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Gives the HHS Secretary authority to review brand-name drug prices each year and declare prices “excessive” using an international reference test and other factors. When a drug is found excessive, the Secretary can void or waive government-granted exclusivities and issue open, non‑exclusive licenses so other makers can use the drug and rely on the regulatory data; licenses must include reasonable royalties and require sales below the excessive price. The bill also creates mandatory annual manufacturer reporting, a public database of excessive-price findings, expedited review for generic/biosimilar applicants that rely on issued licenses, civil enforcement (including recovery of excess revenues), and an antitrust prohibition on conduct that would block these licenses.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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.
Introduced May 21, 2025 by Ro Khanna · Last progress May 21, 2025