[Congressional Record Volume 158, Number 73 (Monday, May 21, 2012)]
[Senate]
[Pages S3300-S3307]
From the Congressional Record Online through the 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 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
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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.
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
the 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.
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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 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
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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 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
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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 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
[[Page S3305]]
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 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;
[[Page S3306]]
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 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
[[Page S3307]]
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.
____________________