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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Proposes Rules on Drug “Designation” Under MUMS Act

FDA Veterinarian Newsletter May/June 2005 Volume XX, No III

On September 26th the Center for Veterinary Medicine (CVM) issued a proposed rule entitled “Designation of New Animal Drugs for Minor Uses or Minor Species.” This rule is being proposed to implement section 573 of the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The intent of this section of the act is to provide incentives to pharmaceutical sponsors to encourage the development of new animal drugs for minor uses and minor species. These incentives are only available to sponsors whose drugs are “designated” by the Food and Drug Administration (FDA), under the criteria proposed in this rule, prior to approval.

The MUMS Act was passed by Congress with support from a coalition of animal health companies, animal health organizations, and animal producer groups, as a way to address the problem of making drugs legally available for the large number of animal species for which few drugs are currently approved.

Animal drug companies have been reluctant to seek costly FDA approvals for animal drugs that have a limited market. These include drugs for “Minor Uses,” which are for diseases affecting a small number of animals in the major animal species (cattle, horses, swine, chickens, turkeys, dogs, and cats), and drugs for “Minor Species,” which include all animals that do not belong to the major species categories. Minor species include zoo animals, and many common pets, such as ornamental fish, parrots, ferrets, and guinea pigs. Minor species also include animals of agricultural importance, including sheep, goats, catfish, and honey bees.

The MUMS Act has three major provisions, including “conditional approval,” which allows drug sponsors to make a drug available on the market before the company has collected all the necessary effectiveness data; drug “indexing,” which will allow legal marketing of an unapproved drug that a qualified expert panel determines to be safe and effective; and “designation.”

The proposed rule for designation represents the first set of implementing regulations for the MUMS Act. Both designation and conditional approval became available to sponsors when the bill was signed. Drugs may not be -indexed until regulations implementing that provision are finalized. Those regulations are scheduled to be published late in 2007.

The designation proposed rule was loosely modeled on the incentives included in the human orphan drug regulations. A significant incentive for drugs that are designated under the MUMS Act is that, at the time of approval or conditional approval, a designated drug will be granted seven years of marketing exclusivity. The exclusive marketing provision protects the drug from generic copying and from approval of another pioneer application for the same drug, in the same dosage form, for the same intended use.

The law also includes a provision that will allow Congress to appropriate funds for grants to defray the costs of safety and effectiveness testing for designated drugs. Such grants cannot be made available until final designation regulations are published late next year and funds are appropriated.

The preamble to the proposed rule discusses the difficult issue of defining “small numbers” of animals for “minor use” requirements. Congress defined minor use in major species as “an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually.” Congress did not determine what would constitute small numbers, instead leaving that task up to FDA. The preamble discusses various aspects of the issues involved in determining small numbers and solicits public comment on this issue.

CVM will collect comments on the proposed rules for 75 days following the date the proposals were published. Written comments on the proposed rule may be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. Comments may be faxed to 301-827-6870. Electronic comments may be submitted to the Federal eRulemaking Portal http://www.regulations.gov or the FDA web site at http://www.fda.gov/dockets/ecomments. All comments on the draft rules should be submitted by December 12, 2005, and should be identified with the full title of the guidance, the Agency name (FDA), and Docket Number 2005N-0329.