[Congressional Record Volume 172, Number 113 (Monday, July 13, 2026)]
[Senate]
[Pages S3835-S3836]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 6636. Mr. JOHNSON 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 end of subtitle G of title X, add the following:
SEC. 10___. USE OF INVESTIGATIONAL INDIVIDUALIZED MEDICAL
TREATMENTS BY PATIENTS DIAGNOSED WITH A LIFE-
THREATENING DISEASE OR CONDITION OR SEVERELY
DEBILITATING ILLNESS.
(a) Definitions.--Section 561B(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb-0a(a)) is amended--
(1) by amending paragraph (1) to read as follows:
``(1) the term `eligible patient' means--
``(A) in the case of a patient requesting an eligible
investigational drug, a patient who has--
``(i) been diagnosed with a life-threatening disease or
condition (as defined in section 312.81 of title 21, Code of
Federal Regulations (or any successor regulations));
``(ii) exhausted approved treatment options and is unable
to participate in a clinical trial involving the eligible
investigational drug, as certified by a physician, who--
``(I) is in good standing with the physician's licensing
organization or board; and
``(II) will not be compensated directly by the manufacturer
of such drug for so certifying; and
``(iii) provided to the treating physician written informed
consent regarding the eligible investigational drug, or, as
applicable, on whose behalf a legally authorized
representative of the patient has provided such consent; or
``(B) in the case of a patient requesting an
investigational individualized medical treatment, a patient
who has--
``(i) been diagnosed with a life-threatening disease or
condition or severely debilitating illness (as such terms are
defined in section 312.81 of title 21, Code of Federal
Regulations (or any successor regulations));
``(ii) considered approved treatment options, as certified
by a physician, who--
``(I) is in good standing with the physician's licensing
organization or board;
``(II) will not be compensated directly by the manufacturer
of such treatment for so certifying; and
``(III) attests to the patient's life-threatening disease
or condition or severely debilitating illness; and
``(iii) provided to the treating physician--
``(I) written informed consent regarding the eligible
investigational drug or, as applicable, on whose behalf a
legally authorized representative of the patient has provided
such consent; or
``(II) as applicable, additional informed consent,
regarding the investigational individualized medical
treatment, or, as applicable, on whose behalf a legally
authorized representative of the patient has provided such
consent;''; and
(2) in paragraph (2)(D), by striking ``and'' at the end;
(3) in paragraph (3), by striking the period at the end and
inserting a semicolon; and
(4) by adding at the end the following:
``(4) the term `eligible health care facility' means a
health care facility that is operating under the Federal
assurance for protection of human subjects pursuant to
section 491(a) of the Public Health Service Act;
``(5) the term `investigational individualized medical
treatment' means a drug or biological product for the patient
based on an analysis of the patient's unique genomic profile,
including their genomic sequence, human chromosomes,
deoxyribonucleic acid, genes, gene products (such as enzymes
and other types of proteins), or metabolites; and
``(6) the term `additional informed consent' means consent
attested to in writing by the patient's physician and a
witness for an investigational individualized medical
treatment that includes--
``(A) an explanation of the currently approved treatments
for the patient's disease or condition;
``(B) the patient's attestation that the patient concurs
with the assessment of their physician that all currently
approved and conventionally recognized treatments are
unlikely to prolong or improve their life;
``(C) clear identification of the specific proposed
investigational individualized medical treatment the
patient's physician recommends; and
``(D) a description, based on the physician's knowledge of
the proposed treatment and the patient's disease, of the
potential outcomes of the treatment.''.
(b) Eligibility for Investigational Individualized Medical
Treatment.--Section
[[Page S3836]]
561B of such Act (21 U.S.C. 360bbb-0a) is amended--
(1) by redesignating subsections (b) through (d) as
subsections (c) through (e), respectively; and
(2) by inserting after subsection (a) the following:
``(b) Eligibility for Investigational Individualized
Medical Treatment.--A manufacturer of an investigational
individualized medical treatment that is in compliance with
all applicable Federal assurance laws and regulations and is
operating within an eligible health care facility may make
available such investigational individualized medical
treatment, and an eligible patient may request access to such
treatment from the eligible health care facility or
manufacturer of such treatment, consistent with the
requirements of this section. A manufacturer of an
investigational individualized medical treatment is not
required to make available such treatment to any patient.''.
(c) Exemptions.--Section 561B(c) of such Act (21 U.S.C.
360bbb-0a(c)), as redesignated by subsection (b)(1) of this
section, is amended--
(1) by inserting ``and investigational individualized
medical treatments'' after ``Eligible investigational
drugs'';
(2) by inserting ``or investigational individualized
medical treatment'' after ``such eligible investigational
drug'';
(3) by inserting ``or investigational individualized
medical treatment'' after ``an eligible investigational
drug''; and
(4) by inserting ``or investigational individualized
medical treatments'' after ``investigational drugs''.
(d) Conforming Amendments.--Section 561B of such Act (21
U.S.C. 360bbb-0a) is amended--
(1) in the section heading, by inserting ``and
investigational individualized medical treatments'' after
``drugs''; and
(2) in subsection (e)(2), as redesignated by subsection
(b)(1) of this section--
(A) in subparagraph (A), by striking ``subsection
(c)(1)(A)'' and inserting ``subsection (d)(1)(A)''; and
(B) in subparagraph (B), by striking ``subsection
(c)(1)(B)'' and inserting ``subsection (d)(1)(B)''.
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