[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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