[Congressional Record Volume 172, Number 118 (Monday, July 20, 2026)]
[House]
[Pages H4652-H4654]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS REAUTHORIZATION ACT
OF 2026
Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the
bill
[[Page H4653]]
(H.R. 8205) 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, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 8205
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) Renewal of Grants for Research on Therapies for ALS
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) Renewal of grants for research on therapies for als
review.--In reviewing applications for renewals of a grant
awarded under this section with respect to an investigational
drug, the Secretary shall request from the manufacturer or
sponsor, and assess, the enrollment, safety, and any
available efficacy data relating to the investigational drug
in the prevention, diagnosis, mitigation, treatment, or cure
of amyotrophic lateral sclerosis.''.
(b) Reporting Safety Data.--Section 2(c) of the
Accelerating Access to Critical Therapies for ALS Act (21
U.S.C. 360ee note) is amended--
(1) in paragraph (2)(B), by striking ``and'' at the end;
(2) in paragraph (3), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(4) the entity seeking such grant will promptly report
any new and serious adverse events and safety information
that is considered to be unexpected with respect to the phase
3 trial to the grant-making institution, in addition to
complying with the safety reporting requirements under
section 312.32 of title 21, Code of Federal Regulations (or
any successor regulations).''.
(c) 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 that begins enrollment
within a timeframe, determined by the Secretary through the
terms and conditions of the grant awarded under this
section.''.
SEC. 4. FDA RARE NEURODEGENERATIVE DISEASE ACTION PLAN.
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
rare neurodegenerative disease action plan'' and inserting
``fda rare neurodegenerative disease action plan''; and
(2) by adding at the end the following:
``(c) FDA Rare Neurodegenerative Disease Action Plan.--
``(1) In general.--Not later than 18 months 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 an action plan that includes a description of
the actions that the Food and Drug Administration intends to
take during the 5-year period following publication of the
action plan with respect to the program enhancements, policy
development, regulatory science initiatives, and other
appropriate initiatives described in subsection (a).
``(2) Report.--Not later than 5 years 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 describes the actions taken by
the Food and Drug Administration under the action plan
published under paragraph (1) and the extent to which such
action plan meets the requirements specified in paragraph
(1).''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Kentucky (Mr. Guthrie) and the gentlewoman from Colorado (Ms. DeGette)
each will control 20 minutes.
The Chair recognizes the gentleman from Kentucky.
General Leave
Mr. GUTHRIE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days to revise and extend their remarks on the
legislation and to include extraneous material on H.R. 8205.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Kentucky?
There was no objection.
Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in strong support of H.R. 8205 led by my
colleagues, Representative Quigley and Representative Calvert.
H.R. 8205 reauthorizes the Accelerating Access to Critical Therapies
for ALS Reauthorization Act, which has supported critical research and
development for ALS therapies. The ACT for ALS program has worked to
expand access to key therapies for both individuals with ALS and those
with other rare neurodegenerative conditions. It is imperative that we
pass this bill today to continue advancing research and therapeutic
development in the fight against this disease.
To my fellow Americans living with ALS and their caregivers, Mr.
Speaker, I want to take a moment to let them know that I recognize
their resilience and their commitment to a better future for themselves
and other patients with ALS. Mr. Speaker, I want them to know that I
stand with them, and I ask that my colleagues do the same.
Mr. Speaker, I encourage my colleagues to support this bill, and I
reserve the balance of my time.
Ms. DeGETTE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, about 5,000 Americans are diagnosed with ALS every year.
It is a disease that causes the nervous system to stop working and die,
leading to muscle weakness and eventually paralysis. Essentially, when
someone gets the diagnosis, it is a death sentence.
I am all too familiar with this disease and its rapid progression
because in 1996, I lost my father-in-law to ALS.
The original Accelerating Access to Critical Therapies for ALS Act
passed in 2021 and unleashed incredible Federal resources to improve
our understanding of this relentless disease in search of a cure. It
revolutionized the way FDA uses real-world evidence to foster the
development of ALS therapeutics and gave patients a chance to try
investigational drugs for rare neurodegenerative diseases.
We have the opportunity today to ensure ALS patients can continue to
access promising new therapies, and our preeminent biomedical research
institutions can continue to work towards a cure. This reauthorization
will provide the continuing statutory basis for the great work that the
Accelerating Access to Critical Therapies for ALS Act began, and it
couldn't come at a better moment.
We have seen immense research progress in the 5 years since passage.
Health Subcommittee members here today heard from Brian Wallach and
Sandra Abrevaya in our hearing on this bill a few months ago when they
told us with no uncertainty how important it is for people facing down
this cruel disease that we keep this momentum going.
Brian and Sandra are an inspiration to all of us and to people
everywhere who are seeking cures for these terrible diseases.
I want to tell Congressman Mike Quigley that his unwavering
leadership on the original Accelerating Access to Critical Therapies
for ALS Act and this reauthorization is saving and improving lives. I
thank them for putting us on the path of finding a cure for ALS.
Mr. Speaker, I yield 3 minutes to the gentleman from Illinois (Mr.
Quigley), who is the sponsor of this bill.
Mr. QUIGLEY. Mr. Speaker, I thank the gentlewoman from Colorado for
her kind remarks.
Mr. Speaker, several years ago, a Chicagoan named Brian Wallach came
to my office and shared the fact that he was just diagnosed with ALS, a
devastating disease that steals a person's ability to move or speak.
The average life expectancy at the time with someone diagnosed with
ALS was 2 to 5 years. When Brian came to visit us in Congress, that was
the reality he was facing.
He cofounded an organization called I AM ALS with his wife, Sandra
Abrevaya. Sandra's life changed overnight, too when she became an ALS
caretaker. Since then, she cofounded a company to improve the care of
people living with ALS.
This awe-inspiring couple came to my office with a big idea to
advance ALS research and access to treatments. After meeting with Brian
and Sandra, I was convinced that ALS was not incurable. The research
was just underfunded. I was moved by their dedication to each other and
the cause.
[[Page H4654]]
Like too many families across the country, my family has been touched
by neurodegenerative disease. I lost my father to Parkinson's. However,
since I started working on the first Accelerating Access to Critical
Therapies for ALS Act, there hasn't been one Member of Congress whom I
talked to who didn't have a personal story or know the impact of one of
these diseases.
Our bipartisan work on the first Accelerating Access to Critical
Therapies for ALS Act broke through the bitter politics that can divide
this place. I believe we have the opportunity to do that again today.
In the last 5 years, ACT for ALS programs have helped people living
with ALS to access promising therapies. They have created new methods
for researchers to share their work and sustain critical natural
history studies.
Since we passed the first bill 5 years ago, we have been able to
secure over $350 million in Federal funding for these programs. Today,
we are voting on a bill to extend these programs for 5 more years.
To everyone living with ALS who has advocated for this bill, I hope
today's vote shows that Congress hears you and we are here for you and
that, every once in a while, we break through. At those moments, I am
proud to serve here.
To Brian who is still with us fighting the disease and Sandra: Thank
you for your tireless advocacy and big dreams.
Finally, I thank Representative Ken Calvert for his work on this
with me in the House, and Senators Chris Coons and Lisa Murkowski for
their work in the Senate.
Mr. Speaker, I urge my colleagues to vote ``yes.''
{time} 1620
Mr. GUTHRIE. Mr. Speaker, I yield myself the balance of my time to
close.
Mr. Speaker, in closing, I will mention Brian and Sandra testified
before our committee. When I was first elected to Congress, the Ensor
family from Bullitt County, Kentucky, came to see me, and I got to know
Mitch. I went to his funeral services, unfortunately. I was touched by
his family, which is why this bill is important to me.
Mr. Speaker, I strongly encourage everybody to vote for this bill.
There may be a procedural call on this bill. This bill will pass this
week. I look forward to seeing it pass, being sent to the Senate, and
hopefully signed into law very soon.
Mr. Speaker, I yield back the balance of my time.
Mr. CALVERT. Mr. Speaker, I rise today in support of the ACT for ALS
Reauthorization Act, H.R. 8205, legislation that will reauthorize
programs that support research and development of drugs and other
therapies to address ALS.
It is hard to believe, but the original ACT for ALS Act was signed
into law a little less than five years ago. As a Co-Chair of the
bipartisan ALS Caucus, I saw first-hand the effort to get that landmark
legislation across the finish line was the result of the passion and
detepnination of the ALS advocacy community.
The passage of the ACT for ALS Act authorized key programs to expand
access to new investigational drugs and grants for research of this
terrible disease. Working with my Appropriations Committee colleagues,
the ALS Caucus, and ALS advocates, we have been successful at making
historic investments into these programs.
In Fiscal Year 2022, Congress invested nearly $30 million in ACT for
ALS programs. That number increased nearly 200 percent in Fiscal Year
2025 to $86 million--nearly matching the $100 million authorization cap
enshrined into law. Since the initial passge, the law has demonstrably
sped infrastructure, access, and targeted progress.
By reauthorizing the ACT for ALS, the trajectory is hopeful due to
better tools, data, and collaboration. ALS patients and families are
relying on us not to lose momentum and to build upon hopeful progress
and someday find a cure for this devastating illness.
I want to thank my ALS Caucus Members, including the bill's sponsor
Representative Quigley, for their work. I want to give my heartfelt
appreciation, once again, to the ALS advocacy community and the
families who have been forever changed by ALS. I urge all of my
colleagues to stand with these families, give them hope, and pass the
ACT for ALS Reauthorization Act.
The SPEAKER pro tempore (Mr. Yakym). The question is on the motion
offered by the gentleman from Kentucky (Mr. Guthrie) that the House
suspend the rules and pass the bill, H.R. 8205, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. GUTHRIE. Mr. Speaker, I object to the vote on the ground that a
quorum is not present and make the point of order that a quorum is not
present.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this question will be postponed.
The point of no quorum is considered withdrawn.
____________________