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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Publishes “Indexing” Final Rule

FDA Veterinarian Newsletter 2007 Volume XXII, No V

The Food and Drug Administration has published the final rule to implement the Legally Marketed Unapproved New Animal Drug Index (the Index) authorized by the Minor Use and Minor Species Animal Health Act (MUMS Act) of 2004.

This rule provides an alternative means for companies to market veterinary drugs for uses that are not amenable to the full FDA approval process, such as products for species too varied or inherently valuable to be used in the studies usually conducted to establish a product’s effectiveness and safety. In short, these will be products for use in animals like ornamental fish, pet birds, laboratory animals, pocket pets, endangered species, and zoo animals.

Indexing will only be an option for species that are not used to produce food, with the exception of certain early life stages such as some fish eggs.

The Indexing final rule was published in the December 6, 2007, Federal Register, and it becomes effective on February 19, 2008. FDA will not be able to accept submissions for Indexing drugs until the final rule becomes effective.

The Indexing process will include three major steps. First, upon a sponsor’s request, FDA will evaluate the eligibility of a new animal drug to be considered for the list. Second, the sponsor will ask FDA to concur with its expert panel selection. This panel of experts will review all of the drug’s available target animal safety and effectiveness data. Third, the panel’s findings will be presented as a report to FDA so the Agency can determine whether the drug should be included in the Index. Drugs successfully reviewed under the Indexing rule are placed in a public index of unapproved drugs that can be legally marketed.

The rule was first proposed in August 2006. It was open for comments a total of 120 days. FDA made some changes to the final rule based on those comments, including changes to the rules concerning scheduling conferences, reviewing the written report of such conferences, and selecting appropriate members for the review panel.

The rule implements Section 572 of the Federal Food, Drug, and Cosmetic Act, entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” The regulations describe the administrative procedures and criteria for listing a drug in the Index.

The Indexing regulations were designed to be a means by which companies can legally market veterinary drugs for certain minor species without going through the long and expensive new animal drug approval process.

The MUMS Act, of which Indexing is a part, was developed to provide new ways to bring products to market for the treatment of rare diseases in major species (cows, pigs, chickens, turkeys, horses, cats, and dogs) and to treat all other animal species (minor species). The MUMS Act was created because sponsors were developing or seeking approval for few drugs for minor uses or minor species due to limited markets or, in some cases, the difficulty in finding means to generate data necessary for approval.

The MUMS Act has two other key provisions already in effect:

Designation makes drugs eligible for 7 years of exclusive marketing rights starting on the day of approval or conditional approval. In addition, when funds are appropriated, FDA will be able to provide grants to defray costs of qualified safety and effectiveness testing as well as manufacturing expenses incurred in the development of designated new animal drugs. The final rule regarding designation can be seen on the CVM Web site. CVM also provides the list of designated drugs.

Conditional approval allows a drug sponsor to make the drug available before collecting full effectiveness data, but after proving that the drug is safe and meets all other approval requirements. The sponsor can keep the product on the market for up to 5 years, through annual renewals, while collecting the needed effectiveness data. In April 2007, CVM granted the first conditional approval to a drug to treat columnaris disease in catfish.

Additional staff member

CVM has also announced that Dr. Joan Gotthardt will join the Center’s Office of Minor Use and Minor Species in February 2008 to direct the implementation of the Indexing provisions of the MUMS Act.

Dr. Gotthardt has been with the Center since 1995. For the past 5 years, Dr. Gotthardt has served as Director of the Division of Therapeutic Drugs for Food Animals in CVM’s Office of New Animal Drug Evaluation.

She received her bachelor’s degree in Animal Science from the University of Maryland and her Doctorate of Veterinary Medicine from the Virginia Maryland Regional College of Veterinary Medicine.

Dr. Gotthardt joins Dr. Bernadette Dunham, who serves as Director of the Office, as well as Deputy Center Director; Dr. Meg Oeller, who handles drug designation and serves as the FDA liaison to the USDA’s minor species program, NRSP-7; and Dr. Andrew Beaulieu, immediate past Office Director, now assisting the Office as a special consultant.

Indexing Implementation Dates

Indexing final rule becomes effective February 19, 2008. CVM can accept requests for eligibility on that date and not before.

The Final Rule was published December 6, 2007.