[Congressional Record (Bound Edition), Volume 162 (2016), Part 11]
[Senate]
[Pages 14621-14624]
[From the U.S. 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.

[[Page 14622]]

  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 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

[[Page 14623]]

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 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

[[Page 14624]]

     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.

                          ____________________