Enhanced Access to Affordable Medicines Act of 2022

Bill: 117-hr-6973
Sponsor: full_name: Rep. Carter, Earl L. "Buddy" [R-GA-1]
Introduced: 2022-03-08
Policy area: Health
Latest action: action_date: 2022-03-09
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2022-03-08
action_desc: Introduced in House
text: <p><b>Enhanced Access to Affordable Medicines Act of 2022</b></p> <p>This bill specifies that the Food and Drug Administration may approve generic drugs with different labels than the brand-name versions if, among other requirements, the brand-name drug is subject to an active patent or exclusivity period and a revised label for the brand-name drug is approved within 90 days (rather than 60 days) of the expiration of the patent or exclusivity period.</p>

tv_txt: I 117th CONGRESS 2d Session H. R. 6973 IN THE HOUSE OF REPRESENTATIVES March 8, 2022 Mr. Carter of Georgia introduced the following bill; which was referred to the Committee on Energy and Commerce 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.

1. Short title This Act may be cited as the Enhanced Access to Affordable Medicines Act of 2022 . 2. Clarifying the conditions of generic drug application approval for last-minute brand name drug labeling changes 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) the application is otherwise eligible for approval under this subsection except that— (I) (aa) the listed drug has an active patent, the listed drug has an active exclusivity period, or there is a delay in approval as described in paragraph (5)(B)(iii); and (bb) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of expiration of a patent, exclusivity period, or delay in approval referenced in item (aa); or (II) 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. .