Opioid Review Modernization Act of 2016

(This measure has not been amended since it was introduced. The expanded summary of the House reported version is repeated here.)

Opioid Review Modernization Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.

The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.

(Sec. 3) As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.

(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4976 Introduced in House (IH)]

<DOC>






114th CONGRESS
  2d Session
                                H. R. 4976

 To require the Commissioner of Food and Drugs to seek recommendations 
 from an advisory committee of the Food and Drug Administration before 
approval of certain new drugs that are opioids without abuse-deterrent 
                  properties, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 18, 2016

   Mr. Sean Patrick Maloney of New York (for himself and Mr. Lance) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To require the Commissioner of Food and Drugs to seek recommendations 
 from an advisory committee of the Food and Drug Administration before 
approval of certain new drugs that are opioids without abuse-deterrent 
                  properties, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Opioid Review Modernization Act of 
2016''.

SEC. 2. FDA OPIOID ACTION PLAN.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 569 of such Act (21 U.S.C. 350bbb-8) the 
following:

``SEC. 569-1. OPIOID ACTION PLAN.

    ``(a) New Drug Application.--
            ``(1) In general.--Subject to paragraph (2), prior to the 
        approval pursuant to an application under section 505(b) of a 
        new drug that is an opioid and does not have abuse-deterrent 
        properties, the Secretary shall refer the application to an 
        advisory committee of the Food and Drug Administration to seek 
        recommendations from such advisory committee.
            ``(2) Public health exemption.--A referral to an advisory 
        committee under paragraph (1) is not required with respect to a 
        new drug if the Secretary--
                    ``(A) finds that such a referral is not in the 
                interest of protecting and promoting public health;
                    ``(B) finds that such a referral is not necessary 
                based on a review of the relevant scientific 
                information; and
                    ``(C) submits a notice containing the rationale for 
                such findings to the Committee on Health, Education, 
                Labor, and Pensions of the Senate and the Committee on 
                Energy and Commerce of the House of Representatives.
    ``(b) Pediatric Opioid Labeling.--The Secretary shall convene the 
Pediatric Advisory Committee of the Food and Drug Administration to 
seek recommendations from such Committee regarding a framework for the 
inclusion of information in the labeling of drugs that are opioids 
relating to the use of such drugs in pediatric populations before the 
Secretary approves any labeling or change to labeling for any drug that 
is an opioid intended for use in a pediatric population.
    ``(c) Sunset.--The requirements of subsections (a) and (b) shall 
cease to be effective on October 1, 2022.''.

SEC. 3. PRESCRIBER EDUCATION.

    Not later than 1 year after the date of the enactment of this Act, 
the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, as part of the Food and Drug 
Administration's evaluation of the Extended-Release/Long-Acting Opioid 
Analgesics Risk Evaluation and Mitigation Strategy, and in consultation 
with relevant stakeholders, shall develop recommendations regarding 
education programs for prescribers of opioids pursuant to section 505-1 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), 
including recommendations on--
            (1) which prescribers should participate in such programs; 
        and
            (2) how often participation in such programs is necessary.

SEC. 4. GUIDANCE ON EVALUATING THE ABUSE DETERRENCE OF GENERIC SOLID 
              ORAL OPIOID DRUG PRODUCTS.

    Not later than 2 years after the end of the period for public 
comment on the draft guidance entitled ``General Principals for 
Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug 
Products'' issued by the Center for Drug Evaluation and Research of the 
Food and Drug Administration in March 2016, the Commissioner of Food 
and Drugs shall publish in the Federal Register a final version of such 
guidance.
                                 <all>