[Congressional Record Volume 172, Number 105 (Tuesday, June 23, 2026)]
[Senate]
[Page S3143]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 6012. Mr. BOOKER (for himself and Mr. Paul) submitted an amendment
intended to be proposed by him to the bill S. 4784, to authorize
appropriations for fiscal year 2027 for military activities of the
Department of Defense, for military construction, and for defense
activities of the Department of Energy, to prescribe military personnel
strengths for such fiscal year, and for other purposes; which was
ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. _____. FREEDOM TO HEAL ACT.
(a) Short Title.--This Act may be cited as the ``Freedom to
Heal Act of 2026''.
(b) 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.''.
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