[Federal Register: March 7, 2007 (Volume 72, Number 44)]
[Notices]
[Page 10224-10225]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr07-111]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0062]
Guidance on Drug Safety Information--Food and Drug
Administration's Communication to the Public; Availability
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 guidance titled ``Drug Safety Information--FDA's
Communication to the Public.'' This guidance describes FDA's current
approach to communicating important drug safety information, including
emerging drug safety information, to the public and the factors that
influence when such information is communicated. This guidance was
developed in connection with FDA's Drug Safety Initiative. This
guidance is the final version and supersedes the previously issued
draft guidance titled ``FDA's Drug Watch for Emerging Drug Safety
Information'' (70 FR 24606, May 10, 2005).
DATES: Submit written or electronic comments on agency guidances at
any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the guidance to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Paul J. Seligman, Associate Director
for Safety Policy and Communication, Center for Drug Evaluation and
Research (HFD-001), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-5570.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled ``Drug
Safety Information--FDA's Communication to the Public.'' This guidance
describes FDA's current approach to communicating important drug safety
information, including emerging drug safety information, to the public
and the factors that influence when such information is communicated.
For many years, FDA has provided information on drug risks and
benefits to healthcare professionals and patients when that information
has generated a specific concern or prompted a regulatory action, such
as a revision to the drug product's labeling. FDA has been reexamining
its risk communication program, including how and when we communicate
emerging drug safety information to the public. More recently, FDA has
begun taking a more comprehensive approach to making information on
potential drug risks available to the public earlier, in some cases
while the agency still is evaluating whether any regulatory action is
warranted. FDA believes that timely communication of important drug
safety information will give healthcare professionals, patients,
consumers, and other interested persons access to the most current
information concerning the potential risks and benefits of a marketed
drug, helping them to make more informed individual treatment choices.
FDA's risk communication efforts are part of a larger drug safety
initiative that began in November 2004, when FDA announced an
initiative to strengthen the safety program for marketed drugs. This
initiative included the following: (1) Sponsoring an independent study
by the Institute of Medicine of the National Academies of the
effectiveness of the drug safety system, with emphasis on postmarketing
risk assessment and surveillance; (2) conducting workshops and Advisory
Committee meetings regarding complex drug safety and risk management
issues, including emerging concerns; and (3) publishing three risk
management guidances. FDA augmented its drug safety initiative in
February 2005 by creating an independent Drug Safety Oversight Board to
enhance oversight of drug safety decision making within the Center for
Drug Evaluation and Research (CDER).
In May 2005, FDA issued a draft guidance titled ``FDA's Drug Watch
for Emerging Drug Safety Information'' (70 FR 24606, May 10, 2005). The
draft guidance described a proposal to establish a new communication
channel, called the ``Drug Watch'' Web page, to provide information to
the public on emerging drug safety issues. In December 2005, FDA held a
public hearing regarding ``FDA's Communication of Drug Safety
Information'' that examined the various risk communication tools
employed by FDA. FDA has carefully reviewed the comments it received on
the draft guidance (30 comments were submitted to the public docket)
and during the public hearing. This final version of the guidance
reflects our consideration of these comments, as well as our experience
with posting emerging drug safety information.
Due to potential confusion between the proposed ``Drug Watch'' and
FDA's existing ``MedWatch'' program, FDA no longer plans to use the
name ``Drug Watch'' to describe the Web page that contains drug safety
information. We have identified drugs that have been the subject of a
Public Health Advisory or an Alert on a single Web page, the Index to
Drug-Specific Information, linked from FDA's Web site. This is part of
our ongoing effort to use and enhance existing FDA communications
mechanisms to better convey important drug safety information to the
public. In addition, we have revised this guidance to describe the
various methods FDA currently uses to communicate established and
emerging drug safety information to the public. It should be noted that
we will continue to evaluate and enhance the effectiveness of the
various methods we use to communicate about important drug safety
issues, including the mechanisms described in this guidance and the
presentation of drug safety information on the Agency Web sites (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder). We intend to update this
guidance, as appropriate, to reflect any substantial modifications to
our communication of drug safety information to the public.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic
[[Page 10225]]
comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 310.305, 314.80, 314.98, and
600.80 have been approved under OMB control numbers 0910-0230, 0910-
0291, and 0910-0308.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: February 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1048 Filed 2-2-07; 10:22 am]
BILLING CODE 4160-01-S