Congress considers minor use/minor species bill

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The House of Representatives will once again consider legislation intended to increase the availability of drugs for minor species and for uncommon indications in all species.

Representative Chip Pickering, R-Miss, introduced HR 1956—the Minor Use and Minor Species Animal Health Act of 2001—on May 23. A version was introduced into both the House and Senate last year, but neither considered it before the end of the session.

"This bill promotes the health of catfish and other minor animal species, protects and benefits human health while at the same time, reduces economic risks and hardships to farmers and ranchers," Pickering said. According to Pickering's office, the bill will help alleviate a shortage of drugs for minor species and uncommon indications in all species.

If passed, the 2001 Act would create a program similar to the Human Orphan Drug program for minor species and minor drug uses, including the development of an office inside the FDA-CVM to support the objectives of the legislation. It would also establish a system for the FDA-CVM to provide conditional approval of drugs that have been proven safe and that have a reasonable expectation of efficacy for a limited period of time prior to full approval.

In addition, the FDA would create an index of legally marketed drugs for nonfood, minor species, listing drugs for which it is unlikely that there will ever be any incentive for achieving full or conditional approval. Incentives, including limited marketing exclusivity, grants, and tax credits, would be provided for companies to develop certain new animal drugs.

Upon introduction, the bill was referred to the House Energy and Commerce Committee and the House Ways and Means Committee for consideration. Original co-sponsors are Rep Larry Combest, R-Texas; Rep Butch Otter, R-Idaho; Rep Karen L. Thurman, D-Fla; Rep Robin Hayes, R-NC; and Rep Michael K. Simpson, R-Idaho.

A number of organizations—including the AVMA, the Animal Health Institute, the National Aquaculture Association, the American Association of Wildlife Veterinarians, the American Feed Industry Association, the American Pet Product Manufacturers Association, Inc, and the American Animal Hospital Association, along with other stakeholders—have formed the Minor Use, Minor Species (MUMS) coalition to help the legislation pass through Congress.

"I think probably the biggest issue for us is that there are a number of drugs out there that are very useful in lots of different species, but it would never be cost-effective to go through all the FDA testing and all the requirements necessary to be approved for those species," said Dr. Michael Thomas, president of the American Animal Hospital Association.

"We just feel like it's the right thing to do to enhance our ability to provide better care for these minor species."

Minor species are defined as any animal species other than cattle, horses, swine, chickens, turkeys, dogs, or cats. Wildlife, zoo animals, aquatic animals, and some household pets, such as hamsters and gerbils, may be among the recipients of these conditionally approved drugs.

"Aquaculture is a very important industry to agriculture, and—it being one of the largest-growing agriculture industries out there—we want to make sure that they have all the resources available to them," said lobbyist Caroline Anderson of the American Farm Bureau. "When animal health companies are trying to decide whether to market and promote an animal health product for cattle vs catfish, I think we know who's going to win out.

The bill would affect the major species, too—the minor use provision refers to major species that have an uncommon indication, or a condition limited to a specific geographic area. Establishing a mechanism for the conditional approval of certain drugs—and expediting the path to full approval—could increase treatment options even for animals such as dogs, cats, and horses.

"There's a potential there to save lives and relieve a lot of suffering, which is, hopefully, what we're here for," said Dr. Thomas of the AAHA. "There are things out there like chemotherapy protocols—drugs that will probably never be approved for use in even some of the major species of animals—that we would be able to use quite effectively."

The AVMA is involved in several educational efforts relating to the bill. Staff and coalition members are developing information packets and scheduling public meetings for legislators, members, and the public regarding the bill. The staff is also working on an e-mail listserver for coalition members and other interested organizations, through which pertinent documents could immediately be sent to leaders of the groups.

For more information on the bill and its status, contact AVMA headquarters at (800) 248-2862, ext 452, or dscarfeatavma [dot] org (dscarfe[at]avma[dot]org); or the AVMA Governmental Relations Division at (800) 321-1473, ext 611, or bdunhamatavma [dot] org.