This bill provides for the classification of drugs or other substances that are part of approved breakthrough therapies as schedule II controlled substances under the Controlled Substances Act. (Schedule II controlled substances are substances that have a high potential for abuse but have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.)
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1393 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 1393
To amend the Controlled Substances Act to define currently accepted
medical use with severe restrictions, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 7, 2023
Ms. Dean of Pennsylvania (for herself and Ms. Mace) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on the Judiciary, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
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--
(1) by redesignating paragraph (58) (defining a serious
violent felony) as paragraph (59);
(2) by redesignating the second paragraph (57) (defining a
serious drug felony) as paragraph (58); and
(3) by adding at the end the following:
``(60)(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 Federal 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 be treated as
meeting 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 the
drug as a breakthrough therapy under section 506(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(a)) or authorized the 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 the drug as a breakthrough
therapy under section 506(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356(a)) or authorized the
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>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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