Opioid Review Modernization Act of 2016
1/11/2023, 1:31 PMCongressional Summary of HR 4976
(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(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."
