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