Opioid Review Modernization Act of 2016

Bill: 114-hr-4976
Sponsor: full_name: Rep. Maloney, Sean Patrick [D-NY-18]
Introduced: 2016-04-18
Policy area: Health
Subjects: Administrative law and regulatory procedures

Advisory bodies

Child health

Congressional oversight

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Drug trafficking and controlled substances

Food and Drug Administration (FDA)

Prescription drugs
Latest action: action_date: 2016-05-12
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2016-04-18
action_desc: Introduced in House
text: <p><b>Opioid Review Modernization Act of 2016</b></p> <p>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.</p> <p>The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.</p> <p>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.</p> The FDA must finalize the draft guidance entitled &quot;General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.&quot;

action_date: 2016-05-10
action_desc: Reported to House without amendment
text: <p>(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)</p> <p><b>Opioid Review Modernization Act of 2016</b></p> <p>(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.</p> <p>The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.</p> <p>(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.</p> (Sec. 4) The FDA must finalize the draft guidance entitled &quot;General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.&quot;

action_date: 2016-05-11
action_desc: Passed House without amendment
text: <p>(This measure has not been amended since it was introduced. The expanded summary of the House reported version is repeated here.)</p> <p><b>Opioid Review Modernization Act of 2016</b></p> <p>(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.</p> <p>The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.</p> <p>(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.</p> (Sec. 4) The FDA must finalize the draft guidance entitled &quot;General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.&quot;

tv_txt: I 114th CONGRESS 2d Session H. R. 4976 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.

1. Short title This Act may be cited as the Opioid Review Modernization Act of 2016 . 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: 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. . 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. 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.

tv_txt: IB 114th CONGRESS 2d Session H. R. 4976 IN THE HOUSE OF REPRESENTATIVES AN ACT 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.

1. Short title This Act may be cited as the Opioid Review Modernization Act of 2016 . 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: 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. . 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. 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.

Passed the House of Representatives May 11, 2016. Karen L. Haas, Clerk.

tv_txt: IIB 114th CONGRESS 2d Session H. R. 4976 IN THE SENATE OF THE UNITED STATES May 12, 2016 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT 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.

1. Short title This Act may be cited as the Opioid Review Modernization Act of 2016 . 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: 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. . 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. 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.

Passed the House of Representatives May 11, 2016. Karen L. Haas, Clerk

tv_txt: IB Union Calendar No. 431 114th CONGRESS 2d Session H. R. 4976 [Report No. 114–557] 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 May 10, 2016 Committed to the Committee of the Whole House on the State of the Union and ordered to be printed 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.

1. Short title This Act may be cited as the Opioid Review Modernization Act of 2016 . 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: 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. . 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. 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.

May 10, 2016 Committed to the Committee of the Whole House on the State of the Union and ordered to be printed