80 FR 17765 - Abuse-Deterrent Opioids-Evaluation and Labeling; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 63 (April 2, 2015)

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.

[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Page 17765]
From the Federal Register Online  [www.thefederalregister.org]
[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