Medication Affordability and Patent Integrity Act

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 2658 Introduced in Senate (IS)] <DOC> 119th CONGRESS 1st Session S. 2658 To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES August 1, 2025 Ms. Hassan (for herself and Mr. Hawley) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. 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 ``Medication Affordability and Patent Integrity Act''. SEC. 2. DISCLOSURE OF INFORMATION. (a) In General.-- (1) In general.--Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the end the following: ``(7)(A) With respect to any application submitted under this subsection or approved under subsection (c), the sponsor of the application or holder of the approved application shall, for any applicable patent-- ``(i) certify to the Food and Drug Administration that the information described in subparagraph (B) that is submitted to the Secretary is, to the best knowledge of the sponsor or holder, consistent with the information such sponsor or holder provided to the United States Patent and Trademark Office and any communications such sponsor or holder had with the United States Patent and Trademark Office; and ``(ii)(I) sub