US Congress Senate Bill 1078 (Prior Session Legislation)

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Sponsorship: Bipartisan Bill
Status: Introduced on May 9 2017 - 25% progression, died in committee
Action: 2017-05-09 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

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.

FDA Accountability for Public Safety Act

Sen. Joe Manchin [D-WV]

Sen. Shelley Capito [R-WV]

Sen. Claire McCaskill [D-MO]

Sen. Angus King [I-ME]

Date	Chamber	Action
2017-05-09	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/115th-congress/senate-bill/1078/all-info
Text	https://www.congress.gov/115/bills/s1078/BILLS-115s1078is.pdf