summary
Introduced
04/18/2016
04/18/2016
In Committee
04/27/2016
04/27/2016
Crossed Over
05/12/2016
05/12/2016
Passed
Dead
01/03/2017
01/03/2017
Introduced Session
114th Congress
Bill Summary
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 (Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."
AI Summary
This bill, the Opioid Review Modernization Act of 2016, mandates that the Food and Drug Administration (FDA) must consult with an advisory committee before approving new opioid drugs (medications that have effects similar to opium, often used for pain relief) unless the FDA determines such a consultation is not scientifically necessary and would not benefit public health, in which case they must notify Congress with their reasoning. Additionally, the FDA is required to convene a specific advisory committee to review and recommend how to label opioids for use in children before approving any such labeling. The bill also directs the FDA to develop recommendations for prescriber education programs for opioids as part of their ongoing evaluation of strategies to manage the risks associated with extended-release and long-acting opioid pain relievers, and requires the FDA to finalize its draft guidance on how to assess the abuse-deterrent properties of generic solid oral opioid drug products.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (2)
Last Action
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 05/12/2016)
Official Document
bill text
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