Opioid Review Modernization Act of 2016

Summary

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 The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

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Timeline

1. 18 April 2016

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

2. 18 April 2016

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

3. 18 April 2016

   Introduced

   Introduced in House

   Source: IntroReferral

4. 18 April 2016

   Introduced

   Introduced in House

   Source: IntroReferral

5. 20 April 2016

   Committee

   Forwarded by Subcommittee to Full Committee by Voice Vote .

   Source: Committee

6. 20 April 2016

   Committee

   Subcommittee Consideration and Mark-up Session Held.

   Source: Committee

7. 25 April 2016

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

8. 26 April 2016

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

9. 27 April 2016

   Reported

   Ordered to be Reported by Voice Vote.

   Source: Committee

10. 27 April 2016

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

11. 10 May 2016

    Calendars

    Placed on the Union Calendar, Calendar No. 431.

    Source: Calendars

12. 10 May 2016

    Reported

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

    Source: Committee

13. 10 May 2016

    Reported

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

    Source: Committee

14. 11 May 2016

    Passed

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

    Source: Floor

15. 11 May 2016

    Passed

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

    Source: Floor

16. 11 May 2016

    Passed

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

    Source: Floor

17. 11 May 2016

    Floor

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

    Source: Floor

18. 11 May 2016

    Floor

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

    Source: Floor

19. 11 May 2016

    Floor

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

    Source: Floor

20. 12 May 2016

    Introduced

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

    Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Referred in Senate · 12 May 2016 · Official file
• Engrossed in House · 11 May 2016 · Official file
• Reported in House · 10 May 2016 · Official file
• Introduced in House · 18 April 2016 · Official file

Documents

11 official files

• Referred in Senate (text)

  Referred in Senate · EN · 12 May 2016

  ViewDownloadOpen at official source

• Referred in Senate (PDF)

  Referred in Senate · EN · 12 May 2016

  ViewDownloadOpen at official source

• Engrossed in House (text)

  Engrossed in House · EN · 11 May 2016

  ViewDownloadOpen at official source

• Engrossed in House (PDF)

  Engrossed in House · EN · 11 May 2016

  ViewDownloadOpen at official source

• Passed House without amendment

  summary · EN · 11 May 2016

  Open at official source

• Reported in House (text)

  Reported in House · EN · 10 May 2016

  ViewDownloadOpen at official source

• Reported in House (PDF)

  Reported in House · EN · 10 May 2016

  ViewDownloadOpen at official source

• Reported to House without amendment

  summary · EN · 10 May 2016

  Open at official source

• Introduced in House (text)

  Introduced in House · EN · 18 April 2016

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 18 April 2016

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 18 April 2016

  Open at official source

Sponsors

• Sean Maloney · D · Sponsor
• Leonard Lance · R · Sponsor
• · sshr00 · Standing
• · hsif00 · Standing

Related records

• related to → Comprehensive Addiction and Recovery Act of 2016
• related to ← Opioid Abuse Crisis Act of 2016