United States 114th Congress Status: Died 1 D cosponsors

HR 4976 — Opioid Review Modernization Act of 2016

Last action — Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

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 (Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

Bill Text

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Read HR 4976 on the official United States source →

Action History

  1. Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  2. Motion to reconsider laid on the table Agreed to without objection.

  3. On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2254-2256)

  4. DEBATE - The House proceeded with forty minutes of debate on H.R. 4976.

  5. Considered under suspension of the rules. (consideration: CR H2254-2256)

  6. Mr. Guthrie moved to suspend the rules and pass the bill.

  7. Placed on the Union Calendar, Calendar No. 431.

  8. Reported by the Committee on Energy and Commerce. H. Rept. 114-557.

  9. Ordered to be Reported by Voice Vote.

  10. Committee Consideration and Mark-up Session Held.

  11. Committee Consideration and Mark-up Session Held.

  12. Committee Consideration and Mark-up Session Held.

  13. Forwarded by Subcommittee to Full Committee by Voice Vote .

  14. Subcommittee Consideration and Mark-up Session Held.

  15. Referred to the Subcommittee on Health.

  16. Referred to the House Committee on Energy and Commerce.

  17. Introduced in House

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

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Frequently asked questions

What does HR 4976 do?
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."
Who sponsors HR 4976?
HR 4976 is sponsored by Sean Maloney (D).
What is the current status of HR 4976?
This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 4976?
Track HR 4976 free on One Click Politics — get push/email alerts when it moves.

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