Small Biotech Innovation Act

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.