[Congressional Record Volume 168, Number 158 (Thursday, September 29, 2022)]
[Senate]
[Page S5730]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  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.''.
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