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No Drugs Approved for Use in Ferrets: Passage of MUMS May Make it Easier to Market Drugs for Ferrets

May 24, 2004

Washington, DC --- Several vaccines are licensed by the United States Department of Agriculture labeled for use in ferrets. But no drugs have been approved for use in ferrets by the Food and Drug Administration (FDA). One reason for the lack of drug approvals may be due to the smaller numbers of ferrets in the US, in contrast to dogs and cats. Currently there are between 7 and 10 million ferrets, in contrast to the 50 million dogs and 60 million cats in the US.

New pending legislation will change the criteria for drug manufacturers, making it easier to get drugs approved for ferrets. Under the proposed “Minor Use and Minor Species Animal Health Act,” (“MUMS”) [House Bill: HR 2079] ferrets would be considered a “minor” species. The act would revise the Federal, Food, Drug and Cosmetic Act under the FDA to provide incentives to drug manufacturers to produce drugs for animals and for indications that may not be as commercially rewarding.

MUMS defines “minor species” as not cattle, horses, swine, chickens, turkeys, dogs, and cats, which are considered to be “major species” due to their large numbers, making drug indications for these species very profitable. Disease indications that are uncommon in these major species are called “minor uses.” Because of the small market shares, low-profit margins involved, and capital investment required, it is generally not economically feasible for new animal drug applicants to pursue approvals for these species, diseases, and conditions.

Alabama Senator Jeff Sessions introduced the MUMS bill in March 2003 and garnered the support of 21 fellow senators who co-sponsored the bill, including the Senate's two veterinarians, Wayne Allard of Colorado and John Ensign of Nevada. FDA Commissioner Mark B. McClellan, MD, PhD, applauded the Senate action, saying the agency “looks forward to providing further technical assistance to the House regarding this legislation.”
Sessions describes MUMS as benefiting “pets and their owners and ….various endangered species and aquatic animals.” He says: “The act also will promote the health of all animal species while protecting human health and will alleviate unnecessary animal suffering. This is commonsense legislation which will benefit millions of American pet owners, farmers, and ranchers."

History of MUMS
In 1996, Congress approved the Animal Drug Availability Act (ADAA) to streamline 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.

In 2001 the American Veterinary Medical Association spearheaded the process to get legislative relief for drug development in non-“major” species animals. Forming a coalition of 43 organizations, the AVMA developed a consensus document that formed the basis for the new legislation. An AVMA whitepaper states: “Due to the nearly complete absence of drugs to treat minor species, most animals either go untreated or treatment is delayed. Delayed treatment is poor treatment; the result is increased suffering, loss of life and loss of social and economic value. The emotional and economic impact of these losses for individual families and the public can be significant.”

MUMS would allow exclusive marketing rights and tax credits for clinical testing expenses. In addition, the FDA could award federal grants and contracts to public and private entities and individuals to alleviate some of the costs of drug testing in these minor species. Similar to the 1983 Orphan Drug Act for people, which has helped to encourage the development of drugs for rare human disorders where patient numbers may be very small, the “Minor Species/Uses Act” should provide comparable incentives for the development of new animal drugs for smaller numbers of animals and for rare conditions.

Under MUMS, new animal drugs designated by the FDA for minor species or minor uses would be eligible to receive “conditional approval” when the drug is demonstrated to be safe and have a reasonable expectation of efficacy. This conditional approval, evaluated annually by FDA, would be limited to five years until full approval is achieved. Included in the bill is a provision creating a category of index drugs which would provide for legal use of drugs in “nonfood minor species” – which includes pets-- for which even conditional approval is not economically feasible. Most importantly, a MUMS law would provide legal basis for veterinarians to use such drugs.

Although no drugs are currently approved for use in ferrets, drugs are routinely used in ferrets under the FDA’s “Extra-Label Use” provisions. Based on these provisions, drugs labeled for use in other animals or humans can legally be used in ferrets. However, the new act should make it easier for drug sponsors to test new animal drugs for safety and efficacy in ferrets, which would give health care providers more information on proper dosing, adverse events and the expected response rates in ferrets.

On March 8, 2004, the bill was passed unanimously by the Senate, and it is scheduled to be voted on by the House of Representatives. If it passes, the FDA would be required to issue proposed and then final regulations on the amended sections of its law. These regulations would be issued for public comment. To view the House Bill, please see: http://www.theorator.com/bills108/hr2079.html.