PlainBillCongress, translated.Legislation. Context. Public interest.Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congressional Research Service
Version 00 · Introduced in Senate · May 9, 2017
FDA Accountability for Public Safety Act
This bill amends the Comprehensive Addiction and Recovery Act of 2016 to expand the scope of the Food and Drug Administration (FDA) advisory committee to make recommendations regarding supplemental applications for opioids. Currently, the committee only makes recommendations on new drug applications.
Only the Commissioner of Food and Drugs may approve a new drug application or supplement to an application for an opioid against the recommendation of the committee. If the Commissioner approves a drug against the recommendation of the committee, the Commissioner must: (1) submit a report to Congress that includes the evidence regarding patient safety that supports the Commissioner's decision and a disclosure of any potential conflicts of interest of FDA officials involved in the decision; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the report.
People & committees
Sen. Manchin, Joe, III [D-WV] · D–WV
Legislative record
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
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Source last updated: Aug 11, 2025. Consult Congress.gov for the current record.
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