S. 4472

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4472 Introduced in Senate (IS)]

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119th CONGRESS
2d Session
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.

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

April 30, 2026

Ms. Murkowski (for herself and Mr. Coons) introduced the following 
bill; which was read twice and referred to the Committee on Health, 
Education, Labor, and Pensions

_______________________________________________________________________

A BILL

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.

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 ``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 
``2026'' and inserting ``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.

(a) Clinical Trial Status Review.--Section 2(b) of the Accelerating 
Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is 
amended by adding at the end the following:
``(4) Clinical trial status review.--
``(A) In general.--In reviewing applications for 
renewals of a grant awarded under this section with 
respect to an investigational drug, the Secretary shall 
assess the status of a clinical trial carried out for 
such drug with respect to data on enrollment of 
patients in such clinical trial.
``(B) Interim clinical trial data.--To enable the 
Secretary to make the assessment under subparagraph (A) 
with respect to an investigational drug, the Secretary 
shall request that the manufacturer of the 
investigational drug share interim clinical trial data 
with respect to such drug with the Secretary.''.
(b) Clarifying Participating Clinical Trial Definition.--Section 
2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 
U.S.C. 360ee note) is amended by adding at the end the following:
``(4) The term `phase 3', with respect to a 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 by adding at the end the 
following:
``(c) Report on ALS and Other Rare Neurodegenerative Disease Action 
Plans.--Not later than one year after the date of enactment of the 
Accelerating Access to Critical Therapies for ALS Reauthorization Act 
of 2026, the Commissioner of Food and Drugs shall publish on the 
website of the Food and Drug Administration a report that contains--
``(1) an updated action plan, including--
``(A) a description of the actions the Food and 
Drug Administration intends to take during the 5-year 
period following publication of the plan with respect 
to the program enhancements, policy development, 
regulatory science initiatives, and other appropriate 
initiatives described in subsection (a);
``(B) a description of the resources necessary to 
implement each section of the plan within such 5-year 
period; and
``(C) specific approaches the Commissioner will 
take to improve coordination of implementation of the 
plan with rare neurodegenerative disease communities 
that are not specifically ALS communities; and
``(2) with respect to the Action Plan for Rare 
Neurodegenerative Diseases including Amyotrophic Lateral 
Sclerosis (ALS) published by the Food and Drug Administration 
on June 23, 2022 (referred to in this section as the `2022 
Action Plan'), a description of--
``(A) the actions taken by the Food and Drug 
Administration under the 2022 Action Plan;
``(B) the effect of the implementation of the 2022 
Action Plan on the development of therapies and 
regulatory consideration of therapies for ALS and other 
rare neurodegenerative diseases;
``(C) any programs and initiatives that established 
or carried out as part of the implementation of the 
2022 Action Plan; and
``(D) the extent to which the 2022 Action Plan was 
implemented with respect to rare neurodegenerative 
diseases that are not amyotrophic lateral sclerosis.''.

SEC. 5. GAO REPORT.

Section 6 of the Accelerating Access to Critical Therapies for ALS 
Act (Public Law 117-79) is amended, in the matter preceding paragraph 
(1)--
(1) by striking ``4 years after the date of the enactment 
of this Act'' and inserting ``5 years after the date of 
enactment of the Accelerating Access to Critical Therapies for 
ALS Reauthorization Act of 2026''; and
(2) by inserting ``, with respect to the 10-year period 
starting on the date of enactment of this Act'' after 
``containing''.
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