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Senate Bill 4351
117th Congress(2021-2022)
Enhanced Access to Affordable Medicines Act of 2022
Introduced
Introduced
Introduced in Senate on Jun 6, 2022
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Text
Introduced in Senate 
Jun 6, 2022
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Introduced in Senate(Jun 6, 2022)
Jun 6, 2022
About Linkage
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Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
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S. 4351 (Introduced-in-Senate)


117th CONGRESS
2d Session
S. 4351


To amend the Federal Food, Drug, and Cosmetic Act to clarify the conditions under which the Secretary of Health and Human Services can approve generic drug applications with labeling temporarily different than the brand name drug, and for other purposes.

IN THE SENATE OF THE UNITED STATES

June 6, 2022

Mr. Romney (for himself, Ms. Hassan, Ms. Rosen, and Mr. Hickenlooper) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to clarify the conditions under which the Secretary of Health and Human Services can approve generic drug applications with labeling temporarily different than the brand name drug, and for other purposes.

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 “Enhanced Access to Affordable Medicines Act of 2022”.

SEC. 2. Enhancing access to affordable medicines.

Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through (iv) and inserting the following:

“(i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for approval under this subsection;

“(ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application; and

“(iii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling.”.