MUMS Issue Brief

Updated 4/16/2004
 

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:

  1. 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;
  2. 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;
  3. Creates incentives for animal drug manufacturers to invest in product development and obtain FDA-drug marketing authorization; and
  4. Creates mechanisms to alleviate the shortage of approved drugs while maintaining and ensuring protection of the public health.

Action Needed: Please contact your Representative and ask him or her to support the unchanged Senate version (S. 741 RFH) of H.R. 2079 since it represents a compromise of consensus between multiple parties.

For further information: Please contact Dr. David Scarfe or Dr. Elizabeth Curry Galvin, at the AVMA-Scientific Activities Division at (800) 248-2862; or Dr. John Melcher at (202) 546-4084.