Speeches & Floor Statements

Floor Speech: 2nd Innovation Markup

Posted on March 9, 2016

Mr. President, last year the law everybody wanted to fix was named No Child Left Behind. Despite many different opinions and many different political attitudes, we got it done. I give great credit to the Senator from Washington, Mrs. Patty Murray, and to the members of our Education committee, 22 Senators of widely divergent political views, for their willingness to do that.

I often say if all you want to do is announce your opinion, you can do that at home. You can stand on the street corner and preach or you can get your own radio program, but if you want to be a U.S. Senator, after you announce your opinion, you are supposed to get a result, and that means work with other people to identify common areas of interest and see if you can, and we were able to do that with the bill that fixed No Child Left Behind.

Not only did we reach a consensus that needed to be fixed, we reached a consensus on how to fix it. The President signed it on December 10. He called it a Christmas miracle. It passed broadly in this body and it had the effect of reversing the trend toward a national school board, of repealing the common core mandate, and according to the Wall Street Journal, being the largest devolution of power from Washington to local control of schools in 25 years. So it was a significant bill, and I would argue that no bill that the Congress enacted last year was more important.

This year, I would suggest that if we are successful, that the most important bill that passes this body will be a bill to advance biomedical research, a companion bill to the 21st Century Cures bill the House of Representatives already passed. That is because this is the opportunity that everybody wants us to take. It is the opportunity to take advantage of the tremendous advances in scientific discovery that have created an environment where we have opportunities to help virtually every American.

We are able to cure some cancers instead of just treat cancers. Children with cystic fibrosis are beginning to be actually cured of their disease, a disease that was completely debilitating. Remarkable advances are being made because of genomic research. We have exceptionally talented people in charge of the agencies in dealing with this; for example, Dr. Francis Collins with the National Institutes of Health and now the recently confirmed Dr. Califf at the Food and Drug Administration. So this is the best opportunity we have to make a mark in the Senate this year to help virtually every American, and we have some catching up to do.

It is rare that I would admit the House of Representatives is ahead of us, but they are. They called their bill the 21st Century Cures bill. We have a common objective; that is, to get cures, drugs, and treatments through the regulatory process and the investment process more rapidly and into the medicine cabinets of the doctors' offices so they can help people. They finished their work last year. The President has taken the lead. He has called for a Precision Medicine Initiative. It is one of his major initiatives. I talked with him about it last year. I said: Mr. President, we will help you do that, and the way to do it is through our Biomedical Innovation Initiative.

What he wants to do, to begin with, is to get a million genomes sequenced so that when the Senator from Arizona is sick—which he rarely is, he is in such good health—or I am sick, the doctor may prescribe medicine that fits our own individual genome and not just a medicine that is, in effect, one-size-fits-all. That is just part of the excitement of precision medicine. And then more recently, the President has announced the Cancer Moonshot to try to make further advances in that.

There is additional interest on both sides of the aisle in a surge of new funding for the National Institutes of Health, possibly including mandatory funding, if it is properly done, which means replacing other mandatory funding. There is bipartisan interest in that.

But none of that will happen unless we move through our committee and on to the floor and to a conference with the House and on to the President's desk our biomedical research bill, our companion bill to the 21st Century Cures.

The only way to get support for the President's Precision Medicine Initiative, the only way to get the Cancer Moonshot, the only way to get a surge of funding that may include mandatory funding for the NIH is to pass this bill. Let's be blunt about it.

The good news is: we are making good progress. We are making good progress. I wanted to report to the Senate that this morning we had our second markup, our second meeting of our full committee where we discussed the measure we have been working on for more than a year for our biomedical innovation bill.

We have come up with 50 bipartisan proposals that Members have been working on, to get patients access to more drugs, cures, and treatments in a safe and effective way. We have held 10 bipartisan hearings on our innovation project, and 6 of those 10 hearings have been on an electronic health care records system. That program, we found, was in a ditch. The taxpayers have spent $30 million on it to try to draw into it doctors and hospitals to use electronic medical records so that you could know what your records are and the doctors could prescribe and diagnosis more easily. The problem was: it wasn't done very well. Stage one was helpful, most of the hospitals and doctors said to me. Stage two was difficult, and stage three, in their words, was terrifying.

Precision medicine will not work unless we have an interoperable electronic health care records system that has as its goal simplifying what happens in the doctor's office or the patient's bedroom in such a way—both with devices and with data—that people can make sense of it. It will improve the practice of medicine. It will reduce the huge amount of time doctors are spending on documentation. Some doctors say they spend 40 or 50 percent of their time doing that. If they are doing that, either they are doing something wrong or the government is doing something wrong, and my guess is we are. That is my guess. So we set out this year to take several steps to change that.

The administration—and I will give them credit—has gotten the message as well, and they, including Dr. DeSalvo and Secretary Burwell and Andy Slavitt, the head of CMS, have made a priority of trying to take this electronic medical records system and get it back on track so that doctors and physicians will see it as an opportunity and not as a burden.

We have several steps in our legislation that will help make electronic medical records work better. They include giving agencies more flexibility for alliances like the Vanderbilt-Google partnership that was announced the other day. They include dealing with the privacy issues that occur when you get a million genomes sequenced. They include encouraging interoperability and data sharing that is essential to doing this. So we are all working together to do that, but it will be necessary to pass our bill for electronic medical records to move more rapidly, and it will be necessary for the electronic medical records system to work if the President's Precision Medicine Initiative is to work.

Last month, we had a markup in our committee where we considered 15 of our bipartisan proposals and 7 bills, and we passed them all. The bills will mean better pacemakers for Americans with heart conditions, better rehabilitation for stroke victims, more young researchers entering the medical field, and better access for doctors to their patients' medical records, as I just described. And for the parents of a child suffering from a rare disease like cystic fibrosis, the bill from Senators Bennet, Burr, Warren and Hatch increases the chances that researchers will find a treatment or cure for your child's disease. That was the good work in the committee last month.

Today, we met all morning and we considered 7 more bills, and about 15 proposals were incorporated in those bills. Each of those bills, the Senators feel, is an important step forward. For example, Senators Casey, Isakson, Brown, and Kirk offered a bill, which was passed, to create drugs to treat or cure rare diseases in children.

Senators Burr, Bennet, Hatch, and Donnelly proposed, and it was passed, to create a new system for breakthrough devices that is similar to the breakthrough for drugs that Senator Burr and Senator Bennet and others worked on in 2012, and that has shown such promise and such results. Everyone is pleasantly—I wouldn't say surprised, but maybe surprised, by how many new drugs have been approved by the FDA using the breakthrough process from 2012. We hope the same will be true with the breakthrough process for devices.

Senators Bennet and Hatch offered a bill that will remove the uncertainty in the definition of “medical devices” that was adopted in 1976. Most people didn't even know what software was in 1976.

Senators Burr, Casey, Isakson and Roberts had a bill to spur the development to save the lives of victims of bioterror.

Senators Isakson, Casey, Donnelly and Roberts offered a bill to prevent the promising new field of combination products from getting caught in red tape at the FDA. By combination products, I mean devices and drugs together.

A bill from Senators Wicker, Klobuchar, Bennet, Collins and Franken would increase the say patients would have in the FDA approval process about treatments received in a clinical trial.

Senators Franken, Nelson, Isakson and Brown had a bill to encourage companies to develop a treatment, cure, or vaccine for the Zika virus.

These were all adopted, but for these to become law, we have to pass our bill. We have to bring it to the floor this year, and we have to do it in a bipartisan way and pass our bill.

At 3 markups—our third one will be in April—we will consider 50 proposals, and every single one of them has bipartisan support. There are two or three areas where we have a difference of opinion. I am glad to see the Senator from Illinois is here because one of the areas we discussed this morning is one where he has been very important, and that is to have a surge of additional funding for the National Institutes of Health. Numbers of us were very proud of the work Senator Murray, Senator Blunt, Senator Durbin, and others did to make sure that we had $2 billion more in the regular appropriations last year for the National Institutes of Health—very important.

A number of us believe that it would be appropriate in connection with this innovation legislation to have a surge of additional funding for specific projects at the National Institutes of Health but not at the expense of a steady increase in the regular discretionary funding. There are a variety of reasons for that. I won't go into them all today because the Senator from Illinois may want to speak. But if we are talking about mandatory funding, mandatory funding is already out of control, and the President's new budget has $682 billion of mandatory funding in it. It also has new taxes to pay for it, which the Congress isn't going to adopt. The more responsible proposal would be to reduce mandatory funding by $682 billion.

In any event, if we have any mandatory funding, it needs to replace other mandatory funding. And we don't want to create a situation where anyone gets the idea that mandatory funding is a substitute for steady increases in discretionary funding, which has happened before. As Senator Blunt pointed out this week in our appropriations hearing, when the Congress put in the mandatory funding for community health centers and the National Health Service Corps, the discretionary funds started to dry up.

So we have different proposals for how to deal with this. The Democratic Senators on our committee have recommended $50 billion over the next 10 years. I recommended an NIH innovation fund which would create a surge of funding for high-priority initiatives at NIH, including the President's Precision Medicine Initiative, the Cancer Moonshot, the BRAIN Initiative, Big BioThink Awards, and a Young Investigator Corps. It would be in addition to discretionary funds, not a replacement for them.

So my hope is that Senator Murray and I and our committee can work together over the next 2 or 3 weeks and complete our work on our biomedical research legislation by our markup on April 6. I hope we can come to the floor and present to Senator McConnell, the majority leader, along with that, a bipartisan consensus for an additional surge of funding, including mandatory funding for medical research in the areas I have suggested. I have said that we will need to replace other mandatory funding in order for it to be considered. I hope we can work that way in the committee, and I hope the Senate will look forward to receiving this.

I will conclude by simply saying that last year I believe no bill was more important that we worked on in the Senate than the bill to fix No Child Left Behind. It affected 50 million children, 3.5 million teachers, and 100,000 public schools. The only reason it happened was because we had Senators of very different backgrounds and attitudes and political differences who agreed that a result was more important. The opportunity everybody wants us to take this year is to take advantage of this magnificent scientific revolution and encourage the research and the other steps we need to take to move treatments and cures and drugs into the medicine cabinets and the doctors' offices more rapidly, in a safe and effective way. I believe we can do that. I hope our work is finished by early April. I hope it is bipartisan.

I look forward to the opportunity of being able to say later this year that the most important bill the Senate worked on with the House and the President is this 21st Century Cures idea. The House has done its job. The President is out front. We need to catch up. I am convinced we can. I thank the Presiding Officer. I yield the floor.