# 119-hr-3731: Small Biotech Innovation Act

119-hr-3731, Small Biotech Innovation Act, is a 119th Congress bill sponsored by Rep. Pfluger, August [R-TX-11] (R-TX); status introduced; PRIA reads it as touching household money (as of 2026-09-21).

- Canonical: https://policyrisk.com/legislation/119-hr-3731
- As of: 2026-09-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-3731
- Congress: 119
- Title: Small Biotech Innovation Act
- Status: introduced
- Introduced: 2025-06-04
- Sponsor: Rep. Pfluger, August [R-TX-11] (R-TX)
- Cosponsors: 4
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-09-21

## Summary

**R&D-based exemption** from Medicare drug price negotiation for a targeted class of small biotechnology makers starting in 2029. It would exclude qualifying single source drugs when the company meets defined R&D spending and ownership criteria. - Small biotech manufacturers: Firms with five or fewer qualifying single source drugs could earn an exemption if they invest a high share of net revenue in research and development. The required share scales with drug count, from **30% up to 70%**. - Medicare negotiation pool and patients: Qualifying single source drugs owned by these "RD-intensive" small biotech manufacturers would be removed from the negotiation-eligible list for initial price applicability years beginning in **2029**, changing which drugs Medicare can negotiate on. - Compliance and ownership rules: Manufacturers must submit annual GAAP-based revenue and R&D reports and may appeal denials under a Secretary-established process. Drugs lost by acquisition become ineligible if the successor does not meet the RD-intensive test at the next plan year start.

## Cosponsors (4)

- Rep. Kustoff, David [R-TN-8] (R-TN), 2025-06-04T00:00:00.000Z
- Rep. Tenney, Claudia [R-NY-24] (R-NY), 2025-12-19T00:00:00.000Z
- Rep. Simon, Lateefah [D-CA-12] (D-CA), 2026-04-14T00:00:00.000Z
- Rep. Moran, Nathaniel [R-TX-1] (R-TX), 2026-07-21T00:00:00.000Z

## Provisions PRIA read

- Some small biotech drugs skip Medicare talks: mixed, medium. Starting in the 2029 price year, some small biotech drugs would be exempt from Medicare price negotiation. A company would qualify only if it has 1–5 single‑source drugs, is not owned or controlled by a foreign government, and is not organized in a covered nation. It would also need to spend a set…

## Related bills

- 119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
- 119-hr-909: Crime Victims Fund Stabilization Act of 2025
- 119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act
- 119-hr-6130: ASAP Act
- 119-hr-1993: 25th Anniversary of 9/11 Commemorative Coin Act
- 119-hr-3151: SHIPS for America Act of 2025

## Sources
- [119-hr-3731 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/3731)

## Related
- [119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-hr-842)
- [119-hr-909: Crime Victims Fund Stabilization Act of 2025](https://policyrisk.com/legislation/119-hr-909)
- [119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act](https://policyrisk.com/legislation/119-hr-4382)
- [119-hr-6130: ASAP Act](https://policyrisk.com/legislation/119-hr-6130)
- [119-hr-1993: 25th Anniversary of 9/11 Commemorative Coin Act](https://policyrisk.com/legislation/119-hr-1993)
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-3731 (as of 2026-09-21).