[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Page 17765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07562]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0045]
Abuse-Deterrent Opioids--Evaluation and Labeling; Guidance for
Industry; 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 guidance for industry entitled ``Abuse-Deterrent
Opioids--Evaluation and Labeling''. This guidance explains FDA's
current thinking about the studies that should be conducted to
demonstrate that a given formulation has abuse-deterrent properties.
This guidance also makes recommendations about how those studies should
be performed and evaluated, and discusses how to describe those studies
and their implications in product labeling. It is intended to assist
sponsors who wish to develop opioid drug products with potentially
abuse-deterrent properties and is not intended to apply to products
that are not opioids or opioid products that do not have the potential
for abuse.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, 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 guidance document.
Submit electronic comments on the 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: Brutrinia D. Cain, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-4633,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Abuse-Deterrent Opioids--Evaluation and Labeling.''
Prescription opioid products are an important component of modern pain
management. However, abuse and misuse of these products have created a
serious and growing public health problem. One potentially important
step towards the goal of creating safer opioid analgesics has been the
development of opioids that are formulated with some properties
intended to deter abuse. FDA considers development of these products a
high public health priority.
The guidance is intended to provide industry with a framework for
evaluating and labeling abuse-deterrent opioid products. The guidance
discusses how the potentially abuse-deterrent properties of an opioid
analgesic formulated to deter abuse should be studied, specifically
addressing in vitro studies, pharmacokinetic studies, clinical abuse
potential studies, and postmarket studies. The guidance also describes
the types of information that may be suitable for inclusion in
labeling.
Providing a clear framework for the evaluation and labeling of the
abuse-deterrent properties of opioid analgesics intended to deter abuse
should help to incentivize the development of safer, less abusable
opioid analgesics, and should also facilitate the dissemination of fair
and accurate information regarding such products.
In the Federal Register of January 14, 2013 (78 FR 2676), FDA
announced the availability of a draft version of this guidance and
provided interested parties an opportunity to submit comments. The
Agency has carefully reviewed and considered the comments it received
in developing this final version of the guidance. The Agency has made
revisions to the guidance as it deemed appropriate.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the evaluation and labeling of abuse-
deterrent opioids. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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 of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
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 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07562 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4164-01-P