117 S4390 IS: Accelerated Approval Transparency Act U.S. Senate 2022-06-14 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS2d SessionS. 4390IN THE SENATE OF THE UNITED STATESJune 14, 2022Mr. Hickenlooper introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo require summary approval information with respect to certain approved drugs and biological products.

1.

Short title

This Act may be cited as the Accelerated Approval Transparency Act.

2.

Summary approval information

With respect to each new drug application for a new molecular entity approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) or biological product licensed under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) pursuant to accelerated approval under section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)), the Secretary of Health and Human Services shall provide for the drug or biologic action package a summary of the basis for approval, including, as relates to such new molecular entity, whether an advisory committee meeting was held and a rationale for a determination by the Secretary that a surrogate endpoint is reasonably likely to predict clinical benefit.