US Congress Senate Bill 954 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on April 15 2015 - 25% progression, died in committee
Action: 2015-04-15 - 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 requires the Commissioner of Food and Drugs to ensure that an advisory committee of the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) evaluates each new drug application for an opioid (a drug with effects similar to opium, such as morphine) and issues a recommendation regarding approval of the drug. If the decision to approve the drug is inconsistent with the committee's recommendation, the Commissioner must make the final decision on approval. If the committee recommends a drug not be approved but the Commissioner decides to approve the drug, 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 to approve the drug; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the required report.

FDA Accountability for Public Safety Act

Sen. Joe Manchin [D-WV]	Sen. David Vitter [R-LA]	Sen. Shelley Capito [R-WV]	Sen. Tim Kaine [D-VA]
Sen. Claire McCaskill [D-MO]	Sen. Angus King [I-ME]

Date	Chamber	Action
2015-04-15	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/senate-bill/954/all-info
Text	https://www.congress.gov/114/bills/s954/BILLS-114s954is.pdf