What This Bill Does
This bill changes the definition of "currently accepted medical use with severe restrictions" under the Controlled Substances Act (a law that regulates drugs). The bill allows certain experimental drugs to count as having medical use if they receive special designations from the U.S. Secretary of Health and Human Services. This could move some drugs from Schedule I (meaning they have no accepted medical use) to Schedule II (meaning they have accepted medical use with restrictions).
Who It Affects
The bill affects the U.S. Attorney General and the Secretary of Health and Human Services who manage controlled substances. It also affects drug companies developing experimental medicines and patients with serious or life-threatening diseases who might gain access to investigational drugs.
Key Provisions
• A drug counts as having "currently accepted medical use with severe restrictions" if it is a component of an experimental drug that receives a breakthrough therapy designation (a special FDA designation for promising treatments) or is approved for expanded access to treat serious or life-threatening diseases with no comparable treatments available (Sec. 1(a)).
• A drug does not count as having this medical use if it has already been formally approved by the FDA or if the expanded access program was placed on clinical hold (a pause in the program) and no other investigational version of the drug has expanded access authorization (Sec. 1(a)).
• When the Secretary of Health and Human Services notifies the Attorney General that a drug has received breakthrough therapy designation or expanded access authorization, the Attorney General must consider moving it from Schedule I to Schedule II using expedited procedures (Sec. 1(b)).
• If a drug no longer meets the criteria for "currently accepted medical use with severe restrictions" and the Secretary recommends returning it to Schedule I, the Attorney General must issue a rule within 90 days (Sec. 1(b)).
What Changes
The legal definition of "currently accepted medical use with severe restrictions" expands to include certain investigational drugs with breakthrough therapy status or expanded access authorization. The process for moving drugs between drug schedules becomes faster when these designations are involved. Drugs that previously could not be classified as having any medical use may now be reclassified.
Important Definitions
• "Currently accepted medical use with severe restrictions" means a drug that is a component of an investigational drug with breakthrough therapy designation or expanded access authorization for serious or life-threatening diseases (Sec. 1(a)).
• "Breakthrough therapy" is a designation the Secretary of Health and Human Services gives to drugs showing promise in treating serious diseases (Sec. 1(a)).
• "Expanded access" means permission to give an investigational drug to patients outside of clinical trials when no comparable treatments exist (Sec. 1(a)).
I
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 fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period
to be subsequently determined by the Speaker, in each case for consider-
ation 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 Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. CURRENTLY ACCEPTED MEDICAL USE WITH
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SEVERE RESTRICTIONS.
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(a) DEFINITIONS.—Section 102 of the Controlled
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Substances Act (21 U.S.C. 802) is amended—
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(1) by redesignating paragraph (58) (defining a
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serious violent felony) as paragraph (59);
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(2) by redesignating the second paragraph (57)
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(defining a serious drug felony) as paragraph (58);
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and
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(3) by adding at the end the following:
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‘‘(60)(A) Subject to subparagraph (B), the
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term ‘currently accepted medical use with severe re-
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strictions’, with respect to a drug or other sub-
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stance, includes a drug or other substance that is an
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active metabolite, moiety, or ingredient (whether in
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natural or synthetic form) of an investigational new
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drug for which a waiver is in effect under section
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505(i) of the Federal Food, Drug, and Cosmetic Act
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(21 U.S.C. 355(i)) or section 351(a)(3) of the Public
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Health Service Act (42 U.S.C. 262(a)(3)) and that
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the Secretary—
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‘‘(i) designates as a breakthrough therapy
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under section 506(a) of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 356(a)); or
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‘‘(ii) authorizes for expanded access under
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subsection (b) or (c) of section 561 of the Fed-
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eral Food, Drug, and Cosmetic Act (21 U.S.C.
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360bbb), either alone or as part of a thera-
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peutic protocol, to treat patients with serious or
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life-threatening diseases for which no com-
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parable or satisfactory therapies are available.
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‘‘(B) A drug or other substance shall not be
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treated as meeting the criteria under subparagraph
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(A) for having a currently accepted medical use with
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severe restrictions if—
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‘‘(i) in the case of a drug or other sub-
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stance described in subparagraph (A)(ii)—
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‘‘(I) the Secretary places the ex-
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panded access or protocol for such drug on
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clinical hold as described in section 312.42
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of title 21, Code of Federal Regulations (or
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any successor regulations);
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‘‘(II) there is no other investigational
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new drug containing the drug or other sub-
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stance for which expanded access has been
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authorized under section 561(a) of the
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Federal Food, Drug, and Cosmetic Act (21
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U.S.C. 360bbb(a)); and
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‘‘(III) the drug or other substance
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does not meet the requirements of sub-
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paragraph (A)(i); or
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‘‘(ii) the drug or other substance is ap-
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proved under section 505 of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 355) or
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section 351 of the Public Health Service Act
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(42 U.S.C. 262).’’.
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(b) AUTHORITY AND CRITERIA FOR CLASSIFICATION
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OF SUBSTANCES.—Section 201(j) of the Controlled Sub-
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stances Act (21 U.S.C. 811(j)) is amended—
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(1) in paragraph (1), by inserting ‘‘a drug des-
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ignated as a breakthrough therapy under section
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506(a) of the Food Drug and Cosmetic Act (21
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U.S.C. 356(a)), or a drug authorized for expanded
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access under subsection (b) or (c) of section 561 of
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the Federal Food, Drug, and Cosmetic Act (21
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U.S.C. 360bbb),’’ after ‘‘subsection (f),’’;
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(2) in paragraph (2)—
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(A) in subparagraph (A), by striking ‘‘;
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or’’ and inserting a semicolon;
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(B) in subparagraph (B), by striking the
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period at the end and inserting a semicolon;
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and
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(C) by adding at the end the following:
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‘‘(C) the date on which the Attorney Gen-
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eral receives notification from the Secretary of
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Health and Human Services that the Secretary
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has designated the drug as a breakthrough
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therapy under section 506(a) of the Federal
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Food, Drug, and Cosmetic Act (21 U.S.C.
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356(a)) or authorized the drug for expanded ac-
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cess under subsection (b) or (c) of section 561
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of the Federal Food, Drug, and Cosmetic Act
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(21 U.S.C. 360bbb); or
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‘‘(D) the date on which the Attorney Gen-
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eral receives any written notification dem-
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onstrating that the Secretary, before the date of
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enactment of this subparagraph, designated the
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drug as a breakthrough therapy under section
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506(a) of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 356(a)) or authorized the
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drug for expanded access under subsection (b)
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or (c) of section 561 of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 360bbb).’’;
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(3) in paragraph (3), by inserting ‘‘or para-
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graph (4)’’ after ‘‘paragraph (1)’’; and
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(4) by adding at the end the following:
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‘‘(4) With respect to a drug moved from schedule I
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to schedule II pursuant to paragraph (1) and the expe-
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dited procedures described under this subsection, if the
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drug no longer has a currently accepted medical use with
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severe restrictions and the Secretary of Health and
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Human Services recommends that the Attorney General
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control the drug in schedule I pursuant to subsections (a)
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and (b), the Attorney General shall, not later than 90 days
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after receiving written notification from the Secretary,
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issue an interim final rule controlling the drug in accord-
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ance with such subsections and section 202(b) using the
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procedures described in paragraph (3) of this subsection.’’.
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