United States 116th Congress Status: In Committee 1 D cosponsors

HR 5632 — FDA Accountability for Public Safety Act

Last action — Referred to the House Committee on Energy and Commerce.

  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

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.

Bill Text

How this bill changes current law

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Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill establishes additional procedures for FDA approval of opioid drugs that go against advisory committee recommendations and requires reporting to Congress.

  • 21 U.S.C. 355(b)

    and shall not be delegated.

    This change mandates that only the Commissioner of Food and Drugs can approve applications for opioid drugs against advisory committee recommendations.

  • 21 U.S.C. 355(b)

    A drug approved as described in subsection (a) shall not be introduced or delivered for introduction into interstate commerce until the report described in subsection (b)(1) has been submitted to Congress.

    This establishes that an opioid drug approved against advisory recommendations cannot be marketed until required reports are submitted to Congress.

  • Public Law 114-198, Section 106(a)(1)(A)

    application → application, or supplement to an application,

    This allows the advisory committee's review to encompass supplements to applications, broadening its scope.

  • Public Law 114-198, Section 106(a)(1)(A)

    of a new → for

    This clarifies the language regarding the review process of applications by the advisory committee.

Action History

  1. Introduced in House

  2. Introduced in House

  3. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

public-safety health-insurance
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Frequently asked questions

What does HR 5632 do?
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.
Who sponsors HR 5632?
HR 5632 is sponsored by Kim, Andy (Democratic).
What is the current status of HR 5632?
This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 5632?
Track HR 5632 free on One Click Politics — get push/email alerts when it moves.

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