S.Amdt. 6204

SA 6204. Mr. MANCHIN (for himself and Mr. Braun) submitted an amendment intended to be proposed to amendment SA 5499 submitted by Mr. Reed (for himself and Mr. Inhofe) and intended to be proposed to the bill H.R. 7900, to authorize appropriations for fiscal year 2023 for military activities of the Department of Defense, for military construction, and for defense activities of the Department of Energy, to prescribe military personnel strengths for such fiscal year, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. ___. 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.”.