H.R. 6434

[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>