Approved animal drugs to increase under new law

Published on September 01, 2004
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Posted Aug.15, 2004 
President Bush signed into law Aug. 2 legislation that will increase the number of approved animal drugs for species and ailments for which treatment options have traditionally been limited.

On July 20, the House of Representatives approved the Senate version of the Minor Use and Minor Species Animal Health Act. The bill was presented to President Bush three days later.

Similar to the program created in 1983 by the Human Orphan Drug Act, which increased the availability of drugs for rare human diseases, the new MUMS law offers pharmaceutical companies incentives to develop drugs for uncommon diseases in major animal species and diseases in minor species.

Minor species encompasses thousands of animal species, including fish and 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 uses and minor species exists because of limited sales opportunity, low profit margins, and the high capital investment necessary for bringing a drug to market.

"This legislation benefits all aspects of clinical veterinary medicine," said AVMA Governmental Relations Division director, Dr. H. Michael Chaddock. "More effective medications will become available for all species of animals with appropriate dosages and safe withdrawal times for food animals."

The president's signing of the MUMS bill marked a great victory for animals and a coalition of 43 organizations that lobbied for the bill's passage through two previous Congresses.

Members of the MUMS Coalition include the AVMA, American Farm Bureau Federation, Animal Health Institute, American Pet Product Manufacturers Association, and National Aquaculture Association.

The AVMA GRD and the Scientific Activities Division, headed by Dr. Lyle P. Vogel, worked in tandem to educate legislators and veterinarians about why the MUMS bill is necessary to promote animal welfare.

Alabama Sen. Jeff Sessions and Mississippi Rep. Charles "Chip" Pickering Jr. introduced the legislation.

"This is common sense legislation that will benefit individuals from the agricultural industry to pet owners to zoo keepers," Pickering said. "On one hand, it will increase the profitability of Mississippi's catfish industry and on the other hand, it will help families who take their children's dogs or cats to the veterinarian."

The MUMS legislation creates the Office of Minor Use and Minor Animal Species Drug Development within the Food and Drug Administration. Its mission is to issue grants, determine eligibility for listing on the drug index, and serve as a liaison among government agencies to improve opportunity for drug approvals.

Furthermore, the FDA is authorized to promulgate regulations allowing drug applications for minor species and minor uses to receive conditional approval when a 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 law establishes a category of index drugs that can be used to treat nonfood minor species in cases when conditional approval is not economically feasible. Most importantly, the legislation makes it legal for veterinarians to use such drugs.

"Increasing the availability of safe and effective drugs to treat minor species and other species with unusual conditions promotes animal welfare and provides additional public health protection from animal diseases that can be transferred to humans," said Dr. Lester M. Crawford, FDA acting director.

"The FDA is pleased by the House and Senate passage of both these important measures," Dr. Crawford added.