[Federal Register Volume 63, Number 14 (Thursday, January 22, 1998)]
[Notices]
[Pages 3328-3329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1417]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0016]
Draft Guidance on Professional Flexible Labeling of Antimicrobial
Drugs; Availability; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft level 1 Guidance for Industry entitled
``Professional Flexible Labeling of Antimicrobial Drugs (#66).'' This
draft guidance is intended to provide specific guidance on the
development of Professional Flexible Labeling (PFL) for therapeutic
veterinary prescription antimicrobial drugs. The agency is requesting
comments on this draft guidance.
DATES: Submit written comments by April 22, 1998.
ADDRESSES: Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Comments should be identified
with the full title of the draft guidance and the docket number found
in brackets in the heading of this document.
Submit written requests for single copies of this draft guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send
two self-addressed adhesive labels to assist that office in processing
your requests.
Copies of this draft guidance document may also be obtained from
the CVM Home Page (http://www.cvm.fda.gov) on the Internet.
FOR FURTHER INFORMATION CONTACT: John D. Baker, Center for Veterinary
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0130. E-mail: [email protected].
SUPPLEMENTARY INFORMATION:
Background
For many years, CVM has approved veterinary prescription
antimicrobial products labeled with single fixed dosages for a narrow
range of specific diseases and organisms. The very narrow label
indications often failed to address the fact that, while some specific
bacteria produce repeatable, recognized disease, many organisms are
either opportunistic or are known to produce a variety of clinical
manifestations. In addition, with the approval of single fixed dosages,
the efficacy of some products could become suboptimal as bacterial
susceptibility patterns change with time.
The basic concept of Professional Flexible Labeling (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, as a function of their medical training,
veterinarians possess the knowledge, skills, and abilities to interpret
medical diagnostic and prescribing information. Accordingly, they are
able to develop these data into appropriate therapeutic regimens. In
the course of their professional studies, veterinarians are trained in
microbiology, the interpretation of bacterial culture and sensitivity
determinative procedures, and pharmacokinetics. This knowledge gives
them the ability to determine the appropriateness of a particular drug
for use in a specific case.
Under section 502 (f)(1) of the Federal Food, Drug, and Cosmetic
Act (the act), a drug is deemed to be misbranded unless its labeling
bears adequate directions for use (21 U.S.C. 352(f)(1)). The
regulations regarding veterinary drugs at 21 CFR 201.105 exempt a drug
from this provision of the act if it is in the possession of a licensed
veterinarian for use in the course of professional practice, is
dispensed in accordance with section 503(f) of the act (21 U.S.C.
353(f)), and its label bears certain stipulated information. Section
504 of the act (21 U.S.C. 354) stipulates that a veterinary feed
directive drug, a drug intended for use in or on animal feed which is
limited to use under the supervision of a licensed veterinarian, is
exempt from section 502(f) when labeled, distributed, held, and used in
accordance with the conditions set forth in section 504.
Drugs labeled in accordance with the PFL concept require the
training of licensed veterinarians to help ensure appropriate clinical
usage. Such labels would not provide adequate directions for use by the
lay person. Therefore, use of PFL on nonprescription or nonveterinary
feed directive drugs would cause the drugs to be misbranded under
section 502 (f)(1) of the act, PFL-labeled drugs must be classified as
prescription animal drugs or veterinary feed directive drugs.
Accordingly, the PFL concept discussed in this document may apply to
either veterinary
[[Page 3329]]
prescription or veterinary feed directive antimicrobial drugs.
The PFL concept has been a topic of discussion for many years.
Recent workshops on PFL were held in April and December 1995 under the
cosponsorship of the Center for Veterinary Medicine, the American
Academy of Veterinary Pharmacology and Therapeutics, the Animal Health
Institute, and the American Veterinary Medical Association.
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. At the conclusion of the
December, 1995 workshop, a task force prepared a report on the PFL
concept. The task force report, which included a model drug label, was
published in the JAVMA on July 1, 1996.
This draft guidance is intended to describe how the PFL concept can
be applied to prescription antimicrobial products to enable veterinary
practitioners to apply their expertise to appropriately, effectively,
and safely use antimicrobials for specific clinical cases. The draft
document provides specific guidance for drug sponsors on the
development of PFL labeling for therapeutic veterinary prescription
antimicrobial drugs. Ultimately, the labeling of products such as
described in this draft guidance will better accommodate the needs of
veterinary practitioners in utilizing animal drugs to treat animals in
the course of their professional practices.
Approaches to PFL may not be equally applicable to all classes of
therapeutic prescription products (e.g., antimicrobials,
antiparasitics, physiologics). Therefore, CVM intends to develop PFL
guidances that are specific to the various classes of drugs. This draft
guidance document specifically addresses the application of the PFL
concept to prescription therapeutic antimicrobial products.
A sponsor may follow the guidance provided in this draft document,
or a sponsor may choose to follow alternate procedures or practices. If
a sponsor elects to use alternate procedures or practices, that sponsor
may wish to discuss the matter a priori with the agency to prevent an
expenditure of money and effort on activities that may later be
determined to be unacceptable to FDA.
This draft document represents current FDA thinking on PFL for
antimicrobial drugs. This draft guidance document does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate approach may be used if such an approach
satisfies the requirements of the applicable statute, regulations, or
both. FDA may amend this draft guidance document based upon comments
submitted by interested persons.
Request for Comments
Interested persons may, on or before April 22, 1998, submit to the
Dockets Management Branch (address above) written comments on the draft
guidance document. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document, and with the full title of the guidance document.
The draft guidance and received comments may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday. An electronic
version of this guidance is available on the Internet at http://
www.fda.gov. After review of these comments, FDA will finalize the
guidance document with any appropriate changes. Thereafter, interested
persons may submit written comment on the guidance document directly to
the CVM Communications Staff (address above).
Dated: January 14, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-1417 Filed 1-15-98; 3:51 pm]
BILLING CODE 4160-01-F