S.1078 - FDA Accountability for Public Safety Act115th Congress (2017-2018)
|Sponsor:||Sen. Manchin, Joe, III [D-WV] (Introduced 05/09/2017)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 05/09/2017 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions)|
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Summary: S.1078 — 115th Congress (2017-2018)All Information (Except Text)
Introduced in Senate (05/09/2017)
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.