A: In the United States, minor animal species do not have the therapeutic agents and drugs needed to ensure their welfare is protected and diseases can be successfully treated. The Act attempts to create an FDA-controlled process to alleviate this problem.
A: Minor animal species are by definition any animal species other than dogs, cats, horses, cattle, swine, chickens and turkeys (these are major animal species). Thus, minor animal species include sheep, goats, game birds (e.g. pheasants, quail), emu, 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).
A: Minor uses of animal drugs include use of a drug in a minor species and uses in major animal species for a disease or condition that occurs infrequently or in a limited geographic area.
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 animal species or minor drug uses. The Act creates opportunity for drugs to be provisionally or conditionally approved for a short time during which efficacy data could be collected. The Act creates a drug index in which drugs could be legally used to treat diseases or conditions of animals for which the animal would not be used for human consumption. The Act also creates an orphan drug-like program that would provide limited funding to companies to help support drug development for minor animal species or uses. The FDA would make all decisions as to whether a drug could be conditionally approved or approved under the drug index. Click Here for the text of the Act. Click here for the text of the proposed Indexing regulations that were published August 22, 2006.
A:
(1) Incorporates the significant proposals made by the FDA's Center for Veterinary Medicine to increase the availability of drugs for minor animal species or rare diseases and conditions in all animals;
(2) creates incentives for animal drug manufacturers to invest in product developoment and obatin drug-marketing approvals;
(3) creates a program very 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; and
(4) creates incentives and sanctioning programs while maintaining and ensuring protection of the public health. Each of the groups participating in this effort believes the Act will help alleviate animal suffering, will promote the health of minor animal species while protecting human health and will benefit the public and their companion animals as well as farmers and their livestock.
Q: How will the Act ensure public health is protected?
A: The Act does not circumvent the FDA oversight over drug uses in the US. The Act does not circumvent the oversight FDA provides to ensure antibiotic resistance does not become a problem as a result of animal uses of antibiotics. Animal welfare will be enhanced because a greater variety of drugs will eventually become available. Public health will be enhanced because their will be greater opportunity to control zoonotic diseases (those that can be transferred from animals to man).
A: The FDA helped develop the proposals contained in the Act. In 1996, the Animal Drug Availability Act (ADAA) was passed. ADAA 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 animal 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 supports the current concepts in the Act.
A: President George W. Bush signed the Act into law on August 2nd, 2004. The implementing regulations have been finalized. For additional information go to the FDA Office of MUMS website.