What This Bill Does
This bill changes how federal drug laws define "currently accepted medical use with severe restrictions." It allows certain experimental drugs being tested in clinical trials to potentially move from the strictest drug classification (Schedule I) to a less restrictive category (Schedule II) if the federal government designates them as breakthrough therapies or approves them for expanded access to treat serious or life-threatening illnesses.
Who It Affects
The bill affects the Attorney General, the Secretary of Health and Human Services, patients with serious or life-threatening diseases, and drug manufacturers developing experimental medications.
Key Provisions
• A drug qualifies as having "currently accepted medical use with severe restrictions" if it is an active part, component, or ingredient of an experimental drug that the federal government has approved as a breakthrough therapy or authorized for expanded access to treat patients with serious or life-threatening diseases when no comparable treatment exists (Sec. 1(a)).
• A drug does not qualify for this status if the government puts the expanded access program on clinical hold, or if another version of the same drug already has expanded access approval, or if the drug has already received full federal approval (Sec. 1(a)).
• When the Health Secretary notifies the Attorney General that a drug qualifies as a breakthrough therapy or expanded access drug, the Attorney General must move the drug from Schedule I to Schedule II following expedited procedures (Sec. 1(b)).
• If a drug no longer qualifies as having "currently accepted medical use with severe restrictions," the Attorney General must issue new rules moving it back to Schedule I within 90 days of receiving written notification from the Health Secretary (Sec. 1(b)).
What Changes
If this bill becomes law, experimental drugs designated as breakthrough therapies or approved for expanded access will be automatically reclassified from the most restrictive drug schedule to a less restrictive one. The Attorney General will have expedited timelines (not to exceed 90 days) to make these reclassifications when notified by the Health Secretary. Additionally, drugs can be moved back to the most restrictive schedule through expedited procedures if they no longer meet the "severe restrictions" criteria.
Important Definitions
The bill defines "currently accepted medical use with severe restrictions" as a drug or substance that is an active metabolite (a substance the body creates when processing a drug), moiety (a distinct part of a molecule), or ingredient of an experimental drug that either receives breakthrough therapy designation or expanded access authorization for treating serious or life-threatening diseases with no comparable or satisfactory treatments available.
II
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 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 by inserting
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after paragraph (7) the following:
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‘‘(7)(A) Subject to subparagraph (B), the term
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‘currently accepted medical use with severe restric-
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tions’, with respect to a drug or other substance, in-
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•S 689 IS
cludes a drug or other substance that is an active
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metabolite, moiety, or ingredient (whether in natural
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or synthetic form) of an investigational new drug for
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which a waiver is in effect under section 505(i) of
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the Federal Food, Drug, and Cosmetic Act (21
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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 Food Drug and
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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 meet
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the criteria under subparagraph (A) for having a
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currently accepted medical use with severe restric-
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tions 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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•S 689 IS
‘‘(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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•S 689 IS
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 a drug as a breakthrough ther-
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apy under section 506(a) of the Food Drug and
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Cosmetic Act (21 U.S.C. 356(a)) or authorized
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a drug for expanded access under subsection
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(b) or (c) of section 561 of the Federal Food,
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Drug, and Cosmetic Act (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 a
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drug as a breakthrough therapy under section
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•S 689 IS
506(a) of the Food Drug and Cosmetic Act (21
1
U.S.C. 356(a)) or authorized a drug for ex-
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panded access under subsection (b) or (c) of
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section 561 of the Federal Food, Drug, and
4
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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