[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4472 Reported in Senate (RS)]
<DOC>
Calendar No. 461
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, Mr. Coons, Ms. Collins, Ms. Klobuchar, Mr.
Padilla, Mrs. Capito, Mr. Curtis, Mrs. Gillibrand, Ms. Hassan, Mr.
Banks, Mr. Markey, and Mr. Daines) introduced the following bill; which
was read twice and referred to the Committee on Health, Education,
Labor, and Pensions
July 16, 2026
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Accelerating Access to
Critical Therapies for ALS Reauthorization Act of 2026''.</DELETED>
<DELETED>SEC. 2. REAUTHORIZATION OF ACCELERATING ACCESS TO CRITICAL
THERAPIES FOR ALS ACT.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED>SEC. 3. IMPROVEMENTS TO PROGRAM FOR GRANTS FOR RESEARCH ON
THERAPIES FOR ALS.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(4) Clinical trial status review.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 4. REPORT ON ALS AND OTHER RARE NEURODEGENERATIVE DISEASE
ACTION PLANS.</DELETED>
<DELETED> 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:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) an updated action plan, including--
</DELETED>
<DELETED> ``(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);</DELETED>
<DELETED> ``(B) a description of the resources
necessary to implement each section of the plan within
such 5-year period; and</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) the actions taken by the Food and
Drug Administration under the 2022 Action
Plan;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(C) any programs and initiatives that
established or carried out as part of the
implementation of the 2022 Action Plan; and</DELETED>
<DELETED> ``(D) the extent to which the 2022 Action
Plan was implemented with respect to rare
neurodegenerative diseases that are not amyotrophic
lateral sclerosis.''.</DELETED>
<DELETED>SEC. 5. GAO REPORT.</DELETED>
<DELETED> Section 6 of the Accelerating Access to Critical Therapies
for ALS Act (Public Law 117-79) is amended, in the matter preceding
paragraph (1)--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (2) by inserting ``, with respect to the 10-year
period starting on the date of enactment of this Act'' after
``containing''.</DELETED>
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;
(C) in the matter preceding paragraph (1), as so
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;
(C) in subparagraph (C), as so redesignated, by
striking 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;
(C) in paragraph (3), by striking the period at the
end and 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''.
Calendar No. 461
119th CONGRESS
2d Session
S. 4472
_______________________________________________________________________
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.
_______________________________________________________________________
July 16, 2026
Reported with an amendment