Legis Daily

FDA Accountability for Public Safety Act

USA118th CongressS-603| Senate 
| Updated: 3/1/2023
Joe Manchin

Joe Manchin

Independent Senator

West Virginia

Cosponsors (2)
Mike Braun (Republican)Angus S. King (Independent)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
FDA Accountability for Public Safety Act This bill establishes additional procedures related to the market approval process for opioids. Under the bill, a Food and Drug Administration (FDA) advisory committee must make recommendations regarding supplemental applications for opioids. Current law requires only that an FDA committee make recommendations on new drug applications. The bill specifies that only the Commissioner of Food and Drugs may approve an opioid-related application against the recommendation of the committee. If the Commissioner approves such an application against a committee recommendation, the Commissioner must submit a report to Congress that includes (1) the evidence regarding patient safety that supports the Commissioner's decision, and (2) a disclosure of any potential conflicts of interest of FDA officials involved in the decision. The Commissioner must also testify before Congress regarding the decision, upon request. The drug in question may not be sold until the Commissioner has submitted the required report.
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Timeline

Bill from Previous Congress

S 116-418
FDA Accountability for Public Safety Act

Bill from Previous Congress

S 117-1439
FDA Accountability for Public Safety Act
Mar 1, 2023
Introduced in Senate
Mar 1, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 116-418
    FDA Accountability for Public Safety Act


  • Bill from Previous Congress

    S 117-1439
    FDA Accountability for Public Safety Act


  • March 1, 2023
    Introduced in Senate


  • March 1, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

FDA Accountability for Public Safety Act

USA118th CongressS-603| Senate 
| Updated: 3/1/2023
FDA Accountability for Public Safety Act This bill establishes additional procedures related to the market approval process for opioids. Under the bill, a Food and Drug Administration (FDA) advisory committee must make recommendations regarding supplemental applications for opioids. Current law requires only that an FDA committee make recommendations on new drug applications. The bill specifies that only the Commissioner of Food and Drugs may approve an opioid-related application against the recommendation of the committee. If the Commissioner approves such an application against a committee recommendation, the Commissioner must submit a report to Congress that includes (1) the evidence regarding patient safety that supports the Commissioner's decision, and (2) a disclosure of any potential conflicts of interest of FDA officials involved in the decision. The Commissioner must also testify before Congress regarding the decision, upon request. The drug in question may not be sold until the Commissioner has submitted the required report.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 116-418
FDA Accountability for Public Safety Act

Bill from Previous Congress

S 117-1439
FDA Accountability for Public Safety Act
Mar 1, 2023
Introduced in Senate
Mar 1, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 116-418
    FDA Accountability for Public Safety Act


  • Bill from Previous Congress

    S 117-1439
    FDA Accountability for Public Safety Act


  • March 1, 2023
    Introduced in Senate


  • March 1, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Joe Manchin

Joe Manchin

Independent Senator

West Virginia

Cosponsors (2)
Mike Braun (Republican)Angus S. King (Independent)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted