[Congressional Record (Bound Edition), Volume 158 (2012), Part 6]
[Senate]
[Pages 7490-7497]
[From the U.S. Government Publishing Office, www.gpo.gov]


  The PRESIDING OFFICER. The Senator from Louisiana.
  Ms. LANDRIEU. Mr. President, I was not here to hear all of my 
colleagues' remarks. I know there is a lot of concern about the end of 
the year and what might happen to try to balance our budget and give us 
a solid platform on which this economy could grow. But one of the 
things that is holding us up is the Republicans' refusal to put any new 
revenues on the table. They have been adamant and wrong and hardheaded 
and stubborn.
  They have been very obstructionist in this way--by not being willing 
to put a penny of new revenue on the table. As a result, we have come 
to a standstill because the income coming into the Federal Treasury to 
support this government is at the lowest level since President 
Eisenhower was President. So they can come to the floor all day long 
and criticize the President, criticize the Democrats, but in the last 2 
years Democrats have put over $2 trillion of cuts and reductions to 
some very important programs on the table.
  Some of us have even been willing to say, yes; we know we have to 
reform Social Security and Medicare and Medicaid. We have also been 
willing to speak those words which are not easy. Yet not one single 
Republican leader, not one on either side, the House or the Senate, not 
one has come to this floor in public. Now, I have heard them say it in 
private. I have been in meetings when they have said it. But not one 
has come to this floor to say: We are willing to put revenues on the 
table so we can match the cuts and move this country forward.
  So I am a little tired of hearing them beat up on either President 
Obama or the Democrats when they are more to blame for the situation we 
are in. The American people are getting tired of it too because they 
can understand it is not 100 percent President Obama's fault. In fact, 
when he took office, the Titanic had already hit the iceberg because 
they had run right smack into it with the economic philosophies and 
policies they had. The ship was already sinking. But all they want to 
do is--either Mitch McConnell or Jon Kyl, one day the Senator from 
Arizona or the Senator from Kentucky--every day come to the floor and 
talk about how it is the President's fault there is no way forward, 
there is no sure path forward, when they are the ones who have put 
boulders in the way every day.
  So I hope the people can see through it. I came to the floor to talk 
about something else, but I am getting a little tired of hearing it 
myself. So I am sure everyone else is as well.
  Again, Democrats have put $2 trillion of cuts before this body, and 
we have implemented some of them already. But we cannot run a 
government on 14 percent of the GDP. The average has been about 20 to 
21 percent. So until they are willing to put some more revenues on the 
table, we are not going to get anywhere, and we are not going to be 
able to extend the tax cuts that cost people money.
  I hope we can do something so we can extend some tax cuts to small 
businesses, which I came to talk about--and you, Mr. President, know 
this well. Instead of giving some of the biggest tax breaks to 
companies that are the biggest in the world and put all of their jobs 
overseas, I wish the Republicans would start talking about tax relief 
to businesses right here at home on Main Street. That is what I want to 
talk about today.
  (The further remarks of Ms. Landrieu are printed in today's Record 
under ``Morning Business.'')
  Ms. LANDRIEU. I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. WYDEN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. WYDEN. Mr. President, I ask unanimous consent to speak as in 
morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                              The Internet

  Mr. WYDEN. Mr. President, I believe the development of the Internet, 
its networks, and the digital economy are one of the great achievements 
of our age.
  The Internet links humanity together, facilitating economic growth, 
bringing education and health resources to remote regions, reshaping 
societies and advancing human rights.
  While networks foster innovation, job creation, and political and 
social progress, networks can also be used by actors with nefarious 
motives. It is in our national interest to deter, detect, and destroy 
real and viable cyber threats, to protect Americans and preserve the 
benefits of the Internet. Americans must not be afraid to go online.
  The Internet works not just because it is open to all but because it 
is founded on the principle of trust. Users trust that their browsers 
are visiting real Web sites, not replicated ones. Internet commerce 
succeeds because people trust that their transactions are private and 
their financial information won't be shared with others. People trust 
the Internet because they believe their service providers work for 
them, not for their advertisers, not for scammers, and not for the 
government.
  Congress's effort to develop a comprehensive approach to 
cybersecurity must not erode that trust. When Americans go online to 
consume digital services and goods, they must believe and know with 
some certainty that their privacy is adequately protected. The content 
that Americans consume must be at least as private as their library 
records, their video rentals, and book purchases in the brick-and-
mortar world. Our law enforcement and intelligence agencies should not 
be free to monitor and catalog the speech of Americans just because it 
is online.
  But the legislation passed by the other body, known as CISPA, would 
erode that trust. As an attempt to protect our networks from real cyber 
threats, CISPA is an example of what not to do. CISPA repeals important 
provisions of existing electronic surveillance laws that have been on 
the books for years, without instituting corresponding privacy, 
confidentiality, and civil liberty safeguards. It creates uncertainty 
in place of trust, it erodes statutory and constitutional civil rights 
protections, and it creates a surveillance regime in place of the 
targeted, nimble, cybersecurity program that is needed to truly protect 
our Nation.
  Unfortunately, S. 2105, the bill before the Senate, shares some of 
these defects. Currently, Internet services and service providers have 
agreements with their customers that allow them to police and protect 
their networks and users. Rather than simply allowing these Internet 
companies to share information on users who violate their contracts and 
pose a security threat, the House and Senate proposals regrettably 
authorize a broad-based information-sharing regime that can operate 
with impunity. This would allow the personal data of individual 
Americans to be shared across a multitude of bureaucratic, military, 
and law enforcement agencies. This would take place

[[Page 7491]]

regardless of the privacy agreements individual Americans have with 
their Internet service providers.
  In fact, both the House and Senate bills subordinate all existing 
privacy rules and constitutional principles to the poorly defined 
interests of what is called cybersecurity.
  These bills would allow law enforcement agencies to mine Internet 
users' personal data for evidence of acts entirely unrelated to 
cybersecurity. More than that, they would allow law enforcement to look 
for evidence of future crimes, opening the door to a dystopian world 
where law enforcement evaluates your Internet activities for the 
potential that you might commit a crime.
  In establishing this massive new regime, these bills fail to create 
the necessary incentives for operators of critical networks to keep 
their networks secure.
  It is a fundamental principle of cybersecurity policy that any 
network whose failure could result in a loss of life or significant 
property should be physically isolated from the Internet. 
Unfortunately, many of our critical network operators have violated 
this principle in order to save money or streamline operations. This 
sort of gross negligence ought to be the first target in any 
cybersecurity program--not the privacy of individual Americans.
  Congress could target this behavior with yet one more rule book and 
one more bureaucracy, creating a cybersecurity contractor full 
employment program. I am not, however, convinced this is a problem that 
requires that kind of solution.
  At the same time, Congress should not allow our critical network 
operators to ignore best practices with impunity. It is vital they 
understand that any liability for a preventable cyber attack is their 
responsibility. There is not going to be a governmental bailout after 
the fact in the cybersecurity area. Shareholders and boards of 
directors must be vigilant and understand the risks to their 
investments. Executives must understand that ignoring critical cyber 
threats in the interest of cost savings and convenience will leave them 
personally exposed.
  Internet providers and backbone operators clearly have a role in this 
fight. When they detect abnormal network activity or have a user 
violating their contract in a way that constitutes a cyber threat, they 
can and should inform our cyber defense officials. If it is necessary 
to grant them immunity to share this kind of information, the Congress 
could grant it--narrowly and with careful consideration.
  Mr. President, there would be bipartisan support for the proposition 
that the Federal Government also has a significant role that does not 
necessarily require billing taxpayers for legions of private 
cybersecurity contractors. The Department of Defense, the Department of 
National Intelligence, Homeland Security, and the Justice Department--
four major parts of our government--all have cybersecurity specialists. 
The Congress ought to be promoting the cyber capabilities of these 
agencies and providing the resources that are needed to protect these 
networks. These Federal agencies should do a better job of consulting 
the private Internet companies to better understand the attacks that 
are occurring every day across the net.
  Some of these steps may require legislation, but many can be carried 
out by responsible actors in the public and private sector without 
waiting for the Congress to act. However, the legislation before the 
Senate and the cybersecurity legislation that passed the other body 
leads our country away from the kind of commonsense approach to 
cybersecurity I have outlined this afternoon.
  As they stand, these bills are an overreaction to a legitimate and 
understandable fear. The American people are going to respond by 
limiting their online activities. That would be a recipe to stifle 
speech, innovation, job creation, and social progress. I believe these 
bills will encourage the development of an industry that profits from 
fear and whose currency is Americans' private data. These bills create 
a cyber industrial complex that has an interest in preserving the 
problem to which it is the solution.
  In terms of the process, the Senate ought to proceed in a way that is 
as open and collaborative as the Internet the Congress seeks to promote 
and protect. On substance, any cybersecurity bill must contain specific 
and clear descriptions of what types of data and when such data can be 
captured, with whom it can be shared, and under what circumstances. 
Anything not specifically covered ought to remain private. Privacy in 
the cybersecurity arena should be the default not the exception. Legal 
immunity to corporations that share information should be the exception 
not the rule and void if privacy protections or contracts are 
disregarded.
  The Congress and the public must have the ability to know how any 
cybersecurity program that is established is to be implemented. That 
means routine public and unclassified reports and hearings to examine 
whether there were any unintended privacy or civil liberty impacts 
caused by the program. No secret law, Mr. President.
  Bad Internet policy is increasingly premised on false choices. 
Earlier this year, during the consideration of the Protect IP Act and 
the Stop Online Piracy Act, the Congress was told again it had a false 
choice. The Congress was told it either could protect intellectual 
property or it could protect the integrity of the Internet. This was a 
false choice. I and others said so at the time because achieving one 
should not and does not require sacrificing the other.
  Now the Congress is being asked once again to make a false choice--a 
choice between cybersecurity and privacy--and I don't think these two 
are mutually exclusive. I think we can have both. Our job is to write a 
cybersecurity bill that protects America's security and the fundamental 
right to privacy of our people. There is no sound policy reason to 
sacrifice the privacy rights of law-abiding American citizens in the 
name of cybersecurity. It is my intent to fight any legislation that 
would force Members of the Senate to make that choice.
  Mr. President, with that I yield the floor.
  The PRESIDING OFFICER. The Senator from Indiana.
  Mr. COATS. Mr. President, I rise today to talk about the Food and 
Drug Administration Safety and Innovation Act. I believe we are going 
to have a cloture vote on this bill tonight, and I am pleased that all 
early indications are it will pass tonight and we will move forward on 
this bill.
  There has been considerable time spent drafting this legislation. It 
gained bipartisan support both in House and Senate committees, and it 
is moving through what I would call a regular process. We haven't seen 
too much of that in the last year and a half or so. This is the regular 
process. For those who say Congress can't get anything done, hopefully, 
with passage of this bill we will take a very significant step forward 
in terms of being able to provide and bring to patients, doctors, 
administrators, and others across the Nation new drugs, new treatments, 
and new medical devices that can ensure better health, prevent 
potential terminal situations, and provide better drug availability and 
device availability. So I think it is very important that this 
legislation goes forward.
  I am pleased we have gotten to this point on a bipartisan basis. I 
think Senators Harkin and Enzi deserve commendation for their work in 
the Senate, and those in the House as well for bringing the bill along 
on a parallel track.
  The whole idea of this legislation is to continue to provide the 
safest, most effective and most efficient drugs and devices for 
American citizens and people around the world. These are two very 
important industries in which the United States has had the leading 
edge as providers and we don't want to lose that. It has meant a lot 
for our economy, and it has meant a lot of jobs for Americans. I think 
the passage of this bill will continue what has been a remarkable 
nearly three decades' worth of innovation that has taken place both in 
the biopharmaceutical industry as well as the medical device industry.

[[Page 7492]]

  Part of this bill deals with drug shortages. I have talked to a 
number of doctors--my staff has been traveling the State talking to 
medical providers--and there is an alarming number of drug shortages in 
critical drugs, particularly those designed to deal with more rare 
instances of health problems and yet, obviously, important to those 
people who are suffering from those incidences of disease or health 
threats.
  It was reported to me that last year FDA received a record number of 
drug shortage reports--more than 250--including critical drugs used in 
surgery, emergency care, and oncology. The problem continues today, but 
this bill addresses that and, hopefully, will move us forward 
significantly in terms of dealing with this current problem.
  In Fort Wayne--my hometown in Indiana--Parkview Health's pharmacy 
director said nearly 80 percent of hospitals consistently face 
shortages in drugs needed for emergencies, including cardiac and 
diabetic prescriptions. This bill incorporates significant reporting 
requirements to the FDA that I hope will help mitigate this critical 
problem. I think we are going to need to figure out ways to further 
address this, but this can be an important first step.
  The whole concept has been somewhat unique in the Federal Government; 
that is, the makers of the products essentially pay a fee to a 
regulatory agency for the regulatory agency to conduct the work 
necessary to gain approval to sell their drugs on the market. We have 
had a situation which is sort of a cornucopia of new innovations in 
drugs and medical devices. Yet they have been delayed by the 
bureaucracy or the inability of the FDA to move in an efficient, 
effective way to run this through the process.
  The biopharmaceutical industry has basically said: Look, we are 
willing to put up between $3.5 billion and $4 billion in new user 
fees--I believe it is over a 5-year period of time--which will account 
for nearly 60 percent of the funding designated by the Center for Drug 
Evaluation and Research. In exchange for putting up those fees, the FDA 
has agreed to new performance goals and process improvements that will 
reduce the time it takes drugs to reach the market.
  So the key is to provide the funds necessary to hire the right people 
and put the right procedures in place to expedite the study and 
approval of safe, effective, efficient drugs that have been sent to the 
FDA for approval so we can get them into the market. Of course, the 
ultimate goal is to get them not only into the market but use them to 
provide health and safety benefits for the American people.
  The Medical Device User Fee Act is also part of this. In Indiana, we 
have not only a very large biopharmaceutical company and a number of 
affiliated companies, we also have a vibrant and dynamic medical device 
industry. That industry employs over 20,000 Hoosiers directly and many 
more indirectly with good-paying jobs. Many of these companies are 
right on the leading edge of new innovation and new developments. So 
included in the legislation that we will be voting on is a 5-year 
agreement known as the Medical Device User Fee Act that improves the 
regulatory pathway for medical devices.
  This is the medical device equivalent of the pharmaceutical user fee. 
Device companies have worked with the FDA, again in an agreement where 
each side contributes. The medical device manufacturers will contribute 
user fees to go to the FDA that can be used to streamline--without 
compromising safety in any way--the regulatory process so the approvals 
can be made.
  Why is this important? Well, it is important not only to getting 
these products into the marketplace so they can be used to safely 
improve the health of American citizens, but this is a dynamic export 
industry where America has been the leading exporter of medical 
devices. I have heard from so many medical device manufacturers 
throughout Indiana that they are faced with the dilemma of having to 
potentially think about moving overseas simply because of the delays 
and the time lapse that exists for approval. They can manufacture these 
products overseas and get approval overseas and sell them on a 
worldwide basis much more quickly, but they do not want to do that. The 
United States is their home and they want to produce here, but they 
have to compete with their competitors across the waters that are 
subjected to fewer delays in implementing approvals.
  To counter that, we simply want to use this medical device user fee 
in a way that will help the FDA's review process and eliminate these 
unnecessary delays, unpredictability, and inconsistency of past 
practices.
  I do want to thank the FDA for paying significant attention to our 
device users by coming to Indiana and listening to them--a forum that I 
convened. There has been interaction back and forth, whether it is FDA 
traveling to Indiana or device manufacturers traveling here to 
Washington. I am pleased that this bill contains some items that are 
the result of all those negotiations and all those exchanges between 
the two.
  Let me mention one last thing before closing, and that is the medical 
device tax, which is not part of this bill. To pay for the so-called 
affordable health care law, the administration included a 2.3-percent 
tax on medical devices, which will begin in 2013. That tax essentially 
was imposed on an industry that is paying its full share of taxes, 
contributing to the user fee, and yet it was slapped on as a way to pay 
for the costly health care bill. That has an enormous impact over a 
period of time on these device manufacturers and jeopardizes 
manufacturers' ability to remain based here in the United States rather 
than looking overseas.
  There are a number of States in addition to Indiana--and my colleague 
from Minnesota is waiting to speak, and her State is also a major 
manufacturer and innovator of medical devices. California, Florida, 
Illinois, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, 
Texas, and Wisconsin will all suffer potential job losses if this 
medical device tax is imposed.
  We are not taking it up in this bill so as not to try to derail the 
bill. I understand an agreement has been made that it would be set 
aside. I know Senator Hatch, on our side, is looking for an opportunity 
to bring that up in another vehicle, and I want to support that. I 
encourage my colleagues to take a look at the impact of that fee on our 
ability as a nation to be the leader in innovation and export of 
medical devices.
  I thank Senators Harkin and Enzi for shepherding the Food and Drug 
Administration Safety and Innovation Act through the committee. I 
believe this legislation will help improve patients' access to new 
medical technology, and it will protect American jobs and improve the 
FDA so that America can remain a global leader in biomedical 
innovation. I encourage my colleagues in the Senate to support this 
important legislation.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Minnesota.
  Ms. KLOBUCHAR. Mr. President, I thank the Senator from Indiana for 
his words.
  We both are from States that have a lot of jobs involved in medical 
devices, and, in fact, this bill is something we worked on very hard. I 
am the cochair of the medical device caucus in the Senate. This has 
been our top priority, to try to move those FDA rules along, and this 
bill does that. It is an agreement--a rare agreement--between 
government and industry, which is something both parties want. We would 
like to move those approvals along for the patients, long-suffering 
patients who should have access to medical devices, and then also for 
the industry, where we have seen way too much venture capital money go 
to places such as Europe simply because that process moves faster. So 
this is a very good bill, and I am so pleased we have bipartisan 
support.
  I see that the Senator from Wyoming, Mr. Enzi, has come into the 
Chamber, and both he and Senator Harkin deserve a lot of praise.
  I wish to focus today on one piece of this bill, something I have 
worked very

[[Page 7493]]

hard on, and it really came out of things I heard in my State, things I 
heard from pharmacists literally 2 years ago, things I have heard from 
patients. I got together with our staff. I see that our legislative 
director, Rose Baumann, and Andrew Hu, who did a lot of work on this 
bill, are here today. We went and talked to all kinds of people 
involved. We talked to pharmaceutical companies to try to figure out 
what was going wrong with drug shortages; we talked to the people who 
were suffering the most--the patients; we talked to the pharmacists, 
and we said: What would work here? And the FDA told us that, in fact, 
when they did get early notification from pharmaceutical companies that 
there was going to be some kind of shortage, it helped. They were able 
to avert that shortage. They have done it successfully over 100 times, 
and they have done it many times with some key drugs. And the earlier 
notice they have, the better it is for everyone because they can, in 
fact, then avert the drug shortage, and that is what this is about.
  I will tell you that, for me, this whole bill and this whole 
provision really comes down to a little boy named Axel Zirbes, a young 
boy with bright eyes and a big smile. Because of leukemia, this little 
boy, when I saw him, had no hair on his head. He and his family were 
thrown into a panic about 1 year ago when they learned that an 
essential drug--cytarabine--was in short supply and might not be 
available for their son, who they had just found out was diagnosed with 
leukemia and was supposed to start treatment, and the doctor says: You 
know what, we don't know if you should start it--you should start it 
immediately, but we don't have this critical cancer drug, this critical 
leukemia drug.
  They decided they would take Axel to Canada, where the drug was 
readily available, and just when they were making those plans to go 
there, they found out that some of the drug had been located and that 
Axel could come in for his treatments. Well, that should never have 
happened, not in the United States of America, not to a family of a 
little 4-year-old boy, both parents working hard to make sure their 
child could have health care and then this happens. It makes no sense.
  There is the story of Mary McHugh Morrison, who joined me at a forum 
I held on this topic in Edina, MN. Mary is a woman whose cancer had, 
unfortunately, returned after a shortage of Doxil. That is a 
chemotherapy drug that had kept her ovarian cancer at bay. In fact, 
this shortage interrupted her chemotherapy regimen. Mary struggled to 
find remaining vials of Doxil and then struggled with the ethical 
dilemmas of using the drug she found when others would not be able to 
use it. She literally talked at the forum about how she had personally 
called people, used connections, tried to find those vials, and she 
realized that when she got those drugs, other people wouldn't have 
them.
  Again, this shouldn't be happening in the United States of America. 
She shared her experience with us. And because of a few delays in 
treatment, Mary's doctor told her that her tumor had, unfortunately, 
returned and that she was then no longer responding to that drug. This 
past February, CT scans, unfortunately, showed that Mary's tumor size 
had doubled. She was immediately accepted into a clinical trial at the 
Mayo Clinic and began treatment. Fortunately, she is so far responding 
well and her health is improving.
  These shortages are happening all over this country. Every single 
Senator in this Chamber has heard about one of them. You heard Senator 
Coats from Indiana talking about what he had heard. So the fact that we 
heard this first in Minnesota I don't think is any surprise. We have an 
active State. We have people who believe you can still make a 
difference. We have pharmacists who are on the front line every day, 
and they came to us to get this bill introduced. We heard from 
emergency medical responders, who have told me that shortages have made 
it difficult to stock lifesaving drugs in their ambulances. I have 
listened to stories from parents whose children rely on drugs to help 
maintain their focus at school. I have seen firsthand how doctors and 
pharmacists have had to struggle to keep their patients alive as they 
look for these drugs.
  These shortages have had significant impact on these patients' 
quality of life, oftentimes forcing them to pay hundreds more for 
expensive alternatives or risking their professional careers to adjust 
for their diseases and spending hours and days just trying to find a 
way to fill a prescription.
  When we are dealing with so many costs and resource issues with 
health care, the last we want is for doctors and nurses and pharmacists 
to be wasting away hours trying to find drugs and then ultimately, in 
most cases, finding them, but this is no way to run a railroad. Across 
the country, hospitals, physicians, and pharmacists are confronting 
unprecedented shortages of these drugs.
  So those are the stories, but here are the numbers.
  The number of drug shortages has more than tripled over the last 6 
years, jumping from 61 drug products--remember, there are thousands of 
shortages, but this is 61 different drug products in 2005 to more than 
200 drug product shortages in 2011.
  A survey by the American Hospital Association found that virtually 
every hospital in the United States has experienced shortages of 
critical drugs in the past 6 months. More than 80 percent reported 
delays in patient treatment due to shortages.
  For some of these drugs, no substitutes are available or, if they 
are, they are less effective and may involve greater risk of adverse 
side effects. The chance of medical errors also rises as providers are 
forced to use second- or third-tier drugs that they are less familiar 
with using.
  A survey conducted by the American Hospital Association showed that 
nearly 100 percent of their hospitals experienced a shortage--100 
percent. Another survey conducted by Premier Health System showed that 
89 percent of its hospitals and pharmacists experienced shortages that 
may have caused a medication safety issue or an error in patient care.
  It is clear that there are a large number of overlapping factors that 
have resulted in these unprecedented shortages. Experts cite a number 
of factors: market consolidation, poor business incentives, 
manufacturing problems, production delays, unexpected increases in 
demand for a drug, inability to procure raw materials, and even the 
influence of the gray market. Literally, people are trying to make 
money off of this now. They hear there is a shortage, and they buy up 
the supply and then sell it at a higher price. Financial decisions in 
the pharmaceutical industry are also a major factor. Many of these 
medications are in short supply because the companies have simply 
stopped production. They decided it didn't work for their profits to 
keep producing them. Mergers in the drug industry have narrowed the 
focus of product lines. As a result, some products are discontinued or 
production is moved to different sites, leading to delays. When drugs 
are made by only a few companies, a decision by any one drug company 
can have a large impact. That would make sense.
  To help correct a poor market environment or to prevent gray market 
drugs from contaminating our medication supply chain, we must address 
the drug shortage problem at its root. Last year I introduced the 
Preserving Access to Life-Saving Medications Act with Senator Bob 
Casey. We also have the support of Senator Collins and others. This is 
a bipartisan bill that would require drug manufacturers to provide 
early notification to the FDA whenever there is a factor that may lead 
to a shortage. We also had support from the Presiding Officer, as well 
as Senator Blumenthal of Connecticut and many other people from across 
the Senate.
  This bill will help the FDA take the lead in working with pharmacy 
groups, drug manufacturers, and health care providers to better prepare 
for impending shortages, more effectively manage shortages when they 
occur, and minimize their impact on patient care. And

[[Page 7494]]

that is why I am pleased that the early notification provision from my 
bill is included in the Food and Drug Administration Safety and 
Innovation Act, the one that Senator Coats and I were just discussing 
and that we are debating today.
  I thank Senator Harkin and Senator Enzi for their leadership on the 
HELP Committee in bringing this legislation forward and including my 
provision. In a bipartisan manner, the HELP Committee brought together 
several working groups to address a wide range of issues, from medical 
device innovation to drug shortages. In the drug shortage working 
group, we spoke with experts from patient groups, providers, drug 
manufacturers, and the FDA to try to find an appropriate solution.
  Ultimately, the legislation now includes many policies that I believe 
will help address shortages. In addition to the early-notification 
requirement, again, the FDA is going to be able to look in our own 
country, and if they can't find something in our own country they can 
look at safe locations overseas. You simply can't keep these patients 
waiting for their treatment.
  In addition, the bill directs the FDA to improve communications 
inside and outside its walls, requires more robust record-keeping and 
reporting, and asks for studies on how pricing factors impact drug 
shortages.
  I believe this bill represents a step forward in our ability to 
prevent these shortages--a strong step forward. With manufacturers 
providing early notification, the FDA's drug shortage team can then 
appropriately use their tools to prevent shortages from happening. As I 
mentioned, in the last 2 years, the FDA, with more information, has 
successfully prevented nearly 200 drug shortages. Imagine the hundreds 
of thousands and millions of patients that has helped. So we need to 
extend it. That is what this bill does.
  One such example is the recent shortage of methotrexate. This is a 
very common drug used in chemotherapy to treat cancers such as 
leukemia. For me, the most devastating part about the shortage is that 
I heard about it from the Zirbes family--the family of this little 4-
year-old boy who had to suffer through the shortage of cytarabine 
earlier. Only this time, the FDA took quick action once it learned of 
this potential shortage and worked with other manufacturers to boost 
production and helped stop the bleeding before this became a major 
crisis. That is an example of what can happen with early notification. 
They are allowed to then go to other manufacturers and find the people 
who can make the drug to get it to the hospitals, to get it to the 
patients. And today, with strong cooperation between the FDA and 
pharmaceutical manufacturers, methotrexate is available for patients 
who rely on it just like that little 4-year-old boy Axel Zirbes.
  Together with Senator Casey, we were able to work with the HELP 
Committee and in a bipartisan manner come up with a solution that would 
give the FDA more tools to prevent drug shortages and ensure patients 
such as Axel or Mary have the drugs they need when they need them. 
Recent announcements by the FDA have proven that early notification and 
cooperation with manufacturers have helped reduce the number of drug 
shortages by over half. There have been 42 newly scarce drugs so far 
this year, compared to 90 in the same period last year. That is 
progress.
  While I applaud the FDA in their efforts to address this crisis, 42 
drugs in shortage is still 42 too many for me. That is why it is so 
important to pass this provision and give the FDA the tools it needs to 
get the number down to zero.
  I understand that early notification requirements may be a short-term 
solution to a long-term problem. That is why I will continue to work 
with my Senate colleagues to come up with a broad permanent solution, 
one that includes methods to address the root causes of drug shortages.
  It has been a long road to get to this point. Nearly 2 years ago I 
began hearing about this drug shortage issue, and when I first talked 
about it some of the doctors said: Really? I haven't heard about it. 
Now, 2 years later, they have all heard about it. That is why we 
introduced the Preserving Access to Lifesaving Medication Act. That is 
why we came together to get an agreement in this legislation. That is 
why the President issued an Executive order that pushed for more 
voluntary notifications from manufacturers, and the FDA released an 
interim final rule that broadened the scope of the current notification 
requirement. That is why it is so important that we pass this 
legislation.
  Patients such as Axel or Mary should not have to be burdened with the 
added stress and worry about whether they are going to have enough 
medication to get through their next treatment. They have enough on 
their minds. Let's get this done. It is a great example of people 
working across the aisle. When they heard something from their 
constituents, they were willing to listen and to put this bill 
together. Me, I would like to have gotten it done 2 years ago, but 
later is better than never. We can get it done this week.
  Mr. President, I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant bill clerk proceeded to call the roll.
  Mr. HARKIN. Mr. President, I ask unanimous consent the order for the 
quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Blumenthal). Without objection, it is so 
ordered.
  Mr. HARKIN. Mr. President, after many months of bipartisan 
negotiation, the Senate will proceed this evening to vote on the motion 
to proceed to consideration of the Food and Drug Administration Safety 
and Innovation Act of 2012. I hope it will receive an overwhelming vote 
so we can move ahead with it and dispense with the bill on the floor 
this week. This bill is the product of excellent bipartisan 
collaboration on the Health, Education, Labor, and Pensions Committee 
which I chair. All Senators on the committee have been involved. Going 
back almost a year, we set up working groups. Different Senators had 
different interests in different parts of the bill. They and their 
staffs on both sides were invited, Republican and Democrat, to be 
involved in those working groups to put this bill together.
  The bill passed overwhelmingly out of our committee--actually by 
voice vote, with only two reserving their ``no'' votes. So it had 
overwhelming support on both sides in our committee.
  This bill, of course, reauthorizes important FDA user fee agreements. 
It modernizes the FDA's medical product authority to help boost 
American innovation and ensure patients have access to the therapies 
they need. The backbone of this legislation is the user fee agreements 
that FDA has negotiated with industry. We must remember that a sizable 
part of FDA's budget comes from user fees that the industry agrees to 
pay, that allows the FDA to hire the personnel and get the equipment 
they need to more quickly review product applications. We need to 
reauthorize this bill to implement those agreements if we want to keep 
the FDA running at full steam, which is critical to preserving jobs at 
both the agency and in industry, and to ensuring that FDA has the 
resources to get safe medical products to patients quickly. Again, 
these agreements affect all of us by helping to maintain and create 
jobs in our home States. For example, in my own State of Iowa, these 
agreements will support our bioscience sector which is growing and is 
increasing employment in our State. Implementation of these agreements 
will continue to foster biomedical innovation and job growth throughout 
our country.
  The bill before us reauthorizes the prescription drug user fee 
agreement, which is known in the nomenclature as PDUFA. The medical 
device user fee agreement is known as MDUFA. These will continue and 
improve the agency's ability to speed market access to both drugs and 
medical devices while ensuring patient safety.
  We have a new part of the bill called the generic drug user fee 
agreement, which is expected to slash review times to a third of 
current levels--from 30 months to 10 months--and will improve the speed 
with which generic products

[[Page 7495]]

are made available to patients. This will generate significant savings 
in our health care system. In the last decade, from 2001 to 2010, it 
saved the U.S. health care system more than $931 billion.
  This agreement will ensure we continue to see those savings and that 
patients will have access to cheaper drugs when they need them. It also 
obviously means taxpayers will be saving money because many of these 
drugs come through both Medicaid and Medicare. By having generic drugs 
available more rapidly than they have been in the past, it will mean 
taxpayers will save a significant amount of money in the future.
  This bill also authorizes another new section, the biosimilars user 
fee agreement, which will further spur innovation by shepherding the 
biologic industry as it matures.
  These agreements are vital to FDA's ability to do its job, to the 
medical products industry's ability to survive some very challenging 
economic times, but, most importantly, to the patients who are the 
primary beneficiaries of this longstanding and valuable collaboration 
between FDA and industry. As I said, after months of negotiations with 
our staffs, with FDA, with the industry, and with consumer groups, I 
think they have crafted win-win agreements that they stand behind. So 
industry is behind this bill, the FDA is behind this bill, and hundreds 
of groups throughout this country have been supporting it. They have 
done their job and now it is time for us to do ours.
  It is absolutely imperative that we authorize these user fee 
agreements before they expire. If we don't, the FDA will lose about 60 
percent of its drug center budget and 20 percent of its device center 
budget. It will have to lay off nearly 2,000 employees, which would 
grind the drug and device approval processes to an unacceptably slow 
pace, with devastating consequences for patients, jobs, for the 
industry, and further innovations both in drugs and devices. We cannot 
let that happen, and that is why for more than a year we have worked 
very closely in our committee.
  I see the ranking member, Senator Enzi, is here. We and our staffs 
have worked together. As I said, we set up these working groups in our 
committee. They were not divided along any kind of partisan lines. They 
were set up along interest groups so we had both Democratic and 
Republican Senators and their staffs working together for years.
  I am sure I can speak for Senator Enzi when I say all along our aim 
has been to ensure that in addition to the user fee agreements and all 
the other things, this is the product of a consensus, bipartisan, 
policymaking process that we have had for the last year. It was an open 
and transparent process. We had input not only from our members but 
other Senators were also involved as they had interest in this bill. 
Throughout negotiations on this bill the stakeholder community-at-large 
was involved.
  Again, I can assure everyone that this legislation benefited greatly 
from all of the diverse input from Senators on both sides, industry 
stakeholders, consumer groups, and patient groups. It is a result of 
concerted efforts to define our common interests, and I believe these 
efforts will directly benefit patients and the U.S. biomedical 
industry.
  Very briefly, I want to say as a broad stroke that this bill 
authorizes key user fee agreements for both drugs and medical devices. 
It streamlines the device approval process while again enhancing 
patient protections.
  We do one other thing. We modernize the FDA's global drug supply 
chain authority so we have a better handle on and better information 
and knowledge of where our products are coming from. Of the drugs 
manufactured in this country, 80 percent of the ingredients come from 
abroad. In the past we have not had a tight handle on where they were 
coming from and what kind of manufacturing processes were involved. 
This bill closes that up. It gives the FDA much better authority over 
that and much better input from where the drugs come from to make sure 
they follow good manufacturing practices. It spurs innovation and 
incentivizes drug development for life-threatening conditions.
  We reauthorized the pediatric trial program and improved it so we 
have specific trial programs for pediatric drugs. Children are not just 
small adults. What may work for an adult in terms of a drug, we don't 
just cut the drug in half and give it to a child. Sometimes it takes 
specialized, specific kinds of drugs for children that are not 
something an adult gets. So this reauthorizes and improves those trials 
for children.
  Senator Enzi and I and others in our committee wanted to do something 
about preventing and mitigating drug shortages, so we have provisions 
in this bill that will do that and help prevent and mitigate these drug 
shortages by making sure the FDA gets timely information from 
manufacturers if there is going to be any interruption at all in the 
supply chain. Also I believe this bill increases FDA's accountability 
and transparency.
  That is sort of a broad-brush stroke of what is in this bill. I will 
be over in the next day perhaps getting into some more of the 
specifics. It is imperative that we keep pace with and adapt to 
technological and scientific advances. Things move very rapidly in this 
area and we want to make sure we get the drugs and devices approved as 
quickly as possible, but always with keeping patient safety foremost. 
That is the single most important aspect, to make sure that patient 
protections will remain key. Keeping pace with the biomedical landscape 
that changes so rapidly is the aim of this bill, to ensure the drugs 
coming from abroad are safe, and to take appropriate measures to 
protect our patients.
  I believe we have a good compromise. Neither Democrats nor 
Republicans got everything they wanted in this bill. As I have said 
before, I didn't get all of what I wanted in this bill. I am sure 
others didn't either, but that is the process of a consensus. And where 
we could not achieve consensus, we didn't allow those differences to 
distract us from the important goal of producing a bill that everyone 
could support.
  Again, it is a true bipartisan bill that is broadly supported by the 
patient groups and industry. I have letters from over 100 groups 
outlining their support. To name a few: the Pew Charitable Trust, 
Consumers Union, the Pharmaceutical Manufacturers Association, the 
Generic Pharmaceutical Industry, the Biotech Industry Organization, 
BIO, the American Academy of Pediatrics, Advanced Medical Technology 
Association, American Foundation for the Blind, and many more. Those 
are just a sampling of over 100 groups.
  Mr. President, I ask unanimous consent that the list of those groups 
be printed in the Record at the conclusion of my remarks.
  Mr. HARKIN. We are expecting that there will probably be some 
amendments to this bill, and that is fine. That is the way the Senate 
should operate. We expect all amendments to this bill will be relevant 
to the bill. I hope Senators on both sides of the aisle who want to see 
this bill passed expeditiously would keep that in mind. If there is a 
relevant amendment and Senators feel they want to bring that up, that 
is fine. That is the way the Senate should operate.
  I hope nonrelevant amendments which have nothing to do with the bill 
will not be promoted on the Senate floor. That would only slow the bill 
down and put us into some untenable position on the Senate floor in 
terms of getting this bill expeditiously done.
  We cannot allow unrelated, partisan disagreements or Presidential-
election year politics to interfere with this bill and keep us from 
completing our job. So amendments that are offered must be relevant to 
the bill, and we must pass it now.
  The clock is ticking. Everything ends by the end of this summer. We 
are out of here in August. We have the 4th of July break and Memorial 
Day break coming up. In order for us to go to conference with the House 
and work out whatever differences we may have and get this back here so 
we can finish it by late June or early July--I hope we

[[Page 7496]]

could even finish this by late June so there would not be any 
disruptions at all in the FDA and their planning for the future or in 
the industry itself.
  I urge my colleagues to join in the bipartisan spirit of cooperation 
that we have witnessed in the HELP Committee over the last year. Let us 
come together to pass this legislation that is of critical importance 
to the American people.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

      Support for Provisions in the FDA Safety and Innovation Act

       A. Philip Randolph Institute; Ablitech, Inc.; Academy of 
     General Dentistry; Academy of Managed Care Pharmacy; Action 
     Aids; Action CF; Advanced Medical Technology Association; 
     AFL-CIO, Maryland and DC Chapter; AIDS Alliance for Children, 
     Youth, and Families; AIDS Delaware; AIDS Foundation of 
     Chicago; Alder Health; Alexion Pharmaceuticals; Allegheny 
     Conference of Community Development; Alliance of AIDS 
     Services--Carolina; Alzheimer's Association--Capital of Texas 
     Chapter; Alzheimer's Association--Indiana Chapter; 
     Alzheimer's Association; American Academy of Child and 
     Adolescent Psychiatry; American Academy of Dermatology 
     Association.
       American Academy of Emergency Medicine; American Academy of 
     Emergency Medicine Residential and Students Association; 
     American Academy of Pediatric Dentistry; American Academy of 
     Pediatrics; American Academy of Periodontology; American 
     Association of Nurse Anesthetists; American Association of 
     Oral and Maxillofacial Surgeons; American Association of 
     Women Dentists; American Cancer Society Cancer Action 
     Network, Colorado Chapter; American Cancer Society, Delaware 
     Chapter; American Cancer Society, South-Atlantic Division; 
     American College of Clinical Pharmacy; American College of 
     Emergency Physicians; American College of Gastroenterology; 
     American Council of the Blind; American Dental Association; 
     American Foundation for the Blind; American Hospital 
     Association; American Liver Foundation--Allegheny Division; 
     American Medical Association.
       American Pediatric Society; American Pharmacists 
     Association; American Printing House for the Blind; American 
     Psychiatric Association; American Public Health Association, 
     Delaware Chapter; American Society for Gastrointestinal 
     Endoscopy; American Society for Parenteral and Enteral 
     Nutrition; American Society of Anesthesiologists; American 
     Society of Clinical Oncology; American Society of Dentist 
     Anesthesiologists; American Society of Health-System 
     Pharmacists; American Society of Hematology; American Society 
     of Pediatric Nephrology; American Thoracic Society; Amgen; 
     Analtech; ARCA Biopharma; Arthritis Foundation; Association 
     of Community Cancer Centers; Association of Medical School 
     Pediatric Department Chairs; AstraZeneca Pharmaceuticals LP; 
     Augmenta Biologicals.
       Bayer Healthcare; BHGR Law; BIO; BioCrossroads; Biogen 
     Idec; BioHouston; BioNJ; BioOhio; BioRelix, Inc.; Biotech 
     Vendor Services; Black Mental Health Alliance of 
     Massachusetts; Bleeding Disorders Alliance Illinois; Blood 
     Bank of Delmarva; Bloomington Chamber of Commerce; Boehringer 
     Ingelheim Chemicals, Inc.; Boehringer Ingelheim 
     Pharmaceuticals, Inc.; Boehringer Ingelheim Vetmedica, Inc.; 
     Boehringer Ingelheim, Inc.; Bristol-Myers Squibb; Burlington 
     Chamber of Commerce.
       Cambridge Chamber of Commerce; CARA Therapeutics; Celgene 
     Corporation; Central Connecticut Chambers of Commerce; 
     Cerebral Palsy Association of Eastern Massachusetts; Chamber 
     of Commerce of Eastern Connecticut; Child Neurology Society; 
     Children's Defense Fund; Children's Hospital Association; 
     Citizens Opposed to Additional Spending and Taxes (COAST); 
     Cleveland Clinic; Coaches Against Multiple Myeloma; Coalition 
     of Texans with Disabilities; Colorado Association of Commerce 
     and Industry; Colorado Bioscience Association; Colorado 
     Gerontological Society; Commerce and Industry Association of 
     NJ; Community Health Charities of Iowa; Connecticut AIDS 
     Resource Coalition; Connecticut Business & Industry 
     Association (CBIA).
       Connecticut Retail Merchants Association; Connecticut State 
     Building and Construction Trades Council; Connecticut United 
     for Research Excellence (CURE, CT's BIO); Consumers Union; 
     Council of Pediatric Subspecialties; CT BEACON; Cubist; 
     D'Souza and Associates; Delaware Academy of Medicine; 
     Delaware AFL-CIO; Delaware Ecumenical Council on Children and 
     Families; Delaware HIV Consortium; Delaware Technology Park; 
     DelawareBIO; Denver Metro Chamber of Commerce; Des Moines 
     Area Community College; Detroit Regional Chamber of Commerce; 
     Develop Indy; Dun & Bradstreet.
       East End Group, LLC; Easter Seals of Massachusetts; 
     Economic Alliance Snohomish County; Eli Lilly and Company; 
     Elizabeth Glaser Pediatric AIDS Foundation; Endocyte; 
     Engineered BioPharmaceuticals; Epilepsy Foundation of Greater 
     Chicago; Exemplar Genetics; Farmington Chamber of Commerce; 
     Feed Energy Company; Fort Wayne Chamber of Commerce; Generic 
     Pharmaceutical Association; GlaxoSmithKline; GlycoMimetrics; 
     Grand Rapids Area Chamber of Commerce; Greater Boston Chamber 
     of Commerce; Greater Des Moines Partnership; Greater New 
     Haven Chamber of Commerce.
       HealthHIV; HeathCare Institute of New Jersey (HINJ); 
     Hematology/Oncology Pharmacy Association; Hep C Connection; 
     Hon. Edd Houck, Former Virginia State Senator; Hospira; 
     Hudson County Cancer Coalition; IBI Scientific; Illinois BIO; 
     Illinois Biotechnology Industry Organization (iBIO); Illinois 
     Chamber of Commerce Healthcare Council; Illinois 
     Manufacturers' Association; Illinois Science and Technology 
     Coalition; Incyte; Indiana Association of Cities and Towns; 
     Indiana Health Industry Forum; Indiana Manufacturers 
     Association; Indiana Medical Device Manufacturer's Council; 
     Indiana State Chamber of Commerce; Infectious Diseases 
     Society of America.
       Innovation NJ; Institute for Safe Medication Practices; 
     Institute For Systems Biology; Integrated Laboratory 
     Services--Biotech; Iowa Academy of Family Physicians; Iowa 
     Biotech Association; Iowa Nurses Association; Johns Hopkins 
     Medicine; Johnson & Johnson; Joy's House; Junior Achievement 
     of Central Maryland; Junior Achievement of Delaware; Junior 
     Blind of America; Juvenile Diabetes Awareness Coalition; 
     Juvenile Diabetes Research Foundation; Kalamazoo Chamber of 
     Commerce; Kidney Cancer Association; Kolltan Pharmaceuticals, 
     Inc.
       Lancaster General Health; Legacy Community Health Services; 
     Leukemia & Lymphoma Society Iowa and Nebraska; Life Science 
     Greenhouse of Central Pennsylvania; LifeScience Alley; 
     Lighthouse International; Lupus Alliance of America--Michigan 
     Indiana Affiliate; Lupus Foundation of America--Illinois 
     Chapter; Lupus Foundation of America DC/MD/VA Chapter; Lupus 
     Foundation of America, Connecticut Chapter, Inc.; Lupus 
     Foundation of America, DC/MD/VA Chapter; Lupus Foundation of 
     New England; Lupus Foundation of Pennsylvania; Maetrics; 
     March of Dimes; Maryland Chamber of Commerce; Maryland State 
     Medical Society; Massachusetts Association of Mental Health; 
     Massachusetts Biotechnology Council; Massachusetts Chamber of 
     Commerce.
       Mayors Committee on Life Sciences; MedCara Pharmaceuticals; 
     Medical Device Manufacturers Association; Medical Imaging & 
     Technology Alliance; Medical Society of Virginia; Mental 
     Health America of Colorado; Mental Health America of Greater 
     Tarrant County; Mental Health America of Illinois; Mental 
     Health America of Indiana; Mental Health Association of 
     Connecticut; Merck; Metro Denver Economic Development 
     Corporation; MichBio; Michigan Chamber of Commerce; Michigan 
     Council of the Blind and Visually Impaired; Michigan 
     Manufacturers Association; Middlesex County Chamber of 
     Commerce; Midwest Business Group on Health; Millennium, The 
     Takeda Oncology Company; Morris County Chamber of Commerce; 
     Mylan.
       NAACP Columbus Chapter; NAMI Colorado; NAMI Indiana; NAMI 
     NC; NAMI-IL; National Alliance for Mental Illness--Gulf 
     Coast; National Alliance for Mental Illness--Metropolitan 
     Houston; National Alliance for Mental Illness--Texas; 
     National Alliance on Mental Illness; National Alliance on 
     Mental Illness, Michigan; National Association of Chain Drug 
     Stores; National Association of Manufacturers; National 
     Association of Pediatric Nurse Practitioners; National Dental 
     Association; National Federation of the Blind; National 
     Kidney Foundation of Indiana; National Organization for Rare 
     Disorders; National Parkinson Foundation, Central and 
     Southeast Ohio Chapter; National Processing Solutions; 
     National Research Center for Women & Families.
       NC Autism Society; NC Bio NC Chamber; NC Psychological 
     Association; Neurofibromatosis Mid-Atlantic; 
     Neurofibromatosis of the Mid-Atlantic; Neurofibromatosis of 
     the Mid-Atlantic; New Jersey Business and Industry 
     Association (NJBIA); New Jersey Community Research 
     Initiative; New Jersey Laborers' Union; New Jersey Life 
     Science Vendors Alliance (NJLSVA); New Jersey State League of 
     Municipalities; Newark Senior Center; NJ Healthcare Advocate 
     Volunteer Effort (NJ Have); North Carolina Association for 
     Biomedical Research; North Carolina Biotechnology; North 
     Dakota Association of the Blind; North Hudson Community 
     Action Corporation; North Texas Commission; Northwest 
     Connecticut Chamber of Commerce.
       Novo Nordisk Inc.; Nuclea Biotechnologies; NYU Langone 
     Medical Center; Ohio Chamber of Commerce; Ohio Coalition of 
     Concerned Black Citizens; Ohio Laborers' District Council; 
     Ohio State Building and Construction Trades Council; One 
     Southern Indiana; Ovarian Cancer National Alliance; PACT, 
     Greater Philadelphia Alliance for Capital and Technologies; 
     Parent Project Muscular Dystrophy (PPMD); Parkersburg 
     Economic Development; Patient Advocates for Advanced Cancer 
     Treatments; Pediatric Infectious Diseases Society; Pediatric 
     Pharmacy Advocacy Group; Pennsylvania Bio; Pennsylvania 
     Chamber of Business and Industry; Peoples Settlement Senior 
     Center; Pew

[[Page 7497]]

     Charitable Trusts; Pfizer, Inc.; PhRMA; Pittsburgh Life 
     Science Greenhouse.
       Pittsburgh Technology Council; Pittsburgh Venture Capital 
     Association; Plymouth/Terryville Chamber of Commerce; Premier 
     healthcare alliance; Prevent Blindness America; Prevent 
     Blindness Mid-Atlantic; Prevent Blindness Ohio; ProteoTech 
     Inc; Psychiatric Society of Virginia; Respiratory Health 
     Association of Metro Chicago; Rib-X Pharmaceuticals; Rio 
     Grande Valley Diabetes Association; Rocky Mountain Stroke 
     Center; Rush To Live Organization; Rx Partnership; San 
     Antonio AIDS Foundation; Sanofi; Seattle BioMed; Sequella, 
     Inc.; Sheet Metal Workers Local 40.
       Society for Adolescent Health and Medicine; Society for 
     Pediatric Research; Somerset County Business Partnership; 
     South Jersey Geriatric Care, P.C.; South Jersey Senior 
     Marketing Group; South Shore Chamber of Commerce; Southwest 
     Michigan Pharmacists Association; Spanish American Merchants 
     Association (SAMA); Stanford Hospital & Clinics; 
     Supercritical Fluid Technologies; Susan G. Komen, Denver 
     Metro Affiliate; Susan G. Komen for the Cure Advocacy 
     Alliance; Takeda Pharmaceuticals U.S.A., Inc.; Targepeutics; 
     Tech Council of Maryland; TECHQuest Pennsylvania; Teva 
     Pharmaceuticals; Texas BioAlliance; Texas Health Care & 
     Bioscience Institute.
       The Arc of Connecticut; The Association for Corporate 
     Health Risk Management; The Center for Health Care Services; 
     Trinity Health--Novi, Michigan; Trust for America's Health; 
     Union of Concerned Scientists; United Mitochondrial Disease 
     Foundation; University City Science Center; University of 
     Utah Health Care; University of Washington; Virginia 
     Biotechnology Association; Virginia Chamber of Commerce; 
     VisionServe Alliance; Visiting Angels; Washington 
     Biotechnology & Biomedical Association.
       Washington Global Health Alliance; Washington State 
     Department of Commerce; Washington State University; 
     Waterbury Regional Chamber of Commerce; We Work For Health; 
     We Work for Health New Jersey; WellDoc, Inc.; Western 
     Economic Council; Western Michigan University; Westside 
     Health; Wolcott Chamber of Commerce; Worcester Chamber of 
     Commerce; Wright Runstad & Company.

  I yield the floor.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Mr. President, I thank the chairman for his remarks and 
wish to be associated with them. It has been a very bipartisan process 
that has resulted in this bill coming to the floor, and I am hoping 
there will only be relevant amendments and that there will be few of 
those. Every amendment has the potential for disrupting the entire 
bill. This has been a very inclusive process that has led to this 
legislation.
  Over a year ago staff began to meet with stakeholders on the policy 
issues that are addressed in S. 3187. Starting in the spring of 2011, 
staff from Republican and Democratic offices on the Health, Education, 
Labor and Pensions Committee began a series of standing meetings. The 
groups proceeded to meet every week for several months. They met with 
stakeholders and discussed policy solutions that each member thought 
would solve the problem. After much discussion of the benefits, costs, 
and possible unintended consequences, members agreed to a list of 
policy concepts. If it was not a consensus on a particular policy, then 
it was not included. The chairman mentioned the importance of 
consensus, and that is what we worked on.
  As this process progressed, my staff met with the Republican staff on 
the HELP Committee for at least 2 hours every week to keep them 
informed of everything that was happening. I personally met with the 
members of the committee before the markup to make sure I understood 
their priorities. No one office got the entirety of what they wanted. 
However, we did find the 80 percent of each solution we could all agree 
could help solve whatever policy the group was working on.
  What we see before us now is the outcome of the hard work of these 
groups. The bill passed the committee by a voice vote. The bill 
reflects the work of every member of the Health, Education, Labor, and 
Pensions Committee. All of them have at least one provision included in 
this legislation, and many members of the committee worked with us to 
find consensus measures that addressed their priorities as well.
  This legislation is a model for how the process can and should work 
no matter what the political environment. This went to committee, it 
was worked in committee, it is now at the Senate floor, and I hope my 
colleagues will join me in supporting this truly bipartisan provision 
that reduces the debt and ensures that the United States will maintain 
its leadership in the innovation of safe and effective biomedical 
product.
  I yield the floor.

                          ____________________