releases: https://www.murphy.senate.gov/newsroom/press-releases/murphy-braun-introduce-bipartisan-legislation-to-conduct-a-new-review-of-currently-approved-opioids
Data license: MIT · Data source: dwillis/congress-press
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| https://www.murphy.senate.gov/newsroom/press-releases/murphy-braun-introduce-bipartisan-legislation-to-conduct-a-new-review-of-currently-approved-opioids | Murphy, Braun Introduce Bipartisan Legislation to Conduct a New Review of Currently Approved Opioids | 2023-12-20 | 2023 | 2023-12 | Democrat | Senate | CT | Christopher Murphy | M001169 | www.murphy.senate.gov | chrismurphy | https://www.murphy.senate.gov/newsroom/press-releases | scraper | WASHINGTON–U.S. Senators Chris Murphy (D-Conn.) and Mike Braun (R-Ind.), both members of the U.S. Senate Health, Education, Labor, and Pensions Committee, on Wednesday introduced bipartisan legislation directing the Food and Drug Administration (FDA) to establish a plan to review all currently approved opioid medications. The Opioid Review Act would require the FDA to consider information that was not available when the drugs were first approved, such as addiction and overdose rates, and to publish a public report detailing next steps. “The United States is five percent of the world’s population, and yet we account for between 70 and 80 percent of the world’s opioid prescriptions. In the years since these drugs were first approved by the FDA, we’ve learned just how addictive they are and far too many families have paid the price. Taking a hard look at whether the current guidance needs updating is one way we can begin to tackle this crisis. I’m glad our bipartisan bill was included in this year’s SUPPORT Act reauthorization, and I’ll keep pushing to ensure it lands on President Biden’s desk,” said Murphy. “Drug overdose deaths continue to rise in the United States and we urgently need to take action to stop these devastating and preventable deaths. The bipartisan Opioid Review Act would direct the FDA to review approved opioids while considering important public health implications, like addiction and overdose rates,” said Braun. Specifically, FDA’s report must be published online and must include: Public comment on the FDA’s regulation of opioid drugs An explanation of the actions the FDA has already taken to review the effectiveness, safety, benefit-risk profile, and use of approved opioid analgesic drugs A timeline for an assessment of the potential need for changes in an opioid drugs’ labeling, revised or additional post marketing requirements, enforcement actions, or withdrawals from market An overview of the steps that the FDA has taken to support the development and approval of non-addictive medical products intended to treat pain or addiction, and actions planned to further support the development and approval of such products An overview of the consideration by the FDA of clinical trial methodologies for analgesic drugs, including the enriched enrollment randomized withdrawal methodology, and the benefits and drawbacks associated with different trial methodologies for such drugs, incorporating any public input received The Opioid Review Act was included in committee passage of the SUPPORT Act Reauthorization last week. ### | 1 | 2026-03-30T01:40:41Z | 2026-04-08T01:14:16Z |