[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4390 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4390

    To require summary approval information with respect to certain 
                approved drugs and biological products.


_______________________________________________________________________


                   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.

    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 ``Accelerated Approval Transparency 
Act''.

SEC. 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.
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