Bill · H.R. 3731· House(119-HR-3731)
Small Biotech Innovation Act
- Introduced
- 6/4/2025
- Last activity
- 6/4/2025 — Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Sponsored by
- August Pfluger
- Cosponsors
- - 3 - 1
- Introduced
- In Committee
What this bill would do
The Small Biotech Innovation Act aims to amend the Social Security Act to create an exception within the Medicare drug price negotiation program. This exception applies to research and development-intensive small biotech manufacturers starting in 2029. It exempts qualifying single source drugs from being considered negotiation-eligible drugs. To qualify, manufacturers must meet specific revenue investment thresholds in research and development and meet certain size and ownership requirements. The bill also outlines the application process and dispute resolution procedures for these manufacturers.
Yes· 3 of 4
Does this make it easier to run a small business?+6
The bill provides significant relief for small biotech manufacturers by exempting them from Medicare price negotiations.
Would business owners be better off under this?+5
The bill specifically benefits small biotech business owners through the negotiation exception.
Does this put more money into scientific research?+3
The bill incentivizes higher R&D investment percentages for qualifying manufacturers.
The opposite· 3 of 7
Does this lower the price of prescription medicines?-4
By exempting certain drugs from negotiation, the bill may result in higher drug costs for Medicare beneficiaries compared to the standard program.
Would people over 65 be better off under this?-3
Seniors on Medicare may face higher costs for drugs that are no longer subject to price negotiation.
Would retired people be better off under this?-3
Retirees relying on Medicare may face higher out-of-pocket costs for certain drugs.
Who it would affect, and how
Potential Positive Impacts for People
- Exception from drug price negotiations: Research and development-intensive small biotech manufacturers would have their qualifying single source drugs exempt from the Medicare drug price negotiation program starting in s price applicability year 2029 (Section 2, subparagraph (D)(i)).
Potential Negative Impacts for People
- Loss of exception upon acquisition: If a manufacturer is acquired after 2029 by a company that does not meet the definition of a research and development-intensive small biotech manufacturer, the drug will no longer be considered a qualifying single source drug under the exception (Section 2, subparagraph (D)(iii)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Business Owners+5Good For Retirees-3Good For Seniors-3Good For Low Income Households-2Good For People With Disabilities-2Good For Veterans-2
- Economy And Finance
- Improves Small Business Support+6Reduces Government Spending-2
- Education And Technology
- Increases Scientific Research Funding+3
- Healthcare
- Increases Research Funding+3Reduces Prescription Drug Costs-4
- 7/21/2026
- 1 Cosponsor added.
- 4/14/2026
- 1 Cosponsor added.
- 12/19/2025
- 1 Cosponsor added.
- 6/4/2025
- Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 1 Cosponsor added.
- Introduced in House
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
David KustoffRepublican · Tennessee
Nathaniel MoranRepublican · Texas
Lateefah SimonDemocrat · California
Claudia TenneyRepublican · New York