Lawmakers mull over minor use/minor species bill

The House is considering a bill that would substantially increase the number of drugs available to treat minor animal species and species with rare illnesses. The legislation proposes increasing the FDA's regulatory flexibility, while offering financial incentives to pharmaceutical companies developing drugs to alleviate the suffering of this largely neglected portion of the animal population.

As introduced June 28 by Mississippi Rep Charles Pickering Jr, the Minor Animal Species Health and Welfare Act of 2000 would establish within the FDA-CVM an office supervising an expedited approval process for minor use drugs. The office would also administer grants and contracts to companies producing animal drugs for minor uses.

In addition to facilitating new drug development, existing animal drugs could receive conditional approval by the office for minor uses when there is reasonable expectation of efficacy and no human food-safety concerns.

Amendments to the Internal Revenue Code would allow companies sponsoring drugs for approval to receive a tax credit equal to 50 percent of the clinical testing expenses. Owners of animals submitted for clinical testing could also apply for a tax break.

The plan is modeled after the successful Human Orphan Drug Program that has, for the past 20 years, encouraged investment in products to treat rare human diseases.

"Minor species" are, by definition, animals other than dogs, cats, horses, cattle, swine, chicken, and turkeys. Included are sheep, deer, rabbits, and aquatic animals. "Minor use" is the use of drugs in minor species, or in any animal species for the control of a disease that occurs infrequently or in limited geographic areas.

Pharmaceutical companies shy away from the costly approval process to produce drugs for a market with low profit expectations. As a consequence, there is a severe shortage of minor use drugs.

"Due to the lack of availability of these minor use drugs, millions of animals go either untreated or treatment is delayed," Pickering said when he introduced the bill. "This act will alleviate much animal suffering. It will promote the health of minor animal species, while protecting and promoting human health."

Treatable illnesses in the sheep industry cause nearly $45 million in losses annually, and losses in the catfish industry are estimated at $60 million.

According to Dr. Stephen A. Smith of the International Association of Aquatic Animal Medicine, only five drugs are permitted for the more than 800 species in the US aquaculture industry.

"This is probably the most important piece of legislation that the aquaculture community has ever had to deal with," Dr. Smith said.

A broad spectrum of animal-interest organizations, ranging from veterinary groups to the animal drug and feed industries, together as the Minor Use Minor Species (MUMS) Coalition, have been pressing for a legislative remedy to the drug shortage. Members include the AVMA, AAHA, American Association of Wildlife Veterinarians, American Association of Zoo Veterinarians, and the American Association of Small Ruminant Practitioners.

Pickering's bill reflects earlier FDA recommendations for streamlining the minor use drug approval process. A provision of the Animal Drug Availability Act of 1996 directed the FDA to identify areas where the process could be improved. In 1998, the agency published those proposals in the Federal Register.

For nearly a year now, the MUMS Coalition has been working closely with the FDA to bring those initiatives to pass.

The bill has strategic support in the House. Initial cosponsors are Texas Rep Larry Combest, chair of the Agriculture Committee; California Rep Richard Pombo, chair of the Livestock and Horticulture Subcommittee; Texas Rep Charles Stenholm, ranking member on the Agriculture Committee; and Texas Rep Ralph Hall, who sits on the Commerce and Science committees. Pickering himself sits on the Commerce Committee.

Arkansas Rep Jay Dickey of the Appropriations Committee has since signed on, and additional cosponsors in the House are expected.

"For original cosponsors, that's a good showing," said coalition lobbyist Fran Boyd, who is not aware of any opposition to the bill, on Capitol Hill or otherwise.

Alabama Sen Jeff Sessions has indicated he will introduce a companion bill in the Senate.

Although the FDA has no official position on the legislation, the agency is providing technical assistance to the coalition as the bill is finalized. The proposal has, however, reached the highest level of the US Department of Health and Human Services without objection, according to CVM director, Dr. Stephen F. Sundlof.

An Office of Minor Use Animal Drug Development would be established within the CVM at the cost of a little over a million dollars annually from 2001-2003. Congress would appropriate additional funding for grants and contracts to offset the expenses drug companies incur during development and while obtaining marketing approval.

Dr. Sundlof explained that congressional funding for the office is critical to the success of the minor use initiative. "What concerns us most is that we'll have passage of legislation and no resources approved to actually have much of an effect. If that occurs, then we really haven't accomplished very much."

The Animal Health Institute shares the agency's funding concerns. Representing companies responsible for roughly 85 percent of the animal drugs and biologics manufactured in the United States, the AHI worries that resources could be diverted from existing drug approval programs.

"It would certainly be trouble if they were taking money out of the new animal drug approval process and utilizing it for grants," said John Keeling, vice president of legislative affairs for the AHI.

Keeling anticipates the most likely outcome of the law will be the extension of the approved uses of existing drugs. Despite the incentives, he explained, the economics of an entirely new drug being developed for minor uses is "difficult."

The FDA hopes the incentives, with an expedited approval process, will be a catalyst for new drug research, however.