-designated new animal drug,” she told FeedNavigator. “The MUMS Grant Program exists solely to support studies that lead to veterinary drug approval.”
For major species, like cattle, swine and poultry, the research applications should be for drugs that are not often used, are used in specific regions or only by a small number of animals, said the FDA.
Grant specifications
The grant process is open to groups including small businesses, nonprofits, special district governments, state, public and private institutions of higher education, state, country, city or township governments, for profit organizations other than small businesses, Native American triable governments and tribal organizations and public or Indian housing authorities, said the FDA.
Application are reviewed in a manner consistent with other National Institute of Health (NIH) awards, said Norris. “An outside panel of experts reviews and evaluates responsive applications for scientific and technical merit and internal experts subsequently review applications for economic validity and ability to support the mission of the granting authority—the FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development,” she added.
“The MUMS Grant Program has historically had enough funding to pay for most of the qualifying studies,” she said. “But we expect this to change as more products receive MUMS designation and the applicant pool grows.”
Two funding levels are offered through the program, said the FDA. Grants can either cover up to $100,000 for two years, or up to $150,000 for three years, depending on the work being done.
“Applications for the smaller grants ($100,000) may be for any routine safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for the designated intended use,” the agency said. “Study proposals for the larger grants ($150,000) must be for necessary studies that are of unusual complexity, duration, or size. A third year of funding is available only for long-term toxicological studies.”
