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The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."| Action Date | Type | Text | Source |
|---|---|---|---|
| 2016-05-12 | IntroReferral | Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. | Senate |
| 2016-05-11 | Floor | Motion to reconsider laid on the table Agreed to without objection. | House floor actions |
| 2016-05-11 | Floor | On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2254-2256) | House floor actions |
| 2016-05-11 | Floor | DEBATE - The House proceeded with forty minutes of debate on H.R. 4976. | House floor actions |
| 2016-05-11 | Floor | Considered under suspension of the rules. (consideration: CR H2254-2256) | House floor actions |
| 2016-05-11 | Floor | Mr. Guthrie moved to suspend the rules and pass the bill. | House floor actions |
| 2016-05-10 | Calendars | Placed on the Union Calendar, Calendar No. 431. | House floor actions |
| 2016-05-10 | Committee | Reported by the Committee on Energy and Commerce. H. Rept. 114-557. | House floor actions |
| 2016-04-27 | Committee | Ordered to be Reported by Voice Vote. | House committee actions |
| 2016-04-27 | Committee | Committee Consideration and Mark-up Session Held. | House committee actions |
| 2016-04-26 | Committee | Committee Consideration and Mark-up Session Held. | House committee actions |
| 2016-04-25 | Committee | Committee Consideration and Mark-up Session Held. | House committee actions |
| 2016-04-20 | Committee | Forwarded by Subcommittee to Full Committee by Voice Vote . | House committee actions |
| 2016-04-20 | Committee | Subcommittee Consideration and Mark-up Session Held. | House committee actions |
| 2016-04-18 | Committee | Referred to the Subcommittee on Health. | House committee actions |
| 2016-04-18 | IntroReferral | Referred to the House Committee on Energy and Commerce. | House floor actions |
| 2016-04-18 | IntroReferral | Introduced in House | Library of Congress |