← Back to Bill Feed
FederalIn Committee
Right to Try for Individualized Treatments Act
Introduced Jun 8, 2026 · Last action Jun 8, 2026 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Track this bill
Save bills and get alerts when status changes.
Sign in to saved bills.
Summary
This legislation is called the Right to Try for Individualized Treatments Act. It is being reviewed by a committee.
Full bill text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4698 Introduced in Senate (IS)]
<DOC>
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)''.
<all>Official legislative text sourced from the public record (cached on CivicsHQ).
Official source
View the original bill, actions, and full legislative record on Congress.gov.
Status
In Committee
- 1Introduced
- 2Committee
- 3Floor
- 4Passed
- 5Signed
Timeline reflects current normalized status only. Full action history is not yet stored in the API.
Sponsors
- Sen. Johnson, Ron [R-WI]RSenateWI
Cosponsors
Votes
Voting records are not yet available for this bill.