ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS REAUTHORIZATION ACT OF 2026

Quick facts

Record: Senate Floor
Section type: Floor speeches
Chamber: Senate
Date: August 4, 2026
Congress: 119th Congress
Why this source matters: This section came from the Senate floor portion of the record.

Linked context

People mentioned: Thune, John
Bills and resolutions: S. 4472 (119th Congress)
Committees: Committee on Health, Education, Labor, and Pensions, Committee on Energy and Commerce

Readable version of the official text

ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS REAUTHORIZATION ACT

OF 2026

Mr. THUNE. Madam President, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 461, S. 4472.

The PRESIDING OFFICER. The clerk will report the bill by title.

The legislative clerk read as follows:

A bill (S. 4472) to amend the Accelerating Access to

Critical Therapies for ALS Act to reauthorize the provisions

of such Act through fiscal year 2031, and for other purposes.

There being no objection, the Senate proceeded to consider the bill,

which

had been reported from the Committee on Health, Education, Labor, and

Pensions with an amendment to strike all after the enacting clause and insert the part printed in italic, as follows:

SECTION 1. SHORT TITLE.

This Act may be cited as the “Accelerating Access to

Critical Therapies for ALS Reauthorization Act of 2026”.

SEC. 2. REAUTHORIZATION OF ACCELERATING ACCESS TO CRITICAL

THERAPIES FOR ALS ACT.

(a) In General.—Section 7 of the Accelerating Access to

Critical Therapies for ALS Act (Public Law 117-79) is amended

by striking “2022 through 2026” and inserting “2027

through 2031”.

(b) Grants for ALS Research.—Section 2(f) of the

Accelerating Access to Critical Therapies for ALS Act (21

U.S.C. 360ee note) is amended by striking “2026” and

inserting “2031”.

SEC. 3. IMPROVEMENTS TO PROGRAM FOR GRANTS FOR RESEARCH ON

THERAPIES FOR ALS.

Section 2 of the Accelerating Access to Critical Therapies

for ALS Act (21 U.S.C. 360ee note) is amended—

(1) in subsection (a), by inserting “(referred to in this

section as `expanded access grants')” before the period at

the end of the first sentence;

(2) in subsection (b)—

(A) by striking “(b) Application—” and all that follows

through “A participating” in paragraph (1) and inserting

the following:

“(b) Application.—A participating”;

(B) by redesignating paragraphs (2) and (3) as paragraphs

(1) and (2) respectively;

redesignated, by striking the period at the end and inserting

“including—”;

(D) by amending paragraph (1), as so redesignated, to read

as follows:

“(1) a description of how data generated through the

proposed expanded access grant will be used to support

research or development related to the prevention, diagnosis,

mitigation, treatment, or cure of amyotrophic lateral

sclerosis;”;

(E) in paragraph (2), as so redesignated—

(i) by striking “Noninterference with clinical trials—”

and all that follows through “shall include”;

(ii) by striking “program” and inserting “grant”; and

(iii) by striking the period at the end and inserting “;

and”; and

(F) by adding at the end the following:

“(3) an assurance that such entity will promptly report to

the Secretary available safety data from any ongoing clinical

trial of the investigational drug as set forth in the terms

and conditions of the grant.”;

(3) in subsection (c)—

(A) by redesignating subparagraphs (A) and (B) of paragraph

(2) as clauses (i) and (ii), respectively, and adjusting the

margins accordingly;

(B) by redesignating paragraphs (1) through (3) as

subparagraphs (A) through (C), respectively, and adjusting

the margins accordingly;

the period at the end and inserting “; and”;

(D) in the matter preceding subparagraph (A), as so

redesignated, by striking “this section, confirm that—”

and inserting the following: “this section—

“(1) confirm that—”; and

(E) by adding at the end the following:

“(2) in the case of a renewal of such a grant, request

from the sponsor of the investigational new drug application

involved, and assess, the enrollment, safety, and any

available efficacy data of the drug related to the

prevention, diagnosis, mitigation, treatment, or cure of

amyotrophic lateral sclerosis.”;

(4) in subsection (d)(1), by striking “request described

in subsection (a)” and inserting “grant”; and

(5) in subsection (e)—

(A) in paragraph (2), by inserting “, and that begins

enrollment within a timeframe as determined by the Secretary

through the terms and conditions of the grant” before the

period at the end; and

(B) by adding at the end the following:

“(4) The term `phase 3 clinical trial' includes a phase 2/

3 combined trial and a planned phase 3 clinical trial that is

not yet enrolling participants.”.

SEC. 4. REPORT ON ALS AND OTHER RARE NEURODEGENERATIVE

DISEASE ACTION PLANS.

Section 4 of the Accelerating Access to Critical Therapies

for ALS Act (21 U.S.C. 360aa note) is amended—

(1) in the section heading, by striking “als and other”

and inserting “fda”;

(2) in subsection (a), in the matter preceding paragraph

(1)—

(A) by inserting “and not later than 1 year after the date

of enactment of the Accelerating Access to Critical Therapies

for ALS Reauthorization Act of 2026 and every 5 years

thereafter,” after “this Act,”; and

(B) by inserting “develop, or update, as applicable, and”

before “publish on”;

(3) in subsection (b)—

(A) in the matter preceding paragraph (1), by striking

“initial”;

(B) in paragraph (2)—

(i) in subparagraph (A), by inserting “of relevant

investigational new drug applications” after “sponsors”;

(ii) in subparagraph (C) by inserting “for the prevention,

diagnosis, mitigation, treatment, or cure of rare

neurodegenerative diseases” before the semicolon; and

(iii) in subparagraph (D), by striking “; and” and

inserting a semicolon;

inserting “; and”; and

(D) by adding at the end the following:

“(4) for each action plan published after the date of

enactment of the Accelerating Access to Critical Therapies

for ALS Reauthorization Act of 2026, include a description

of—

“(A) previous actions taken by the Food and Drug

Administration to implement the previous action plan

published under subsection (a);

“(B) any other planned actions to implement such action

plan; and

“(C) any barriers to implementing such action plan and

related recommendations, which may include an estimate of

resources necessary to address such barriers.”.

SEC. 5. REPORTS.

Section 6 of the Accelerating Access to Critical Therapies

for ALS Act (Public Law 117-79) is amended—

(1) in the heading, by striking “gao report” and

inserting “reports”;

(2) by striking “Not later than” and inserting the

following:

“(a) GAO Report.—Not later than”;

(3) in the matter preceding paragraph (1) of subsection

(a), as so designated, by striking “this Act” and inserting

“the Accelerating Access to Critical Therapies for ALS

Reauthorization Act of 2026”; and

(4) by adding at the end the following:

“(b) HHS Report.—Not later than 4 years after the date of

enactment of the Accelerating Access to Critical Therapies

for ALS Reauthorization Act of 2026, the Secretary of Health

and Human Services shall, in a manner that does not duplicate

the information described in the action plan published

pursuant to section 4, submit to the Committee on Health,

Education, Labor, and Pensions of the Senate and the

Committee on Energy and Commerce of the House of

Representatives a report assessing the effectiveness of the

activities carried out under sections 2, 3, and 5 and making

recommendations to improve such activities.”.

SEC. 6. TECHNICAL AMENDMENTS.

Section 3 of the Accelerating Access to Critical Therapies

for ALS Act (42 U.S.C. 280g-7b) is amended—

(1) in subsection (a), in the matter preceding paragraph

(1), by striking “amytrophic” and inserting

“amyotrophic”; and

(2) in subsection (b)(3)(A)(iii), by striking “rational”.

Mr. THUNE. Madam President, I ask unanimous consent that the committee-reported substitute amendment be agreed to and the bill, as amended, be considered read a third time.

The PRESIDING OFFICER. Without objection, it is so ordered.