Speeches & Floor Statements

Floor Speech: Biomedical Innovation

Posted on February 9, 2016

Today I would like to report some good news about the work of the Senate that should be of interest to every single American family; that is, that we are moving ahead in the Senate on a package of 50 bipartisan proposals that will help move medical devices, medical cures, and medical drugs through the long, expensive, regulatory process and into medicine cabinets and doctors' offices, where they can help patients. We call this our Innovation Project. It is a companion to work that has been done in the House of Representatives already that they call their 21st Century Cures Act. It is also work that President Obama has talked about in important ways. The reason that the House has already done its work, that the President has talked about this in his State of the Union Address, and that we in our health committee in the Senate have been working for a year to develop 50 bipartisan proposals that we hope to bring to the floor of the Senate, is because we have never had a more exciting time in biomedical research in America than today. We are talking about actually curing some cancers, not just treating cancers. We are talking about using 3-D printing to actually help replace knees.

I was in a medical device office in Memphis a few weeks ago, and that company told me that in one-third of the cases where it sells knee replacement equipment, it also sells a tool to the doctor made with 3-D printing so that if he or she--the doctor--is replacing the knee of the Senator from Oklahoma, the doctor uses this tool that is just made especially for the knee of the Senator from Oklahoma and virtually eliminates the possibility of a mistake by the doctor in that surgery. The company told me it not only uses 3-D printing in one-third of the cases but that it could easily do it in all of the cases and expects it will soon.

At our hearing about 3 weeks ago, I asked Janet Woodcock, the head of the Center for Drug Evaluation and Research at the Food and Drug Administration, if there had ever been a case of a 3-D of printing of a drug, and she said, yes, there had been one. They have used 3-D printing to manufacture a medicine for epilepsy.

That is not all. Last year when the President announced his Precision Medicine Initiative, he introduced a young man whose cystic fibrosis had been cured by a new medicine, which he takes every day. While that only benefits some cystic fibrosis patients, the drugs that are used to cure that number of patients are the same kind of drugs they believe eventually will cure every patient with cystic fibrosis.

On that day, the President announced what he calls his Precision Medicine Initiative and that he wanted to assemble 1 million human genomes so that if my doctor is prescribing for me a medicine by knowing what my genome is and what that medicine has done in other genomes, he can make a very specific sort of prescription, one that is more likely to help me and less likely ever to hurt me.

I attended the President's ceremony. I told him afterward that we would do our best to incorporate his Precision Medicine Initiative into our work in the Senate on our Biomedical Innovation Project. The House was making good progress on its 21st Century Cures project. So I told the President: Mr. President, I can't imagine why we can't get a result in this Congress.

Since that time, the President has announced a cancer task force that Vice President Biden is leading to work to speed up treatments and cures for cancer. The House has passed its 21st Century Cures Act. In our committee in the Senate during the past year we have held 10 bipartisan hearings, including 6 on how to improve the electronic medical records systems that hospitals and doctors are using. We have had five bipartisan staff working groups that have met or held briefings more than 100 times in the last year, and the result of their work has been 50 bipartisan legislative proposals. As I said, every single one of those has support from Democrats as well as Republicans on the committee.

Today in our committee we debated and approved the first 7 of these bills, which included 12 of the 50 bipartisan proposals I just mentioned. We had an open process. Any Senator who wished to could have offered an amendment. The bills have had so much work on them that there weren't any amendments, but they were important pieces of work.

Our committee probably is the most diverse in the Senate. I know that is saying a lot, but if you look up and down the Democratic and Republican aisle, we span the whole spectrum. Last year we worked together, despite our differences of opinion, and produced a bill to fix No Child Left Behind. A lot of people thought we couldn't do that. I expect the same sort of bipartisan effort led by Senator Murray, the senior Democrat on her side, and me as chairman, to work well for us again.

We have a second markup of legislation scheduled for March 9 and a third for April 6. My expectation is that after we meet these 3 times and consider 50 legislative proposals, when we are finished it will all add up to bipartisan companion legislation to the House's 21st Century Cures legislation, and our legislation will include important elements of the President's Precision Medicine Initiative in his Cancer Moonshot.

The 21st Century Cures Act, the House bill, includes $9.3 billion in so-called mandatory funding over 5 years, mostly for the National Institutes of Health. Several of President Obama's other proposals in his new budget involve mandatory funding, and several Members of our committee have talked to me about mandatory funding for some of the work we need to do.

Here is my view about mandatory funding: I don't want to get the cart before the horse. When I was Governor of Tennessee and we needed a new road system, people would say to me: Are you going to raise the gas tax? I said we are not going to talk about the gas tax. There are lots of different ways to pay for the road. You can borrow the money. You can use discretionary money. You can raise the fuel tax. You can build a toll road. We are not going to talk about any of that. First, we are going to decide on what we want to do. What we decided to do was to have three big road programs to attract the auto industry suppliers to Tennessee, and it worked.

The decision we made after we decided what we wanted to do was in that case to raise the fuel tax three times because we didn't want any road debt. We have among the best roads in the country and zero road debt, and we have the auto industry. That worked out pretty well for us 30 years ago. I would like to apply the same sort of thinking here.

I don't want to talk about how we pay for something before I decide what the something is. Here is the something I am thinking about. I am thinking about something called the NIH—National Institutes of Health—Innovation Projects Fund; five areas, in addition to the things we normally fund, that require extraordinary support, one-time support for ideas that have a start and a finish. In other words, they are not built into the budget for a long period of time. The National Institutes of Health Director would have the authority to direct allocations of this fund to specific areas of importance.

The five areas of importance I have in mind are helping the President launch his Precision Medicine Initiative and an American Young Investigators Corps. We have heard from Dr. Collins, the head of NIH, and many others how important it is for young investigators have enough money to give them the money to do their research. The BRAIN Initiative – all of us are staggered by the prospect of the personal anguish that Alzheimer's and other brain diseases will cause individuals and their families, and we are excited about the prospect of relieving that anguish. We know how much this is going to cost us—in the tens and tens of billions of dollars. If we can find a way to develop new understandings of neurological disorders, which help discourage Alzheimer's disease or prevent it or deal with it, it saves money as well as saving anguish. A Big Biothink Award—Dr. Collins had suggested this in some of his testimony. During this exciting time, let's let each of the 24 Institutes that fund grant awards at the National Institutes of Health issue a challenge and let them identify the most promising big ideas in the country in their areas and fund it; for example, cancer, mental health. Let's see what comes out of this remarkable country of ours when we challenge them in that way. Then the Cancer Moonshot--now that the President and the Vice President are involved in this way, we want to make sure we do all we can to take advantage of curing some cancers as well as treating some cancers. There may be some aspects of that effort that have a start and a finish that could be part of what I call NIH Innovation Projects Fund.

I go into some detail about my Innovation Projects Fund proposal because we may be able to fund these needs in the regular appropriations process, but I am willing to consider using mandatory funding for these five areas because, No. 1, they have a start and a finish. They help jump-start. They are limited. In that sense, they are not subject to being appropriated forever, as appropriations often are. No. 2, I believe we should reduce other mandatory funding in order to use this mandatory funding. We should be about setting priorities in the Senate. I cannot think of a more important priority than biomedical research.

I mentioned we have 50 legislative proposals for which we have bipartisan support, but we do not have bipartisan agreement in the Senate committee on how to deal with any of these items that are paid for by mandatory funding, and neither do we have enough money within the jurisdiction of our committee to deal with it. So we will deal with both the Innovation Projects Fund and the mandatory funding--if that is what it turns out to be to pay for it--once the bill comes to the floor.

We have to decide first what programs we want and then how to pay for them. We should do that on the floor. We know we will have to have 60 votes to do it in that way that includes mandatory funding. We had some experience with that.

Last year we had some very difficult issues with the Elementary and Secondary Education Act. I had one of them that had to do with vouchers. That drives some people on the other side of the aisle up the wall. If I insisted on putting the scholarships for kids proposal that I had on the bill in the committee, the bill may never have gotten to the floor. Senator Franken, on the other hand, had an important piece of legislation to him on discrimination, but if he had gotten that on the bill in the committee, it would never have gotten to the floor. We agreed, since we needed 60 votes to get a result--and a result is what we want and the American people expect us to get--that we would withhold our controversial amendments until the floor and see if we could develop bipartisan support on the floor to have at least 60 votes and get a result.

We followed, in our education bill, the rule that the late Senator Kennedy and Senator Enzi followed when they were the ranking members of this committee, and that was let's find the 80 percent we agree on and work on that first, and let's take the things we disagree on and do those later, but most important, just as Senator Kennedy did with Senator Enzi, just as the full Senate did last year on fixing No Child Left Behind, we kept in our mind getting a result.

I said on the floor many times last year that if all you want to do is make a speech or assert your point of view, you can stay home. You can get your own radio program. You don't have to travel as much. There is no need for you to come to the U.S. Senate. You can have your say here, but if you really want to do your job here, you can work with other people and see if we can get a result, especially when we are talking about issues that affect every American family in such an important way.

I am determined to get a result. I am delighted I have the opportunity on this committee to work with the Senator from Washington, Mrs. Patty Murray. She is a strong Democrat. She is a leader in the Democratic caucus, but because of her leadership and her interest in getting a result, we were able to succeed last year. I believe, working with her and the other Members of our committee, we will be able to succeed this year.

The House of Representatives has done its work. It has passed the 21st Century Cures legislation. The President has made his proposals for precision medicine and for a cancer moonshot. He talked to all of us during his State of the Union Address in the last two sessions. We have worked for a year in our committee to produce 50 bipartisan legislative proposals that should go through the committee and be ready in early April to come to the floor.

The majority leader, Senator McConnell, has said to me, and he has said to all of us, that even though this is a Presidential year and we have less time here, he is still looking for important ideas that benefit a large number of Americans that have bipartisan support and that the President will sign into law.

I can't think of a single piece of legislation that the Senate could consider this year that fits that definition better than our companion legislation to the House of Representatives' 21st-Century Cures legislation.

I wish to say a word about the legislation we passed today. As I mentioned, these were all bipartisan pieces of legislation. The first one was introduced by Senator Bennet, Senator Warren, Senator Burr, and Senator Hatch. It had to do with rare diseases such as cystic fibrosis. This is what Senator Susan Collins of Maine said about that piece of legislation during the debate in our committee: If you ask the parents of sons or daughters--primarily sons--with muscular dystrophy who suffer from Duchenne's, a very rare kind of muscular dystrophy, whether the bill we just approved is important, believe me they will tell you that it is. We approved it unanimously, and it is ready for the Senate to consider.

Senator Burr, a Republican, and Senator Franken, a Democrat, offered the FDA Device Accountability Act of 2015. This legislation would help move innovative medical devices ahead—such as artificial knees, insulin pumps for people with diabetes, stents for people who have suffered a heart attack—and new surgical tools that can get bogged down in the FDA. In other words, we want to keep the safe and effective gold standard, but we want to get these devices through the system as rapidly as we can, at the lowest cost we can, so people can afford and use them.

Senator Baldwin and Senator Collins—Democrat and Republican—offered a bill called the Next Generation Researchers Act. We know that biomedical research is our best weapon against diseases, illness, and death, and we can't afford to lose young scientists to other countries, so this bill helped to attract young scientists by promoting opportunities at the National Institutes of Health.

This is what Senator Collins had to say about that: If you asked Dr. Francis Collins—the head of NIH—whether the bill that Senator Baldwin and I have sponsored is important to attracting and keeping young researchers, believe me he would say yes.

Senator Kirk, a Republican, Senator Bennet, a Democrat, along with Senator Hatch, Senator Murkowski, Senator Isakson, and Senator Collins, introduced another piece of legislation, S. 800. This bill will help millions of Americans with disabilities, illnesses, and chronic conditions that require them to go to medical rehabilitation. Senator Kirk, a stroke victim, spoke movingly about the importance of that bill.

This morning, Senator Collins said: If you ask stroke victims whether the rehabilitation bill that we passed is important, they would say yes.

There were four other bills we enacted. The one by Senator Isakson—we didn't enact it—we approved it by committee. Senator Isakson and Senator Murphy had legislation on advancing research for neurological diseases.

This is what Senator Collins said about that one: If you asked families that are struggling with neurological diseases such as Parkinson's, MS, or Alzheimer's, whether the bill that is on the agenda today is important, they would say yes.

Senator Murray offered the Preventing Superbugs and Protecting Patients Act, which is based on incidents that happened in her home State of Washington.

Before I yield the floor, I wish to make a brief statement about the legislation Senator Murray and I introduced. The electronic medical record system in this country is in a ditch. Doctors and hospitals that use it have come to dread it.

The administration recognizes that there are problems. They haven't taken all of my advice about what to do about it, but I do give them credit. I thank Secretary Burwell, Dr. Karen DeSalvo, the National Coordinator for Health Information and Technology, and the head of CMS, Andy Slavitt, for working with our committee, Senator Murray and me, to try to find ways to make the electronic medical record system something that genuinely helps patients and that doctors look forward to instead of dreading. We have to do this because almost every advance we need to make in biomedical innovation depends upon this. Certainly the President's Precision Medicine Initiative absolutely depends upon our getting electronic medical records right. Perhaps the most important piece of legislation we approved today, among those seven pieces of legislation, was doing what we could do in legislation to get the electronic medical record system out of the ditch and onto a better track so that doctors use it rather than dread it. We are counting on the administration to continue to work with us to finish that job.

I believe this is good news for the American people. It means we are on a path, step by step, to do our part of the job. There was some debate in our committee about whether the bills we were passing were important.

I ask unanimous consent that following my remarks, Senator Collins' comments, which remind us why each of the seven pieces of legislation is important, be printed in the Record.

There was some talk about the fact that we disagreed about the level of mandatory funding or whether to do it at all. We disagreed about that. We don't have bipartisan consensus on it, but we do have bipartisan consensus on 50 legislative proposals that we need to move ahead, and we will move ahead with them. Twelve of the 50 were done today, and the rest will be done in early March and early April.

My hope is that by early April, the Senate will be able to join the House of Representatives and President Obama and say: Here is our contribution to the most important step we can take to make the quality of health better for virtually every American family by passing our companion legislation to 21st-Century Cures.

Mr. President, I also ask unanimous consent to have printed in the Record, following my remarks, the summary of each of the seven bills our committee approved today. I thank the Presiding Officer, and I yield the floor.

 

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