[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24606-24607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9297]
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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Draft Guidance for Industry on the Food and Drug Administration's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availability of a draft guidance for industry entitled ``FDA's `Drug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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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://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access to the draft guidance document.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FDA is announcing the availability of a draft guidance for industry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://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://www.fda.gov/cder/guidance/index.htm or 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