[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Notices]
[Pages 10908-10909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4341]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0074]
Draft Guidance for Industry on Medication Guides--Distribution
Requirements and Inclusion of Medication Guides in Risk Evaluation and
Mitigation Strategies; 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availability of a draft guidance for industry entitled ``Medication
Guides--Distribution Requirements and Inclusion in Risk Evaluation and
Mitigation Strategies (REMS).'' This draft guidance addresses two
topics pertaining to Medication Guides for drug and biological
products. First, the draft guidance addresses when FDA intends to
exercise enforcement discretion regarding dispensing requirements for
Medication Guides that must be distributed with a drug or biological
product dispensed to a healthcare professional for administration to a
patient instead of being dispensed directly to the patient for self-
administration or to the patient's caregiver for administration to the
patient. Second, the draft guidance addresses when a Medication Guide
will be required as part of a REMS. The draft guidance is intended to
answer questions that have arisen concerning these topics.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 31, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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; or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or 301-827-1800. 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
[[Page 10909]]
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kristen E. Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6226, Silver Spring, MD 20993-0002, 301-
796-5400; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Medication Guides--Distribution Requirements and Inclusion
of Medication Guides in Risk Evaluation and Mitigation Strategies
(REMS).'' This draft guidance is intended to address two topics
pertaining to Medication Guides for drug and biological products.
Medication Guides are primarily for prescription drug and
biological products used on an outpatient basis without direct
supervision by a healthcare professional. Questions have arisen
concerning when a Medication Guide must be distributed with a drug or
biological product dispensed to a healthcare professional for
administration to a patient in certain situations, for example, in an
inpatient setting or an outpatient setting such as a clinic or infusion
center. This draft guidance is intended to articulate the circumstances
under which FDA intends to exercise enforcement discretion regarding
Medication Guide distribution.
The second topic addressed by the draft guidance is when a
Medication Guide will be required as part of a REMS. Under section 505-
1(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 355-1(e)), FDA may require that a REMS for a drug include one or
more of the elements described in section 505-1(e), including (when the
criteria in part 208 (21 CFR part 208) are met), the requirement for an
applicant to develop a Medication Guide for distribution to each
patient when the drug is dispensed. Since the enactment of the Food and
Drug Administration Amendments Act of 2007, FDA has, as a matter of
policy, considered any new Medication Guide (or safety-related changes
to an existing Medication Guide) to be part of a REMS. However, the
Agency has the authority to determine, based on the risks of a drug and
public health concern, how a Medication Guide should be required when
the standard in part 208 is met. Based on the risks and public health
concern, the Agency may require:
(1) A Medication Guide in accordance with part 208 that is not a
part of a REMS or
(2) A Medication Guide in accordance with part 208 and section 505-
1 of the FD&C Act that is part of a REMS, which will include other
parts of a REMS (such as the timetable for submission of assessments)
and possibly other REMS elements (including elements to assure safe
use).
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 when FDA
intends to exercise enforcement discretion regarding Medication Guide
distribution and inclusion of Medication Guides in REMS. 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. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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 draft 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 Sec. Sec. 314.70 and 600.12 have been
approved under OMB control numbers 0910-0001 and 0910-0338; the
collections of information in part 208 have been approved under OMB
control number 0910-0393.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.
Dated: February 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4341 Filed 2-25-11; 8:45 am]
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