EFFECTIVE Act

Bill: 118-s-607
Sponsor: full_name: Sen. Manchin, Joe, III [D-WV]
Introduced: 2023-03-01
Policy area: Health
Latest action: action_date: 2023-03-01
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2023-03-01
action_desc: Introduced in Senate
text: <p><b>Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act or the EFFECTIVE Act</b></p> <p>This bill specifies that the Food and Drug Administration may deny an application for a new opioid analgesic drug (i.e., opioid medication) upon a determination that the drug does not provide a significant advantage with respect to safety or effectiveness as compared to other drugs.</p>

tv_txt: II 118th CONGRESS 1st Session S. 607 IN THE SENATE OF THE UNITED STATES March 1, 2023 Mr. Manchin (for himself and Mr. Braun ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs.

1. Short title This Act may be cited as the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act or the EFFECTIVE Act . 2. Requirement for approval of new opioid analgesics Section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) is amended by adding at the end the following: (6) Notwithstanding any other provision of this section, the Secretary may deny approval of an application submitted under subsection (b) for an opioid analgesic drug if the Secretary determines that such drug does not provide a significant advantage, in terms of greater safety or effectiveness, compared to an appropriate comparator drug, as determined by the Secretary. .