[Congressional Record Volume 162, Number 170 (Tuesday, November 29, 2016)]
[Senate]
[Pages S6534-S6536]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
21ST CENTURY CURES BILL
Mr. ALEXANDER. Mr. President, tomorrow the U.S. House of
Representatives will vote on a piece of legislation that many in this
body on both sides of the aisle have worked on and that the majority
leader of the Senate has described as the single most important piece
of legislation that will pass this year. We call it the 21st Century
Cures Act, and it includes three mental health reform acts--the most
significant reforms in mental health programs in 10 years.
I ask unanimous consent to have printed in the Record at the
conclusion of my remarks the more than 200 organizations from all
across the country supporting the 21st Century Cures legislation.
Why would the majority leader say it is the most important
legislation the Senate might act on--because we do a lot of important
stuff around here, whether it is Defense authorization, whether it is
cyber security, whether it is the bill to fix No Child Left Behind that
we passed in a bipartisan way last December. I think it is because this
legislation will affect virtually every American family because we are
entering the most exciting period of medical research in our country.
That is the first part of it.
The second part, which has to do with mental health, affects so many
families. We know that about one out of every five adult Americans
suffers from some form of mental illness. This concentrates a large
amount of money we actually spend on mental health programs every year
from the Federal Government and spends it in a more effective way to
actually help people.
In the next few minutes, I would like to acquaint the Senate again
with how we have gone about this and remind Senators of how many of us
have had a hand in this legislation. It is a remarkable 2 years of work
that has involved many, many, many hearings, dozens of meetings, and
that has been done in a large committee of 22 Senators of very
different points of view in a largely bipartisan way.
I will summarize. The first thing I would mention, the legislation
includes $6.3 billion of funding and $1 billion of that is for State
opioid grants. Whether it is Senator Whitehouse of Rhode Island or
Senator Ayotte and Senator Portman, probably most Senators of this body
have seen on the front pages of their newspapers the tragedies of
opioid abuse. I know that is true in Tennessee. This bill helps in two
ways. The most immediate way is to provide State grants--Federal
dollars to go to States--over the next 2 years to help States fight
opioid abuse.
The other way it helps, when we get to the part about 21st Century
Cures, is that Dr. Francis Collins, head of the National Institutes of
Health--Dr. Collins calls it the ``National Institutes of Hope''--says
that one of the groundbreaking discoveries we expect to happen in this
country is a non-addictive pain medicine. The problem with opioids is,
they are addictive. Now, people need it. If you have a back surgery or
if you have terrible pain, opioids can help people. We know that, but
it is addictive and it is causing problems. What if we had non-
addictive pain medicine? So this bill helps that in two ways.
There is other funding in this legislation: $4.8 billion to the
National Institutes of Health. The first 1.8 billion of that is for
Cancer Moonshot. This is Vice President Biden's initiative. He is
motivated for many reasons by it. His son died of cancer. Many of us
have family members or friends with cancer. There are startling
discoveries going on in cancer today. This is $1.8 billion in support
of the Vice President's Cancer Moonshot.
Then there is $1.4 billion for the Precision Medicine Initiative.
This is one of President Obama's most important initiatives. I know he
has said that very realistically he expects it to happen anyway, but he
would like to move it along. This helps move it along. What this means
is that if the Senator from Oklahoma and I each have a disease, that
because of our genetic background, the medicine we might get for that
disease should be different. If we know that genetic difference between
the two of us, the doctor can prescribe for it. That is called
personalized medicine or precision medicine.
Then there is $1.6 billion for the BRAIN Initiative. This includes
groundbreaking research in Alzheimer's, for example. I talked to one
drug manufacturer that has spent more than $1 billion trying to develop
a medicine that will help identify Alzheimer's before it shows symptoms
and then another medicine that will slow the progression of
Alzheimer's. Imagine what could happen in our country if, for the tens
of millions of Americans who are going to suffer with Alzheimer's, we
could find that out before they actually have the symptoms and we can
then slow down the progression of Alzheimer's. Think of the suffering
that would help avoid. Think of the billions of dollars it would save.
This is for that kind of research. Dr. Collins says that during this
next 10 years, he expects that we will be able to identify individuals
at high risk for Alzheimer's before any symptoms appear and provide
them with effective medicines to slow or prevent the disease.
It also includes $500 million for the Food and Drug Administration to
help pay for the extra work we are giving the FDA.
One Senator was on the floor talking about this bill and suggested
this isn't enough money. Let's talk about money just a minute. The
United States spends more on biomedical research and development than
Europe, Japan, and China--almost as much as those three put together.
There has nevertheless been a real need for increased funding for the
kinds of things I just mentioned, but the way we do things here is, we
have authorization bills, which this is, where we decide what our
policies and our programs are going to be. Some of us are on those
committees--like the committee I chair, and of which Senator Murray of
Washington is the ranking Democrat, the Health, Education, Labor, and
Pensions Committee in this case. Then we have Appropriations Committees
that decide how much we can afford to spend on that. We do that
separately.
Last year, this Congress, a Republican majority, I would point out--
but Senator Blunt, chairman of the Appropriations Committee for the
Senate, would quickly give Senator Murray, the ranking Democrat, full
credit--added $2 billion to the National Institutes of Health budget
for 1 year. That means $20 billion over 10 years. This year, the same
Republican Congress, with the cooperation of the Democratic Members,
added another $2 billion to the National Institutes of Health budget.
That is another $20 billion over 10 years. The Cures legislation that I
have just described is another $5 billion. So that--20, 20, and 5--adds
up to 45 billion new dollars approved. The first $20 billion is law,
the second $20 billion has just been approved by the Appropriations
Committees--hopefully it will become law--and the $5 billion I just
described. Now, that is real money.
It is unusual to find an appropriations bill stuck on an
authorization
[[Page S6535]]
bill, but we have done it this time because this is an unusual
opportunity, and we have done it in a way that Speaker Ryan and the
House of Representatives believe is fiscally responsible. That means it
doesn't add any new mandatory spending. That kind of spending has the
budget going through the roof so it doesn't do that. It means it is
paid for. That means we have reduced other spending to pay for it. When
we look at the entire budget, it doesn't add a penny to the entire
budget--we call it the discretionary plus the mandatory part--because
it is paid for by reducing other spending.
We have set priorities, we have done our job, and the Appropriations
Committee has done its job in consecutive years, approving $20 billion
more over 10 years for the National Institutes of Health and will add
another 5 here just to the National Institutes of Health.
Let's talk about the bipartisan nature of this bill. I am going to go
through this fairly quickly, but for those watching, I think it is
important to see this because sometimes when bills are popular--and I
think this one will be popular. Everyone says: Well, that is easy.
Tomorrow, the House of Representatives will vote on the 21st Century
Cures bill. It includes the mental health bill--that I will describe in
just a minute. I think it will be on suspension, which means they
expect a big vote over there. I expect a big vote over here because I
don't expect many Senators would want to vote no on a $1 billion grant
program that will fight opioid abuse in their home State. I don't think
there will be a lot of Senators who want to vote no on more money to
fight cancer and to help the Vice President with the Cancer Moonshot. I
suspect there will be a lot of Senators who want to vote yes to help
the President advance his precision medicine legacy. I know there are
families affected by Alzheimer's all over the country who hope Senators
vote yes on the BRAIN Initiative. I imagine we will get a big vote when
it comes up next Monday and Tuesday, after the House passes it
tomorrow, but as we put this bill together, there was plenty of
controversy, there was plenty of conflict, but virtually everything we
did was bipartisan.
The money I just described is certainly bipartisan--the President's
initiative, the Vice President's initiative, the opioid initiative.
That is bipartisan, but look at the bills we are talking about.
Here is one called the Advanced Targeted Therapies, which allows
researchers to use their own data from previously approved therapies to
help find a faster treatment for serious genetic diseases--Senator
Bennet, Democrat; Senator Warren, Democrat; Senator Burr, Republican;
Senator Hatch, Republican--and it passed by voice vote.
I am very quickly going to go through 19 different bills that are the
core of the 21st Century Cures legislation. They came out of our
committee which has 22 Members, and the largest number of recorded
votes against any one of those 19 bills was two because every single
one of these bills had a Democratic sponsor and a Republican sponsor,
except for one, and that was Senator Murray's bill, and she is the
ranking Democrat on our committee. So don't let anyone suggest that a
bill that has $6.3 billion of appropriations, that include Democratic
priorities and bipartisan priorities, and the core of it is 19 bills of
FDA and NIH reform that has a Democratic sponsor for every single bill
and that was approved by a 22-member committee and only had two
recorded votes against it--was the most that was against it--don't let
anybody say this is not a bipartisan bill. Anyone who says that simply
hasn't spent the time to be involved in the process.
Let's go to the next one.
Burr and Franken, Republican and Democrat, FDA Device Accountability.
It will bring innovative devices like artificial knees and insulin
pumps to patients more quickly by getting rid of unnecessary
regulations.
One of the major things we need to do--and we do it in this bill--is
to bring cures and discoveries through the regulatory process more
quickly and at less cost. All of us are concerned about the price of
drugs. One factor contributing to that cost is that it takes a billion
dollars and 13 or 15 years to take a new discovery through the process.
We would like to shorten that process as long as we can do it in a way
that ensures that it is safe.
The next one is called the Next Generation Researchers Act--Senator
Baldwin, Democrat; Senator Collins, Republican. It improves
opportunities for our young researchers. It was passed by voice vote.
That means there was no objection.
The next one is called the Enhancing Rehabilitation Research at the
National Institutes of Health--Kirk, Republican; Bennet, Democrat;
Hatch, Republican; Murkowski, Republican; Republicans Isakson and
Collins. Enhancing Rehabilitation Research was passed by voice vote.
Neurological Diseases Research. Here we have Isakson and Murphy,
Republican and Democrat, advancing Research for Neurological Diseases.
The next one has do with superbugs and protecting patients. You know
about these. You get an infection, and you take a medicine to treat it,
but the medicine doesn't work because the infection is a superbug. This
bill will clarify that the FDA requires cleaning and validation data
for reusable medical devices. In other words, this will make it less
likely that will be a problem. That is Senator Murray's bill.
Improving Health IT. This is about electronic health records. The
government has spent a huge amount of money on that, over $32 billion,
including hospitals and doctors to adopt electronic medical records. It
is very important to precision medicine, to personalized medicine,
because if you can't use all this data, a doctor is not going to
prescribe something for the Senator from Oklahoma that is different
from something for the Senator from Tennessee.
We found that the electronic medical records system was a mess. We
had six hearings on it, and we worked with the Obama administration
because they could do some things to fix it and we could do some things
to fix it. I thank Secretary Burwell in the Obama administration--I
thank her and Andy Slavitt at CMS for the efforts they have made to do
what they could do. And these are the things that we could do. Senator
Murray was involved, Senator Cassidy, Senator Whitehouse, Senator
Hatch, Senator Bennet. It was a bipartisan effort to reduce physician
documentation burden--electronic health records to make it more
interoperable and to get this system moving again.
Advancing Breakthrough Medical Devices. One of the great successes we
have had in legislation was a few years ago when Senator Bennet and
Senator Burr, among others, introduced a bill and made it law that
brought breakthrough medicines through the Food and Drug Administration
more rapidly. More than 49 have been approved and 464 requests for
breakthrough designation in about 4 or 5 years. We are applying that
same breakthrough strategy to medical devices. Of course, we have
bipartisan support for that.
The Advancing Hope Act. If you are a parent of a child with a rare
disease, such as brain cancer, this increases the opportunity that the
drugs will help.
Medical Electronic Data Technology. We had Senator Bennet, Democrat;
Senator Hatch, Republican.
Medical Countermeasure Innovation Act. This is very important.
Senators Burr and Casey have been real leaders in dealing with medical
countermeasures. These are in case there is a bioterror attack,
anthrax--some kind of man-made or naturally-occurring problem like
that. Are we ready to deal with that? This helps to do that.
There are just a few more. Some will say: Why are you going on for so
long? Because I would like for people to know when it happens that this
Senate is capable of taking a great big, complex subject, and Democrats
and Republicans are capable of working together to produce a result
that deserves a big vote.
The Combination Products Innovation Act. This helps to bring to the
market a products that are made up of medical devices and medicines.
There is a bill by Wicker, Bennet, Collins, Klobuchar, Isakson, and
Franken on Patient Focused Impact Assessment.
There is one to modernize the FDA workforce. Dr. Califf told us that
his biggest problem at the FDA is that he can't hire all the people he
needs to deal with all of the exciting things
[[Page S6536]]
going on. This gives him new authority to do that. Everybody thinks
that would be an important thing to do. It was approved by voice vote.
Advancing Precision Medicine. This is legislation that I introduced
and supported the President's Precision Medicine Initiative, which I
have talked about before.
There is other legislation that went through. The point of all of
this is that 19 different bills are the core of this 21st Century Cures
Act. The most recorded number of votes against this bill was two, and
every single one was sponsored by a Democrat as well as a Republican,
except for one, which was Senator Murray's bill. She is the ranking
Democrat on the committee.
In conclusion, we are fortunate to be able to add to the bill the
Mental Health Reform Act. Actually, we include three mental health
bills, and together they make up the most significant reform of mental
health programs that we have had in more than a decade. I want to give
particular credit to Senator Murphy, Democrat, and to Senator Cassidy,
Republican, for working together through some real landmines to get
this to a place where it can pass the House almost unanimously and
where it will be a part of the bill that we will vote on next week.
I want to thank the majority whip, Senator Cornyn, who also added an
important judicial part to this legislation and helped us navigate some
difficult issues. In other words, these Senators showed that they know
how to legislate. They could have stood up and made a speech. They
could have insisted on doing things exactly their way, but they said to
look for the area where we might agree on 80 percent of the policy and
let's agree that.
This is one of those bills. Look at the number of Republicans and
Democrats who have passed that. Here is the second mental health bill
we are talking about. You can see the number of Senators. I have taken
some time to go through the legislation that will be coming to the
Senate early next week and that will be voted on tomorrow in the House
of Representatives. I do think it likely represents, as the majority
leader has suggested, the most important piece of legislation that we
could act on this year. Because it affects virtually every American
family, Forbes magazine reported that 78 percent of the American people
favored Congress taking action on medical innovation because they have
heard people like Dr. Francis Collins, the head of the National
Institutes of Health, talk about within the next 10 years having a Zika
vaccine and HIV/AIDS vaccine, identifying Alzheimer's before symptoms
appear and slow its progression, an artificial pancreas for those with
diabetes, and a non-addictive type of pain medicine.
These are magnificent opportunities for us. We have strong leadership
at the National Institutes of Health. We have put our money where our
mouth is. It is true that we will have to approve it every year, and it
is true that we had to reduce other spending in order to have this
spending, but that is the way we are supposed to do things.
What we have done is take a bipartisan core of bills; we worked hard
for two years in a bipartisan way and produced a result that had very
few ``no'' votes along the way. It includes Democratic priorities as
well as Republican priorities. It has the avid interest of the
Democratic President of the United States, the Democratic Vice
President of the United States. It is a part of the agenda forward in
health care for the Republican Speaker of the House, and the Republican
majority leader in the Senate says it is the most important bill we are
going to act on.
I would think that would get a big vote tomorrow in the House, and I
would think it deserves a big vote in the U.S. Senate next week. It has
been my privilege to work with Senator Murray and the other members of
the Committee on Health, Education, and Labor to produce the bill.
I yield the floor.
There being no objection, the material was ordered to be printed in
the Record, as follows:
ORGANIZATIONS SUPPORTING 21ST CENTURY CURES
IBM, Premier Healthcare Alliance, American Society of
Clinical Oncology, National Patient Advocate Foundation,
Parent Project Muscular Dystrophy, Alliance of Specialty
Medicine, Advanced Medical Technology Association (AdvaMed),
Association of American Medical Colleges, Association of
Public & Land-Grant Universities/Association of American
Universities, United for Medical Research; Epstein Becker
Green on behalf of: Coalition for CLIA Waiver Reform,
Advanced Medical Technology Association, National Coalition
of STD Directors, Abbott, Alere, Becton Dickinson & Company,
BioFire Diagnostics, ChemBio Diagnostic Systems, Roche
Diagnostics, Sekisui Diagnostics, Spartan Bioscience, TearLab
Corporation.
Coalition of 217 rare disease foundations: AKU Society of
North America, Alpha-1 Foundation, ALS Association,
Alternating Hemiplegia of Childhood Foundation, American
Behcet's Disease Association (ABDA), American Brain Tumor
Association, American Multiple Endocrine Neoplasia Support
(AMEN Support), Association for Frontotemporal Degeneration
(AFTD), Association of Gastrointestinal Motility Disorders,
Inc. (AGMD), Association for Glycogen Storage Disease, Batten
Disease Support and Research Association, BCC Nevus Syndrome
Life Support Network, BRBN Alliance, Children's PKU Network.
Cholangiocarcinoma Foundation, Chromosome Disorder Outreach
Inc., Cicatricial Alopecia Research Foundation, Council For
Bile Acid Deficiency Diseases, CureCADASIL (CADASIL
Association Inc.), CureCMD, Cure HHT, Cutaneous Lymphoma
Foundation, The Desmoid Tumor Research Foundation, Inc.,
Dystonia Advocacy Network, Dystonia Medical Research
Foundation, dystrophic epidermolysis bullosa research
association of America (debra of America), The
Erythromelalgia Association, Everylife Foundation for Rare
Diseases, Foundation for Ichthyosis & Related Skin Types,
Inc., Foundation for Prader-Willi Research, Foundation to
Eradicate Duchenne (FED), Friedreich's Ataxia Research
Alliance (FARA), GBS/CIDP Foundation International, The
Global Foundation for Peroxisomal Disorders, The Guthy-
Jackson Charitable Foundation, Hermansky-Pudlak Syndrome
Network Inc., Histiocytosis Association, HLRCC Family
Alliance, The Huntington's Disease Society of America,
HypoPARAthyroidism Association, Immune Deficiency Foundation,
Indian Organization for Rare Disorders, The International
Advocate for Glycoprotein Storage Diseases, International FOP
Association, International Foundation for CDKL5 Research,
International Myeloma Foundation, International Pemphigus and
Pemphigoid Foundation (IPPF), International WAGR Syndrome
Association, Jack McGovern Coats' Disease Foundation,
Kennedy's Disease Association, LAL Solace, The Life Raft
Group, Lymphangiomatosis & Gorham's Disease Alliance, The
Marfan Foundation, MEBO Research, MitoAction, Moebius
Syndrome Foundation, The Morgan Leary Vaughan Fund.
Mucolipidosis Type IV Foundation, Muscular Dystrophy
Association (MDA), The Myositis Association, National Adrenal
Diseases Foundation, National Alopecia Areata Foundation,
National Ataxia Foundation, National Eosinophilia Myalgia
Syndrome Network, National Lymphedema Network (NLN), National
MPS Society, National Organization for Rare Disorders (NORD),
National PKU Alliance, National Spasmodic Dysphonia
Association, National Tay-Sachs & Allied Diseases
Association, Inc. (NTSAD), NBIA Disorders Association,
NephCure Kidney International, Neuroendocrine Tumor Research
Foundation, Neurofibromatosis Network, The Oley Foundation,
Organic Acidemia Association, Osteogenesis Imperfecta
Foundation, Oxalosis and Hyperoxaluria Foundation, Parent
Project Muscular Dystrophy (PPMD), Parents and Researchers
Interested in Smith-Magenis Syndrome (PRISMS), PKD
Foundation, Prader-Willi Syndrome Association (USA), PRP
Alliance, Pulmonary Hypertension Association, RASopathies
Network USA, Rett Syndrome Research Trust, Scleroderma
Foundation, Spastic Paraplegia Foundation, Sturge-Weber
Foundation, Tarlov Cyst Disease Foundation, Tuberous
Sclerosis Alliance, United Leukodystrophy Foundation, The
United Mitochondrial Disease Foundation, US Hereditary
Angioedema Association, Vasculitis Foundation, VHL Alliance,
Williams Syndrome Association, Wilson Disease Association,
Worldwide Syringomyelia & Chiari Task Force, XLH Network.
Mr. ALEXANDER. I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The bill clerk proceeded to call the roll.
Mr. CORNYN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________