[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14402-14403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5777]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0085]
Draft Guidance on Classifying Significant Postmarket Drug Safety
Issues; 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availability of a draft guidance entitled ``Classifying Significant
Postmarket Drug Safety Issues.'' This draft guidance describes FDA's
current approach to classifying a significant postmarket drug safety
issue as a ``priority'' tracked safety issue (TSI) or a ``standard''
TSI, with the capability of elevating some priority TSIs to an
``emergency'' status. The draft guidance was developed in connection
with the Center for Drug Evaluation and Research's (CDER's) Safety
First Initiative.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 8, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Michie Hunt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6153, Silver Spring, MD 20993-0002, 301-
796-3504.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Classifying Significant Postmarket Drug Safety Issues.'' This draft
guidance describes CDER's current approach to determining whether a
significant postmarket drug safety issue should be classified as a
``priority,'' as a ``standard,'' or as an ``emergency'' tracked safety
issue (TSI).
CDER receives a constant flow of information about potential drug
safety issues, and the seriousness of reported problems varies widely.
Those that CDER determines to be significant safety issues are tracked
in the Center's Document Archiving, Reporting, and Regulatory Tracking
System (DARRTS), a centralized data base that enables staff working
across the Center to share information. To be considered significant,
the safety issue of concern must meet certain criteria. In general,
CDER considers postmarket safety issues to be significant if they have
the potential to lead to any of the following actions:
Withdrawal of an approved drug from the market.
Withdrawal of an approved indication.
Limitations of a use in a specific population or
subpopulation.
Additions or modifications to the Contraindications or
Warnings and Precautions sections of the labeling, to the Medication
Guide or other required Patient Package Insert, including safety
labeling changes required under the Food and Drug Administration
Amendments Act (FDAAA).
Establishment of or changes to the proprietary name/
container label/labeling/packaging to reduce the likelihood of
medication errors.
Establishment or modification of a risk evaluation and
mitigation strategy (REMS).
A requirement that a sponsor conduct a safety-related
postmarket clinical trial or observational epidemiological study.
The conduct of a safety-related observational
epidemiological study by FDA.
Since the DARRTS safety tracking function was introduced in 2007,
about 1,000 TSIs have been entered into the system. Although all of
these issues are considered significant, not all TSIs are equally
urgent. Furthermore, CDER does not have adequate resources to manage
all TSIs equally rapidly. In the past, prioritization of the TSIs has
been handled informally and on a case-by-case basis, without an agreed
upon framework for establishing priority.
The Center is now seeking to establish a formal framework for
assessing the relative urgency of TSIs, so that CDER can direct
resources more effectively toward the issues that pose the greatest
potential risk for patients. This framework will classify TSIs as
``priority'' or ``standard'' for CDER review. In addition, the Center
will recognize a special ``emergency'' category for certain priority
TSIs. The use of a formal framework is intended to ensure that staff
working in different offices across CDER reaches similar conclusions
about the relative urgency of TSIs, and help them direct attention to
those that need to be addressed most expeditiously. It will also inform
CDER decisions about public drug safety communications, so that health
care practitioners and patients receive timely information about safety
risks with the greatest public health significance.
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 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. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division
[[Page 14403]]
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5777 Filed 3-8-12; 8:45 am]
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