What does Preamble of Small Biotech Innovation Act do?

This bill proposes to amend title XI of the Social Security Act. It aims to establish an exception from the Medicare drug price negotiation program. The exception is intended for small biotechnology manufacturers that are research and development-intensive.

What does SHORT TITLE. of Small Biotech Innovation Act do?

This bill is formally titled the Small Biotech Innovation Act.

What does RESEARCH AND DEVELOPMENT-INTENSIVE SMALL BIOTECH MANUFACTURER of Small Biotech Innovation Act do?

This section amends Section 1192(d)(2) of the Social Security Act to create an exception from the Medicare Drug Price Negotiation Program for qualifying single-source drugs of research and development-intensive small biotech manufacturers, starting in 2029. A 'research and development-intensive small biotech manufacturer' is defined as a manufacturer with five or fewer qualifying single-source drugs, not controlled by a foreign government, and investing at least a specified 'applicable percent' of their net revenue in research and development. The 'applicable percent' increases based on the number of qualifying single-source drugs a manufacturer has: 30% for 1 drug, 40% for 2, 50% for 3, 60% for 4, and 70% for 5. Manufacturers must apply annually to the Secretary, providing information on revenue and research and development expenditures to be considered eligible for the exception. A drug loses its exception status if the manufacturer is acquired after 2029 by a company that doesn't meet the definition of a research and development-intensive small biotech manufacturer. The Secretary will establish a dispute resolution process for manufacturers who disagree with a determination that they are not research and development-intensive.

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Small Biotech Innovation Act

Last updated: 6/4/2025 · Introduced: 6/4/2025

Author: August Pfluger (R-TX)

TL;DR (AI)

This bill establishes an exception from the Medicare drug price negotiation program for qualifying single-source drugs produced by research and development-intensive small biotechnology manufacturers, beginning in 2029.
To qualify, manufacturers must have five or fewer drugs, not be controlled by a foreign government, and invest a percentage of their net revenue in research and development, with the required percentage increasing based on the number of drugs they produce.
Manufacturers must annually apply to the Secretary of Health and Human Services to maintain their exception status, and a dispute resolution process is established for those disagreeing with the Secretary’s determination.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 1 more.

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