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US SB1930
Bill
AI Summary
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Exempts qualifying drugs from small biotech manufacturers from Medicare drug price negotiations starting in 2029, provided the manufacturer meets research and development investment thresholds
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Defines "small biotech manufacturer" as a company with 5 or fewer qualifying single source drugs that is not owned, controlled, or organized under the laws of a covered foreign nation (such as China, Russia, Iran, or North Korea)
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Requires R&D spending thresholds based on number of drugs: 30% of net revenue for 1 drug, scaling up to 70% for 5 drugs, calculated as a 3-year average
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Removes exemption if a qualifying small biotech manufacturer is acquired by a larger company that doesn't meet the R&D-intensive criteria, effective the following plan year
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Establishes annual application process requiring manufacturers to submit revenue and R&D expenditure data with certification, plus a dispute resolution process for eligibility determinations
Legislative Description
Small Biotech Innovation Act
Health
Last Action
Read twice and referred to the Committee on Finance.
6/3/2025