[Federal Register Volume 72, Number 44 (Wednesday, March 7, 2007)]
[Notices]
[Pages 10224-10225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1048]


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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draft guidance titled ``FDA's Drug Watch for Emerging Drug Safety 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://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://www.fda.gov and 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://www.fda.gov/cder/guidance/index.htm or 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