H.R. 4976 · 114th Congress
Opioid Review Modernization Act of 2016
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Passed the House without a recorded vote, then expired. It passed by voice vote or unanimous consent, which don't record how each member voted, but didn't become law before the 114th Congress ended.
D
MaloneySponsor1 cosponsor · 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
- House Introduced Apr 18, 2016
- House Passed May 11, 2016
What it does: CRS summary · 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(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Opioid Review Modernization Act of 2016
Latest action (May 12, 2016): Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: House · Introduced: Apr 18, 2016
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
- House Introduced Apr 18, 2016
- House Passed May 11, 2016
No recorded floor vote found.