A bill to expedite FDA approval of new animal drugs for minor uses and minor species (MUMS) was unanimously approved this week by a House Energy & Commerce Committee subcommittee, clearing the way for full committee action next week and floor action soon after.
The bill, patterned after the Animal Drug Availability Act (ADAA) enacted in 1997, is part of a package that reforms FDA’s authority to require public information on food packages related to allergens in food products. The bill has already passed the full Senate.
The MUMS package will clarify FDA authority and provide expedited approval systems to get badly needed animal health products for use in what are defined as minor species, including aquaculture, some rare bird poultry production, etc. It will also enhance availability and provide incentives for development of or expansion of uses for existing animal drugs to treat diseases considered to be minor by FDA. [Source: AFIA]
Background
Minor Use and Minor Species Animal Health Act
In the United States, there is a critical shortage of approved animal drugs intended for minor uses or minor species. The MUMS Act is similar to the human Orphan Drug Act of 1983. It is intended as a mechanism to provide FDA authorized drugs for uncommon animal disease conditions in a major species (major species include: cattle, horses, swine, chickens, turkeys, dogs, and cats), and for conditions in minor species where therapies are unavailable. Minor species include: sheep, goats, game birds (e.g. pheasants, quail), emus, ranched deer, elk, rabbits, guinea pigs, lizards, caged-birds, free ranging wildlife, zoo animals, and all fish and shellfish (e.g. farmed catfish, trout, bait fish, ornamental fish, oysters, clams, lobsters, striped bass).
Because veterinarians, animal owners, and livestock producers have limited options for treating rare diseases in major animal species and in most minor animal species, incentives that encourage the introduction of drugs for these purposes are essential. In many cases, animal owners and veterinarians face the unfortunate choice of leaving an ill animal untreated or treating the animal with an unapproved drug. Failure to treat sick animals appropriately may increase public health hazards. For example, the transmission of disease from animals to humans or the shedding of disease-producing organisms by untreated animals into the environment may increase health risks to humans as well as other animals. Further, the economic impact can be significant. The sheep industry loses nearly $45 million worth of sheep each year and the catfish industry estimates their losses at $60 million from disease conditions for which therapeutic medicines are unavailable.
The Animal Drug Availability Act (ADAA) (Public Law 104-250) was passed in October 1996. Among other things, the legislation recognized particular problems relating to the availability of approved new animal drugs for minor uses in major species and for use in minor species. Section 2(f) of the ADAA directed the Secretary to consider legislative and regulatory options for facilitating approval under section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) of new animal drugs intended for use in minor species or for minor uses. The ADAA further required the Secretary to announce proposals for legislative or regulatory change to the approval process for new animal drugs intended for use in minor species or for minor uses.
The MUMS Act:
Creates a program similar to the successful human Orphan Drug Program that has, over the past 20 years, dramatically increased the availability of drugs to treat rare human diseases;
Incorporates the significant proposals made by the FDA's Center for Veterinary Medicine to increase the availability of drugs for minor species or uncommon conditions in all animals;
Creates incentives for animal drug manufacturers to invest in product development and obtain FDA-drug marketing authorization; and
Creates mechanisms to alleviate the shortage of approved drugs while maintaining and ensuring protection of the public health.
For further information: Dr. David Scarfe (Dscarfe@avma.org) or Dr. Elizabeth Curry Galvin (EGalvin@avma.org), at the AVMA-Scientific Activities Division at (800) 248-2862; or Dr. John Melcher at (202) 546-4084.
[Source: American Veterinary medical Association]
