[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Draft Guidance on Classifying Significant Postmarket Drug Safety 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availability of a draft guidance entitled ``Classifying Significant 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 This draft guidance describes FDA's 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 The draft guidance was developed in connection 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 8, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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    FDA is announcing the availability of a draft guidance entitled 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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