FDA Accountability for Public Safety Act

Summary

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

1. 28 April 2021

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 28 April 2021

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 28 April 2021 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 28 April 2021

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 28 April 2021

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 28 April 2021

  Open at official source

Sponsors

• Sen. Manchin, Joe, III [I-WV] · D · Sponsor
• Shelley Capito · R · Sponsor
• Angus King · I · Sponsor
• · sshr00 · Standing

Related records

• related to → FDA Accountability for Public Safety Act
• related to ← FDA Accountability for Public Safety Act