Legis Daily

Small Biotech Innovation Act

USA119th CongressHR-3731| House 
| Updated: 6/4/2025
August Pfluger

August Pfluger

Republican Representative

Texas

Cosponsors (1)
David Kustoff (Republican)

Ways and Means Committee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This bill amends the Social Security Act to establish an exception for certain **research and development-intensive small biotech manufacturers** from the Medicare drug price negotiation program, effective for initial price applicability years beginning in 2029. The primary purpose is to support innovation by exempting smaller, R&D-focused drug developers from these price controls. To qualify, a manufacturer must be a **small biotech manufacturer**, meaning it has five or fewer qualifying single-source drugs and is not controlled by a foreign government from a covered nation. It must also be **research and development-intensive**, investing an "applicable percent" of its average net revenue from the previous three years into R&D, with this percentage ranging from 30% to 70% based on the number of drugs. Manufacturers are required to submit annual applications with financial data and certifications to the Secretary to demonstrate eligibility. The exception includes a provision that if a qualifying manufacturer is acquired by a non-qualifying entity after 2029, its drugs will lose the exception. Additionally, the Secretary must establish a **dispute resolution process** for manufacturers to appeal eligibility determinations.
View Full Text

Suggested Questions

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

Timeline
Jun 3, 2025

Latest Companion Bill Action

S 119-1930
Introduced in Senate
Jun 4, 2025
Introduced in House
Jun 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.
  • June 3, 2025

    Latest Companion Bill Action

    S 119-1930
    Introduced in Senate


  • June 4, 2025
    Introduced in House


  • June 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.

Health

Related Bills

  • S 119-1930: Small Biotech Innovation Act

Small Biotech Innovation Act

USA119th CongressHR-3731| House 
| Updated: 6/4/2025
This bill amends the Social Security Act to establish an exception for certain **research and development-intensive small biotech manufacturers** from the Medicare drug price negotiation program, effective for initial price applicability years beginning in 2029. The primary purpose is to support innovation by exempting smaller, R&D-focused drug developers from these price controls. To qualify, a manufacturer must be a **small biotech manufacturer**, meaning it has five or fewer qualifying single-source drugs and is not controlled by a foreign government from a covered nation. It must also be **research and development-intensive**, investing an "applicable percent" of its average net revenue from the previous three years into R&D, with this percentage ranging from 30% to 70% based on the number of drugs. Manufacturers are required to submit annual applications with financial data and certifications to the Secretary to demonstrate eligibility. The exception includes a provision that if a qualifying manufacturer is acquired by a non-qualifying entity after 2029, its drugs will lose the exception. Additionally, the Secretary must establish a **dispute resolution process** for manufacturers to appeal eligibility determinations.
View Full Text

Suggested Questions

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

Timeline
Jun 3, 2025

Latest Companion Bill Action

S 119-1930
Introduced in Senate
Jun 4, 2025
Introduced in House
Jun 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.
  • June 3, 2025

    Latest Companion Bill Action

    S 119-1930
    Introduced in Senate


  • June 4, 2025
    Introduced in House


  • June 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.
August Pfluger

August Pfluger

Republican Representative

Texas

Cosponsors (1)
David Kustoff (Republican)

Ways and Means Committee, Energy and Commerce Committee

Health

Related Bills

  • S 119-1930: Small Biotech Innovation Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted