Accelerating Access to Critical Therapies for ALS Act

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.

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.

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.

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. 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. Speaker, I yield 2 minutes to the gentlewomen from California (Ms. Eshoo), the chairwoman of the Health Subcommittee.

Mr. Speaker, I yield 2 minutes to the gentlewoman from Illinois (Ms. Schakowsky), the chairwoman of the Subcommittee on Consumer Protection and Commerce.

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.

Madam Speaker, I thank the gentleman for yielding.

Madam Speaker, pending Senate passage of the CR tonight without amendment, the House will not be in session tomorrow--I want to reiterate, pending passage of the CR tonight. If the CR is not passed, we will be in session tomorrow at 9.

If the Senate fails to act, as I just said, we will meet at 9 a.m. for legislative business and expect to vote on some of the postponed suspensions. Members are encouraged to keep their schedules flexible as we work to fully fund government and prevent a shutdown at 12 midnight tomorrow night.

Next week, on Monday, pending Senate action on full government funding and H.R. 6119, the Further Extending Government Act, being signed into law, the House is no longer expected to meet. This is a change from our previously announced schedule. We will not be in session Monday, assuming we have funded the government.

On Tuesday, the House will meet at 12 p.m. for morning hour and 2 p.m. for legislative business.

On Wednesday and Thursday, the House will meet at 10 a.m. for morning hour and 12 p.m. for legislative business.

On Friday, the House will meet at 9 a.m. for legislative business, as was previously scheduled.

The House will consider several bills under suspension of the rules. The complete list of suspension bills will be announced by the close of business tomorrow.

Additionally, the House will pass H.R. 4350, the National Defense Authorization Act, again, a second time, to provide our troops with the pay they deserve and our military with the tools it needs to carry out its missions safely and effectively, keep America safe, and keep the peace.

Again, I will reiterate that is the second time we will pass this version. As I understand it, it will be the conference-agreed version of the defense bill. This has been a discussion between the House and the Senate.

The House will also consider H.R. 8363, the Protecting Our Democracy

Act, to reassert Congress' role as a coequal branch of government by addressing the vulnerabilities exploited by the former President and his enablers to weaken our democracy, undermine the rule of law, and subvert the systems of checks and balances enshrined by the Framers in our Constitution.

The House may also consider legislation to address the debt limit and prevent a manufactured economic catastrophe that would derail our recovery from the pandemic and cause needless suffering to millions of American families.

I would reiterate that while we don't know the exact date at which America will be unable to pay its bills, we will address this next week, hopefully, in a bipartisan fashion.

Moreover, the House will be ready to act on H.R. 5376, the Build Back Better Act, should the Senate amend it and send it back to the House.

Lastly, of course, additional legislative items are possible.

We have a list of suspension bills, which has been announced and has been on our calendar for consideration. Those would be the pieces of legislation with which we would deal, pending action by the Senate.

Well, I think we will probably have to wait to see exactly what is going to happen. As the gentleman knows, we have passed a debt limit twice through this House. There has been a problem in the Senate, and I would expect Senator Schumer and Senator McConnell will be discussing that in the next few days.

Senator McConnell has made it very clear that he thinks that failing to protect the full faith and credit of the United States of America would have dire adverse consequences, so he has made it very clear he thinks we ought not to do that. Senator Schumer has done the same.

Essentially, my answer to the gentleman is, we have passed it twice in one form or another, so we can pass it and will pass it once the Senate agrees on a version. The two leaders are discussing that, I am sure. Now, I haven't talked to either one of them, but that is my premise.

Madam Speaker, I thank the gentleman, and I agree with his comments. It is my understanding, although I haven't talked personally, but it is my understanding that introducing the conference-agreed bill in the House, and passing it through the House will, under Senate procedures, facilitate them resolving this issue, hopefully, in a positive way next week.

Madam Speaker, I agree with the gentleman. We have talked to the sponsor, and we have talked to others. I expect this bill to be on the floor next week.

If the gentleman would yield?

With respect to the issues that I think we have broad agreement on, the cliffs that were created on Medicare and sequester are not good policy, and we ought to act on those. We are very seized of that issue, and hopefully, we can resolve something next week.

The gentleman mentions doing it in a bipartisan fashion. The good news is, and I know the gentleman will agree, that earlier this year, we delayed to January 1 of this coming year these items, particularly the 2 percent sequester by a vote of 90-2 in the Senate, meaning only two people voted against it, and in the House, 384. We were unanimous on our side, but you had the overwhelming majority on your side as well. So by 384-38, we extended that.

I am hopeful that we will do that again in a bipartisan way because not to do so, I think, would be very harmful to the medical community, to the country, and, obviously, to patients that are served by the medical community.

I am hopeful that we can resolve that as early as next week.

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.

Madam Speaker, I rise for the purpose of inquiring of the majority leader the schedule for next week. I yield to my friend, the gentleman from Maryland (Mr. Hoyer), to talk about the schedule for next week.

Madam Speaker, I thank the gentleman for that update. As it relates to tomorrow's schedule, as the gentleman from Maryland said, it could be fluid, depending on how the CR is processed in the Senate. If the CR does not pass the Senate tonight, are there bills that are specifically designated to come up tomorrow, or is that a to-be- determined issue?

Madam Speaker, I thank the gentleman for that update.

As it relates to the debt ceiling, we had a discussion a few weeks ago relating to the debt ceiling. Would there be a bipartisan negotiation? We haven't had that so far. Is there anticipation that there would be a plan to try to engage both sides in a negotiation on the debt ceiling, or is this something that we are just going to have to wait to see next week?

Well, then we will see what develops from that discussion.

As it relates to the National Defense Authorization Act, and as the gentleman pointed out, we are aware there are bipartisan negotiations between both the House and Senate, Republicans and Democrats.

I share the hope and expectation that they can come to an agreement. There are a few final details that both sides are trying to work out. I think they have already agreed, which we both share, that our troops deserve a pay raise, need a pay raise, and that number has been agreed to.

Hopefully, that is part of this, as well as the proper funding levels for our Nation's defense as we see threats emerging throughout the world. We also know the detriment of not having proper defense funding because they can't enter into the contracts that are necessary.

Both of those conversations seem to be, from what we are hearing, going well. Hopefully, that is a bill that can come to the floor next week, and we can all come together to help pass that.

Madam Speaker, I yield to the gentleman for any comments.

Madam Speaker, there are two specific pieces of legislation I would like to ask the gentleman to look at.

One is, by the end of the year, as you know, there are some potential cuts coming to entities like Medicare if Congress doesn't take action. There is a bipartisan bill that members of the Doctors Caucus and other members of the Committee on Energy and Commerce and other committees of jurisdiction have worked on. It is H.R. 6020. That would stave off those cuts to our healthcare providers.

It would need to be passed by the end of the year--otherwise, those cuts would automatically kick in--if the gentleman could take a look at that bill and see if that is something we could do in a bipartisan way before we leave for the year.

Another would be, you and I have had this conversation successfully on other legislation dealing with ALS. The Steve Gleason Act was one of those; there are others. I have spoken to Steve Gleason recently. There is a piece of legislation that we were able to work on that got out of the Committee on Energy and Commerce unanimously. It is H.R. 3537, the Accelerating Access to Critical Therapies for ALS Act.

I would just ask if the gentleman could look at that bill. It came out unanimously, bipartisan, from the Committee on Energy and Commerce, and it is something that, obviously, would help a lot of people who could use that help.

Madam Speaker, I yield to the gentleman.

Well, that would be great news to so many people across the country.

Madam Speaker, I share that sentiment the gentleman had, and hopefully, we can achieve those bipartisan victories.

As you mentioned, H.R. 3537 would be a tremendous victory for people who struggle with ALS to continue to seek out new therapies and be able to live their lives in the best way possible. I appreciate the gentleman's past efforts as well as the offer to bring that bill to the floor next week.

Madam Speaker, if the gentleman doesn't have anything else, I thank the gentleman, and I yield back the balance of my time.

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,

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. Speaker, I yield 2 minutes to the gentleman from Utah (Mr. Curtis).

Mr. Speaker, I yield 2 minutes to the gentleman from Louisiana (Mr. Scalise), the distinguished Republican whip.

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).

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.

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.