[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices]               
[Page 24606-24607]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-95]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0062]

 
Draft Guidance for Industry on the Food and Drug Administration's 
``Drug Watch'' for Emerging Drug Safety Information; 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availability of a draft guidance for industry entitled ``FDA's `Drug 
Watch' for Emerging Drug Safety Information.'' This document provides 
guidance about how FDA intends to develop and disseminate important 
emerging drug safety information concerning marketed drug products to 
healthcare professionals and patients. This information will appear on 
an FDA Web page to be called the ``Drug Watch.''

DATES: Submit written or electronic comments on the draft guidance by 
August 8, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Deborah J. Henderson, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 301-594-5400.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``FDA's `Drug Watch' for Emerging Drug Safety Information.'' 
This document provides guidance about how FDA intends to develop and 
disseminate important emerging drug safety information concerning 
marketed drug products to healthcare professionals and patients.
    In the last several months, members of patient groups, the medical 
community, and Congress have raised concerns regarding the way in which 
FDA has handled certain drug safety issues, most recently in connection 
with the withdrawal of Vioxx from the market and with the management of 
the risks of suicide associated with pediatric use of antidepressants. 
As a result, FDA is carefully evaluating its institutional approach to 
drug safety issues, focusing especially on the ways in which the agency 
responds to new safety concerns and resolves scientific disagreements 
about product safety between agency components. As part of this 
process, FDA is also reexamining its risk communication program, 
including how and when we communicate significant emerging safety 
information to healthcare professionals and patients.\1\
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    \1\ For information about the other steps FDA is taking see 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/bbs/ topics/news/2004/NEW01131.html.

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    FDA has long provided information on drug risks and benefits to 
healthcare professionals and patients. In the past, we provided that 
information when we were certain of its significance or it prompted a 
regulatory action, such as a labeling change. We have now decided to 
make important drug safety information available to healthcare 
professionals and patients in a new format and earlier than we have in 
the past. This information will appear on an FDA Web page called the 
``Drug Watch.''

II. The Drug Watch Program

    The goal of the Drug Watch program is to ensure that patients and 
healthcare professionals have quick access to the most up-to-date and 
accurate product information available in an easily accessible form. 
The Drug Watch Web page will post significant emerging safety 
information that FDA has received about certain drugs (or classes of 
drugs) while the agency continues to actively evaluate the information. 
The Drug Watch page is not intended to be a list of drugs that are 
particularly risky or dangerous for use; listing of a drug on the Drug 
Watch should not be construed as a statement by FDA that the drug is 
dangerous or that it is inappropriate for use. All drugs have risks, 
and prescribers must balance the risks and benefits of a drug when 
making judgments about an individual patient's therapy. However, 
sometimes after a drug is approved, rare but serious new side effects 
emerge as the drug is more widely used or is prescribed for off-label 
uses. Sometimes these emerging risks appear to be life-threatening, 
while in other cases they may appear to be less serious. In most 
instances, however, there is a period of uncertainty while FDA and the 
drug's sponsor evaluate new, emerging safety information to determine 
whether the safety concern in fact relates to the drug, and whether 
regulatory or other action is appropriate. The purpose of the Drug 
Watch is to provide a forum from which FDA can communicate emerging 
safety information to the public while we

[[Page 24607]]

continue to evaluate that information. We intend to work as quickly as 
possible to assess and address the safety issues identified on the Drug 
Watch, and we will continue to communicate important information about 
drug risks that are known with greater certainty using traditional 
means, such as public health advisories. Our goal with the Drug Watch 
is to share emerging safety information before we have fully determined 
its significance or taken final regulatory action so that patients and 
healthcare professionals will have the most current information 
concerning the potential risks and benefits of marketed drug products.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on FDA's Drug 
Watch for emerging drug safety information. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed 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. The 
draft guidance and received comments are available for public 
examination in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

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: May 4, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9297 Filed 5-5-05; 3:42 pm]

BILLING CODE 4160-01-S