What This Bill Does
This bill clarifies that the existing Federal Right to Try law applies to schedule I substances (drugs classified as having high abuse potential and no accepted medical use) that have completed phase I clinical trials (the first stage of testing a drug on humans). The bill removes legal barriers that prevent eligible patients from accessing these experimental schedule I drugs.
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Who It Affects
Eligible patients seeking access to experimental schedule I drugs that have completed phase I clinical trials. The Food and Drug Administration (the federal agency that regulates drugs). Manufacturers of eligible investigational drugs (experimental drugs being tested).
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Key Provisions
• The Federal Right to Try law applies to schedule I substances for which a phase I clinical trial has been completed (Sec. 2)
• The Controlled Substances Act (the federal law controlling drug classification) cannot prohibit patients from using, possessing, distributing, dispensing or transporting eligible investigational drugs under the Right to Try law (Sec. 3)
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What Changes
Currently, eligible patients cannot legally access schedule I drugs even if those drugs completed phase I trials. If this bill becomes law, eligible patients can access schedule I drugs that have completed phase I testing without violating the Controlled Substances Act.
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Important Definitions
Schedule I substances: drugs classified as having high potential for abuse with no accepted medical use. Phase I clinical trial: the first stage of testing an experimental drug on human subjects.
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Effective Date
Not specified in bill text
I
118TH CONGRESS
1ST SESSION H. R. 1825
To clarify that the Federal Right to Try law applies to schedule I substances
for which a phase I clinical trial has been completed and to provide
access for eligible patients to such substances pursuant to the Federal
Right to Try law.
IN THE HOUSE OF REPRESENTATIVES
MARCH 28, 2023
Mr. BLUMENAUER (for himself, Ms. MACE, Ms. DEAN of Pennsylvania, Mr.
BIGGS, and Mr. CORREA) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to
the Committee on the Judiciary, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned
A BILL
To clarify that the Federal Right to Try law applies to
schedule I substances for which a phase I clinical trial
has been completed and to provide access for eligible
patients to such substances pursuant to the Federal
Right to Try law.
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. SHORT TITLE.
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This Act may be cited as the ‘‘Right to Try Clarifica-
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tion Act’’.
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•HR 1825 IH
SEC. 2. FINDINGS.
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Congress finds as follows:
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(1) The Trickett Wendler, Frank Mongiello,
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Jordan McLinn, and Matthew Bellina Right to Try
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Act of 2017 (Public Law 115–176) was enacted in
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2018.
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(2) Section 561B of the Federal Food, Drug,
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and Cosmetic Act (21 U.S.C. 360bbb–0a), as added
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by the Act described in paragraph (1) (referred to
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in this section as the ‘‘Federal Right to Try law’’),
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does not exclude from the application of such law
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schedule I substances for which a phase I clinical
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trial has been completed.
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(3) Multiple schedule I drugs have progressed
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through phase I clinical trials and have been des-
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ignated by the Food and Drug Administration as
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breakthrough therapies under section 506 of the
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Federal Food, Drug, and Cosmetic Act (21 U.S.C.
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356) because of preliminary clinical evidence indi-
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cating that such drugs demonstrate substantial im-
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provement over existing therapies, but eligible pa-
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tients have not been permitted access to these drugs
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pursuant to the Federal Right to Try law.
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SEC. 3. AMENDMENT TO FEDERAL RIGHT TO TRY LAW.
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Section 561B(b) of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 360bbb–0a(b)) is amended by insert-
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•HR 1825 IH
ing ‘‘any provision of the Controlled Substances Act (21
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U.S.C. 801 et seq.) that prohibits the unauthorized use,
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possession, distribution, dispensation, or transportation of
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an eligible investigational drug,’’ before ‘‘and parts’’.
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Æ
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