This act, referred to as the MUMS Bill, is in many respects, similar to the human Orphan Drug Act of 1983. It is intended as a mechanism to provide safe and effective drugs for uncommon animal disease conditions, and for minor species, for which therapies are unavailable.
True Facts About the MUMS Legislation (PDF)
Q: Why is the "Minor Use and Minor Species Animal Health Act" needed?
A: In the United States, many animal species do not have drugs specifically labeled for them, to ensure their welfare is protected and diseases can be successfully treated. This Act attempts to create an FDA controlled process by which this problem can be alleviated.
Q: What are minor species?
A: Minor species are, by definition, any animal species other than dogs, cats, horses, cattle, swine, chickens and turkeys (major species). Thus, minor species include sheep, goats, game birds (e.g. pheasants, quail), emus, ranched deer, elk, rabbits, guinea pigs, earthworms, crickets, frogs, salamanders, lizards, caged-birds, free ranging wildlife, zoo animals, and all fish and shellfish (e.g. farmed and non-farmed catfish, trout, bait fish, ornamental fishes, oysters, clams, lobsters, striped bass).
Q: What are minor uses?
A: A minor use is the use of a drug in a major species for an indication that occurs infrequently or in limited geographical areas.
Q: What does the Act do?
A: The Minor Use and Minor Species Animal Health Act expands on the current FDA drug approval process, to provide FDA some flexibility when dealing with minor species or minor uses. The Act creates an opportunity for drugs, shown to be safe, to be provisionally or conditionally approved for a short time, during which efficacy data could be collected for full approval. The Act also creates a drug index in which drugs could be legally used to treat diseases or conditions in minor species that are not consumed by humans. The Act also creates an orphan drug-like program that would provide limited funding to companies to help support drug development for these situations. In all cases, the FDA would make all decisions concerning conditional or index approval of any drug.
Q: How will the Act ensure public health is protected?
A: The Act does not circumvent the FDA oversight over drug uses in the United States, nor does it circumvent FDA oversight to control possible antibiotic resistance. Animal welfare will be enhanced because of the availability of safe and effective drugs not previously available. Public health will be enhanced because there will be greater opportunity to control zoonotic diseases (those that can be transferred from animals to man).
Q: What is the FDA's position on this bill?
A: The FDA helped develop the proposals contained in the bill. In 1996, the Animal Drug Availability Act (ADAA) was passed. This bill streamlined the animal drug approval process with the goal of increasing the number of products available to prevent and treat disease in companion and food animals. The ADAA did not mandate specific changes to improve the availability of drugs for minor species or minor uses, but it did require the FDA to propose ways this might occur. FDA produced a Minor Use Minor Species (MUMS) document that described several ways more drugs might be safely made available. The Act was developed in cooperation with the FDA. FDA may suggest some improvements to the current Act but they support the current concepts in the Act.
Q: Why should the House of Representatives adopt the Senate version (S. 741 RFH) as is?
A: It represents a compromise consensus between multiple parties, and if the House does not adopt the S.74 RFH, there is a strong possibility MUMS will not pass the 108th Congress.