Small Biotech Innovation Act

Sponsor: August Pfluger (Republican-TX)June 4, 2025

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Introduced

In Committee

Passed One Chamber

Passed Both Chambers

Signed into Law

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.

Lets small drugmakers avoid some Medicare drug price talks

This bill would create an exception for certain small biotech companies from Medicare's drug price negotiation program. Starting in 2029, their qualifying new drugs would not be subject to these price talks. This change aims to support small companies that invest heavily in developing new medicines.

What Would Change

Today, certain drugs are part of the Medicare drug price negotiation program without a specific exception for small biotech companies focused on research and development. If this bill becomes law, starting in 2029, qualifying single-source drugs from these research-intensive small biotech manufacturers would be exempt from those negotiations.

Key Provisions

Exempts certain new drugs from Medicare drug price negotiations starting in 2029.
Defines "small biotech manufacturer" as a company with 5 or fewer qualifying drugs, not controlled by certain foreign governments.
Requires these small companies to invest a specific percentage of their revenue (30% to 70%) in research to qualify for the exemption.
Requires companies to apply each year to get this exception, providing details on their income and research spending.
Ends the exception for a drug if its small biotech manufacturer is acquired after 2029 by a larger company that does not qualify.
Requires the Secretary of Health and Human Services to create a way for companies to challenge decisions about their eligibility.

View on Congress.gov

HR 3731 · 119th Congress · June 4, 2025 · AI Summary by gemini-2.5-flash · 8/10

Lobbying Activity

5 filings mentioned this bill

Top Lobbying Clients

EXELIXIS, INC.

$120K

2 filings

ACADIA PHARMACEUTICALS

2 filings

EXELIXIS INC.

1 filing

Top Lobbying Firms

1.ARNOLD & PORTER KAYE SCHOLER LLP2 filings

2.ACADIA PHARMACEUTICALS2 filings

3.EXELIXIS INC.1 filing

Amounts reflect total quarterly lobbying spend reported to the Senate, not bill-specific spending. Source: Senate LDA filings.

5 filings mentioned this bill

Top Lobbying Clients

EXELIXIS, INC.

$120K

2 filings

ACADIA PHARMACEUTICALS

2 filings

EXELIXIS INC.

1 filing

Top Lobbying Firms

1.ARNOLD & PORTER KAYE SCHOLER LLP2 filings

2.ACADIA PHARMACEUTICALS2 filings

3.EXELIXIS INC.1 filing

Amounts reflect total quarterly lobbying spend reported to the Senate, not bill-specific spending. Source: Senate LDA filings.