S. 4698

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4698 Introduced in Senate (IS)]

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119th CONGRESS
2d Session
S. 4698

To amend the Federal Food, Drug, and Cosmetic Act to authorize the use 
of investigational individualized medical treatments by patients 
diagnosed with a life-threatening disease or condition or severely 
debilitating illness, and for other purposes.

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

June 8, 2026

Mr. Johnson (for himself and Mr. Tuberville) introduced the following 
bill; which was read twice and referred to the Committee on Health, 
Education, Labor, and Pensions

_______________________________________________________________________

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to authorize the use 
of investigational individualized medical treatments by patients 
diagnosed with a life-threatening disease or condition or severely 
debilitating illness, and for other purposes.

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 ``Right to Try for Individualized 
Treatments Act''.

SEC. 2. 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;'';
(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 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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