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Bill114th CongressFiled Apr 18, 2016Health
H.R. 4976

Opioid Review Modernization Act of 2016

Bill journey · stage 2 of 5

Under committee review

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Law

What it doesSummary passed house without amendment (May 11, 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(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

What just happenedMay 12, 2016

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

Who’s behind it

Rep. Maloney, Sean Patrick [D-NY-18](D-NY)Sponsor
1 cosponsor1 R
Read on Congress.gov
1cosponsors2committees20actions2related bills9subjects
  1. May 12, 2016IntroReferral

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

    Health, Education, Labor, and Pensions Committee
  2. May 11, 2016FloorH38310

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

  3. May 11, 2016FloorH37300

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

  4. May 11, 2016Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H2254-2256)

  5. May 11, 2016FloorH8D000

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

  6. May 11, 2016FloorH30000

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

  7. May 11, 2016FloorH30300

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

  8. May 10, 2016CalendarsH12410

    Placed on the Union Calendar, Calendar No. 431.

  9. May 10, 2016CommitteeH12200

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

    Energy and Commerce Committee
  10. May 10, 2016Committee5000

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

    Energy and Commerce Committee
  11. Apr 27, 2016Committee

    Ordered to be Reported by Voice Vote.

    Energy and Commerce Committee
  12. Apr 27, 2016Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  13. Apr 26, 2016Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  14. Apr 25, 2016Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  15. Apr 20, 2016Committee

    Forwarded by Subcommittee to Full Committee by Voice Vote .

    Health Subcommittee
  16. Apr 20, 2016Committee

    Subcommittee Consideration and Mark-up Session Held.

    Health Subcommittee
  17. Apr 18, 2016Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  18. Apr 18, 2016IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  19. Apr 18, 2016IntroReferralIntro-H

    Introduced in House

  20. Apr 18, 2016IntroReferral1000

    Introduced in House

Passed House without amendmentMay 11, 201681

(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."
Reported to House without amendmentMay 10, 201679

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

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."
Introduced in HouseApr 18, 2016

Opioid Review Modernization Act of 2016

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.

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.

The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."
Opioid Review Modernization Act of 2016 — Informed