Hatch-Waxman Improvement Act of 2022

Bill: 117-s-4378
Sponsor: full_name: Sen. Marshall, Roger [R-KS]
Introduced: 2022-06-13
Policy area: Health
Latest action: action_date: 2022-06-13
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2022-06-13
action_desc: Introduced in Senate
text: <p><b>Hatch-Waxman Improvement Act of 2022</b></p> <p>This bill extends through FY2026 provisions that establish a period of market exclusivity for certain new drugs with single enantiomers (i.e., one of a pair of molecules that are mirror images of one another).</p>

tv_txt: II 117th CONGRESS 2d Session S. 4378 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Marshall introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To reauthorize a provision of the Federal Food, Drug, and Cosmetic Act pertaining to drugs containing single enantiomers.

1. Short title This Act may be cited as the Hatch-Waxman Improvement Act of 2022 . 2. Reauthorization of provision pertaining to drugs containing single enantiomers Section 505(u) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(u) ) is amended— (1) in paragraph (1)(A)(ii)(II), by adding (other than bioavailability studies) after any clinical investigations ; and (2) in paragraph (4), by striking October 1, 2022 and inserting October 1, 2027 .