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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6434 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 6434
To establish a special registration under the Controlled Substances Act
for schedule I eligible investigational drugs under the Federal Right
to Try law.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 4, 2025
Ms. Dean of Pennsylvania (for herself, Ms. Mace, Mr. Correa, Mr.
Khanna, Mr. Lieu, Mr. Crenshaw, Mr. Bergman, and Mr. Luttrell)
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 establish a special registration under the Controlled Substances Act
for schedule I eligible investigational drugs under the Federal Right
to Try law.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Freedom to Heal Act of 2025''.
SEC. 2. SPECIAL REGISTRATION REQUIREMENTS RELATED TO RIGHT TO TRY.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended by adding at the end the following:
``(p) Special Registration for Schedule I Eligible Investigational
Drugs Under Right To Try.--
``(1) Definitions.--In this subsection, the terms `eligible
investigational drug' and `eligible patient' have the meanings
given those terms in section 561B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-0a).
``(2) Special registration process.--The Attorney General
shall register physicians to directly administer eligible
investigational drugs in schedule I to eligible patients under
section 561B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-0a) in accordance with paragraphs (3) through (8)
of this subsection.
``(3) Requirements.--
``(A) Application.--A physician desiring a
registration to directly administer an eligible
investigational drug as described in paragraph (2)
shall submit to the Attorney General an application
containing--
``(i) evidence of a valid registration to
dispense or administer controlled substances in
schedules II through V;
``(ii) evidence of compliance with section
561B of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-0a), including--
``(I) documentation from the
manufacturer or sponsor verifying the
investigational drug in schedule I is
an eligible investigational drug;
``(II) an agreement from the
manufacturer or sponsor to supply the
eligible investigational drug, along
with guidance on its administration, to
the requesting physician for the
treatment of eligible patients; and
``(III) an affirmation that the
physician will only directly administer
the eligible investigational drug to
treat eligible patients in a manner
consistent with the guidance provided
by the manufacturer or sponsor;
``(iii) the quantity of the eligible
investigational drug to be supplied by the
manufacturer or sponsor to the physician to
treat eligible patients;
``(iv) evidence that the physician may
treat eligible patients with eligible
investigational drugs under the laws of the
State in which the treatment will take place;
``(v) evidence of training, credentials, or
experience relevant to treating patients with
the eligible investigational drug;
``(vi) a description of the site at which
the physician intends to store and administer
the eligible investigational drug; and
``(vii) any additional information the
Attorney General determines necessary to
prevent diversion.
``(B) Approval.--Not later than 45 days after
receiving an application containing the information
required under subparagraph (A), the Attorney General
shall--
``(i) register the applicant; or
``(ii) serve an order to show cause upon
the applicant in accordance with section
304(c).
``(4) Electronic submissions.--The Attorney General shall
provide a means for a physician to submit an application under
paragraph (3)(A) electronically.
``(5) Limitation on amounts.--A physician treating eligible
patients with an eligible investigational drug in schedule I
under this subsection may only possess the amounts of the
eligible investigational drug identified in--
``(A) the application submitted to the Attorney
General under paragraph (3)(A); or
``(B) a supplemental notification that the
physician may submit to the Attorney General if the
physician needs additional amounts of the eligible
investigational drug for the treatment of eligible
patients, which supplemental notification--
``(i) shall include--
``(I) the name of the physician;
``(II) the additional quantity of
the eligible investigational drug
needed; and
``(III) an attestation that the
treatment with the eligible
investigational drug is consistent with
the scope of treatment that was the
subject of the application under
paragraph (3)(A); and
``(ii) shall be deemed approved on the date
that is 30 days after the date on which the
physician submits the supplemental notification
to the Attorney General, unless the Attorney
General serves an order to show cause upon the
applicant in accordance with section 304(c).
``(6) Single registration for related treatment sites.--A
physician may treat eligible patients with an eligible
investigational drug in schedule I under a single registration
under this subsection if--
``(A) the treatment occurs exclusively on sites all
of which are--
``(i) within the same city or county; and
``(ii) under the control of the same
institution, organization, or agency; and
``(B) before commencing the treatment, the
physician notifies the Attorney General of each site
where the eligible investigational drug will be stored
or administered in accordance with paragraph
(3)(A)(vi).
``(7) Rulemaking.--Notwithstanding the requirements of
section 553 of title 5, United States Code, not later than 240
days after the date of enactment of this subsection, the
Attorney General shall issue an interim final rule to implement
this subsection, including with respect to--
``(A) the manner in which an eligible
investigational drug may be delivered to an approved
registrant;
``(B) the storage and security of an eligible
investigational drug;
``(C) the maintenance of records for an approved
registrant;
``(D) the process for renewal, suspension, or
revocation of a registration; and
``(E) any other matters necessary to ensure
effective controls against diversion.
``(8) Final rule.--Not later than 2 years after issuing an
interim final rule under paragraph (7), the Attorney General
shall issue a final rule to implement this subsection in
accordance with section 553 of title 5, United States Code.''.
<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.
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