[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S5080-S5081]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2866. Mr. BOOKER (for himself, Mr. Paul, and Mr. Boozman) 
submitted an amendment intended to be proposed by him to the bill S. 
4638, to authorize appropriations for fiscal year 2025 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 end of subtitle H of title X, add the following:

     SEC. 1095. CURRENTLY ACCEPTED MEDICAL USE WITH SEVERE 
                   RESTRICTIONS.

       (a) Definitions.--Section 102 of the Controlled Substances 
     Act (21 U.S.C. 802) is amended by inserting after paragraph 
     (7) the following:
       ``(7)(A) Subject to subparagraph (B), the term `currently 
     accepted medical use with severe restrictions', with respect 
     to a drug or other substance, includes a drug or other 
     substance that is an active metabolite, moiety, or ingredient 
     (whether in natural or synthetic form) of an investigational 
     new drug for which a waiver is in effect under section 505(i) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(i)) or section 351(a)(3) of the Public Health Service Act 
     (42 U.S.C. 262(a)(3)) and that the Secretary--
       ``(i) designates as a breakthrough therapy under section 
     506(a) of the Food Drug and Cosmetic Act (21 U.S.C. 356(a)); 
     or
       ``(ii) authorizes for expanded access under subsection (b) 
     or (c) of section 561 of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360bbb), either alone or as part of a 
     therapeutic protocol, to treat patients with serious or life-
     threatening diseases for which no comparable or satisfactory 
     therapies are available.
       ``(B) A drug or other substance shall not meet the criteria 
     under subparagraph (A) for having a currently accepted 
     medical use with severe restrictions if--
       ``(i) in the case of a drug or other substance described in 
     subparagraph (A)(ii)--
       ``(I) the Secretary places the expanded access or protocol 
     for such drug on clinical hold as described in section 312.42 
     of title 21, Code of Federal Regulations (or any successor 
     regulations);
       ``(II) there is no other investigational new drug 
     containing the drug or other substance for which expanded 
     access has been authorized under section 561(a) of the 
     Federal Food,

[[Page S5081]]

     Drug, and Cosmetic Act (21 U.S.C. 360bbb(a)); and
       ``(III) the drug or other substance does not meet the 
     requirements of subparagraph (A)(i); or
       ``(ii) the drug or other substance is approved under 
     section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355) or section 351 of the Public Health Service Act 
     (42 U.S.C. 262).''.
       (b) Authority and Criteria for Classification of 
     Substances.--Section 201(j) of the Controlled Substances Act 
     (21 U.S.C. 811(j)) is amended--
       (1) in paragraph (1), by inserting ``a drug designated as a 
     breakthrough therapy under section 506(a) of the Food Drug 
     and Cosmetic Act (21 U.S.C. 356(a)), or a drug authorized for 
     expanded access under subsection (b) or (c) of section 561 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb)'' 
     after ``subsection (f),'';
       (2) in paragraph (2)--
       (A) in subparagraph (A), by striking ``; or'' and inserting 
     a semicolon;
       (B) in subparagraph (B), by striking the period at the end 
     and inserting a semicolon; and
       (C) by adding at the end the following:
       ``(C) the date on which the Attorney General receives 
     notification from the Secretary of Health and Human Services 
     that the Secretary has designated a drug as a breakthrough 
     therapy under section 506(a) of the Food Drug and Cosmetic 
     Act (21 U.S.C. 356(a)) or authorized a drug for expanded 
     access under subsection (b) or (c) of section 561 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb); or
       ``(D) the date on which the Attorney General receives any 
     written notification demonstrating that the Secretary, before 
     the date of enactment of this subparagraph, designated a drug 
     as a breakthrough therapy under section 506(a) of the Food 
     Drug and Cosmetic Act (21 U.S.C. 356(a)) or authorized a drug 
     for expanded access under subsection (b) or (c) of section 
     561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360bbb).'';
       (3) in paragraph (3), by inserting ``or paragraph (4)'' 
     after ``paragraph (1)''; and
       (4) by adding at the end the following:
       ``(4) With respect to a drug moved from schedule I to 
     schedule II pursuant to paragraph (1) and the expedited 
     procedures described under this subsection, if the drug no 
     longer has a currently accepted medical use with severe 
     restrictions and the Secretary of Health and Human Services 
     recommends that the Attorney General control the drug in 
     schedule I pursuant to subsections (a) and (b), the Attorney 
     General shall, not later than 90 days after receiving written 
     notification from the Secretary, issue an interim final rule 
     controlling the drug in accordance with such subsections and 
     section 202(b) using the procedures described in paragraph 
     (3) of this subsection.''.
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