117 HR 8586 IH: Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act U.S. House of Representatives 2022-07-28 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I117th CONGRESS2d SessionH. R. 8586IN THE HOUSE OF REPRESENTATIVESJuly 28, 2022Mr. Trone (for himself and Mr. Meuser) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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.

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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.

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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 or clinical superiority, in terms of greater safety or effectiveness, compared to an appropriate comparator drug, as determined by the Secretary..