[Congressional Record Volume 167, Number 212 (Wednesday, December 8, 2021)]
[House]
[Pages H7509-H7514]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




         ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS ACT

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 3537) to direct the Secretary of Health and Human Services 
to support research on, and expanded access to, investigational drugs 
for amyotrophic lateral sclerosis, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 3537

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

[[Page H7510]]

  


     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Accelerating Access to 
     Critical Therapies for ALS Act''.

     SEC. 2. GRANTS FOR RESEARCH ON THERAPIES FOR ALS.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     award grants to participating entities for purposes of 
     scientific research utilizing data from expanded access to 
     investigational drugs for individuals who are not otherwise 
     eligible for clinical trials for the prevention, diagnosis, 
     mitigation, treatment, or cure of amyotrophic lateral 
     sclerosis. In the case of a participating entity seeking such 
     a grant, an expanded access request must be submitted, and 
     allowed to proceed by the Secretary, under section 561 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) and 
     part 312 of title 21, Code of Federal Regulations (or any 
     successor regulations), before the application for such grant 
     is submitted. 
       (b) Application.--
       (1) In general.--A participating entity seeking a grant 
     under this section shall submit to the Secretary an 
     application at such time, in such manner, and containing such 
     information as the Secretary shall specify.
       (2) Use of data.--An application submitted under paragraph 
     (1) shall include a description of how data generated through 
     an expanded access request under section 561 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) with respect 
     to the investigational drug involved will be used to support 
     research or development related to the prevention, diagnosis, 
     mitigation, treatment, or cure of amyotrophic lateral 
     sclerosis.
       (3) Noninterference with clinical trials.--An application 
     submitted under paragraph (1) shall include a description of 
     how the proposed expanded access program will be designed so 
     as not to interfere with patient enrollment in ongoing 
     clinical trials for investigational therapies for the 
     prevention, diagnosis, mitigation, treatment, or cure of 
     amyotrophic lateral sclerosis.
       (c) Selection.--Consistent with sections 406 and 492 of the 
     Public Health Service Act (42 U.S.C. 284a, 289a), the 
     Secretary shall, in determining whether to award a grant 
     under this section, confirm that--
       (1) such grant will be used to support a scientific 
     research objective relating to the prevention, diagnosis, 
     mitigation, treatment, or cure of amyotrophic lateral 
     sclerosis (as described in subsection (a));
       (2) such grant shall not have the effect of diminishing 
     eligibility for, or impeding enrollment of, ongoing clinical 
     trials for the prevention, diagnosis, mitigation, treatment, 
     or cure of amyotrophic lateral sclerosis by determining that 
     individuals who receive expanded access to investigational 
     drugs through such a grant are not eligible for enrollment 
     in--
       (A) ongoing clinical trials that are registered on 
     ClinicalTrials.gov (or successor website), with respect to a 
     drug for the prevention, diagnosis, mitigation, treatment, or 
     cure of amyotrophic lateral sclerosis; or
       (B) clinical trials for the prevention, diagnosis, 
     mitigation, treatment, or cure of amyotrophic lateral 
     sclerosis for which an exemption under section 505(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) has 
     been granted by the Food and Drug Administration and which 
     are expected to begin enrollment within one year; and
       (3) the resulting project funded by such grant will allow 
     for equitable access to investigational drugs by minority and 
     underserved populations.
       (d) Use of Funds.--A participating entity shall use funds 
     received through the grant--
       (1) to pay the manufacturer or sponsor for the direct costs 
     of the investigational drug, as authorized under section 
     312.8(d) of title 21, Code of Federal Regulations (or 
     successor regulations), to prevent, diagnose, mitigate, 
     treat, or cure amyotrophic lateral sclerosis that is the 
     subject of an expanded access request described in subsection 
     (a), if such costs are justified as part of peer review of 
     the grant;
       (2) for the entity's direct costs incurred in providing 
     such drug consistent with the research mission of the grant; 
     or
       (3) for the direct and indirect costs of the entity in 
     conducting research with respect to such drug.
       (e) Definitions.--In this section:
       (1) The term ``participating entity'' means a participating 
     clinical trial site or sites sponsored by a small business 
     concern (as defined in section 3(a) of the Small Business Act 
     (15 U.S.C. 632(a))) that is the sponsor of a drug that is the 
     subject of an investigational new drug application under 
     section 505(i) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(i)) to prevent, diagnose, mitigate, treat, or 
     cure amyotrophic lateral sclerosis.
       (2) The term ``participating clinical trial'' means a phase 
     3 clinical trial conducted pursuant to an exemption under 
     section 505(i) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(i)) or section 351(a) of the Public Health 
     Service Act (42 U.S.C. 262(a)) to investigate a drug intended 
     to prevent, diagnose, mitigate, treat, or cure amyotrophic 
     lateral sclerosis.
       (3) The term ``participating clinical trial site'' means a 
     health care facility, or network of facilities, at which 
     patients participating in a participating clinical trial 
     receive an investigational drug through such trial.
       (f) Sunset.--The Secretary may not award grants under this 
     section on or after September 30, 2026.

     SEC. 3. HHS PUBLIC-PRIVATE PARTNERSHIP FOR RARE 
                   NEURODEGENERATIVE DISEASES.

       (a) Establishment.--Not later than one year after the date 
     of enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall establish and implement a Public-Private Partnership 
     for Neurodegenerative Diseases between the National 
     Institutes of Health, the Food and Drug Administration, and 
     one or more eligible entities (to be known and referred to in 
     this section as the ``Partnership'') through cooperative 
     agreements, contracts, or other appropriate mechanisms with 
     such eligible entities, for the purpose of advancing the 
     understanding of neurodegenerative diseases and fostering the 
     development of treatments for amytrophic lateral sclerosis 
     and other rare neurodegenerative diseases. The Partnership 
     shall--
       (1) establish partnerships and consortia with other public 
     and private entities and individuals with expertise in 
     amyotrophic lateral sclerosis and other rare 
     neurodegenerative diseases for the purposes described in this 
     subsection;
       (2) focus on advancing regulatory science and scientific 
     research that will support and accelerate the development and 
     review of drugs for patients with amyotrophic lateral 
     sclerosis and other rare neurodegenerative diseases; and
       (3) foster the development of effective drugs that improve 
     the lives of people that suffer from amyotrophic lateral 
     sclerosis and other rare neurodegenerative diseases.
       (b) Eligible Entity.--In this section, the term ``eligible 
     entity'' means an entity that--
       (1) is--
       (A) an institution of higher education (as such term is 
     defined in section 1001 of the Higher Education Act of 1965 
     (20 U.S.C. 1001)) or a consortium of such institutions; or
       (B) an organization described in section 501(c)(3) of the 
     Internal Revenue Code of 1986 and exempt from tax under 
     subsection (a) of such section;
       (2) has experienced personnel with clinical and other 
     technical expertise in the field of biomedical sciences and 
     demonstrated connection to the patient population;
       (3) demonstrates to the Secretary's satisfaction that the 
     entity is capable of identifying and establishing 
     collaborations between public and private entities and 
     individuals with expertise in neurodegenerative diseases, 
     including patients, in order to facilitate--
       (A) development and critical evaluation of tools, methods, 
     and processes--
       (i) to characterize neurodegenerative diseases and their 
     natural history;
       (ii) to identify molecular targets for neurodegenerative 
     diseases; and
       (iii) to increase efficiency, predictability, and 
     productivity of clinical development of therapies, including 
     advancement of rational therapeutic development and 
     establishment of clinical trial networks; and
       (B) securing funding for the Partnership from Federal and 
     non-Federal governmental sources, foundations, and private 
     individuals; and
       (4) provides an assurance that the entity will not accept 
     funding for a Partnership project from any organization that 
     manufactures or distributes products regulated by the Food 
     and Drug Administration unless the entity provides assurances 
     in its agreement with the Secretary that the results of the 
     project will not be influenced by any source of funding.
       (c) Gifts.--
       (1) In general.--The Partnership may solicit and accept 
     gifts, grants, and other donations, establish accounts, and 
     invest and expend funds in support of basic research and 
     research associated with phase 3 clinical trials conducted 
     with respect to investigational drugs that are the subjects 
     of expanded access requests under section 561 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb).
       (2) Use.--In addition to any amounts appropriated for 
     purposes of carrying out this section, the Partnership may 
     use, without further appropriation, any funds derived from a 
     gift, grant, or other donation accepted pursuant to paragraph 
     (1).

     SEC. 4. ALS AND OTHER RARE NEURODEGENERATIVE DISEASE ACTION 
                   PLAN.

       (a) In General.--Not later than 6 months after the date of 
     enactment of this Act, the Commissioner of Food and Drugs 
     shall publish on the website of the Food and Drug 
     Administration an action plan describing actions the Food and 
     Drug Administration intends to take during the 5-year period 
     following publication of the plan with respect to program 
     enhancements, policy development, regulatory science 
     initiatives, and other appropriate initiatives to--
       (1) foster the development of safe and effective drugs that 
     improve or extend, or both, the lives of people living with 
     amyotrophic lateral sclerosis and other rare 
     neurodegenerative diseases; and
       (2) facilitate access to investigational drugs for 
     amyotrophic lateral sclerosis and other rare 
     neurodegenerative diseases.
       (b) Contents.--The initial action plan published under 
     subsection (a) shall--
       (1) identify appropriate representation from within the 
     Food and Drug Administration to be responsible for 
     implementation of such action plan;
       (2) include elements to facilitate--
       (A) interactions and collaboration between the Food and 
     Drug Administration, including the review centers thereof, 
     and stakeholders including patients, sponsors, and the 
     external biomedical research community;
       (B) consideration of cross-cutting clinical and regulatory 
     policy issues, including consistency of regulatory advice and 
     decisionmaking;
       (C) identification of key regulatory science and policy 
     issues critical to advancing development of safe and 
     effective drugs; and
       (D) enhancement of collaboration and engagement of the 
     relevant centers and offices of the Food and Drug 
     Administration with other operating divisions within the 
     Department of Health and Human Services, the Partnership, and 
     the broader neurodegenerative disease community; and

[[Page H7511]]

       (3) be subject to revision, as determined appropriate by 
     the Secretary of Health and Human Services.

     SEC. 5. FDA RARE NEURODEGENERATIVE DISEASE GRANT PROGRAM.

       The Secretary of Health and Human Services, acting through 
     the Commissioner of Food and Drugs, shall award grants and 
     contracts to public and private entities to cover the costs 
     of research on, and development of interventions intended to 
     prevent, diagnose, mitigate, treat, or cure, amyotrophic 
     lateral sclerosis and other rare neurodegenerative diseases 
     in adults and children, including costs incurred with respect 
     to the development and critical evaluation of tools, methods, 
     and processes--
       (1) to characterize such neurodegenerative diseases and 
     their natural history;
       (2) to identify molecular targets for such 
     neurodegenerative diseases; and
       (3) to increase efficiency and productivity of clinical 
     development of therapies, including through--
       (A) the use of master protocols and adaptive and add-on 
     clinical trial designs; and
       (B) efforts to establish new or leverage existing clinical 
     trial networks.

     SEC. 6. GAO REPORT.

       Not later than 4 years after the date of the enactment of 
     this Act, the Comptroller General of the United States shall 
     submit to the Committee on Energy and Commerce of the House 
     of Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report containing--
       (1) with respect to grants awarded under the program 
     established under section 2--
       (A) an analysis of what is known about the impact of such 
     grants on research or development related to the prevention, 
     diagnosis, mitigation, treatment, or cure of amyotrophic 
     lateral sclerosis; and
       (B) data concerning such grants, including--
       (i) the number of grants awarded;
       (ii) the participating entities to whom grants were 
     awarded;
       (iii) the value of each such grant;
       (iv) a description of the research each such grant was used 
     to further;
       (v) the number of patients who received expanded access to 
     an investigational drug to prevent, diagnose, mitigate, 
     treat, or cure amyotrophic lateral sclerosis under each 
     grant;
       (vi) whether the investigational drug that was the subject 
     of such a grant was approved by the Food and Drug 
     Administration; and
       (vii) the average number of days between when a grant 
     application is submitted and when a grant is awarded; and
       (2) with respect to grants awarded under the program 
     established under section 5--
       (A) an analysis of what is known about the impact of such 
     grants on research or development related to the prevention, 
     diagnosis, mitigation, treatment, or cure of amyotrophic 
     lateral sclerosis;
       (B) an analysis of what is known about how such grants 
     increased efficiency and productivity of the clinical 
     development of therapies, including through the use of 
     clinical trials that operated with common master protocols, 
     or had adaptive or add-on clinical trial designs; and
       (C) data concerning such grants, including--
       (i) the number of grants awarded;
       (ii) the participating entities to whom grants were 
     awarded;
       (iii) the value of each such grant;
       (iv) a description of the research each such grant was used 
     to further; and
       (v) whether the investigational drug that was the subject 
     of such a grant received approval by the Food and Drug 
     Administration.

     SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

       For purposes of carrying out this Act, there are authorized 
     to be appropriated $100,000,000 for each of fiscal years 2022 
     through 2026.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Kentucky (Mr. Guthrie) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 3537.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, in July, the Committee on Energy and Commerce held a 
hearing to learn about the challenges associated with finding 
treatments for neurodegenerative diseases, including ALS.
  We heard from the lead scientist from the National Institutes of 
Health and the Food and Drug Administration, and researchers at top 
universities, who discussed the difficulties scientists have had in 
understanding the complexities of the disease and developing 
biomarkers, a critical tool for drug development.
  FDA told us about the guidance they had provided to the industry on 
ensuring clinical trials were inclusive, and the agency's willingness 
to consider novel clinical research methods. However, we also heard 
from patients who said that FDA's guidance was not doing enough to get 
results on the ground.
  Given the length of time it often takes to diagnose ALS, many 
patients have found themselves locked out of clinical trials, despite 
the guidance urging developers to allow more flexible enrollment.
  As a result, patients and their families are left to fight this 
devastating disease with very limited medical interventions. According 
to the patient advocates, FDA's guidance was not being implemented by 
developers and was not being followed by the agency itself. So H.R. 
3537, the Accelerating Access to Critical Therapies for ALS Act, takes 
real steps to improve processes and activities at FDA to ensure 
patients can access clinical trials.
  This legislation will help us get closer to effective cures and 
treatments for ALS. It requires FDA to develop and carry out an action 
plan to show how the agency will address ALS and other 
neurodegenerative diseases over the next 5 years.
  The bill also creates a new grant program at FDA to cover research 
costs to characterize rare neurodegenerative diseases, identify 
molecular targets for the diseases, and increase efficiency and 
productivity of clinical trials.
  Additionally, the bill creates a new grant program at the Department 
of Health and Human Services that will help pay for investigational 
drugs to prevent, diagnose, mitigate, treat, or cure ALS in expanded 
access programs. Expanded access is an important pathway for patients 
to receive experimental treatments, which should only be used when 
clinical trials and other effective treatments are not available.
  Mr. Speaker, in committee, we ensured there would be a path forward 
for patients who are not able to participate in clinical research, but 
also clarified the intent and parameters of the program to maintain the 
scientific integrity of our research agencies.
  The legislation now requires the Government Accountability Office to 
measure the program ahead of a 5-year sunset to ensure that these novel 
grant programs are benefiting patients and researchers. The grants 
included in this bill are charting new territory for NIH, and it is 
important we measure their level of success before we explore efforts 
to expand this program beyond ALS.
  Mr. Speaker, this bill would not be here on the floor today were it 
not for the steadfast determination of patients and their families. At 
our hearing on this legislation in July, Brian Wallach and his wife, 
Sandra Abrevaya, cofounders of ``I Am ALS,'' spoke so eloquently of 
their own personal fight against ALS, and charged us with the task of 
passing this bill.

                              {time}  1500

  Hundreds of patient advocates across the country have made their 
voices heard to Members as well. To Brian, Sandra, and all the patients 
and their families, I reiterate what I said during our full committee 
markup: We heard you and now we are acting. We are grateful for your 
collaboration and willingness to work with us to improve this bill.
  I also want to acknowledge the work of Representative   Mike Quigley, 
the sponsor of this legislation, who has been tireless in his efforts 
to see this legislation across the finish line. I appreciate his 
willingness to work with us to get this bill to the committee so that 
it was ready for action here on the floor. I also want to thank our 
chairwoman of the Health Subcommittee, Ms. Eshoo, for all that she has 
done to move this bill.
  Mr. Speaker, I urge my colleagues to support the ACT for ALS, and I 
reserve the balance of my time.
  Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of H.R. 3537, the Accelerating 
Access to Critical Therapies for ALS Act.
  I am a proud cosponsor of this bill and want to thank Representatives 
Fortenberry and Quigley for their tireless efforts to move this bill 
forward. We would not be here today without your hard work and the 
tremendous advocacy efforts of the ALS community, who have so 
passionately made the need for this legislation known to Congress.
  ALS is a devastating neurodegenerative disease that affects nerve 
cells in the brain and spinal cord. Many people lose the ability to 
speak,

[[Page H7512]]

eat, move, and even breathe. Over 5,000 people are diagnosed with this 
disease each year, and the average life expectancy is only 2 to 5 years 
after diagnosis.
  Recent years have brought a wealth of new scientific understanding 
regarding this disease. There are currently five drugs available to 
treat ALS, and while this is a remarkable achievement, we have more 
work ahead of us.
  H.R. 3537 establishes a grant program through HHS to support research 
and access to investigational therapies to treat ALS for those patients 
who cannot access clinical trials. It also directs HHS to establish a 
public-private partnership for neurodegenerative diseases, which will 
advance the development and regulatory approval of drugs to help treat 
ALS and other rare neurodegenerative diseases.
  This bill will ring hope to those with ALS and their loved ones by 
promoting access to potentially breakthrough treatments and help us to 
one day find a cure for this vicious disease.
  Mr. Speaker, I urge my colleagues to support this bill, and I reserve 
the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from 
Illinois (Mr. Quigley), the sponsor of the bill and the champion in the 
fight against ALS.
  Mr. QUIGLEY. Mr. Speaker, everything is impossible; until it isn't. 
Nothing has a cure; until it does. Today, people diagnosed with ALS are 
expected to live between 2 to 5 years. During that time, they 
progressively lose their ability to use their limbs, to speak, to 
swallow, and ultimately to breathe. Being diagnosed with ALS is a death 
sentence; for now.
  After my friend Brian Wallach was diagnosed with ALS an odds-defying 
4 years ago, he made ending the disease the fight of his life. Not 
today, ALS, he frequently says, not today.
  Mr. Speaker, ALS is not incurable; it is just that we have not fully 
committed to finding a cure yet. Not like Brian has, not like Brian's 
wife Sandra has, or the organization they founded, I AM ALS has.
  ACT for ALS will give people living with ALS access to promising 
treatments and improve the research infrastructure we need to one day 
find the cure. Cruelly, up to 90 percent of people living with ALS are 
ineligible for clinical trials.
  For people with such an aggressive disease to have neither an 
effective FDA-approached treatment nor access to promising drugs is a 
tragedy. ACT for ALS will correct this.
  I would like to thank the 331 colleagues who have cosponsored this 
bill, Chairman Pallone, Subcommittee Chairwoman Eshoo, and their 
staffs, for standing with the ALS community. I also want to extend a 
special thank you to Congressman Fortenberry, the colead on this bill, 
who has pursued our shared goal with relentless dedication. I thank my 
staff, Allison Jarus and David Steury, who have gone above and beyond 
in pursuit of this legislation.
  This indeed is not a congressional achievement, it is an achievement 
of a community of advocates all around the country who are fighting for 
their lives, the lives of their loved ones, and the lives of everyone 
affected by ALS.
  In addition to Brian and I AM ALS, I want to thank the Muscular 
Dystrophy Association and the ALS Association for their dedication. ALS 
may rob people of their physical ability to speak, but make no mistake, 
this community has made themselves heard. It is their will that has 
brought this vote to us today; it is their will, and with that will 
there is a way.
  Where there is consensus, there can be progress. Where there is 
funding, a cure will follow. Today belongs to the tireless advocates, 
to the families of people with ALS, and to every American living with 
the disease.
  Mr. Speaker, I urge a ``yes'' vote.
  Mr. GUTHRIE. Mr. Speaker, I yield 2 minutes to the gentleman from 
Utah (Mr. Curtis).
  Mr. CURTIS. Mr. Speaker, I rise to share my support for expanding 
access for individuals to investigative drugs because I am concerned 
that we are not moving swiftly enough in order to prevent diagnosis, 
mitigate, treat, or cure ALS.
  This is very personal to me, it is very personal to the committee. It 
hits extremely close to home for so many of us who have lost friends, 
and have seen good friends and neighbors struggle with their families 
with this difficult disease.

  I had the opportunity to speak about this earlier today in the Energy 
and Commerce Committee hearing on biomedical innovation. We are not 
moving fast enough and we have more work to do.
  Mr. Speaker, I applaud this Accelerating Access to Critical Therapies 
for ALS Act for working to create and further develop public-private 
partnerships and to prevent policies from being enacted that impede 
private sector investments and advancements.
  Mr. Speaker, I urge my colleagues to support this bill.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewomen from 
California (Ms. Eshoo), the chairwoman of the Health Subcommittee.
  Ms. ESHOO. Mr. Speaker, I rise today in the strongest support of this 
legislation, Accelerating Access to Critical Therapies for ALS. It is 
called the ACT for ALS.
  As chairwoman of the Health Subcommittee, I am so proud to have 
advanced this legislation which enjoys 331 bipartisan cosponsors, more 
than any other bill pending in the House. This legislation establishes 
grant programs to advance treatments for neurodegenerative diseases 
like ALS, allowing more patients to receive critical medicines through 
compassionate care programs.
  Jamie Berry, one of my constituents, wrote a poignant letter to me, 
and said the following: ``With ALS, a piece of you dies every day. We 
are simply asking for a fighting chance to live the lives we were meant 
to live.'' As we gather here to pass this bill, Jamie is a patient in 
the neuro ICU unit at Stanford University Hospital.
  Jamie, if you are listening, stay tuned, because your wish is going 
to come true today. To you, Jamie, and all your fellow ALS patients, I 
am proud that the United States House of Representatives will vote for 
this legislation to support your fighting chance against this deadly 
disease.
  This is a transformational bill to make sure that people with ALS are 
given treatment options, and something they all deserve--it is spelled 
H-O-P-E, hope.
  I salute Representatives Quigley and Fortenberry, for the phenomenal 
job they have done on this legislation, both in introducing it and 
building it up to be the most cosponsored legislation in the House.
  Mr. Speaker, I urge all my colleagues to support the bill, ACT for 
ALS.
  Mr. GUTHRIE. Mr. Speaker, I yield 2 minutes to the gentleman from 
Louisiana (Mr. Scalise), the distinguished Republican whip.
  Mr. SCALISE. Mr. Speaker, I thank my friend from Kentucky (Mr. 
Guthrie) for yielding time.
  Mr. Speaker, I want to first associate myself with the remarks made 
by Ms. Eshoo of California, as well as Mr. Pallone, and stand up in 
strong support of this bill. I also thank the lead authors, Mr. 
Fortenberry and Mr. Quigley, and all of us who have worked on this and 
other issues to help patients with ALS.
  This goes back to other legislation that we have worked on, including 
the 21st Century Cures Act, where Congress came together, Republicans 
and Democrats, through the Energy and Commerce Committee, to help put a 
sharper focus on finding cures for diseases like ALS, diseases like 
Alzheimer's, and so many other debilitating diseases where you have got 
people that just want hope; as Ms. Eshoo said, where you have people 
who want the ability to live their lives to the fullest.
  I know I have worked on so many of these ALS-related issues with a 
hero back home in my district, Steve Gleason. Steve Gleason was, for 
awhile, more famous as a player for the New Orleans Saints, somebody 
who gave us a light in the darkness of Hurricane Katrina, but then 
Steve was diagnosed with ALS. He turned his notoriety into a call for 
action for other people with ALS to be able to live their lives to the 
fullest.
  Steve has been an inspiration to so many. He has a speech device that 
allows him to communicate; and he stays incredibly active. Steve 
brought this bill up over a year ago. So this is one more thing that we 
can do to help people with ALS; so that they can bring new therapies so 
that people living with ALS do have more ability to treat this disease.

[[Page H7513]]

  This means lifesaving drugs will now be available for individuals who 
are not otherwise able to get into ALS clinical trials.
  Mr. Speaker, on behalf of heroes, inspirational battlers like Steve 
Gleason, and so many of us have other heroes in our districts, I rise 
in strong support of this great piece of legislation that brings 
Republicans and Democrats together to take action for those people who 
are counting on us.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
Illinois (Ms. Schakowsky), the chairwoman of the Subcommittee on 
Consumer Protection and Commerce.

  Ms. SCHAKOWSKY. Mr. Speaker, I thank the chairman of the Energy and 
Commerce Committee and the chair of the Health Subcommittee for this 
legislation.
  Mr. Speaker, I rise today to remember my friend Artie. Artie and I 
were friends from the time we were in third grade in Chicago, and we 
stayed in touch all the many, many years. I was pretty devastated when 
he told me that he had ALS.
  A couple of years ago Artie made the decision, because ALS is a 
really cruel disease, to take his own life, to set the date so that he 
would just make the decision himself and not suffer so horribly to the 
bitter end, because at that time he saw no hope.
  Mr. Speaker, I rise today on behalf of my constituent, Brian Wallach 
and his wife, Sandra, who saw that there was hope in the future. They 
would fight in order to get legislation that would make access to what 
is promising therapies right now, therapies that weren't available or 
even on the horizon to Artie.
  I am so proud to join with colleagues across the aisle to say that we 
can provide that hope, that opportunity to people who are facing what 
has been a death sentence, and that we can see a future that is bright 
for now the ALS victims.
  Mr. Speaker, I want to thank I AM ALS, the organization, and many of 
the organizations that have been fighting for this. The advocates have 
done a great job to bring this to our attention and bring this day 
about and get over 300 cosponsors to this legislation. I am proud to be 
among them.
  Mr. GUTHRIE. Mr. Speaker, as I mentioned, there are over 300 
cosponsors, and we all know that is not an easy task to do at all. It 
takes a lot of work, a lot of leg work, a lot of effort. The two 
hardest working people that we have seen this session are Mr. Quigley 
from Illinois, and my good friend Jeff Fortenberry from Nebraska, who 
put such effort into this.
  Mr. Speaker, I yield 7 minutes to the gentleman from Nebraska (Mr. 
Fortenberry).

                              {time}  1515

  Mr. FORTENBERRY. Mr. Speaker, I thank my friend, Brett Guthrie, for 
his kind and generous words. It is very meaningful.
  Mr. Speaker, one of the first books that I recall reading as a child 
was about the life of the famous New York Yankees first baseman named 
Lou Gehrig. He was nicknamed The Iron Horse due to his athletic ability 
and endurance. He could hit. He could run. He could field. He was an 
amazing athlete. And then, everything just changed. Amyotrophic lateral 
sclerosis stole that man's abilities, causing him to lose control of 
basic functions.
  This merciless, cruel, and aggressive neurodegenerative condition 
mocked Lou Gehrig's famous durability. The disease became known as Lou 
Gehrig's disease, and today we call it ALS.
  Mr. Speaker, there was no cure then, and there is no cure now.
  Before he died in 1941, at a ceremony at home plate in Yankee 
Stadium, Lou Gehrig had this to say. He said: ``For the past 2 weeks, 
you have been reading about a bad break. Yet today, I consider myself 
the luckiest man on the face of the Earth.''
  That story, Mr. Speaker, Lou Gehrig's story, stayed with me as a 
child. I don't know why, but it did, and I remember it so well.
  Now, fast-forward decades later. While serving here as a Member of 
Congress, this same cruel disease has swept upon my own family.
  I want to do this, Mr. Speaker, if you will indulge me. Pictured here 
is my wife, Celeste, with her little brother and godson, Joe Gregory. 
In his mid-thirties, Joe began to notice that his hand was shaking. He 
started a battery of tests, but somehow, he just knew it was probably 
going to be the worst of the worst. He was diagnosed with ALS, but he 
faced his plight with both dignity and courage. He volunteered to be a 
part of an experimental trial. He said: Well, if it doesn't work for 
me, maybe it will help someone else.
  He died when he was 37 years old, and he left behind Melanie, his 
wife, and four little children. On his tombstone are the words from the 
prophet Isaiah: ``Here I am; send me.''
  Mr. Speaker, as Joe began to die, we as a family quickly learned 
about this profound trauma that affects so many families all across 
America. It happens over and over out of view. Most of us never see it.
  I soon became acquainted with this amazingly strong and determined 
ALS community. It was so uplifting to me to meet people filled with so 
much hope. You have heard that word over and over today, Mr. Speaker, 
and it is appropriate. So many people filled with so much hope amidst 
their own suffering but who rightfully sought a different approach and 
a better way.
  Out of this experience was born the ACT for ALS.
  Mr. Speaker, for over 50 years now and over 50 clinical trials, ALS 
patients have submitted themselves to tests, trials, therapies, and 
placebos in accordance with the rules of the current healthcare policy 
framework. But progress has been uneven, even debatable, with serious 
impediments to promising new treatments. Many have sacrificed their 
lives to science as they weakened and died.
  But today, here we are, Mr. Speaker, with over 330 cosponsors from 
both sides of the aisle, and we are standing for a new way.
  ACT for ALS represents a monumental shift in the way in which we 
approach ALS and other neurodegenerative diseases. At the core of this 
bill, it does two things. It transforms the paradigm of disease 
research and regulation, and it creates a new pathway for promising 
treatments. It drives the hope. With this groundbreaking law, we can 
break through faster for those who have suffered so much.
  I want to publicly say thank you to Representative Quigley for his 
tireless leadership in driving this hope, and my very close friends, 
Representatives Anna Eshoo and Cathy McMorris Rodgers, for their 
leadership in shepherding this bill as well. It is truly bipartisan. It 
was not easy, but here we are on the precipice of doing something good 
for so many people.
  Mr. Speaker, I may be just a little bit like Lou Gehrig. I, too, am a 
lucky man, and for this reason: I have met so many beautiful people who 
have shared their sufferings, their vulnerability, and their gratitude 
toward this effort today. People of good heart, courageous, and who are 
fighters have created a family of solidarity to help us creatively 
rethink how to attack this disease through sound science, through 
technology, and through improved public policy.
  Mr. Speaker, one last note: There are so many heroes who deserve 
special recognition, but you have heard one singled out today, and I 
want to single him out as well. This fight's Iron Horse is my friend 
and founder of the organization I AM ALS, Brian Wallach. As Brian said 
in congressional testimony in July with his wife, Sandra, there: ``This 
is our argument for our lives.''
  Yes, it is, Brian.
  So, Mr. Speaker, I should say publicly: Thank you, Brian; thank you, 
Joe; and thank you to the ALS community. We could not be here without 
you today.
  Mr. GUTHRIE. Mr. Speaker, I yield myself the balance of my time to 
close.
  Mr. Speaker, I would be remiss if I didn't mention a family as well.
  Mr. Speaker, when you first come to Washington, you start getting to 
know people who come to advocate for diseases and treatments like this. 
I met the Ensor family. A lady named Kay Ensor came here with her 11- 
or 12-year-old daughter at the time, Shelby. Shelby came to my office 
and said:

       I can't get a hug from my father anymore, and I don't want 
     any other little girl to feel this way. It may be too late 
     for us, but I don't want it to be too late for somebody in 
     the future.

  I got to know them, and I visited them in Lebanon Junction, Kentucky.

[[Page H7514]]

Their son, Tanner, was probably 8 or 9 at the time. They rigged up a 
wheelchair so he could go hunting with his father. But then it got to 
the point where they couldn't do that at all. Then, unfortunately, I 
was able to attend Mr. Ensor's funeral.

  I don't have personal experiences in my family, but just seeing the 
effort that a family has to go through and the love that they do it in 
was an example for me to get involved in this issue, and the suffering 
that the patient goes through but also the extremely difficult 
circumstances for a family but how they were so loving in everything 
they did.
  I want to close with this: I know that Brian and his wife, Sandra, 
were there at the hearing and touched every one of us. I want to yield 
back in honor of the Ensor family from Lebanon Junction, Kentucky, Mr. 
Speaker.
  Mr. Speaker, I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, after listening to the personal stories on 
both sides of the aisle, I don't think anyone would question why this 
bill is important in order to provide hope to so many, as the speakers 
said, in order to try to find a cure and in order to try to find more 
treatments and clinical trials. All these are basically put into this 
legislation.
  Mr. Speaker, again, I urge unanimous support for this bill on both 
sides, and I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 3537, 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. WEBER of Texas. Mr. Speaker, on that I demand the yeas and nays.
  The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution 
8, the yeas and nays are ordered.
  Pursuant to clause 8 of rule XX, further proceedings on this motion 
are postponed.

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