[Congressional Record (Bound Edition), Volume 162 (2016), Part 2]
[Senate]
[Pages 1527-1530]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           INNOVATION PROJECT

  Mr. ALEXANDER. Mr. President, 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 HELP 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

[[Page 1528]]

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 and do 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 to have 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 the leader of 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

[[Page 1529]]

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.
  Finally, Senator Murray and I offered legislation to improve 
electronic medical records. Our committee did not set out to deal with 
electronic medical records, but the more we got into our discussion----
  The PRESIDING OFFICER. The Senator has used 20 minutes of his time.
  Mr. ALEXANDER. We have used 20 minutes?
  The PRESIDING OFFICER. Yes, sir. The Senator asked to be notified 
when he reached 20 minutes, and he has reached 20 minutes. The Senator 
still has the floor.
  Mr. ALEXANDER. I thank the Presiding Officer very much. I will 
complete my remarks. I see the Senator from Florida is here.
  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.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

             Senator Collins Remarks at Innovation Mark-up

       Before I turn to the bill that I am honored to cosponsor 
     with Senator Baldwin, which addresses a real problem of 
     keeping our young researchers at NIH, I do want to respond to 
     some of the earlier comments that have been made about the 
     approach we are taking today.
       First--I want to commend the Chairman and the Ranking 
     Member for scheduling these important bills for markup by 
     this committee.
       If you ask the parents of sons and daughters--primarily 
     sons--with muscular dystrophy who suffer from Duchenne's, a 
     very rare kind of muscular dystrophy, whether the bill that 
     we just approved is important, believe me they will tell you 
     that it is.
       If you ask stroke victims whether the rehabilitation bill 
     that we passed is important, they would say yes. 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.
       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.
       And the fact is that this congress has come together and 
     approved a much needed $2 billion dollar funding increase for 
     NIH--that is the largest increase for NIH's budget since 2003 
     we also approved, and I know this well because I was Chairman 
     of it as part of the bipartisan Alzheimer's task force--
     nearly a 60% increase in Alzheimer's funding bringing us to 
     $936 million. Is it enough? Given that we spend billions 
     caring for people with Alzheimer's--no.
       The National Advisory Council on Alzheimer's says we need 
     to spend $2 billion per year. But to imply that a 60% 
     increase in funding for Alzheimer's research is nothing; is 
     just not accurate. There is widespread bipartisan support for 
     biomedical research because there simply is no investment 
     that promises greater returns for Americans than that 
     investment.
       It not only leads to discoveries and the developments of 
     effective new treatments for families who are coping with 
     these diseases but it also can have a dramatic impact on the 
     budgets of families, states and the federal government. I am 
     pleased with the progress we are making, I support the 
     approach that the chairman has taken and I believe that the 
     bills that we are considering at this markup and at the 
     upcoming March 9 markup are important bills that will make a 
     real difference to American families.

     Innovation Bills Approved Today by the Senate Health Committee


 Sens. Bennet (D-Colo.), Warren (D-Mass.), Burr (R-N.C.), and Hatch (R-
 Utah)--The Advancing Targeted Therapies for Rare Diseases Act of 2015 
                               (S. 2030)

       Many rare diseases, like Cystic Fibrosis, have multiple 
     genetic mutations, making it

[[Page 1530]]

     difficult for researchers to find enough patients with the 
     same mutation for a clinical trial. This bill will help 
     expand the successful treatment of people suffering from rare 
     diseases like this.


       Sens. Burr (R-N.C.) and Franken (D-Minn.)--The FDA Device 
                  Accountability Act of 2015 (S. 1622)

       These innovative medical devices, items like artificial 
     knees, insulin pumps for people with diabetes, or stents for 
     people who have suffered a heart attack, or new surgical 
     tools to minimize scarring and reduce post-surgery 
     complications, can get bogged down at the FDA. This bill 
     reduces unnecessary regulations while maintaining the gold 
     standard of safety and efficacy to keep us safe.


  Sens. Baldwin (D-Wisc.) and Collins (R-Maine)--The Next Generation 
                       Researchers Act (S. 2014)

       Biomedical research is our best weapon against disease, 
     illness and death and we can't afford to lose young 
     scientists to other countries or professions because they're 
     frustrated by the lack of opportunity or funding--so this 
     bill helps attract talented young scientists by promoting 
     opportunities at the National Institutes of Health (NIH).


  Sens. Kirk (R-Ill.), Bennet (D-Colo.), Hatch (R-Utah), Murkowski (R-
  Alaska), Isakson (R-Ga.), and Collins (R-Maine)--The Enhancing the 
 Stature and Visibility of Medical Rehabilitation Research at NIH Act 
                                (S. 800)

       This bill will help millions of Americans with 
     disabilities, illnesses and chronic conditions that require 
     them to go to medical rehabilitation. For example, this is 
     important to people who have suffered from strokes, 800,000 
     happen every year in the U.S. according to the Centers for 
     Disease Control and Prevention. This bill ensures that the 
     NIH is focusing on research into helping these people, and 
     others who suffer from debilitating illnesses each year.


Sens. Isakson (R-Ga.) and Murphy (D-Conn.)--The Advancing Research for 
               Neurological Diseases Act of 2015 (S. 849)

       This bill will help people with neurological diseases like 
     Parkinson's, Multiple Sclerosis, and Alzheimer's by helping 
     to advance our understanding of these diseases and helping 
     researchers access data on these diseases in order to 
     discover new therapies and cures.


Sen. Murray (D-Wash.)--The Preventing Superbugs and Protecting Patients 
                             Act (S. 2503)

       If you would ask patients and families or anyone who has 
     undergone a procedure in a hospital or outpatient facility 
     that involve reusable medical devices--and if you asked the 
     people of the states of Washington and Illinois--whether they 
     thought this legislation was important, they would say yes.
       There was a tragic outbreak of antibiotic-resistant 
     infections linked to contaminated scope devices in Sen. 
     Murray's home state of Washington, where the devices were not 
     being properly disinfected between operations, and this bill 
     helps FDA in its work to ensure that reusable devices like 
     these are safe for patients.


 Sens. Alexander (R-Tenn.) and Murray (D-Wash.)--The Improving Health 
                  Information Technology Act (S. 2511)

       If you asked doctors, hospitals, or patients who want 
     access to complete and useful patient records to both deliver 
     care and understand more about their own health--and I think 
     that's most Americans--whether they think this bill is 
     important, they would say yes.
       This bill takes several steps to get health records flowing 
     between doctors, hospitals, and patients to help realize the 
     promise of health information technology by turning these 
     systems from something that doctors and hospitals dread into 
     something that actually helps patients.

  The PRESIDING OFFICER. The Senator from Florida.
  Mr. NELSON. Mr. President, I ask unanimous consent to speak for up to 
20 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.

                          ____________________