July 23, 2004
July 23, 2004 -- Congress this week passed legislation meant to increase the number of approved animal drugs for species and ailments for which treatment options traditionally have been limited. The House of Representatives approved the evening of Tuesday, July 20, the Senate version of the Minor Use/Minor Species (MUMS) Animal Health Act.
Similar to the program created in 1983 by the Human Orphan Drug Act, which increased the availability of drugs for rare human diseases, the MUMS bill offers pharmaceutical companies incentives to develop drugs for uncommon diseases in major animal species and diseases in minor species, the latter of which includes sheep. Minor uses are drug treatments for animal diseases that occur infrequently or in limited geographic areas in any animals.
A critical shortage of approved animal drugs for minor use/minor species can be attributed to limited sales opportunities, low profit margins and the high capital investment necessary for bringing a drug to market.
Tuesday?s House vote marked a great victory for animals and a coalition of 43 organizations, including the American Sheep Industry Association (ASI), which lobbied for the bill?s passage through two previous Congresses.
?This is a great step for the sheep industry and the rest of the MUMS coalition,? said ASI President and Ohio sheep producer Guy Flora. ?We and others have been working since the early 1990s on this and when the Animal Drug Availability Act was passed in 1996, the MUMS provision was dropped at the last minute in order to help secure passage of the primary legislation.
?It has taken since then to build the coalition, and to work with FDA and Congress to get this legislation passed,? added Flora. ?However, our job is not yet finished. In addition to regulatory implementation of the bill and funding some initiatives, the ?tax incentives? portion of the MUMS legislation, which was not included in this bill, is very important in order to see the maximum benefits to the sheep industry. We will begin working on this with the MUMS coalition during the next session of Congress.?
Sens. Jeff Sessions (R-AL) and Charles ?Chip? Pickering, Jr. (R-MS) introduced the MUMS legislation. Once signed by the president, the legislation will authorize the Food and Drug Administration to publicize regulations allowing drug applications for minor uses and minor species to receive conditional approval when the drug is demonstrated to be safe and have a reasonable expectation of efficacy.
This conditional approval, evaluated annually, would be limited to five years, until full approval is achieved.
Additionally, the bill established a category of index drugs that can be used to treat nonfood minor species in cases when conditional approval is not economically feasible. Of most importance, the legislation makes it legal for veterinarians to use such drugs.
The bill now awaits President Bush?s signature.
Staff contact: Peter Orwick, ext. 33