(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(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee by Voice Vote .
Committee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported by Voice Vote.
Reported by the Committee on Energy and Commerce. H. Rept. 114-557.
Reported by the Committee on Energy and Commerce. H. Rept. 114-557.
Placed on the Union Calendar, Calendar No. 431.
Mr. Guthrie moved to suspend the rules and pass the bill.
Considered under suspension of the rules. (consideration: CR H2254-2256)
DEBATE - The House proceeded with forty minutes of debate on H.R. 4976.
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H2254-2256)
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2254-2256)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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