[Congressional Record Volume 162, Number 23 (Tuesday, February 9, 2016)]
[Senate]
[Pages S721-S724]
From the Congressional Record Online through the 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 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
[[Page S722]]
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 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
[[Page S723]]
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 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 and prevension. 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. 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.
[[Page S724]]
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.
____________________