Alexander: Biomedical Innovation Would Be The Most Important Bill Signed Into Law This Year

Wednesday, March 9, 2016
Senate health committee Chairman Lamar Alexander said Wednesday that if the committee succeeds on its bipartisan biomedical innovation agenda, “it will be the most important bill signed into law this year.”

“I do not know of another way this year to get support for the president’s Precision Medicine Initiative and cancer moonshot and a short-term surge of funding for the National Institutes of Health unless we act on this bill,” Senator Alexander said. “This is the train most likely to get to the station and if we don’t succeed, we’ll lose those opportunities.”

The committee on Wednesday, at its second of three markups, passed seven bipartisan bills that supporters say will spur the development of treatments for Zika, children suffering from rare diseases, medical countermeasures for bioterror victims, the promising new field of combination products, and devices that help Americans stay healthy, such as Fitbits or Apple watches.
That follows a markup last month, in which the committee unanimously supported another seven bipartisan bills that 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.

The committee has worked on a bipartisan basis for more than a year to develop pieces of legislation that will together form legislation authorizing the president’s Precision Medicine and cancer moonshot initiatives and serve as a companion to the House-passed 21st Century Cures legislation.

Senator Alexander said that the committee will continue to work in a bipartisan manner to reach agreement on a short-term surge of mandatory funding to boost high-priority research projects at the National Institutes of Health. “Because of our budget deficit, we need to fund that new surge in mandatory funding by reducing existing mandatory funding. We can discuss these ideas in committee, but everything we’ve done in committee has had bipartisan support and we do not have a bipartisan consensus on how to do this.”

Senator Alexander said the committee would work toward an agreement they can offer when the bill comes to the floor.

The chairman’s opening remarks follow: 

Last week I went to the White House last week for a seminar about the president’s Precision Medicine Initiative, which involves mapping the genomes of 1 million volunteers and making the data available to researchers so they can develop treatments and cures tailored to a patient’s genome, rather than one-size-fits-all treatments.

While I was there, the president asked me where we are on in the Senate innovation agenda, this legislation. That’s because I talked to him about that a year ago and said to him then that I would do my best to fully support what he needed on the Precision Medicine initiative and I told him last week the same thing about the vice president’s cancer moonshot initiative.

Here’s what I mean by our innovation agenda:

One way to talk about it is to say that it is a companion to the effort by the House of Representatives, called 21st Century Cures, which they passed last year. We’re in the middle of considering as many as 50 bipartisan proposals that we’ve been working on for more than a year. Our goal is to try to help America’s patients get access to safe drugs, devices, cures, and treatments more rapidly, as well as being safe and effective, which is the mission of the Food and Drug Administration (FDA). 

We have held 10 bipartisan hearings on the innovation project, six of them have been on improving how our electronic health records systems work. There has been a lot of participation on both sides of the aisle on that. We’ve had 5 bipartisan staff working groups working for about a year who have held more than 100 meetings and briefings.

Last month, at our markup on the first set of proposals from all this work, we considered 7 bipartisan bills containing about 15 bipartisan proposals and each one passed with unanimous support. These 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.

And if you are the parent of a child suffering from a rare disease like Cystic Fibrosis, the bill from senators Bennet, Warren, Burr, and Hatch increases the chances that researchers will find a treatment or cure for your child’s disease.

That was the work of the committee last month.

Today we will consider seven more bills incorporating about 15 of the bipartisan proposals that we have worked on.

Senators Casey, Isakson, Brown, and Kirk have a bill to encourage companies to create drugs to treat or cure rare diseases in children.

A bill from Senators Burr, Bennet, Hatch and Donnelly to get breakthrough devices through the FDA review process more quickly—a lot like the bill Senators Burr and Bennet introduced for drugs in 2012.

A bill from Senators Bennet and Hatch will make sure that uncertainty regarding the definition of medical devices, which dates all the way back to 1976, does not deter companies from innovations such as Fitbits or watches that help them keep up with their health.

A bill from Senators Burr, Casey, Isakson, and Roberts will help spur the development of treatments to save the lives of victims of bioterror.

Senators Isakson, Casey, Donnelly, and Roberts have a bill to prevent the promising new field of combination products from getting caught in red tape at FDA. A great many senators have been interested in that.

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

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

So I think you can see that these bills are bipartisan and important. The 15 of 22 committee members who cosponsored bills at this markup or the last one believe they are important to the American people.

In our three markups, we’ll consider 50 proposals and every single one of them has bipartisan support, which means they are introduced from senators on both sides of the aisle on this committee. There will be two or three areas where we have a difference of opinion. That is not surprising in the United States Senate. That’s what we are here to do really—resolve differences in opinion—and so we’ll vote on those either in committee or on the floor. That’s a remarkable amount of consensus for a diverse group of senators on a big complicated issue.

One of those differences still remaining has to do with mandatory funding for research at the National Institutes of Health. Or I would prefer to call it a surge of additional funding for research at the NIH.

The best way to support NIH is by steady increases in appropriations. That’s what Congress did last year, $2 billion more dollars with thanks to Senators Blunt, Murray, and others for taking the lead on that.

Unfortunately the president’s budget reduced that by $1 billion. In other words it went backwards. And then they replaced it with mandatory funding of $1.8 billion for one year.

Now, there are some problems with that proposal.

One is that it’s not realistic; the president’s budget has $682 billion in increases of mandatory funding. In other words, things they couldn’t find room for in the discretionary funding, they just made mandatory funding proposals that will be paid for by higher taxes. I think everyone knows Congress is not going to approve that.

A more responsible proposal would have been to reduce mandatory funding by $682 billion dollars because mandatory funding is squeezing out discretionary spending that we depend on every year for the National Institutes of Health or FDA. An alarming figure is that over the next 10 years, according to the Congressional Budget Office, if we do nothing about it, the discretionary budget is going from 32 percent of the entire budget to 22 percent of entire budget.

This year, for the first time, the Congressional Budget Office projects that federal spending for the major health care programs  (Medicare, Medicaid, SCHIP, Obamacare) will represent the largest fraction—more than 60 percent—of the projected growth in mandatory spending in 2016. Even more than the growth in Social Security.

My own view is that mandatory funding should not be a substitute for discretionary funding. As Senator Blunt pointed out at the appropriations hearing last week on the budget for the Department of Health and Human Services, mandatory funding was used to replace the traditional discretionary spending for community health centers and National Health Service Corps. Then the discretionary funding started to dry up.

Now we have different approaches to this, Democratic members of the committee have proposed spending $50 billion over the next 10 years. I suspect we will hear about that today.

I have suggested a different approach, what I would call an innovation projects fund that would create a surge in funding for high priority initiatives at NIH. These would include: Precision Medicine, the Cancer Moonshot; the BRAIN initiative, Big Biothink Awards, and a Young Investigator Corps.

But these would be in addition to discretionary funds—not a replacement for them—these projects would have a beginning and an end. 

It might even help us bring up our discretionary funding more rapidly.

Because of our budget deficit, we need to fund that new surge in mandatory funding by reducing existing mandatory funding.

We can discuss these different ideas in committee, but everything we’ve done in committee has had bipartisan support and we do not have a bipartisan consensus on how to move ahead on mandatory funding.

Now the House did move ahead on mandatory funding but the House Energy and Commerce Committee had within its jurisdiction enough pay-fors to pay for the $9 billion they approved—we do not. The Finance Committee in the Senate has much of the jurisdiction that the House Energy and Commerce has.

Second, all of the pay-fors that the House identified for its mandatory funding were stolen in the Omnibus legislation. So they have zero ways to pay for it so far. 

So we will work hard together to find a way to have a surge in mandatory funding for the National Institutes of Health. But I am willing to do that.

We developed some trust and confidence working on the education bill by working together and reserving some especially difficult issues for floor, and I hope we can have that same attitude here today.

So here is my pledge: I pledge is to work with Senator Murray and other members of the committee to try to achieve a bipartisan consensus that will arrive on the floor at the same time as this innovation package does. I know the innovation package is not likely to get 60 votes unless we have some sort of bipartisan way to have a surge in funding, mandatory funding, for NIH. By bipartisan, I don’t mean unanimous, but I mean sufficiently bipartisan to make sure that we can achieve 60 votes and have a consensus in the Senate.

Last year the law everybody wanted fixed was called No Child Left Behind and we did it despite many different political opinions and attitudes. I give Senator Murray and the Democratic members of this committee as well as the republican members much credit for the way they conducted themselves in this. I said at the time that if all we wanted to do was announce our differences than we could preach on the street corner or get a radio program. But we are United States Senators and our job is to get a result.

So we worked together, held some amendments to the floor. And achieved what the president called a Christmas miracle, and it affected lots of people, 50 million children in 100,000 schools.

It was the most important bill passed by the Congress last year I believe.

This year, the most important opportunity that everybody wants to take advantage of is this remarkable scientific opportunity in biomedical research. It offers the promise of help for virtually every American. And I believe if we would succeed, it will be the most important piece of legislation signed into law this year.

The president is very interested. He has been working with all of us on his Precision Medicine initiative.

We have already approved support for electronic medical records, which are essential for the Precision Medicine. It won’t work unless we improve electronic health records.

We have in our legislation fixes on privacy, flexibility for partnerships like Google and Vanderbilt University on sharing data.

The House has moved ahead on its 21st Century Cures. So we have the House and the president on the same track which doesn’t always happen. So it’s up to us to catch up and join the effort.

So we’ve reached the point after working for a year, and I would respectfully ask the members of the committee to please keep in mind the word: “result.” Virtually every American could be helped by what we’re doing.

The president and the house are pretty well lined up. We’re on a very good track, we need to come to an agreement.

And I would close with this: I do not know of another way this year to get support for the president’s Precision Medicine Initiative or support for the cancer ‘moonshot’ or a surge for mandatory funding for the National Institutes of Health, unless we act on his bill. All those things that I mentioned have to be authorized. And we’re the train that’s most likely to get to the station. And if we don’t succeed, we will lose those opportunities. I don’t think any of us want to do that and I look forward to our coming to an agreement.

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