Opioid Review Modernization Act of 2016
Floor Speech
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Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the bill (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.
The Clerk read the title of the bill.
The text of the bill is as follows: H.R. 4976
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.
Mr. Speaker, I rise in support of H.R. 4976, the Opioid Review Modernization Act of 2016, introduced by the gentleman from New York (Mr. Sean Patrick Maloney) and the gentleman from New Jersey (Mr. Lance).
Opioid use disorder and overdose deaths have reached epidemic levels. A comprehensive approach is needed to reverse these trends and the tragic toll they have taken on families and communities across our country.
The Food and Drug Administration does have a critical role to play in such an approach. Patients living with serious pain must have access to safe and effective therapies to help them function and lead productive lives. FDA reviews prescription pain relievers, like all new drug products, to determine whether their benefits outweigh their risks.
It is important that the FDA hear recommendations from expert advisory committees prior to making key product and labeling decisions, particularly to ensure that any such risks are effectively communicated, understood, and mitigated.
Specifically, H.R. 4976 requires that FDA receives input from an advisory committee regarding approval of new opioids that do not utilize abuse-deterrent properties, in addition to developing a framework for labeling any opioid intended for pediatric use.
The bill also requires the agency to finalize guidance on evaluating abuse deterrence in generic opioid medications and issue recommendations regarding prescriber education tied to the risk evaluation mitigation strategy programs.
This bill would strengthen FDA's Opioid Action Plan, defining outcomes with meaningful timeframes. I urge my colleagues to support H.R. 4976.
Mr. Speaker, this bill, the FDA's Opioid Action Plan, is important in our larger package of bills. I urge my colleagues to support this measure, H.R. 4976.
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