# 116-hr-5632: FDA Accountability for Public Safety Act

116-hr-5632, FDA Accountability for Public Safety Act, is a 116th Congress bill sponsored by Sen. Kim, Andy [D-NJ] (D-NJ); status Referred to the House Committee on Energy and Commerce. (as of 2025-11-18).

- Canonical: https://policyrisk.com/legislation/116-hr-5632
- As of: 2025-11-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 116-hr-5632
- Congress: 116
- Title: FDA Accountability for Public Safety Act
- Status: Referred to the House Committee on Energy and Commerce.
- Introduced: 2020-01-16
- Sponsor: Sen. Kim, Andy [D-NJ] (D-NJ)
- Cosponsors: 0
- Policy area: Health
- Touches household money: no
- Last recorded action: 2025-11-18

## 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.

## Related bills

- 116-hr-8988: Save Jobs During the Pandemic Act of 2020
- 116-hr-8966: COVID–19 Vaccine Awareness Support Act of 2020
- 116-hr-8801: Air America Act of 2020
- 116-hr-8762: Fast Track Advanced Apprenticeships Now Act
- 116-hr-8755: Expanded Telehealth Access Act
- 116-hr-8702: Holding Providers Harmless From Medicare Cuts During COVID–19 Act of 2020

## Sources
- [116-hr-5632 on Congress.gov](https://www.congress.gov/bill/116th-congress/house-bill/5632)

## Related
- [116-hr-8988: Save Jobs During the Pandemic Act of 2020](https://policyrisk.com/legislation/116-hr-8988)
- [116-hr-8966: COVID–19 Vaccine Awareness Support Act of 2020](https://policyrisk.com/legislation/116-hr-8966)
- [116-hr-8801: Air America Act of 2020](https://policyrisk.com/legislation/116-hr-8801)
- [116-hr-8762: Fast Track Advanced Apprenticeships Now Act](https://policyrisk.com/legislation/116-hr-8762)
- [116-hr-8755: Expanded Telehealth Access Act](https://policyrisk.com/legislation/116-hr-8755)
- [116-hr-8702: Holding Providers Harmless From Medicare Cuts During COVID–19 Act of 2020](https://policyrisk.com/legislation/116-hr-8702)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/116-hr-5632 (as of 2025-11-18).