Small Biotech Innovation Act

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.