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FDA Accountability for Public Safety Act

USA117th CongressS-1439| Senate 
| Updated: 4/28/2021
Joe Manchin

Joe Manchin

Independent Senator

West Virginia

Cosponsors (2)
Angus S. King (Independent)Shelley Moore Capito (Republican)

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
Apr 28, 2021
Introduced in Senate
Apr 28, 2021
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


  • April 28, 2021
    Introduced in Senate


  • April 28, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Congressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFederal officialsFood and Drug Administration (FDA)Government ethics and transparency, public corruptionMarketing and advertisingPrescription drugs

FDA Accountability for Public Safety Act

USA117th CongressS-1439| Senate 
| Updated: 4/28/2021
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
Apr 28, 2021
Introduced in Senate
Apr 28, 2021
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


  • April 28, 2021
    Introduced in Senate


  • April 28, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Joe Manchin

Joe Manchin

Independent Senator

West Virginia

Cosponsors (2)
Angus S. King (Independent)Shelley Moore Capito (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFederal officialsFood and Drug Administration (FDA)Government ethics and transparency, public corruptionMarketing and advertisingPrescription drugs