81 FR 16186 - General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 58 (March 25, 2016)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.'' This draft guidance recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug.

[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16186-16187]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0785]


General Principles for Evaluating the Abuse Deterrence of Generic 
Solid Oral Opioid Drugs Products; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``General 
Principles for Evaluating the Abuse Deterrence of Generic Solid Oral 
Opioid Drug Products.'' This draft guidance recommends studies, 
including comparative in vitro studies, which should be conducted to 
demonstrate that a proposed generic solid oral opioid drug product is 
no less abuse-deterrent than its reference listed drug.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 24, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-0785 for ``General Principles for Evaluating the Abuse-
Deterrence of Generic Solid Oral Opioid Drugs.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

[[Page 16187]]

    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Office of Generic 
Drugs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-9291, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``General Principles for Evaluating the Abuse Deterrence of 
Generic Solid Oral Opioid Drug Products.'' Prescription opioid 
analgesics are an important component of modern pain management. 
However, abuse and misuse of these drug products have created a serious 
and growing public health problem. One important step toward the goal 
of creating safer opioid analgesics has been the development of opioid 
drug products that are formulated to deter abuse. FDA considers the 
development of these products a high public health priority. It is 
important that generic versions of opioids that reference listed drugs 
whose labeling describes abuse-deterrent properties are available to 
help ensure availability of analgesics for patients who need them.
    For FDA to approve an abbreviated new drug application (ANDA), the 
Agency must find, among other things, that the generic drug product has 
the same active ingredient(s), dosage form, route of administration, 
strength, and, with limited exceptions, labeling as the reference 
listed drug (RLD); is bioequivalent to its RLD; that the methods used 
in, or the facilities and controls used for, the manufacture, 
processing, and packing of the drug are adequate to assure and preserve 
its identity, strength, quality, and purity; and that the inactive 
ingredients and composition of the generic drug are not unsafe for use 
under the conditions prescribed, recommended, or suggested in the 
labeling (see, e.g., the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) 505(j)(2)(A) and (j)(4) (21 U.S.C. 355(j)(2)(A) and (j)(4))). FDA 
classifies as ``therapeutically equivalent'' those products that meet 
the following general criteria: (1) They are approved as safe and 
effective; (2) they are pharmaceutical equivalents in that they: (a) 
Contain identical amounts of the same active ingredient in the same 
dosage form and route of administration, and (b) meet compendial or 
other applicable standards of strength, quality, purity, and identity; 
(3) they are bioequivalent; (4) they are adequately labeled; and (5) 
they are manufactured in compliance with current good manufacturing 
practices regulations. (See preface of Approved Drug Products with 
Therapeutic Equivalence Evaluations (commonly referred to as the Orange 
Book).) FDA believes that a product classified as therapeutically 
equivalent can be substituted with the full expectation that the 
substituted product will produce the same clinical effect and safety 
profile as the reference product.
    Accordingly, if the RLD's labeling describes abuse-deterrent 
properties, the ANDA applicant should evaluate its product to show that 
it is no less abuse-deterrent than the RLD with respect to all 
potential routes of abuse. Marketing a generic opioid drug product that 
is less abuse-deterrent than the RLD could lead opioid abusers to 
preferentially seek out and abuse generics.
    This draft guidance describes FDA's current thinking about the 
studies that should be conducted by a potential ANDA applicant and 
submitted to FDA in an ANDA to demonstrate that a generic solid oral 
opioid drug product is no less abuse-deterrent than its RLD with 
respect to all potential routes of abuse.
    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 current thinking of FDA on the principles 
for evaluating the abuse-deterrence of generic solid oral opioid drug 
products. 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.
    FDA intends to hold a public meeting following the close of the 
comment period to discuss further the evaluation of the abuse 
deterrence of generic opioid drug products and related issues, as 
appropriate. Further details will follow in a notice of public meeting 
published in the Federal Register.

II. 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 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06766 Filed 3-24-16; 8:45 am]
 BILLING CODE 4164-01-P