To require the Secretary of Health and Human Services to prepare a report that outlines a plan for completing a review of approved opioid analgesic drugs that considers the public health effects of such opioid drugs.
About This Bill
Committee
Latest Action · December 19, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
This bill requires the Secretary of Health and Human Services to publish a comprehensive report within one year that outlines a plan for reviewing all FDA-approved opioid pain medications and their public health effects. The report must include opportunities for public input on opioid regulation, document what the FDA has already done to assess opioid safety and effectiveness, and establish a timeline for determining whether drugs need new warning labels, additional safety requirements, enforcement actions, or removal from the market. The legislation also directs the FDA to describe its efforts to support development of non-addictive pain treatments and alternatives to opioids, and to evaluate different clinical trial methods used to test pain medications. The bill affects the FDA and opioid manufacturers but is primarily aimed at improving how federal regulators oversee opioid drugs in response to the ongoing public health crisis related to opioid addiction and overdoses. No specific funding amount is allocated in the bill.
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