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U.S. Department of Health and Human Services

Animal & Veterinary

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PROFESSIONAL FLEXIBLE LABELING GUIDANCE RELEASED FOR PUBLIC COMMENT

by John D. Baker, D.V.M. and William T. Flynn, D.V.M.
FDA Veterinarian Newsletter March/April 1998 Volume XIII, No II

On January 22, 1998, the Center for Veterinary Medicine (CVM), announced in the Federal Register, the availability for public comment of a draft Guidance for Industry on "Professional Flexible Labeling of Antimicrobial Drugs." This document is intended to provide specific guidance on the development of Professional Flexible Labeling (PFL) for therapeutic veterinary prescription and veterinary feed directive (VFD) antimicrobial drugs.

In the past, CVM has approved veterinary prescription product labels with single fixed dosages that carry indications against a narrow range of specific diseases and organisms. As a result of using this approach, the label did not reflect many current uses for therapeutic agents in veterinary medicine. Specifically, for antimicrobial products, narrowly approved uses fail to address the fact that, while some specific bacteria do produce repeatable, recognized disease, many organisms are either opportunistic or are known to produce a variety of clinical manifestations.

Such restricted labeling has led to veterinary prescription products that have limited practical usefulness if administered strictly according to their approved conditions of use and has served as an impetus to development of the PFL concept. Workshops on PFL, cosponsored by the Food and Drug Administration/Center for Veterinary Medicine, the American Academy of Veterinary Pharmacology and Therapeutics, the Animal Health Institute, and the American Veterinary Medical Association were held in Rockville, MD in April and December, 1995. A summary of the discussions and opinions expressed in the April, 1995 workshop were published in the Journal of the American Veterinary Medical Association (JAVMA), October 1, 1995. Following the December, 1995 workshop, a task force was assembled to prepare a report on PFL concepts. The task force report, which included a model drug label, was published in the JAVMA, July 1, 1996.

The basic concept of PFL is to provide prescription veterinary products that carry useful prescribing information for the range of clinical situations included within their approved conditions of use. Implementation of PFL is based on the recognition that veterinarians, as a function of their medical training, possess the knowledge, skills, and abilities to interpret diagnostic and prescribing medical information and to develop these data into appropriate therapeutic regimens. The document should prove valuable in the process of developing and labeling prescription veterinary antimicrobial drugs and should render a greater service to practitioners and their clients by providing for current, accurate information in product labeling. Ultimately, products labeled as described in the PFL guidance will be consistent with and better reflect how veterinarians utilize animal drugs in the course of their professional practice.

Though this document represents FDA's current thinking on the development and labeling of therapeutic veterinary prescription antimicrobial drugs, it does not bind the agency or the public. As with any Center guidance, pharmaceutical companies may decide to follow alternate procedures or practices. In that event, CVM suggests that they discuss the matter with the agency a priori to prevent an expenditure of money and effort on activities that may later be determined to be unacceptable to the FDA. CVM also recognizes that the general concepts of PFL expressed in the guidance on antimicrobial drugs may not be equally applicable to other classes of therapeutic prescription products (e.g., antiparasitics, physiologics). Therefore, it is CVM's intention to develop PFL guidances that are specific to various classes of drugs.

Copies of the guidance document may be obtained from CVM's Internet Home Page or by contacting the FDA Veterinarian. Individuals are encouraged to submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, Room 1-23, 12420 Parklawn Dr., Rockville, MD 20857. Comments should be identified with the full title of the draft guidance and docket number 98D-0016 and be submitted by April 22, 1998. Comments received on the draft guidance may be seen at the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. After review of these comments, FDA will finalize the guidance document with any appropriate changes.