RARE Act

[AI summary unavailable — showing source text] [Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 3716 Introduced in Senate (IS)] <DOC> 119th CONGRESS 2d Session S. 3716 To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES January 28, 2026 Ms. Baldwin introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Retaining Access and Restoring Exclusivity Act'' or the ``RARE Act''. SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICENSURE OF ORPHAN DRUGS. (a) In General.--Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended-- (1) in subsection (a), in the matter following paragraph (…