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Small Biotech Innovation Act

USA119th CongressS-1930| Senate 
| Updated: 6/3/2025
Bill Cassidy

Bill Cassidy

Republican Senator

Louisiana

Cosponsors (1)
Roger Marshall (Republican)

Finance Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This bill aims to establish an exception from the Medicare drug price negotiation program for certain manufacturers. Beginning in 2029, qualifying single source drugs from a research and development-intensive small biotech manufacturer will be exempt from negotiation. A "small biotech manufacturer" is defined as one that has five or fewer qualifying single source drugs and is not owned or controlled by a foreign government. To be considered "research and development-intensive," a small biotech manufacturer must invest an "applicable percent" of its net revenue from the previous three years into research and development. This applicable percent ranges from 30% for a manufacturer with one qualifying drug to 70% for one with five drugs. The exception also stipulates that if an exempted manufacturer is acquired by a non-qualifying entity after 2029, the drug will lose its exception. Manufacturers must submit an annual application with financial data and a certification, and a dispute resolution process will be established for eligibility determinations.
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Timeline

Bill from Previous Congress

S 118-5029
Small Biotech Innovation Act
Jun 3, 2025
Introduced in Senate
Jun 3, 2025
Read twice and referred to the Committee on Finance.
Jun 4, 2025

Latest Companion Bill Action

HR 119-3731
Introduced in House
  • Bill from Previous Congress

    S 118-5029
    Small Biotech Innovation Act


  • June 3, 2025
    Introduced in Senate


  • June 3, 2025
    Read twice and referred to the Committee on Finance.


  • June 4, 2025

    Latest Companion Bill Action

    HR 119-3731
    Introduced in House

Health

Related Bills

  • HR 119-3731: Small Biotech Innovation Act

Small Biotech Innovation Act

USA119th CongressS-1930| Senate 
| Updated: 6/3/2025
This bill aims to establish an exception from the Medicare drug price negotiation program for certain manufacturers. Beginning in 2029, qualifying single source drugs from a research and development-intensive small biotech manufacturer will be exempt from negotiation. A "small biotech manufacturer" is defined as one that has five or fewer qualifying single source drugs and is not owned or controlled by a foreign government. To be considered "research and development-intensive," a small biotech manufacturer must invest an "applicable percent" of its net revenue from the previous three years into research and development. This applicable percent ranges from 30% for a manufacturer with one qualifying drug to 70% for one with five drugs. The exception also stipulates that if an exempted manufacturer is acquired by a non-qualifying entity after 2029, the drug will lose its exception. Manufacturers must submit an annual application with financial data and a certification, and a dispute resolution process will be established for eligibility determinations.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 118-5029
Small Biotech Innovation Act
Jun 3, 2025
Introduced in Senate
Jun 3, 2025
Read twice and referred to the Committee on Finance.
Jun 4, 2025

Latest Companion Bill Action

HR 119-3731
Introduced in House
  • Bill from Previous Congress

    S 118-5029
    Small Biotech Innovation Act


  • June 3, 2025
    Introduced in Senate


  • June 3, 2025
    Read twice and referred to the Committee on Finance.


  • June 4, 2025

    Latest Companion Bill Action

    HR 119-3731
    Introduced in House
Bill Cassidy

Bill Cassidy

Republican Senator

Louisiana

Cosponsors (1)
Roger Marshall (Republican)

Finance Committee

Health

Related Bills

  • HR 119-3731: Small Biotech Innovation Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted