S. 1078 · 115th Congress
FDA Accountability for Public Safety Act
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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
ManchinSponsor3 cosponsors · 1 D, 1 R, 1 I
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: FDA Accountability for Public Safety Act
Latest action (May 9, 2017): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: May 9, 2017
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.