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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 689 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                 S. 689

  To amend the Controlled Substances Act to define currently accepted 
     medical use with severe restrictions, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             March 7, 2023

 Mr. Booker (for himself and Mr. Paul) introduced the following bill; 
  which was read twice and referred to the Committee on the Judiciary

_______________________________________________________________________

                                 A BILL

 
  To amend the Controlled Substances Act to define currently accepted 
     medical use with severe restrictions, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. 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, 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.''.
                                 <all>
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