Posted 27 February 2015
By Alexander Gaffney, RAC
Have an idea for a new animal drug intended to help treat a rare disease in animals or an unusual creature? The US Food and Drug Administration (FDA) says it may have some funding for you.
The money relates to a little-known regulatory designation established under the Minor Use and Minor Species Animal Health Act (MUMS Act) of 2004.
Under the law, animal conditions are effectively treated as rare if they meet either of two conditions:
- If the condition affects a "major" animal species—cattle, horses, swine, chickens, turkeys, dogs, and cats—but in a quantity or distribution insufficient to spur investment, meaning it would only receive "minor use.”
- If the condition affects a "minor" species (i.e. not a "major" species) in any capacity.
The law is loosely modeled off the Orphan Drug Act of 1984, which provided special incentives for new human drugs intended to treat rare diseases, defined as any condition affecting fewer than 200,000 persons in the US. So-called "orphan" drugs approved to treat rare diseases are awarded seven years of market exclusivity—more than the five years ordinarily given—and are also eligible for tax credits and research grants.
Similarly, MUMS products are eligible for three years of market exclusivity, during which time the same drug (i.e. a generic) may not be marketed for the same use.
How Rare is Rare?
FDA's definition of rare differs when it comes to different animal species. For humans, the threshold is 200,000. But for "major" species, a "minor use" can range between 70,000 animals and 72 million animals.
|Current MUMS Act Definitions of "Small Number of Animals"|
All other animals are, by default, considered "minor" species.
Money for Development
While the design of MUMS is intended to assist development by providing stronger protection from competition, it's not the only way FDA is permitted to assist drug development.
On 27 February 2015, FDA announced its intent to fund several awards through its Office of Minor Use and Minor Species Animal Drug Development (OMUMS). "The FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing," the agency explains in its notice.
Its funding—multi-year grants between $100,000 and $150,000 per year—is meant to "result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug for a designated intended use," it said.
Smaller grants meant to help funds studies of "unusual complexity, duration or size" are also available, FDA wrote.
FDA Funding Announcement