Accelerated Approval Transparency Act

Bill: 117-s-4390
Sponsor: full_name: Sen. Hickenlooper, John W. [D-CO]
Introduced: 2022-06-14
Policy area: Health
Latest action: action_date: 2022-06-14
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2022-06-14
action_desc: Introduced in Senate
text: <p><b>Accelerated Approval Transparency Act</b></p> <p>This bill requires the Food and Drug Administration to include a summary of the reasons a drug or biologic received accelerated approval to treat a serious or life-threatening disease or condition in the public action package for the drug or biologic. </p>

tv_txt: II 117th CONGRESS 2d Session S. 4390 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Hickenlooper introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To 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.