[Congressional Record (Bound Edition), Volume 158 (2012), Part 7]
[Senate]
[Pages 9920-9936]
[From the U.S. Government Publishing Office, www.gpo.gov]




    FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT OF 2012--
                               Continued

  The PRESIDING OFFICER. For the information of the Senate, cloture 
having been invoked on the motion to concur in the House amendment to 
S. 3187 yesterday, the motion to refer fell, being inconsistent with 
cloture.
  Under the previous order, there will be 6 hours 15 minutes of debate, 
with 2 hours controlled by the Senator from Iowa, Mr. Harkin; 4 hours 
controlled by the Senator from North Carolina, Mr. Burr; and 15 minutes 
controlled by the Senator from Kentucky, Mr. Paul.
  The Senator from Iowa.
  Mr. HARKIN. Mr. President, again, we are on the Food and Drug 
Administration Safety and Innovation Act of 2012. As the chair just 
said, we have 6 hours 15 minutes of debate time. I am hopeful we don't 
utilize it all and that we can vote on this sometime later this 
afternoon.
  We just considered this bill in the Senate a few weeks ago and passed 
it 96 to 1. Following the conference with the House, the House passed 
the bill unanimously last week. Today I trust that we will finish the 
job.
  I am genuinely proud of this legislation. It will ensure that the FDA 
has the resources to speed market access to drugs and devices while 
continuing to ensure patient safety. For the first time, it will make 
new resources available to allow the FDA to clear its backlog of 
applications for generic drugs, which will help ensure that patients 
have access to less expensive medications. It will make sure the FDA 
has the funds to prevent there ever being a backlog in applications for 
biosimilars. These resources are vital to FDA's ability to do its job, 
to the medical products industry's ability to make these products and, 
most importantly, to patients who need both access to drugs and 
devices, and assurances that they are indeed safe.
  This legislation has benefited from input from a diverse range of 
interested parties, Senators on both sides of the aisle, our colleagues 
in the House, industry stakeholders, consumer groups, and patient 
groups.
  Over 1 year ago the parties started bringing policy ideas to the 
table. We worked together in bipartisan working groups to reach 
consensus on these policy measures. Where we could not achieve 
consensus, we didn't allow those differences to distract us from the 
critically important goal of producing a bill that could be broadly 
supported. As a result of this bipartisan process, we have a bill that 
advances our shared goals of patient safety, patient access, a well-
functioning FDA, and strong and viable American businesses. We 
streamlined the device approval process while also enhancing patient 
protections. We modernized FDA's authority to ensure that drugs and 
drug ingredients coming to the United States from overseas are safe and 
to ensure that our domestic companies compete on a level field with 
foreign ones. We addressed the critical problem of drug shortages. We 
helped spur innovation and incentivized drug development for life-
threatening conditions. We reauthorized and improved the incentives for 
studying drugs in children.
  Finally, we increased accountability and transparency at FDA. So the 
bill strikes a balance. It will help keep our regulatory system in pace 
to adapt to technological and scientific advances. It will create the 
conditions to foster innovative advances in medical technologies. 
Again, it will do all of this without losing sight of the most 
important function of the FDA--ensuring patient safety.
  So it has been a long road leading up to this moment. We have been 
working on this bill for well over 1 year and 3 or 4 months with the 
help of Senators on and off the committee.
  Again, I thank my colleague, the ranking member of the Health 
Committee, Senator Enzi, for all of his diligent and hard work and that 
of his staff for helping to bring all the different parties together 
and making sure we had a consensus bill that responded to all of those 
inputs.
  So we have had a great collaboration. I think we have an excellent 
bill. Again, I am hopeful we can have our comments and discussions this 
afternoon, but I urge all my colleagues to vote today to pass the FDA 
Safety and Innovation Act. It is critically important to the agency, 
the industry, and to the patients we get this done. This will be the 
final step.
  As I said, the House passed it unanimously. If we pass it today, it 
can go to the President for his signature as soon as we pass it this 
afternoon.
  Mr. President, I yield such time as he may consume to my good friend 
and colleague and ranking member, Senator Enzi.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Mr. President, I thank the chairman of the committee. I 
thank him for his kind words, but I also thank him for his leadership 
on this issue. We have had a great teamwork effort both between the 
Senators and between the staff. This isn't something that just came 
together a couple of weeks ago. This is something that has been worked 
on for about 1\1/2\ years, with pretty constant meetings on Fridays of 
all of the interested groups and then stakeholders. It takes a 
tremendous amount of work to put something like this together and have 
it be in a bipartisan way like this. It is largely because it came to 
committee.
  In committee we took a look at all of the amendments that were 
suggested, we got the people together who had very similar amendments, 
and they usually were able to work out something to satisfy everybody 
in that instance, and we came up with a bill. As Senator Harkin 
mentioned, it passed 96 to 1. Anytime we get something to pass, it is 
kind of a landmark success. But when we get something that bipartisan, 
it is even more landmark.
  We have been trying to get this bill wrapped up before the Supreme 
Court decision came out on health care. The reason we have been trying 
to do that is, who knows what it is going to say or what kind of ideas 
people will come up with when that happens. This is a group of 100 idea 
generators, so we wanted this cleared up by that time. We are on a path 
to get that done right now and a path that will keep the people 
employed who are taking a look at new drugs and devices and generics 
and biosimilars and continue to get those on the market so people will 
have the latest innovations.
  One of the things we included in the bill was some use of foreign 
clinical trials if they were approved by the FDA, and that should even 
speed up the process. Of course, when we went to conference there were 
a lot of things people wanted to have that they brought up as 
amendments. It is very critical in the bill, and we get some of them 
and we don't get others.
  I know Senator Alexander played a huge role; he had seven items in 
the bill and we got six of them. Senator Burr had 12 items in the bill, 
and we got 11 of them. I have to mention, of course, that the one we 
did not get is a particularly important but particularly difficult 
issue that is going to take more time to get worked out. It is one that 
deals with drug distribution security, and that is something we cannot 
avoid. We have to do it. But it is going to take longer to work that 
out. It deserves some extra time and some more understanding on both 
sides of the aisle on that one and in a number of different States. It 
doesn't just involve the Senate; it doesn't just involve the drug 
companies; it also involves the whole chain that these things have to 
go through, including the local pharmacist whom we don't want to 
overload with work, and the people who have to transport these drugs 
whom we don't want to overload with work or make it extremely 
complicated when they cross different State lines and have to do 
different kinds of reporting.
  Senator Isakson had four amendments, and we were able to get three of 
them. Senator Paul had two, and we got one. Senator Hatch had six, and 
he got all of them. Senator McCain had

[[Page 9921]]

two, and we got one. Senator Roberts had two, and we got both of those. 
Senator Murkowski had two, and we got both of those. Senator Kirk had 
two, and we got one of those. Senator Grassley had two, and we got one 
of those. Senator Portman had two, and we got both of those. And 
Senator Coburn had two, and we got one of those. Senator Corker had 
two, and we got both of those.
  So there are a lot of things we did on the Senate side that became 
possible on the House side. There are a number of things they did on 
the House side that we couldn't agree with on this side either. But we 
did reach agreement--and we reached it in pretty much record time. We 
now have a bill that can go ahead and be passed and go to the President 
for signature to assure that the level of safety we have in our drugs 
not only continues but improves, and drugs can get on the market faster 
than they had before by streamlining the process and also making sure 
there are better foreign inspections so the ingredients that go into 
the drugs don't cause problems.
  So this legislation reauthorizes the Food and Drug Administration's 
user fee program, and it ensures that Americans get better access to 
safe innovative medicines and medical devices. It will make significant 
changes. It will improve the FDA's review and approval of new drugs and 
devices.
  Unfortunately, FDA's current process for reviewing and approving 
medical devices too often creates delay and unpredictability. This in 
turn threatens patient access to the best possible treatments for their 
conditions. In some cases, this has forced American patients to travel 
overseas to obtain access to lifesaving new devices that FDA has not 
approved in the United States.
  The bill goes a long way toward solving these problems and makes the 
most significant changes to the law of governing FDA's review of 
devices in decades.
  This bill will speed the approval of devices by reducing the redtape 
associated with the ``least burdensome'' standard that FDA uses to 
approve such devices. The bill will also make it easier for FDA to 
approve devices for patients with rare diseases who might not otherwise 
be able to have their conditions treated most effectively. It will also 
enable FDA to expedite safety determinations, to resolve appeals, and 
to improve their postapproval surveillance activities to detect 
problems as they occur. It is not good enough to get them approved, we 
also want them watched after they are approved, and this will do it.
  The bill also contains important reforms to foster drug innovation 
and patient access to new therapies. It modernizes the accelerated 
approval pathway for drugs to reflect advances in science over the past 
20 years. It formalizes a new process to expedite the development and 
approval of breakthrough therapies. These changes are particularly 
important for patients with rare diseases where there are no therapies 
available, and it is not feasible or ethical to require large 
conventional clinical trials.
  Nobody wants to be the one who is a test case when there might be 
something that would work for them, and there aren't the sizes of the 
populations to do the conventional clinical trial anyway. The patient 
community strongly supports these improvements because these will save 
lives.
  The bill also contains important reforms that will help mitigate the 
problems associated with drug shortages. It will require better 
coordination within FDA as well as the other Federal agencies such as 
the DEA. It will also allow FDA to move faster, to take actions, and to 
address shortages through expedited reviews and approvals.
  The bill also makes important changes to how FDA uses Risk Evaluation 
and Mitigation Strategies, REMS. REMS play a critical role in 
protecting patients and public health and this bill includes a 
provision that clarifies the process for modifying REMS--especially 
with regard to minor modifications.
  The provision in the bill being passed today does not change 
Congress' expectation that a non-minor modification will generally be 
based on the best available science including an assessment 
demonstrating that the modification is necessary or appropriate. Nor 
does the clarification indicate that a modification should be approved 
if it would reduce the REMS' effectiveness in addressing the drug's 
known risks.
  The bill follows what I call the 80 percent rule. When we focus on 80 
percent of the issues on which we can reach agreement rather than 
focusing exclusively on the parts and the issues we can never resolve, 
we can achieve amazing results. Over 1 year ago staff began to work on 
identifying the 80 percent. A group of staff from Republican and 
Democratic offices on the Health, Education, Labor, and Pensions 
Committee began a series of standing meetings and 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 on a list of policy concepts. If there was 
not a consensus on a particular policy, it wasn't included. This is the 
80 percent rural in action.
  As this process has progressed, my staff also met with the Republican 
staff on the Health Committee for at least 2 hours every week to keep 
them informed and to seek their input. I also personally met with the 
members of the committee before markup to ensure I understood their 
priorities.
  This 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. Many members of the committee worked with 
us to find consensus measures that addressed their priorities as well.
  As I mentioned, not everyone got everything they wanted. We did, 
however, find the 80 percent of each solution that we could all agree 
would help solve the problem, and the bill passed the committee by a 
voice vote. This legislation could be a model for how the process can 
and should work regardless of the political environment. We followed 
this model as we transitioned from the committee process to the Senate 
floor. We worked with members who filed amendments in committee to 
address some of the concerns in the manager's amendment. We also worked 
with Members who filed amendments on the Senate floor.
  We did the same thing in our discussions with the House. You can see 
that the results are very positive. We preserved and we improved 
policies to foster drug innovation and patient access, and to promote 
accountability and transparency at the FDA. We also made significant 
improvements to the Senate's medical device reforms for startup and 
emerging growth companies, and with respect to the 510(k) process.
  We thank Senator Harkin for his tireless effort on this bill. I know 
he spent countless hours and attended dozens of meetings, working with 
Senators and stakeholders and advocates to address their concerns. This 
bill would not have had such broad bipartisan support without all of 
his work.
  Senator Harkin's staff has also worked tirelessly on this bipartisan 
bill. Their knowledge, professionalism, their graciousness were 
instrumental in addressing all of the issues in this bill. They worked 
many late evenings, they worked through weekends, they worked through 
countless working group discussions to be able to get the bill where it 
is today.
  Specifically, I want to recognize Elizabeth Jungman, Bill McConagha, 
Kathleen Laird, and Kate Wise for all their work. I thank Pam Smith, 
Senator Harkin's staff director, for her leadership getting this bill 
to the finish line. I especially want to recognize Jenelle 
Krishnamoorthy, whose organization and diplomatic skills helped us 
resolve the most difficult challenges and made sure that the priorities 
of all the members of the committee are reflected in the bill.
  I also wish to thank the staffs of the Legislative Counsel, the 
Congressional Budget Office, and the Federal Drug

[[Page 9922]]

Administration for all of their technical assistance. Again, there are 
people in those groups who had to work through the weekends when we 
were finishing up.
  Finally I would thank my staff--Keith Flanagan, Melissa Pfaff, Grace 
Stuntz, Katy Spangler, Rob Walton, and my health policy director, Chuck 
Clapton.
  I would be really remiss if I didn't thank my staff director Frank 
Macchiarola for his work on this bill, especially as the bill 
progressed through the HELP Committee, the Senate floor, and 
discussions with the House. My staff has been working around the clock 
for many days, for weeks, and for months. I sincerely appreciate their 
dedication to getting this bill passed and for helping to work with the 
80-percent rule.
  I urge my colleagues to support this bipartisan bill that makes 
important changes to the FDA and I ask them to support this process 
that expedites getting the conference done. We will have a real and 
meaningful impact on millions of American patients.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from North Carolina.
  Mr. BURR. Mr. President, I wish to start off by thanking the chair 
and the ranking member for the great work they have accomplished with 
what has always been a very delicate piece of legislation. Their staffs 
have been tireless on both sides, trying to work out differences, and 
we would not be here today if it were not for their commitment to this 
legislation.
  Let me say to the chair and the ranking member, I plan to go on for 
some time. If I were you, I would take the opportunity to leave for a 
while because I will go for an hour or two or maybe three. And it is 
not all going to pertain specifically to this legislation, but I have a 
lot to say because I have heard some of the opening statements. I have 
heard statements such as ``our goal is to finish before the Supreme 
Court.'' I have a question: Why? Why a crucial piece of legislation 
that affects so many Americans and so many patients around the world--
why did it have to be done before the Supreme Court? I am not sure 
anybody can give an answer, but somebody started that as a goal and it 
sort of was adopted.
  I heard the legislation was accomplished at record speed. I don't see 
that as something to herald. Speed is indicative of something that we 
rushed our way through. I know on behalf of the chairman's staff and 
the ranking member's staff, they have been working on this for a long 
time. So has my staff. But from a standpoint of when we marked up the 
legislation and came to the floor--how fast we went to the floor--we 
did it because there was an understanding that we were going to try to 
hold the Senate product together.
  I don't want to take issue with the numbers. I had two amendments 
that were dropped in conference so I am not sure how I had 12 and got 
11 but, regardless, the question we are here to answer, the purpose of 
this legislation, is that this is supposed to drive innovation in 
America and bring lifesaving drugs, devices, and biologics to 
patients--here in America first, but around the country, around the 
world. That is the goal behind this legislation.
  I have to take issue with my ranking member. I don't think the 80-
percent rule applies to health care. I can't look at a patient and say: 
If we can get 80 percent of the right policy, I am going to feel good. 
If I am in the 20 percent that is left out, I am going to be really 
pissed off.
  One of the reasons our health care costs are so high today is that we 
have been able to innovate as a country to where we maintain disease 
extremely well. But we are right on the cusp of being able to cure 
things such as breast cancer and diabetes. It is not going to be cheap. 
It is not going to be fast. You are not going to find it in the 80-
percent category. You are going to find it in the 20-percent category. 
It is going to take a while. It is going to take people investing 
capital and companies that are committed to their shareholders that 
they are not going to have the returns because they are invested in 
something important and that is the long-term future of our country and 
our country's health.
  That is what I see in a 5-year PDUFA bill. This is not a 1-year 
reauthorization of something. Granted, this is not a piece of 
legislation that this committee drafted from scratch. It is important 
that everybody understands that for this legislation, in the 
negotiations between drugs, devices, biologics, generics industry with 
the Federal Drug Administration, there is not a Member of Congress and 
no staff of Congress in the room as they negotiate what fees they are 
going to pay to the FDA to actually process their applications. So the 
focus of this committee was to look at what happened in the 
negotiations and try to figure out how could we make this bill better--
how could we assure ourselves there was a level of transparency we 
could understand, that the negotiations they had entered into in fact 
benefited American patients.
  If this doesn't benefit the health care costs and the health care of 
Americans, then we have missed the mark. The whole objective is to put 
America in a better position after the passage of this bill.
  I will be boring because some of what I am going to talk about a lot 
of people in this institution know. But I am not sure the American 
people understand the background that is here. The Federal Drug 
Administration is responsible for assuring the safety and efficacy and 
the security of human and animal medical products. One element of FDA's 
statutory mission is to promote the public health and the FDA 
accomplishes this mission in part by timely--timely--approving 
lifesaving, life-enhancing innovations that make medicine safer, more 
effective and in many cases more affordable.
  FDA's broad regulatory authority crosses a range of products and has 
resulted in the agency overseeing products that amount to 25 cents of 
every dollar of the U.S. economy. Let me say that again. The FDA 
regulation extends to 25 cents of every dollar spent in the U.S. 
economy. Therefore, the FDA's review and decision process not only 
impacts our Nation's patients and innovators, their work has a 
significant impact on many sectors of our Nation's economy. As 
consumers and patients, the American people have serious interests in 
assuring that the FDA is accountable, transparent, efficient, and 
making sound decisions in as timely a fashion as possible.
  You see, that is why I am on the floor today. If the goal is to have 
transparent, efficient, sound decisions in a timely fashion, you don't 
rush through it. You make sure that there is a matrix in place--not one 
that was designed by the agency and not one that was designed by the 
industry, but one that is designed by the body that is responsible to 
do oversight over Federal agencies, the Congress of the United States, 
the HELP Committee. It is our job. That is why concerns about 
timeliness and predictability of FDA's regulatory process must be taken 
seriously and they must be addressed.
  Unfortunately, too often Congress is guilty of not paying close 
enough attention to how well things are working or not working at the 
FDA on behalf of the patients, the very people for whom the most is at 
stake. Every 5 years, drug and device industries negotiate their user 
fees that are then sent to Congress with the expectation that we will 
quickly act upon them to ensure the continuity of the agency. Let me 
assure you, this year is no exception. They dropped these agreements on 
Congress's lap and said: Would you pass these as quickly as you can 
with no changes? And to their credit, the chair and the ranking member 
said: No, Congress has a role to play. And staff has had tremendous 
input into what the final product was.
  Unfortunately, rushing the bills through the House and the Senate has 
resulted in bipartisan track-and-trace provisions not being included in 
the bill we have before us today. As the ranking member said, I am very 
disappointed that these important bipartisan provisions were sacrificed 
as the expense to attain speed. I understand the difficulty of the 
lift. I acknowledge that to my colleagues and to their staff. But I 
also question how hard we

[[Page 9923]]

tried, on an issue that we knew going in was tough. There is no such 
thing as spending too much time when it comes to getting something as 
important as drug distribution security right.
  I assure all my colleagues that my friend from Colorado, Senator 
Bennet, and I will continue to work together to get these important 
provisions done. I might add, I have had the commitment from the chair 
and the ranking member to work with us on other legislation to try to 
address this.
  But let me say today, it will not be any easier than it is right now. 
It may be tougher then because this was a vehicle that had to go, 
therefore people would have swallowed a lot more that is in this bill.
  As my colleagues know, FDA and industry tell us not to make any 
changes because it would ``open up the agreement.'' Think about that. 
The industry and the FDA told Congress don't put anything else in here 
because we would consider that as opening up our agreement.
  When did Congress become so irrelevant that a Federal agency would 
suggest that we not get involved? Yet it requires our passage for this 
to go in statute.
  I have explained before, Congress is told to tiptoe around the 
agreements and we focus our efforts on the belt-and-suspenders policies 
to complement the agreement. This does not make for the most consistent 
and deliberative process in considering how Congress can work with FDA 
and industry to strengthen and improve FDA's drug and device work on 
behalf of our Nation's patients, but this is the process Members have 
to work within, which is why it is so important to assure that the 
right policy riders, including transparency and accountability, are 
included in the final package.
  One thing that has been made quite clear over the past few years is 
the importance of FDA reporting on the right matrix. I can predict with 
some confidence, since this is a 5-year bill, we will be here 5 years 
from now and hopefully there will be at least one Member of the Senate 
who steps up and says: How did the FDA hold up against what they said 
they were going to do in the agreements?
  That is at the heart of transparency and accountability. If we do not 
have a matrix established that everyone understands here is where we 
are and here is where we promised we would get to, then how in the 
world 5 years from now do we measure this? How do you know then that if 
you raise the user fees, that it is justified, that the beneficiary of 
it is the American patient? I am going to say that is candidly obvious 
to everybody listening. When drug companies, device companies, biologic 
companies, generic companies pay more money to get their application 
approved, who pays for it? The consumers. The people who buy the drugs, 
use the devices, and buy the generics. This is the first time we have 
ever had a user fee for generic pharmaceuticals. Generics were called 
that because generics were created after the patent life expired so we 
could bring low-cost products to the market.
  What are we doing? We are creating generic user fees which will raise 
the generic price for the American people. It may alter the fact 
whether it is cheaper for a person to pay for their generic 
prescription or whether it is cheaper to have their copayment do it on 
their insurance card. That is the reality of what we are dealing with. 
I am not suggesting it is bad, but why would we rush through it without 
understanding what the impact is? That is where we are today.
  Reporting only on the negotiated user fees performance goals agreed 
to by the industry and the FDA has not provided a complete picture of 
how well the FDA is working to fulfill its mission on behalf of 
patients. The bottom line is what gets measured gets done. So it has to 
be measured.
  In the Wall Street Journal op-ed earlier this year, former FDA 
Commissioner Andy von Eschenbach highlighted what is at stake if 
Congress does not get the user fee reauthorization package right and 
fix the underlying problems at the FDA. He writes:

       The stakes couldn't be higher for our health. The U.S. 
     biomedical industry is one of the crown jewels of the 
     American economy. It employs about 1.2 million people 
     directly and over five million throughout its supply chain, 
     with a total output of $519 billion in 2009 . . . Many of the 
     firms are among the world's most innovative: From 2001 to 
     2010, the Milken Institute report shows, U.S.-based companies 
     produced nearly 60% of the world's new medicines, up from 42% 
     the previous decade.
       But U.S. firms won't continue to lead unless the FDA 
     retains its role as the world's ``gold standard'' for 
     evaluating new medical products.

  Many people establish the gold standard as being the hurdle they have 
to pass in order to be approved. The gold standard is also how 
difficult the process is that they have to go through, and will the 
capital be there to finance the research and development so approval is 
something they see as a light at the end of the tunnel. These all have 
to be weighed in the policies they put in place, and I will say we have 
come up somewhat short.
  Last year the National Venture Capital Association released a report 
that underscores America's risk of losing its standing as the world 
leader in medical innovation. Their survey clearly showed that the 
FDA's regulatory challenges, the lack of regulatory certainty, the day-
to-day unpredictability, and unnecessary delays are stifling investment 
in the development of lifesaving drugs and devices. Instead of 
deterring investment and innovation in lifesaving treatments such as 
cardiovascular disease, diabetes, and cancer, we should accelerate it. 
Instead of deterring that capital to come in, we should be finding 
policies to accelerate that capital to chase cures in heart disease, 
diabetes and cancer and work with America's innovators on behalf of 
patients who are depending on the next breakthrough drug or device.
  Our Nation's health care system is unsustainable. We all agree we 
must lower health care costs in America. Predictable regulatory 
pathways that facilitate innovative medical products that reach 
patients in as timely a manner as possible is key for lowering our 
health care costs. This survey is another serious call for the need to 
restore regulatory certainty and predictability at the FDA.
  As we comb through this bill, we see the two amendments that were 
voted and accepted in the Senate markup of the bill were dropped and 
discarded because somebody was too concerned with requiring too many 
reports. There is a reason we get granular with what we put in 
legislation and, more important, what we require an agency to produce. 
Predictable regulatory pathways that facilitate innovative medical 
products reaching patients in a timely manner will lower our health 
care costs.
  It is clear the FDA's global leadership in innovation is at risk. A 
2011 report by the California Healthcare Institute and the Boston 
Consulting Group highlighted this point. The report found that in 
recent years the environment for medical innovation has deteriorated 
and the most critical factor has been the FDA, the Food and Drug 
Administration. Let me repeat that. The report found the environment 
for medical innovation has deteriorated and the most critical factor 
has been the Food and Drug Administration. The report states:

     . . . for the Agency's policies and activities exemplify 
     President Obama's critique of a regulatory system whose 
     ``rules have gotten out of balance, placing unreasonable 
     burdens on business--burdens that have stifled innovation and 
     have had a chilling effect on growth and jobs.''

  Now, all of a sudden, we are talking about a piece of legislation we 
have rushed through the process because we wanted to beat the Supreme 
Court decision on Thursday. We did it at an accelerated pace, faster 
than we have ever done through the Senate, and we realize this 
legislation affects the economy and jobs. It is not just about health 
care. It is not just about patients. It is about jobs.
  Dr. David Gollaher, president and CEO of the California Healthcare 
Institute, raises a clear alarm in his report we should all heed. He 
concludes:

       The result of uneven performance of the Agency has been to 
     increase the risk associated with regulation, dampening 
     investment in companies whose products face FDA regulation. 
     Meanwhile, as global competition in

[[Page 9924]]

     high-tech industries has intensified, other nations have 
     adapted their regulatory systems to out-compete the FDA. The 
     flight of medical technology product launches to European 
     Union countries should be a serious cause of concern for 
     policymakers and patient advocates alike.

  What does that mean in layman's terms? We are losing them here and 
the EU is attracting them there. Why? Because their policies are easier 
to understand. It is not that their threshold for safety and efficacy 
is any lower, but they carry on an honest partnership with the 
applicants, and most will say dealing with the FDA is akin to inviting 
your worst relative to spend the week with you in your house.
  Exporting lifesaving innovation overseas--and the jobs that come with 
it--will not help patients or our economy here at home. It erodes our 
Nation's standing as the global leader in medical innovation and 
results in America's patients having to wait longer for lifesaving 
therapies or jeopardizing their access to them at all.
  I am not sure in America we ever thought we would go to another 
country where they had approved a new therapy we couldn't get in the 
United States, but I would be willing to bet that every family in 
America knows somebody who has gone outside the country to get some 
type of treatment or some type of dosage of something we haven't 
approved here, and one might think they are not safe or effective. The 
likelihood is that those products have never even applied for FDA 
approval. Why? Because the process has become so unpredictable and so 
expensive that a company has to justify the potential sales of a 
product to meet the billion-dollar cost just to get through the FDA 
application process.
  Exporting lifesaving innovation overseas and the jobs that come with 
it will not help our patients and will not help the economy. It erodes 
the Nation's economy and results in America's patients having to wait 
longer. I just said it.
  The FDA is supported by both user fees and taxpayer dollars, so 
Congress has a critical oversight role in ensuring that the FDA is 
meeting its requirements under the law. Moreover, as elected 
representatives of the American people, Congress institutionally has a 
duty to ensure that the FDA is broadly fulfilling its statutory mission 
and promoting the public health through its review and regulation on a 
range of medical products.
  The reauthorization of the drug and device user fees agreement is an 
important opportunity for Congress to ensure that the FDA is fulfilling 
its mission. Why would we in any way water down the accountability and 
transparency if, in fact, we are the ones to ensure the FDA is 
fulfilling its mission? But closely examining these issues once every 5 
years is not going to help address the underlying problems at the FDA 
that we all know must be fixed. The only way that is going to happen is 
with the FDA, Congress, patients, and innovators consistently working 
together with the right data points. The bottom line is we don't know 
what we don't measure. If we don't know it, how can we ensure that it 
is right?
  Another report by the California Healthcare Institute and the Boston 
Consulting Group in 2012 underscores the importance of reliable data at 
the FDA and how FDA performance is a function of management. The report 
finds there would be great value in regularly gathering and analyzing 
the best possible data and updating performance metrics during this 
PDUFA cycle in order to track performance consistently and 
longitudinally with the goal of the most accurate possible measures of 
agency performance.
  Do you sense a trend that every outside evaluation--not industry, not 
FDA, not Congress--of the user fee agreement is basically saying: Hey, 
Congress, don't miss this opportunity. If we want to track performance, 
then we have to set up the metrics and collect the data. Why in the 
world would we drop from the bill the transparency and accountability 
provisions that get the granular data we need to make this assessment? 
I guess we will never know.
  Congressional oversight can help highlight the processes that are 
working well at the FDA, as well as reveal areas where the FDA needs to 
make improvements to ensure timely and predictable regulatory decisions 
on behalf of America's patients. Recently, the GAO reports over the 
past year have underscored these points and why the right metrics must 
be reported on to paint a full and complete picture. Now all of a 
sudden we have the General Accounting Office, the GAO, saying the same 
thing that all these third parties have said. Why? Because they are the 
ones we turn to when we want to ask them to do an evaluation of the 
FDA, and they are telling Congress: Hey, don't miss this opportunity to 
get this stuff in there. You actually can get the data we can't get 
because it is not in the statute.
  Every 5 years when we pass the final user fee package, FDA's 
authority and responsibilities grow. Think about that. With more 
employees and higher costs, it seems like things would be getting 
better, but without the metrics, without the accountability, without 
transparency, we don't know. This bill is no exception. The FDA is 
going to get an unprecedented level of user fees and more new 
authority, billions in user fee dollars. With this unprecedented level 
of user fees, there must be unprecedented transparency, oversight, and 
accountability. It does not exist.
  Let me be clear. There are good provisions in this bill that should 
help to improve transparency, accountability, and regulatory certainty. 
However, throughout the committee's work on various issues, I 
repeatedly raised the point that if we did not fix the underlying 
issues at the FDA, the new responsibilities and expectations we are 
going to create with this bill would not achieve the desired outcome. 
Quite simply, that is why I am disappointed that some key transparency 
and accountability provisions included in the Senate bill did not 
survive the final bill. While key GAO reporting provisions may have 
been removed from the final bill, I wish to take this opportunity to 
inform my colleagues and the FDA that I personally intend to pursue 
this oversight analysis outside of this bill. Just because it is not in 
this bill does not mean I am going to go away.
  What has happened is that speed has trumped policy--the attempt to 
speed through this bill, the attempt to get it done before the Supreme 
Court announces its decision on ObamaCare. I have yet to have anybody 
explain to me why we are benefited by moving this before the Supreme 
Court ruling. If somebody has a concern that there is something in the 
bill that might be affected by what the Supreme Court ruling is, would 
we not be smart to delay this until after the ruling to see if there is 
some adverse reaction to what we have done? If I thought there was any 
reason to do that, I would be on the Senate floor pleading with my 
colleagues today. But the truth is that there is nothing that will come 
out in the Supreme Court decision that will affect the user fee 
relationship between drugs, devices, biologics, generics, and the Food 
and Drug Administration. But somebody wanted to finish it, and they set 
that as the goal that everybody could see.
  (Mr. FRANKEN assumed the chair.)
  Mr. BURR. Because of the hard work of my colleagues on both sides of 
the aisle, the final bill includes new incentives intended to help spur 
the next generation of lifesaving antibiotics. This is a good thing, 
and my colleagues should be commended for their bipartisan work on this 
important issue.
  Unfortunately, the requirement for the FDA to submit a strategy and 
implementation plan that would have helped to ensure greater regulatory 
certainty and predictability regarding FDA's work with antibiotics was 
not included in the final bill. Yet we have all watched stories on TV 
about a young lady who was attacked by a virus that has eaten her hands 
and her feet--an infection. What does she need? She needs a 
breakthrough in antibiotic therapy.
  This was a real opportunity for us to send a message out there that 
not only are we committed to doing it, we are committed to setting up a 
regulatory structure that allows it to happen.
  Carefully drafted GAO reporting requirements intended to help FDA and

[[Page 9925]]

Congress identify progress against regulatory challenges in this space 
have also fallen away. This had nothing to do with Richard Burr or 
Michael Bennet, this was the General Accounting Office. Unfortunately, 
the reporting requirement that remains is not nearly as robust as the 
language passed by the Senate earlier this year. These requirements 
were intended to help identify and root out the regulatory challenges 
in this space to ensure that the incentives included in the final bill 
are as meaningful as possible and ultimately do achieve the goal of the 
next generation of novel antibiotics reaching patients. I cannot think 
of anything more important than for us to make sure.
  I know the Presiding Officer comes from a State where devices are a 
key part of the economy.
  Another reporting requirement that fell away is one my colleagues 
have heard me talk about a lot over the past year. The medical device 
user fee agreement includes reporting on the total time to decision in 
calendar days, not FDA days. This sounds a little bit like Disney 
World. What in the heck are FDA days? I know what calendar days are. 
Tomorrow is going to be one number higher than today, and yesterday was 
one number lower, and every 28 to 31 days, we switch and it becomes a 
new month and we start counting again. Not at the FDA. That is why it 
was important that calendar days be substituted for what we call FDA 
days at the FDA. Patients do not care about FDA days; patients care 
about how long it takes in calendar days for safe and effective 
products to reach them.
  My colleagues may recall that last year the final Agriculture 
appropriations bill included a requirement for the FDA to report on 
calendar days because knowing the average number of calendar days it is 
taking FDA-approved therapies to reach patients is important for 
ensuring that we see the full picture of how well the FDA is working in 
a metric that the American people understand.
  Last year, when the Senate considered the issue of counting calendar 
days for medical products, Dr. Paul Howard, a senior fellow and the 
director of the Manhattan Institute's Center for Medical Progress, 
described the importance of counting calendar days. He wrote:

       The PDUFA clock stops when the FDA requests more 
     information from the sponsor . . . so repeated requests for 
     information from the FDA can significantly draw out the time 
     before a product reaches the market, even if the agency 
     completes its review within the specified PDUFA timeframe. . 
     . . knowing actual calendar days that elapse from between the 
     time that a sponsor submits an application to the time it is 
     approved should give Congress some sense of how efficient--

  How efficient--

       the review process is. If the FDA is repeatedly asking for 
     more information and lots of time is added to the approval 
     process, it has important implications for patients (who wait 
     longer for new therapies) and investors (who may perceive the 
     regulatory process as arbitrary and time consuming).

  Here again, another independent analysis of what should be important 
to the American health care system and an assessment that calendar days 
are absolutely vital to Congress's ability to understand how long it 
really takes at the FDA. And we are not even the person trying to 
finance the breakthrough.
  I appreciate that the final bill will now require more granular 
reporting with respect to the prescription drug user fee agreement, 
which is a good thing, but I am baffled that a reporting requirement 
which Congress has supported in the past and which was included for 
generic drugs was not included in the final bill.
  Talking about calendar days, how in the world could calendar days be 
important enough to put in the generic bill part and dropped from 
everything else? Why? Because FDA did not want it. FDA has gotten used 
to that little stopwatch they have. When they ask you for a little more 
information, they reset it, so they get to start again.
  My dear colleague Tom Coburn and I both are disappointed that a 
provision offered by him, and which I supported, was removed from the 
final bill.
  I have talked about a number of things removed from the final bill. I 
am not sure how the ranking member gave me a number at the beginning 
that I had interest in 12 things and that I had 11 accepted. I cannot 
count them as I am going through my presentation, but I think I am on 
three or four that have been dropped.
  The medical device user fee agreement includes the requirement for an 
independent assessment of FDA's management of devices. Unfortunately, 
the assessment included in the prescription drug user fee agreement and 
final bill will look at only one-third of the FDA's work with drugs. 
Let me say that again. The medical device user fee agreement includes 
the requirement for an individual assessment of FDA's management of 
devices. Unfortunately, the assessment included in the prescription 
drug user fee agreement and final bill will look at only one-third of 
the FDA's work with drugs. Calendar days apply in one section. Generic 
drugs do not apply, and devices, drugs, biologics. Now, all of a 
sudden, we have an independent assessment of FDA's management of the 
devices industry where we are only applying that to one-third of the 
area of drug evaluation and not to generics and not to biologics.
  Senator Coburn's provision, which was first introduced in a bill 
Senator Coburn and I introduced, the PATIENTS' FDA Act, would have 
ensured an independent assessment of all of FDA's drug work. Upon 
introduction of the PATIENTS' FDA Act, Dr. Paul Howard wrote that this 
provision was ``perhaps the most important provision'' because ``the 
outcome of that review may or may not be welcome by the FDA--but it 
will force Congress to pay attention and highlight the FDA's importance 
as the gateway for medical innovation not just in the U.S., but for the 
world.'' Paul Howard is no relation to me. This is, again, an 
independent doctor who makes a comment on a provision in an obscure 
bill that was introduced in Congress, and he says ``perhaps the most 
important provision.'' Yet it only applies now to one-third of the drug 
area, and all we wanted to do was to apply it to the whole thing. Not 
including this independent assessment is a missed opportunity for 
Congress, consumers, and patients to have a complete, independent, and 
objective look at FDA's management of its mission and resources with 
respect to drugs.
  I understand that some of my colleagues are concerned about 
overreporting, but I would come back to the basic point that you do not 
know what you do not measure. This is about how Congress and the FDA 
prioritize, and, given what is at stake, not including targeted 
reporting requirements that will help FDA to better achieve their 
mission on behalf of patients is a huge, huge missed opportunity. Why? 
Speed over policy.
  I would also like to talk about a key provision in the Senate's 
upstream supply chain provisions that is not included in the final 
bill.
  As many of my colleagues know, the globalization of the drug supply 
chain presents unique challenges in ensuring the safety of the drugs 
American patients receive. Quite a bit of time has understandably been 
devoted to this issue. Unfortunately, while the bill includes many 
bipartisan provisions that will help FDA better target inspections of 
drug facilities based on risk, the final bill falls short in addressing 
end-to-end supply chain security. That is sort of important. I think 
the American people sort of take for granted that we have that in place 
now.
  In addition to not including bipartisan downstream provisions, the 
final bill does not include the Senate's bipartisan provision to 
accredit third-party auditors to conduct drug safety audits of drug 
establishments. To be clear, these third-party drug safety audits would 
not have replaced official FDA inspections, but they would have been an 
important risk-based tool for the FDA to leverage in taking steps to 
ensure a safer global prescription drug supply chain. I actually 
believe that America thinks we have that in place right now. Who could 
be opposed to such a commonsense solution? It was a bipartisan 
initiative. Was it the House that kicked it out? Was it the FDA that 
kicked it out? It really does not

[[Page 9926]]

matter. This was smart to have in the bill. The only conclusion I can 
come to is that speed trumps policy, that our quest to get this done 
quickly meant we did not look closely enough at the things we should 
have done and could have done and we did not do.
  Now, the ranking member talked about my disappointment and his 
disappointment on the downstream drug distribution security. I want to 
take a brief moment and comment on downstream. I thank Senator Bennet, 
from the other side of the aisle. We worked together. And because of 
his hard work and dedication to this issue, I think I can say that we 
are both disappointed that the final bill does not include bipartisan 
provisions that we have been working on together for the past few 
months.
  My colleagues all know why this is an important issue. It is 
important for America's patients and consumers.
  I remain committed to establishing a workable and reasonable 
traceability system that strengthens the integrity of the 
pharmaceutical distribution supply chain. It is critical that we 
replace the current patchwork of inconsistent, inefficient, and costly 
State laws with a predictable, workable, and appropriate Federal 
standard. I am committed to getting this done.
  As I said to the ranking member and the chair, it is not going to be 
easy. We knew that when we took this on. You can't do it fast. I did 
not know we had a stopwatch on how quickly we could get this bill 
through the Senate and how quickly we could get through conference and 
how quickly we could get it passed. I remind my colleagues that the 
current user fee agreement does not expire until later this year. It 
did not have to be done now, but it was. And for now 45 minutes I have 
pointed out things we could have done, should have done, and did not 
do, and it is embarrassing. This could have been done. This was the 
right vehicle to put this in because it was a must-pass piece of 
legislation.
  Now let me, if I could, talk about some of the provisions Senator 
Coburn and I introduced in the PATIENTS' FDA Act. I am pleased we were 
able to find a bipartisan path forward on some of these provisions 
which will put in place an unprecedented level of transparency and 
accountability at the FDA.
  While FDA should have already done many of the things that will now 
be explicitly required of them, by ensuring that we hold FDA 
accountable to measures and reports on specific requirements, there is 
a greater chance that they are going to actually get done. There is no 
certainty without congressional oversight. Greater transparency and 
accountability provisions included in the package today will help to 
ensure greater regulatory certainty and timely decisions on behalf of 
America's patients, which is key to ensuring that America maintains its 
role as a world leader in medical innovation and that our patients have 
access to the most cutting-edge therapies in as timely a fashion as 
possible.
  FDA will be required to develop a regulatory science strategy and 
implementation plan with clear priorities and report on the progress 
made in achieving these priorities in fiscal year 2014 and fiscal year 
2016. The current FDA Commissioner has acknowledged that the FDA is 
relying on 20th-century regulatory science to evaluate 21st-century 
medical products.
  Let me read that again. The current FDA Commissioner has acknowledged 
that the FDA is relying on 20th-century regulatory science to evaluate 
21st-century medical products. Let's stop. Let's get this right. Even 
the Commissioner of the FDA is saying: You know what. We are not even 
in the same century in how we do what we are trying to accomplish. In 
other words, the products the FDA is required to regulate are advancing 
faster than the agency's ability to regulate them. I will be honest. 
That is a big problem.
  Former FDA Commissioner von Eschenbach was right when he said that 
the FDA must be capable of ensuring that its reviewers know just as 
much about advances in emerging sciences as the creators of the 
products they regulate.
  Listen, I will be the first to say that at the Food and Drug 
Administration we have some of the best and the brightest. They are 
some of the most dedicated Federal workers. They are some of the 
smartest folks I have ever seen. But they process approvals. They are 
not on a bench doing research and development. They do not understand 
how medicine and science have changed since they themselves left the 
bench. There is every reason to believe that people should be required 
to go back and be innovators and not necessarily make a lifetime of 
work as a reviewer at the FDA.
  There has been much talk about regulatory science, but it is hard to 
tell if these efforts are targeted and achieving the desired results of 
helping the FDA to apply the most cutting-edge scientific tools in 
their research and their review of medical products. The agency must 
have clearly defined goals and metrics against which their progress 
will be tracked. This is the only way to ensure that the advances in 
regulatory science are being applied and that FDA is prepared to 
regulate the most novel and cutting-edge medical products ever created.
  GAO has well documented FDA's management challenges. The user fee 
agreement included in the final bill will further increase these 
challenges by adding more than 1,200 new FDA FTEs, or employees, and 
further growing the scope of the agency's mission and regulatory 
responsibilities.
  Many of the concerns about the lack of predictability and uncertainty 
at the FDA are symptoms of unaddressed, systemic management issues. 
This is the agency that regulates 25 cents of every dollar of our 
economy.
  A February 2010 GAO report found that FDA does not fully use 
established practices for effective strategic planning and management. 
FDA agreed with the GAO recommendation to take several actions to 
improve FDA's strategic planning and management, such as the 
development of a strategic management plan and working to make FDA's 
performance measures more results-oriented. I cannot think of a 
business in America that does not do that today. However, 2\1/2\ years 
later, FDA has failed to adopt many of the key recommendations.
  To address this concern, the final bill requires the FDA to submit to 
Congress a strategic integrated management plan with specific 
accountability metrics as recommended by the GAO. Even though the FDA 
admitted to the GAO, based on their recommendations, that they needed 
to do this and that they would do it, 2\1/2\ years later we are now 
putting it in statute in the user fee bill.
  GAO has well documented FDA's challenges to sufficiently and 
successfully utilize its information technology process. GAO has also 
noted how these challenges undermine FDA's ability to use accurate and 
timely information to augment its regulatory mission. GAO reports in 
2009 and 2012 found that the FDA has made mixed progress in 
establishing the IT management capabilities essential to supporting the 
FDA's mission. That is the information technology. So an agency that is 
on the cutting edge of medical approval in this country in 2009 and 
2012 was found to have made mixed progress in establishing the 
management capabilities essential through technology to complete its 
mission.
  A comprehensive IT strategy plan is vital for guiding and helping to 
coordinate the FDA's IT activities. A comprehensive IT strategy plan, 
including results-oriented goals and performance measures, is vital for 
guiding and helping to coordinate the FDA's IT activities, especially 
since the user fee agreement includes specific IT goals. The final bill 
requires the FDA to report on their progress in developing and 
implementing the comprehensive IT package called for by the GAO. To 
ensure further congressional oversight, GAO will report on the progress 
FDA makes on meeting the results-oriented goals and performance 
measures set out in the IT plan they submit to Congress.
  Enhanced reporting requirements with respect to biosimilars and 
generic drugs include key reporting on clearing the backlog of generic 
applications and will also provide important transparency in the FDA's 
work and serve as

[[Page 9927]]

an early-warning indicator if the agreements are not being fulfilled.
  I am also pleased we were able to find a path forward on important 
pro-patient provisions from the PATIENTS' FDA Act and provisions that 
will also reduce unnecessary regulatory burdens for innovators. I wish 
to thank my colleagues, Senators Mikulski, Alexander, and Hagan, for 
working with us to ensure that the unnecessary redtape does not get in 
the way of meeting patients' unique medical device needs.
  The custom device provision in the bill provides an important path 
forward to ensure that doctors are able to meet patients' most unique 
medical device needs in as timely a manner as possible. The risk-
benefit framework included in the user fee agreement and codified by 
the final bill will facilitate the balanced consideration of benefits 
and the risks of FDA's drug decisionmaking.
  As innovators have increasingly turned to global markets and 
opportunities overseas, FDA's work with its global peer regulators has 
taken on an even greater significance. FDA's work with its global 
regulatory counterparts to encourage uniform clinical trials standards 
will optimize global clinical trials to ensure that the need to conduct 
duplicative clinical trials is minimized while FDA maintains the gold 
standard for approval.
  I wish to thank Senator Paul. I thank Senator Paul for working with 
me to ensure that we have optimized global clinical trial work and that 
FDA works with global peer regulators as much as possible to reduce 
unnecessary regulatory hurdles.
  Senator Paul was a champion in the committee to say: Why don't we 
accept the data we get from trials in Europe for applications that are 
under review for approval in the United States? And the answer I gave 
him was that in 1997, when we wrote the food and drug cosmetic 
modernization bill, we gave FDA the authority to do that. And now some 
15 years later it has never, ever, ever been used. As a matter of fact, 
the FDA will not even consult with a company that says: Tell us how we 
need to design our trial in Europe so you will accept our data. That 
has not happened. But you know what. It has to happen in the future if 
we want drugs to be cost-effective so people can afford them, if we 
want innovation to happen here as well as over there. If innovation and 
the place where it is ultimately approved is determined by whether you 
can recover the costs of your investment, I will assure you we are all 
going to shop somewhere else for our drugs, our devices, our biologics, 
and even our generics. It will not be here unless we learn how to share 
that data from continent to continent.
  I wish to highlight some specific medical device regulatory 
improvements. There may be any number of reasons a sponsor wants to 
conduct certain clinical studies that are not directly to the 
classification or approval of medical devices by the FDA. However, some 
sponsors have noted the tendency of the FDA to effectively prejudge the 
approval of a medical device by basing its decision related to a 
request to conduct clinical investigations of a device on whether the 
FDA believes the clinical study will be adequate to support the 
ultimate classification or approval of a device. If the FDA approves 
the investigational use of a device only using the more narrow 
regulatory standard of device approval or classification, clinical 
research in the United States could be unduly restricted. The final 
bill would return the investigational device exemption approval process 
to the standard authorized by the statute, which is a good thing for 
both patients and for innovators.
  The final bill will also improve regulatory certainty, transparency, 
and accountability with respect to medical devices by requiring FDA to 
provide a substantive summary of the scientific or regulatory rationale 
for significant decisions.
  As many of my colleagues know, section 510(k) of the Food, Drug, and 
Cosmetic Act requires device manufacturers to notify FDA of their 
intent to market a medical device at least 90 days in advance.
  Medical device manufacturers are required to submit a pre-market 
notification if they intend to introduce a device into commercial 
distribution for the first time or reintroduce a device that will be 
significantly changed or modified to the extent that its safety or 
effectiveness could be affected. Such change or modification could 
relate to the design, material, chemical composition, energy source, or 
manufacturing process. There are legitimate concerns about recent 
guidance issued by FDA that could significantly increase the regulatory 
burden related to 510(k) modifications without clear benefit to 
patients. The final bill will go a long way in restoring regulatory 
certainty and balance with respect to the 510(k) modification process 
by making it clear that the 1997 guidance remains the standard until 
FDA issues new guidance, with appropriate input from stakeholders, on 
this subject.
  While I wish that we could have gone further to strengthen and 
improve the device third-party review and inspection programs, the 
final bill does reauthorize these programs and includes a provision 
from the PATIENTS' FDA Act to set forth a process for reaccreditation 
and reauthorization of third-party reviews. This is a first and 
important step in enhancing the third-party review program.
  Another thing we placed in the 1997 act is the hope that we would see 
academia in America actually be approved as third party evaluators--not 
for heart stints or that class of device, but how about things such as 
Band-Aids? How about those things on which we should not waste an FDA 
reviewer's time? Couldn't the company contract with an academic 
institution to reapprove and recredit? FDA chose to do that in-house. 
This is the first important step to enhance the third party review 
program.
  Next is affirming the ``least burdensome'' requirements.
  Also, the final bill underscores the importance of the ``least 
burdensome'' requirements we put into the 1997 law to streamline the 
regulatory process and reduce burdens to improve patient access to 
medical devices.
  A central purpose of the FDA Modernization Act of 1997, or FDAMA as I 
like to call it, was to ensure the timely availability of safe and 
effective new products that will benefit the public and that our nation 
continues to lead the world in new product innovation and development. 
The goal was to streamline the regulatory process and reduce burden to 
improve patient access to breakthrough technologies. This law required 
FDA to eliminate unnecessary burdens that may delay the marketing of 
beneficial new products, but the statutory requirements for clearance 
and approval remained the same. The sections of the statute that 
capture these provisions are commonly referred to as the ``least 
burdensome'' provisions.
  For years, FDA included ``least burdensome'' language in guidance 
documents and letters. Yet, toward the end of 2009 the ``least 
burdensome'' language disappeared only to reappear after Congress 
expressed significant concern regarding FDA's failure to consistently 
apply these requirements in its work with medical devices.
  The lack of consistent application of the ``least burdensome'' 
requirements has added to regulatory uncertainty and unnecessary 
regulatory burden in a manner completely inconsistent with the law. It 
is sad that Congress needs to reaffirm a provision that has been the 
law since 1997, but I thank Senators Klobuchar and Bennet for working 
with me to underscore the importance of affirming the ``least 
burdensome'' requirements in the final bill.
  The final bill restores a more appropriate balance to FDA's conflicts 
of interest rules. This is an issue on which many patient groups have 
weighed and many members have worked because of its importance to 
patients and, ultimately, overall confidence in FDA's Advisory 
Committees. Ensuring that the FDA has access to the most qualified 
experts is vital to ensuring FDA's scientific capabilities and 
confidence in its regulatory decisions. It is critical that patients 
have the benefit of the very best expertise when weighing decisions 
that impact patient access to

[[Page 9928]]

lifesaving products. Unfortunately, since 2007, increasingly complex 
and restrictive conflicts of interest rules have often resulted in the 
Agency being unable to consult with leading experts and difficulty in 
filling key advisory committee positions. These challenges are 
compromising the quality and timeliness of FDA's decision-making. The 
final bill should help to address these concerns and ensure FDA can 
draw upon the most knowledgeable experts.
  Lastly, I'd like to highlight the Advancing Breakthrough Therapies 
for Patients Act, bipartisan legislation I was pleased to join Senators 
Bennet and Hatch in supporting because it will ensure patients have 
access to targeted, life-saving therapies as efficiently as possible. 
As former FDA Commissioner Von Eschenbach has rightly stated, 
``breakthrough technologies deserve a breakthrough in the way the FDA 
evaluates them.'' This legislation is supported by Friends of Cancer 
Research and the National Venture Capital Association.
  Earlier this year, an op-ed penned by former FDA Commissioner, Dr. 
Mark McClellan, and Ellen Sigal of Friends of Cancer Research, noted 
how the sequencing of the human genome has helped to unlock an even 
greater understanding of disease at the molecular level, helping to 
make personalized medicine become a reality. They note two main goals 
of the breakthrough legislation: First, to reduce the total development 
time and cost of the most promising ``breakthrough'' treatments; and 
second, to minimize the number of patients that would be given a 
``control'' regimen or a currently available treatment that doesn't 
work well. They are right to underscore that in order to fulfill the 
promise of ``breakthrough'' therapies and this legislation, the 
regulators at FDA must be fully engaged, working with sponsors early on 
in the development and review process once a product has received the 
breakthrough designation.
  More than 45 organizations representing patients, advocates, 
physicians, caregivers, consumers and researchers have weighed in with 
Congress urging the Advancing Breakthrough Therapies for Patients Act 
to be included in the final user fee package because they recognize 
that employing such an ``all hands on deck'' approach at FDA for these 
therapies will ultimately result in the most efficient development 
program and help to ensure that the most promising new treatments reach 
patients as safely and efficiently as possible.
  Many would argue that the modernization of the accelerated approval 
and fast track pathways have been a long time coming since Congress has 
not significantly updated either pathway since 1997. Earlier this year, 
Dr. Paul Howard in writing about the breakthrough legislation noted 
that, ``the most important section of the legislation may be the clause 
that requires the Secretary of HHS to commission an independent entity 
to assess the `quality, efficiency, and predictability' of how FDA has 
applied the directives in the legislation no later than four years 
after the bill passes.'' He goes on to say ``that may be the best way 
to ensure that we won't have to wait another 15 to 20 years to 
understand how well the FDA is utilizing the authority granted to it by 
Congress.'' Unfortunately, this independent assessment did not make it 
into the final bill. Speed trumps policy.
  FDA faces unprecedented challenges today--challenges we could not 
have envisioned a generation ago. Yet FDA still regulates a decade ago, 
based on the commission. The agreements and many of the provisions in 
the final bill are intended to help address these challenges. 
Unfortunately, the final bill does not bring to bear all of the tools 
that could have been included to ensure the greatest certainty, 
transparency, and accountability for patients and taxpayers. This is a 
missed opportunity.
  I ask my colleagues where we will be if the provisions enacted as 
part of this bill--like the breakthrough therapy provision--do not 
achieve their stated purposes? Where will we be if Congress does not do 
our part to ensure accountability on the part of the Agency by carrying 
out consistent congressional oversight?. Where will America's patients 
be in five years? Will FDA's regulatory standard still be the global 
gold standard?
  Will America still lead the world in innovation? Will the world's 
leading drug and device innovators choose to innovate in America, or 
continue the disturbing trend of exporting great innovation and good 
jobs overseas in the continued face of regulatory uncertainty?
  There are good provisions in this final bill, but more work remains 
to be done. America's patients and innovators are counting on Congress 
to conduct the proper oversight in the months and years ahead to ensure 
that these user fee agreements, authorities, and new responsibilities 
are implemented and fulfilled consistent with the law. They are also 
counting on Congress to complete the unfinished business of doing all 
that we can to ensure that FDA fulfills its mission on behalf of 
America's patients and our Nation's global leadership in medical 
innovation is restored. I commit to my colleagues, constituents, and 
the FDA that I intend to complete the unfinished business before us 
here today.
  Mr. President, you have been patient. At this time, I will yield to 
my colleague Senator Paul. When he concludes, I will continue with the 
2\1/2\ additional hours I have reserved.
  The PRESIDING OFFICER. The Senator from Kentucky.


                              Foreign Aid

  Mr. PAUL. Mr. President, I am not a big fan of foreign aid. We have a 
lot of problems in our country. I don't see how we can send billions of 
dollars overseas when we have bridges falling down in our country. Two 
bridges in my State were impassable. One was hit by a boat and has been 
impassable for 6 months. We have another bridge that is over 50 years 
old that was shut down for emergency repairs, and traffic stacked up 
for miles. Yet we send billions of dollars overseas when we don't have 
enough to fix our own bridges. It doesn't make any sense. We borrow $1 
trillion a year from China to turn around and send it to some other 
country. It makes no sense.
  I am not a big fan of sending our money overseas. But I am even less 
of a fan of sending our money to countries that don't seem to be our 
friends. Pakistan has worked with us on the war on terror. But recently 
Pakistan has chosen not to let any of our supplies--food and military 
supplies--traverse Pakistan. Recently, Pakistan has said we owe them $3 
billion. We are giving them $2 billion a year, and they say we owe them 
$3 billion that is not included in that. Recently, Pakistan also said 
they want to charge us $5,000 per container of food that goes across 
their land.
  For years bin Laden lived contentedly right in the middle of Pakistan 
underneath their noses. What is up with that? We are giving them $2 
billion a year and bin Laden was twiddling his thumbs there and they 
are not letting our supplies go across and they are demanding a past 
payment of $3 billion for who knows what and we continue to pay them.
  Recently, it has gotten even worse. Dr. Shakil Afridi is a doctor who 
helped us get bin Laden. Somehow his name was leaked. I don't know who 
leaked the name or if they were trying to puff themselves up and make 
themselves look as if they were strongly fighting terrorism, but by 
leaking Dr. Afridi's name, he is now in prison in Pakistan for 33 
years.
  Dr. Shakil Afridi is a Pakistani and they have put him in prison for 
33 years. His life has been threatened. If he is released--which I hope 
he will be--his life has been threatened because his name is public. 
How did it become public? Somebody leaked his name. This is 
inexcusable. If this came from within our government, whoever leaked 
his name or this information should be held accountable. I mean put in 
prison in our country for leaking state secrets.
  Dr. Afridi's name is now known in public, and he is being threatened, 
and his family is being threatened. Not only that, anybody around the 
world who wants to help us stop terrorism,

[[Page 9929]]

who is willing to stand and help America, is now threatened. Do you 
think people are going to want to help us if they know their names will 
be printed in the New York Times? We have to have things that we don't 
divulge about people who are helping us. But Dr. Afridi is in prison 
for 33 years, and I am going to do what I can to free him.
  We should not send Pakistan any more money. I say stop immediately. I 
am not saying take a small amount out next year; I say don't send them 
one more penny this year or next year. Don't send any of the $3 billion 
they want. We don't even have it to send to them. We have to borrow it 
from China. I would give them one chance. If they release Dr. Afridi, I 
would stand down.
  My bill was blocked. I tried to have a vote on it last week, and the 
leadership said: No, you won't have that vote. But we have a process 
where if you get enough signatures from Senators, you can ask for a 
vote and get it. That is where we are now. I have enough signatures to 
have the vote.
  I am going to be meeting with the Pakistani Ambassador, and meeting 
with President Obama's State Department, and what I will tell them is 
what I am telling you. This is not a secret. If Dr. Afridi is not 
successful with his appeal, which is coming up in the next 3 weeks, if 
he is not released and provided safe passage out of Pakistan, if he 
wishes, then I will have this vote. And I defy anyone in this body to 
stand here and vote to send U.S. taxpayer dollars to Pakistan when they 
are treating us this way. So we will have a vote in this body on ending 
all aid to Pakistan immediately if we don't get some results.
  This doesn't mean I don't want to have diplomacy with Pakistan. 
Pakistan has been a friend over many years, and I see no reason to end 
that. Pakistan has many elements that are pro-Western and that want to 
engage in the world. I am all for that. But we shouldn't have to buy 
our friends. We shouldn't have to pay a ransom. We shouldn't have to 
lavish them with taxpayer dollars.
  In fact, I think it encourages a disrespect when you give people so 
much money. Let's let them earn our respect. Let's work with them. 
Let's be friends with Pakistan. Let's have diplomatic ties to Pakistan. 
Let's try to help each other. Terrorism doesn't help Pakistan. They are 
threatened equally by it. I can list four Pakistani leaders who have 
been assassinated in the past 15 years. Why were they assassinated? 
Because of radical elements in their own country. So they should be 
with us in trying to stop extremism, on trying to stop this radicalism.
  My words for the Senate today and for the American people are that I 
am watching out for your money. I realize we have needs here at home 
that must come first, but also that I will force a vote on this. I am 
not going to send any more of your money or try not to let the Senate 
send any more of your money to Pakistan unless they are willing to 
cooperate, unless they are willing to be friends with America, unless 
they are willing to release the man who helped us get bin Laden.
  I will ask for a vote, it will come in the next few weeks, and I will 
keep everyone in America up to date on this.
  I thank the Senate for allowing me this time, and I suggest the 
absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. BURR. 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. BURR. Mr. President, I thank Senator Paul for relinquishing the 
microphone, and just for the purposes of Members who are planning, I 
think we will be about another hour. We will know shortly, and I will 
put that word out, if in fact that is going to be the case, but I 
intend to make sure everybody is able to make a 5 o'clock briefing.
  I have spent the first hour talking about the FDA user fee agreement 
bill, the history of it, what this bill did, and a lot about how this 
bill came up short. I would like to jog in a few different directions 
over the next period of time.
  Of great interest to me, and great interest to a lot of Members, is 
the commitment we owe to our Nation's military heroes. Over four 
decades ago, at one of the two Marine Corps bases in America--Camp 
Lejeune in Jacksonville, NC--they experienced serious contamination of 
their water. That contamination is likely the worst environmental 
exposure incident on a domestic military installation in the history of 
the country, both in the magnitude of the population potentially 
exposed to volatile organic solvents and the duration of the 
contamination--estimated to be 30 years or longer, with hundreds of 
thousands of veterans, their families, along with civilian workers 
having cycled through Camp Lejeune from the busy years of World War II 
through the Vietnam conflict and into the mid 1980s as we rebuilt our 
modern military.
  During these decades, unbeknownst to the base residents, the wells 
feeding the water supply on the base were drawing water from an aquifer 
contaminated with industrial chemicals that were dumped on the base, 
such as the degreasing solvent TCE, a known human carcinogen; and 
another carcinogen, benzene, from leaking underground fuel storage 
tanks; along with the dry cleaning solvent PCE; and a third human 
carcinogen, vinyl chloride. The Navy and Marine Corps began to test 
some of the base wells in the 1980s to comply with Federal regulations 
and, apparently, to also locate the source of various contaminations, 
yet it would take several more years and numerous warning signs before 
the Navy finally decided it should shut the wells down in 1985 through 
1987.
  As we know now, the Navy and Marine Corps had specific regulations of 
their own to maintain safe drinking water and test for contaminants. 
Had they adhered to their regulations, the many years of problems at 
Camp Lejeune might have been avoided. It is also important to note the 
source of those contaminations should never have been in question, 
since Lejeune's drinking water was then and is now solely derived from 
the wells located within the perimeters of Camp Lejeune, NC.
  In 1989, the EPA designated Camp Lejeune a Superfund site, and in 
1991 the CDC, via its Agency for Toxic Substances and Disease 
Registry--or ATSDR--began a statutorily mandated study of the 
contamination. Those studies continue to this day, in large part 
because the Navy's records of the contamination were not completely 
turned over to the ATSDR until 2009 and 2010. Scientists at the ATSDR 
and others involved in the review of the Navy's records have stated the 
levels of certain contaminants recorded in well samples taken by the 
Navy were at such high levels they have never been seen before, and in 
many cases they far exceed what we now consider to be safe levels for 
drinking water.
  The Veterans Administration is awarding disability benefits to 
Lejeune veterans on a case-by-case basis today, but that is a slow and 
unpredictable process, while many are suffering without adequate health 
care. It is my hope in the coming weeks we will finally pass critical 
legislation in this Congress to require the VA to take care of these 
veterans and their family members. Many of them are ill from exposure-
related conditions and have no other means of getting health care. They 
are rightly looking to the VA and to the Congress for help. If we can 
get this legislation passed, it will be a starting point on the road to 
doing the right thing for those who have sacrificed so much for our 
Nation.
  I think it is absolutely a crime that some 40 years later we haven't 
even completed the studies to understand the severity of the problems 
we have. I might add that some of the servicemembers and some of the 
family members who served at Camp Lejeune during this time are no 
longer with us. It may be hard to reconstruct exactly why, but I can 
assure you, when some estimate there are 10 times the number of male 
breast cancer cases from people who lived on that base during that

[[Page 9930]]

time, one might conclude it was a hotspot based upon its drinking 
water.
  My hope is this Congress will move forward with a very small initial 
step, but also make a commitment to these family members and 
servicemembers to not quit until we do the right thing.
  This week the Supreme Court is going to rule on the President's 
health care law. One would have to live under a rock not to realize it 
is going to happen Thursday morning at 10 o'clock. We have waited 
patiently every time the Supreme Court has rolled out their 
announcement for the last 3 weeks of cases they have decided as the 
Court comes to the end of their session this summer.
  Two years ago, then-Speaker Nancy Pelosi told Americans, ``We have to 
pass the bill so that you can find out what's in it.'' Let me repeat 
that: ``We have to pass the bill so that you can find out what's in 
it.'' It seems fitting that we stop and take stock of what the American 
people have learned about the President's health care law over the past 
2 years.
  The American people have found they can't afford the President's 
health care law. The Medicare Chief Actuary, in his final estimate of 
the health care law, projected it will increase health care spending 
across the economy by $311 billion. That is a 10-year number, but 
understand the President promised the health care law would reduce 
cost. It wasn't a goal. He promised it would reduce cost. 
Unfortunately, it has made things worse by increasing health care 
costs. And I think the estimate given by Medicare's Chief Actuary is 
probably a very conservative estimate--an increase of $311 billion.
  Growth in U.S. health care spending will almost double by 2014 due to 
the President's new law. This is at a time when we already are in a 
situation where we are on a financially unsustainable path. The 
predictions the President's health care law would increase insurance 
premiums are already being felt by the American people. Depending upon 
where you live, who you are an employee of, and whether you buy your 
own insurance depends on how hard you have been hit, but there is 
nobody in America who has not seen their premium go up since Congress 
passed this health care bill that was supposed to reduce the cost of 
health care.
  The Congressional Budget Office estimated the new law will increase 
health insurance premiums by 10 to 13 percent. This means a family 
purchasing coverage on their own will have to pay $2,100 a year more 
because of the President's health care law. And by the way, 10 to 13 
percent is what many Americans have felt as an increase on an annual 
basis.
  New taxes. New taxes on lifesaving drugs, devices, and health plans. 
Think about that, with the hour I just finished. I talked about the 
fact Congress needs to be focused on the efficiencies of government, 
and how we bring innovative products, devices, pharmaceuticals, 
biologics, and generics to the marketplace. Yet embedded into ObamaCare 
are new taxes on drugs, devices, and health plans.
  The American people haven't felt this yet. At a time we are supposed 
to be passing legislation to bring down health care costs, not only 
does the Congressional Budget Office say this is going to increase 
premium cost, not only does the President's Chief Actuary--CMS is under 
the executive side of government, not under Congress's authority--say 
health care spending across the economy, based upon the health care 
law, is going to be $311 billion, we have yet to kick in the new taxes 
on lifesaving drugs, devices, and health plans, which will drive up 
consumer cost and additionally drive up premium cost.
  Just after passage of the new law in May 2010, the Director of the 
Congressional Budget Office said:

       Rising health costs will put tremendous pressure on the 
     Federal budget. In CBO's judgment, the health legislation 
     enacted earlier this year does not substantially diminish 
     that pressure.

  The question is what were we thinking? And now we have the Supreme 
Court that will decide whether this is constitutional. CBO's latest 
long-term fiscal outlook notes that spending on health care has been 
growing faster than the economy for many years, posing challenges for 
Medicare, Medicaid, State and local government, and the private sector.
  Sometimes this is missed by Members of Congress and our constituents. 
There is a tremendous cost that we shift to States and local 
governments depending upon how they share in the Medicaid State 
obligations for cost sharing. States are picking up a tremendous amount 
of additional cost because of the passage of the President's health 
care plan because we are doubling, through legislation, the amount of 
people who are on Medicaid.
  So now you are going to get hit by the increase in your insurance 
premium; you are going to get hit by the increase in overall health 
care costs; you are going to get hit by the new taxes on lifesaving 
drugs, devices, and health care plans; and, oh, by the way, you are 
going to get hit in your State taxes because of the increased burden of 
Medicaid beneficiaries who are in part funded by the State and are 
going to now require States to find new ways to raise revenue, which is 
typically through our State taxes.
  CBO was right to conclude that such rates of growth cannot continue 
indefinitely because total spending on health care would eventually 
account for all the country's economic output, which CBO concludes ``is 
an impossible outcome.''
  We need real reform that actually lowers costs, not increases costs. 
We need real policy that institutes better outcomes, not rationing of 
care. The American people need to look at what the President promised 
when he created this legislation. He promised: If you like your plan, 
you get to keep it.
  Unfortunately, the administration has estimated that up to 69 percent 
of all businesses could lose the ability to keep what they have as a 
result of the administration's grandfather health plan regulation. The 
former Director of CBO, Doug Holtz-Eakin, warned that the law 
``provides strong incentive for employers and their employees to drop 
employer-sponsored health insurance for as many as 35 million 
Americans.''
  Well, if employers drop their health care coverage, how can employees 
cash in on the President's promise to keep what they have?
  Millions of seniors will lose access to their Medicare Advantage 
Plan. I am not quite there, but some of my colleagues have reached that 
magic number.
  Do seniors not deserve choice? Is that what it is? Do we just want to 
give them one thing and no choice? The truth is we allowed--we didn't 
create it; the private sector created it, but we allowed the private 
sector to create Medicare choice years ago, and for many seniors they 
chose to take the private sector product. Why? Because it provided more 
coverage to them. It provided preventive care. They actually got 
covered physicals every year. In many cases they didn't have 
copayments. In many cases their prescriptions were covered long before 
we created Part D Medicare.
  So what does the President's health care plan do? It tightens the 
requirements on Medicare Advantage to the point that some seniors who 
are on it today will lose it because it is no longer an option in the 
markets they live in. How in the world can someone do that and make the 
promise: If you like it, you get to keep it?
  Health plans offered by religious-affiliated organizations will be 
compelled to offer products that violate the tenets of their faith--a 
new mandate that jeopardizes an employee's existing coverage and 
infringes on religious liberty. That is going into ground we have never 
entered, and I think there is a reason we have allowed people to hold 
to their moral standards they believe are important.
  Then-Speaker of the House Pelosi said the health care law will create 
4 million jobs--400,000 jobs almost immediately. Yet the Director of 
the Congressional Budget Office testified that the new law will reduce 
employment over the next decade by 800,000 jobs.
  Think about that. Then-Speaker Pelosi said 4 million jobs--400,000 
almost immediately--and the CBO Director testified we are going to lose

[[Page 9931]]

800,000. That is a difference of 4.8 million jobs in America.
  The President said he was not going to touch Medicare. We heard that 
over and over. He said to seniors: I am not going to touch Medicare. He 
had already taken Medicare Advantage away as a choice, but he wasn't 
going to touch Medicare. The law took more than $500 billion out of 
Medicare, a health care plan that today is not financially sustainable, 
and the President, in his health care legislation, shifted $500 billion 
out of Medicare--not to put Medicare on a sustainable path but to fund 
new government programs the American people cannot afford.
  Arbitrary cuts to providers that jeopardize access to care will not 
put Medicare on a sustainable path for current and future retirees. 
What does that mean? Doctor cuts. We cut the reimbursements to doctors, 
we cut the reimbursements to hospitals. We now have doctors who will 
not see Medicare beneficiaries. If you are 65 and you move to Raleigh, 
NC, the likelihood is you are not going to find a primary care doctor 
that is going to take you if you are on Medicare. To that person, to 
that senior, that is rationing. I don't care how you say it. And the 
reality is this bill caused that.
  The President promised no family making less than $250,000 a year 
will see any form of tax increase. I just covered a second ago that the 
new health care law is riddled with new taxes and penalties that 
directly fall on the middle class and will harm small businesses. New 
taxes on lifesaving drugs, devices, and health plans are all going to 
be passed on to consumers. It is disingenuous to say everybody in the 
system is not going to feel the effects of taxes. They might not be 
directly on us, but they are on the products that constitute our health 
care system. We should be advancing policies that help small business 
to thrive in America, not policies that increase health care costs. We 
should not be advancing policies that encourage innovators to export 
innovation and good-paying jobs overseas. We should be advancing 
policies that focus on helping to get our economy back on track.
  Unfortunately, the President's health care law does just the 
opposite. According to the U.S. Chamber of Commerce Survey on Small 
Business, 74 percent of small businesses said the health care spending 
law makes it harder for their firms to hire new workers. Thirty percent 
said they are not hiring due to the law.
  There is only one issue in America: How do we get the American people 
back to work right now? How do we turn this economy around right now? 
We can have all the cuts we want to have from the standpoint of 
spending. But unless we are willing to put Americans back to work and 
get them productive and participating in the revenue collection of this 
country, we are not going to get on a pathway to financial 
sustainability.
  This country wasn't created because people came here and said: Let's 
create a place called America where everything is free. It was created 
as an area of unlimited opportunity. That is why millions a year come 
here, for unlimited opportunity, not for unlimited handouts.
  When de Tocqueville left the United States, he talked about ``the 
greatest country in the world,'' and he defined it this way: the 
capacity of the American people to give of their time and their 
resources for people who are in need. He never mentioned State or 
Federal Government.
  He talked about a responsibility of the American people to help 
somebody that was down on their luck, hungry, homeless. Do you know 
what. For those of us who are adults, it is our responsibility to set 
the example for the next generation to come and assume the same 
individual responsibility. But now it seems as though all we talk about 
is legislation that inserts the Federal Government or the State 
government or the local government in the place of what historically 
made this country great, which was our willingness to assume the 
responsibility ourselves.
  Let me assure you, we shouldn't be surprised by the results of the 
assessment that the government running health care means job loss and 
increased costs. We have to make sure we provide more choice, not less 
choice. We have to get the American people engaged in negotiating their 
health care costs, not letting the Federal Government negotiate their 
health care costs.
  I came here for the first time 18\1/2\ years ago. I worked for a 
company of 50 employees. I came to the U.S. House of Representatives 
and chose the same plan I had with that small employer in Winston-
Salem, NC. The only difference was that when I got here, the Federal 
Government paid 75 percent where my employer had paid 75 percent. I 
paid 25 percent here; I paid 25 percent there. I got exactly the same 
plan and the same coverage. Everything was identical.
  When I left Winston-Salem to become a Member of the U.S. House of 
Representatives, my cost of that health care plan was $105. When the 
Federal Government got through negotiating my same health care plan, it 
went up to $160. I knew on day one I did not want the Federal 
Government negotiating my health care because it meant higher prices 
and no change in coverage.
  I think many Americans have realized that about ObamaCare. My hope 
and my plea and my prayers are that Thursday the Supreme Court 
nullifies this bill and this Congress is challenged with going back and 
step by step or in a comprehensive fashion write a health care bill 
that includes the participation of the American people and puts 
responsibility on everybody. Everybody in America should have the 
responsibility to pay something when they go in to access it. It 
doesn't matter whether it is private insurance, it doesn't matter 
whether it is Medicare, it doesn't matter whether it is Medicaid.
  If we want to solve the financial hole we are in in this country, 
then we have to income-test everything that comes out of the Federal 
Government. It means people who have more pay more. It means people who 
have less pay something. But we have to be a country of unlimited 
opportunity and not of unlimited handouts.
  A February 2012 Gallup survey found that 48 percent of small 
businesses are not hiring because of the potential cost of health care. 
Studies indicate that the law's innovative tax killing on medical 
devices could cost an additional 43,000 jobs in America. The 
President's health care bill is the wrong prescription for America.
  Regardless of the Supreme Court's decision this week, it is clear: We 
must advance commonsense sustainable reforms that actually fulfill the 
promise to lower health care costs. Without that America should be 
outraged and, I believe, will be outraged.
  Also in the news in the last several weeks is an issue that is 
somewhat personal to me as a member of the Senate Intelligence 
Committee, as a former member of the House Intelligence Committee, as 
one who has dealt with the work of the Intelligence Committee since the 
year 2000, and as one who lived up close and personal with everything 
that has happened since 9/11. We have seen an incredible spree of 
security leaks--leaks of classified and sensitive information.
  When I go home on the weekends and there is a news report on 
something, my wife will look at me and say: Why is this reported? There 
is no reason for the American people or for anybody in the world to 
know about that.
  I can tell you it was not that long ago that even if the press found 
out, they would never print it. Today, routinely there are leaks of 
classified and sensitive information. Recently there has been a series 
of articles published that have described, in some cases in extreme 
detail, highly classified unilateral and joint intelligence operations.
  I am not talking about suggesting that it might be there without 
detail, I am talking about specifics of what happened. To describe 
these leaks as troubling and frustrating is an understatement. They are 
inexcusable by whomever. Our intelligence professionals, our allies, 
and, most importantly, the American people, deserve better than

[[Page 9932]]

what they have seen over the last several weeks. I am personally sick 
and tired of reading articles about sensitive operations based on 
``current and former U.S. officials--individuals who were briefed on 
the discussions--officials speaking on condition of anonymity to 
discuss the clandestine programs--a senior American officer who 
received classified intelligence reports--according to participants in 
the program--according to officials in the room--and individuals none 
of whom would allow their names to be used because the evidence remains 
highly classified and parts of it continue today.''
  That is the basis on which these front-page stories run. I am not 
confirming or denying that anything in it is accurate or inaccurate 
because as a member of the committee I sign an obligation that says no 
covert action will I even comment on. Any person who holds a secret 
compartmentalized clearance has an obligation to never acknowledge the 
existence of a program.
  I asked, not long ago, was the drone program still a classified 
program? The answer I got is yes. But the White House Press Secretary 
for the last 3 weeks stood at the podium and talked about drone 
attacks--on a program that I technically cannot go out and acknowledge 
either exists or does not.
  Our freedom, with understanding that politics trumps security, has 
reached a new level. It has to stop and it has to stop now. The 
unauthorized disclosure of classified intelligence at best violates 
trust and potentially damages vital liaison relationships and at worst 
it gets people killed. Clandestine operations are often, as I wrote 
with Senators Coats and Rubio in the Washington Post, ``highly 
perishable and they depend on hundreds of hours of painstaking work and 
the ability to get foreigners to trust our Government. I strongly 
believe that these leakers are also violating the trust of the most 
important constituency of all--the American people.''
  Even more troubling is that there appears to be a pattern to these 
stories and leaks, that they may be designed to make the administration 
look good on national security. It used to be that the good stuff was 
buried by the media and the worst was run. Not anymore. Truth be told, 
rarely have I seen a story that paints this administration in a bad 
light. Then, when we are about to, the administration invokes executive 
privilege. They can do that. That is OK. But there is a big difference 
between invoking executive privilege on not producing documents for 
Fast and Furious, and releasing classified information that puts at 
risk individuals who are embedded in terrorist organizations, who are 
doing their job to keep America safe.
  This has crossed the line. I wish this administration was as 
concerned about preventing leaks of classified information as it is 
about keeping a lid on the information Congress is asking for. As a 
member of the Senate Intelligence Committee I understand firsthand the 
grave importance of keeping information secure. The unauthorized and 
reckless disclosure of classified information undermines the hard work 
of our intelligence officers and puts lives at risk, and it jeopardizes 
our relationship with overseas partners. Congress's intelligence 
oversight committees will not tolerate it, nor should the American 
people.
  Simply, I come to the floor today to deliver a message to those 
individuals who were briefed on the discussions, who were part of the 
program, who were in the room, who are speaking on condition of 
anonymity: Stop talking. Whatever agenda you have, I can assure you it 
is not worth the damage you are causing and the lives you are putting 
at risk. We cannot continue to tolerate leaks at any level or branch of 
government.
  My colleagues and I are considering every available legislative 
option to ensure the security of the intelligence community operations 
and the people who support them. If you have access to classified 
information and are tempted to leak that information for whatever 
reason, I ask you to remind yourself what you may be hurting and what 
trust you are violating and, more importantly, keep your mouth shut.
  The Intelligence Committees on both sides of the Hill I think will 
take action in their authorization bill to try to address a structure 
that brings a new level of oversight and hopefully prosecution to those 
who choose to leak secrets. In the interim, I am still considering the 
fact that for any person who openly talks about a program that is 
secret or compartmentalized, the day they say one word about that 
program they lose their top secret clearance. I would love to see them 
lose their pension but I understand how problematic that is. But at 
least we can stop the bleeding by taking away their access to the 
conversations or the meetings they happen to be a participant in or the 
information they happen to be entrusted with in a fashion that allows 
them to go out and publicly talk about that and jeopardize the lives of 
Americans, the lives of our partners and, more importantly, the 
security of the American people.
  On August 5, 2011, Standard & Poor's downgraded the credit rating of 
the United States for the first time in our history and they cited out-
of-control debt and lack of a serious plan to address it as its main 
reason. Nearly a year later the administration has done nothing to 
remedy this problem. As a matter of fact, sometime at the end of this 
year we are going to run out of our ability to borrow money. It is 
called the debt ceiling. I cannot tell you today, because we are not 
told, whether that is going to happen in October, November, December, 
January--but it doesn't go much past the end of the first of the year. 
I sort of pity the next President, whoever that is. They are probably 
going to get inaugurated one day and the next day they are going to 
have to come to Congress and ask for a $3 trillion increase in the 
national debt.
  As difficult as it is for me to say, we are going to have to do it. 
The country has to have the capacity, the capabilities to borrow money 
to function. But you would think with this all known we would take the 
opportunity now to begin to change the grotesque spending habits, to 
begin to prioritize the investments we make, that we would attempt to 
reform the programs that cost us the most and lead to an unsustainable 
financial future for the United States--a country that will soon be 
$17.8 trillion in debt, a debt I will not be here to pay back but my 
children and my grandchildren will.
  You have to ask yourself as a parent: Is that fair? The answer is it 
is not. Instead of doing anything, last year the debt ceiling needed to 
be increased by $2.1 trillion. We are about to blow through it. Why? 
Because we spend $1 trillion more on an annual basis than what we 
collect. There is no business, no family, no institution in the world 
that could spend $1 trillion more than they collect and be in 
business--nor can this country. The time is running out.
  By the way, it is hard to put a calculation on $1 trillion. What is 
$1 trillion? It is 100 percent of the Federal investment in K-12 
education, 100 percent of the Federal investment in higher education, 
it is 30 percent of the VA budget, it is 100 percent of the National 
Institutes of Health; it is 100 percent of the cost of the National 
Science Foundation, it is 100 percent of the Federal partnership with 
States and localities for infrastructure--bridges, roads, sidewalks. It 
is 100 percent of our national defense, it is all branches of the 
military, active and reserve, all bases of the military, domestic and 
foreign. It comes up to about $942 billion. If you want to balance this 
year's budget you have to cut everything I just talked about and find 
$60 billion more, just to balance this year's budget.
  The take-away from this is we are not going to delete our national 
security. We are not going to decrease our investment in the National 
Institutes of Health, National Science Foundation. We are going to be a 
partner in K-12 and higher education. There are a lot of places we can 
cut and should prioritize and we can do it, but the take-away is we 
can't get there unless we are willing to reform entitlements, unless we 
are willing to look at where the majority of the money is spent. We 
cannot get there.

[[Page 9933]]

  We have to do something. I tell you it starts with addressing the 
imbalance we have in spending and collection right now--not next year.
  Consistent with this is the Senate still has not passed a budget. In 
fact, the President's own budget did not receive a single vote in 
Congress when we voted on it. I should not laugh. We are on track for 
another year with a $1 trillion deficit. How could anyone run their 
company on an annual basis without a budget, without a financial 
roadmap as to what they do? But now, for over 1,000 days the U.S. 
Senate has not passed a budget. And the law says we have to do it. That 
is incredible. It is absolutely incredible. Over the last 3\1/2\ years 
we have added $5 trillion to the national debt, more than in the 
previous 8 years combined, and current estimates by the CBO put Federal 
debt at 70 percent of our gross domestic product by the end of this 
year.
  We are reaching irreversible levels of debt, as it relates to the 
size of our economy. It is unsustainable and it is dangerous for the 
fiscal health of our country. The status quo needs to change. Congress 
needs to address the impending fiscal cliff or risk another downgrade 
in the coming months.
  We can accomplish this by passing a budget that moves us toward 
balance. We can accomplish this by reforming entitlements and not 
putting Band-Aids on issues for another time. Our debt will begin to 
decrease when we put the American people back to work and we get 
policies in place that encourage the investment of capital.
  How about something novel? Why don't we reform our Tax Code? Give me 
the ability to go to a small business in North Carolina and tell them 
they are going to pay exactly the same thing GE pays. It is hard for me 
to explain how they pay 36 percent and GE paid nothing. I am not 
faulting GE, don't get me wrong. That is exactly what the Tax Code 
currently says. That doesn't make it right. It doesn't mean we have an 
obligation to leave it like that in the future. I look at it as an 
opportunity for us to bring equity. But as we bring equity, why don't 
we bring everybody's obligation--their rates--down. It is time for us 
to reform individual corporate taxes in America, to do away with 
loopholes and deductions, to flatten the rates for everybody, to 
broaden the participation by more Americans. Guess what. If we do that, 
we will be like a magnet for global capital. What does it take to 
create jobs in the United States? It takes an investment. Reform the 
Tax Code, flatten the rates, broaden the base, and we will attract 
capital that will flee to America and create jobs like we have never 
seen. At a time where the world continues to try to figure out how to 
get out of a hole, we have an option to do it.
  I yield to the Senator from Iowa.
  Mr. HARKIN. Madam President, I ask unanimous consent that Senator 
Burr have the time until 4:40 p.m.; that I be recognized for up to 5 
minutes, following the remarks of Senator Burr; further, that after my 
remarks, all remaining time be yielded back, the motion to concur with 
an amendment be withdrawn, and the Senate proceed to vote on adoption 
of the motion to concur in the House amendment to 3187.
  The PRESIDING OFFICER (Mrs. Shaheen). Is there objection? Without 
objection, it is so ordered.
  Mr. HARKIN. I thank the Senator from North Carolina.
  Mr. BURR. I thank the Senator from Iowa. So I just gave us a recipe 
for solving our economic crisis in America. Some might say it will not 
work. I don't know. I think it will. I can say this. What we are doing 
is not working. We are not putting anybody back to work. We are still 
losing. My State of North Carolina has 9.4 percent unemployment. How 
long does it have to continue before we look at it and say this might 
be a systemic problem? Can we recover from this?
  How many law school graduates can we look at this year where 60 
percent of the class of graduates from the first of May to the end of 
June doesn't have a job? As a parent, I always thought the toughest job 
was to make sure my kids got in school and that they graduated in 4 
years. Now the greatest burden on a parent is to make sure when they 
get out, they get a job that has a paycheck and maybe that check puts 
them in a situation where they are self-sustainable. That is not the 
promise we made to our kids and that ought to be the driving force 
behind every adult in this country demanding a change.
  Most of our kids did exactly what we asked them to do--stay in 
school, make good grades, go to college, get a major. If they do that, 
they will be guaranteed a job and an unlimited future. Now the seniors 
who graduate from college who are not finding a job, their experience 
is being questioned by their little brother or sister at home who is 
struggling to get through high school and wondering why they want to do 
6 more years of education if their older sibling can't find a job.
  It doesn't have to be like this. All we have to do is muster up the 
backbone we need to pass legislation that creates the atmosphere for 
capital to be invested in job creation.
  I am not rich, but I am getting tired of us dividing America in as 
many pieces as we can divide it. We already divide it based on 
political boundaries. Now we are trying to divide it on everything we 
can find. Yet for every politician when they give that big speech on 
TV, they boil it down to this is about America. But when we look at the 
campaign rhetoric out there, they slice it and dice it and try to 
divide it in many ways. Let me assure everyone, we are not going to 
solve this if America doesn't solve it. It is not going to be solved in 
the Halls of Congress unless the American people demand it. It is not 
just one segment of America; it is all segments of America.
  I talked about de Tocqueville's definition of the greatness of 
America earlier. He didn't point out some Americans who did it good or 
did it right. He looked at America as one.
  As a matter of fact, when we look historically at this country--and I 
realize I only have a couple minutes left; I will be brief. When the 
Capitol dome was torn off and the new construction started, it was 
because of the wing we are currently in, the Senate, and the identical 
wing that was built on the House side. When those wings were added, 
architecturally, the dome that was on top of the Capitol was out of 
proportion, and that dome was called a Bulfinch dome. In about 1851 or 
1852, they started building the dome we see today, made of 9 million 
pounds of cast iron. As that dome was about one-third of the way 
finished, Abraham Lincoln was President, and they could actually watch 
the Civil War battles across the Potomac on the other side of the 
river.
  Then came the end of the war and Lincoln was President and had every 
right to be punitive to the South because they lost. I challenge 
everybody to go back and read Lincoln's speeches after the Civil War. 
Remember, the first action was to let every southerner go and keep 
their gun because he knew they needed to eat. In every speech President 
Lincoln gave after the end of that conflict where he could have in his 
remarks been punitive to the South, President Lincoln talked about one 
Nation, one people. As the leader of the United States, he understood 
his single job was to bring this country back together. Even though he 
probably had the greatest reason to draw division in America, he 
refrained from that temptation and spent all his time redefining what 
makes America great; that is, a united country of people.
  In the temptation to win elections and the temptation to show the 
highlights or successes of one party over the other, I will conclude 
with this: As leaders in the country, we have a real opportunity to set 
by example how we go forward. Let's quit the political divisions. Let's 
start it with the two Presidential candidates. Don't slice and dice 
America to where it is that group against this group and that group. 
Let's realize if we want to change the direction of this country, 
somebody has to stand and bring America together. My belief is we need 
to do it now or there may not be another opportunity.
  I can look at my good friend Senator Harkin and myself and we are at 
an age where we are not going to drastically change the future. We made 
the

[[Page 9934]]

bed we are going to sleep in. But for our children and our 
grandchildren, the impact of what we do can drastically change the 
opportunities they have for a lifetime.
  I would love to leave this institution believing we have had an 
impact that extends prosperity and opportunity for generations to come. 
But for a majority of the 2\1/2\-plus hours I have taken today, if we 
don't have the backbone to take it on, it is not going to happen. If we 
don't do it, nobody else will. Let's demand that the leadership we put 
in place is willing to show the leadership needed to bring this country 
back together for a common purpose. That purpose is to be a country of 
unlimited opportunities, where everybody is being treated fairly.
  I thank the Presiding Officer for her attention.
  I yield the floor.


                            New Antibiotics

  Mr. MENENDEZ. Madam President, I ask to be recognized to engage in a 
colloquy with my good friend from Iowa, the Chairman of the HELP 
Committee, Senator Harkin.
  I want to thank the Chairman for his leadership on this bill, the 
Food and Drug Administration Safety and Innovation Act. This is a 
critically important piece of legislation and I am proud to support it. 
I wanted to ask the Senator to clarify something for me regarding 
language in the bill dealing with the development of new antibiotics. 
This bill contains language to incentivize the development of 
antibiotics, both for newly-discovered infections where antibiotics do 
not yet exist as well as for those resistant infections where currently 
available antibiotic treatments may no longer work. These incentives 
are available for qualified infectious disease products, that is, 
products intended to treat serious or life-threatening infections, 
including those caused by resistant gram positive pathogens and multi-
drug resistant gram negative bacteria. It is my understanding that 
products intended to treat serious or life-threatening infections 
caused by gram negative anaerobic bacteria are also considered 
qualified infectious disease products, and therefore eligible for the 
incentives contained in this provision. Is that the case?
  Mr. HARKIN. I thank my friend from New Jersey for the opportunity to 
clarify this point. The Senator is correct that this provision aims to 
provide incentives in the form of extended market exclusivity for 
certain antibacterial and antifungal drugs that treat serious or life-
threatening infections. He is also correct that the list of qualified 
pathogens in the legislation is illustrative, and not exhaustive. 
Products intended to treat serious or life threatening infections 
caused by gram negative anaerobic bacteria would be qualified 
infectious disease products and would therefore be eligible for the 5 
years of extended market exclusivity.
  Mr. MENENDEZ. I appreciate the Senator clarifying that point. As he 
knows, infections caused by gram negative anaerobic bacteria such as 
Bacteroides and Garnerella have a disproportionate impact on women of 
color and cause an increased risk of HIV infection and complications of 
pre-term labor. I am pleased that this bill takes the steps necessary 
to ensure treatments for these infections can come to market and help 
those in need. Again, I thank the Senator for his leadership on this 
bill and for clarifying this point today.
  Ms. MIKULSKI. Madam President, I come to the floor to talk about 
antibiotic resistance, a public health threat to Americans across the 
country. I have heard first hand from hospitals, health care providers, 
public health officials, scientists, and life sciences companies in 
Maryland that we need new antibiotics in our arsenal. Bacteria, like 
viruses, are crafty and constantly evolving to thwart existing 
treatments. Everyday, Americans are infected by multi-drug resistant 
microbes.
  In most instances, antibiotics, much like vaccines, are not meant to 
be used everyday to treat a condition for months, years, or a lifetime. 
You use antibiotics sparingly, so you do not build up resistance. Yet, 
drug development for these infectious pathogens can take just as long 
as developing any other drug whether it is for HIV, heart disease, or 
cancer. Because antibiotics are used for a short period of time, they 
are not really profitable to the companies investing the time and money 
to develop the product. There are not many small start-up companies or 
big pharma companies that want to take the risk. Research and 
development costs hundreds of millions of dollars, so these companies 
are reluctant to invest in a safe and effective drug that doctors are 
told to use sparingly. Bottom line, developing a next generation Viagra 
pill is far more profitable for shareholders.
  So, House and Senate Republicans and Democrats came together and 
worked on a bipartisan bicameral solution to incent development of 
drugs to treat serious or life-threatening bacterial infections. We 
need to get more antibiotics in the drug development pipeline. We are 
running out of antibiotics to treat MRSA, tuberculosis, acute pelvic 
infections, complicated urinary tract infections, or complicated intra-
abdominal infections. There are many anaerobic gram negative and 
anaerobic gram positive bacteria that are fatal, cause lifelong 
injuries, increase the transmission of HIV and other sexually 
transmitted diseases, or affect the reproductive and gastrointestinal 
tracts.
  Title VIII of our bill, provides incentives for the development of 
antibiotics to treat serious or life-threatening infections, including 
infections where tolerance and resistance to existing antibiotics make 
them ineffective. We need to clear up infections that can cause poor 
outcomes for patients or negatively impact the public's health.
  This bill will increase exclusivity for manufacturers that invest the 
time as well as the research and development dollars to bring new 
antibiotics to the market that knock out infections that cause pre-term 
labor or target bacterial infections in patients with unmet needs.
  Mr. LEAHY. Madam President, I am pleased that Congress will finally 
send to the President the bipartisan Food and Drug Administration 
Safety and Innovation Act, FDASIA. This legislation previously received 
overwhelming support in the Senate and was passed by the House of 
Representatives by a voice vote just last week. This final action by 
the Senate will reauthorize the prescription drug user fee program and 
medical device user fee which are set to expire on October 1, 2012. It 
will also authorize two new provisions to allow the FDA to review and 
approve generic drugs and biosimilar drugs in a timely manner. 
Importantly, this bill includes several provisions that I have 
supported to prevent access to dangerous drugs.
  Passage of the FDASIA will help stop drug shortages that affect 
thousands of Americans. I have heard from a number of Vermonters 
concerned about the uncertainty of availability of lifesaving drugs and 
devices. While the FDASIA will not stop all drug shortages, I hope it 
will give Vermonters who depend on these medications relief knowing 
more steps are being taken to ensure these shortages don't happen.
  This legislation also includes an important provision I have been 
proud to author to address the problem of counterfeit drugs. In March, 
the Senate passed by unanimous consent bipartisan legislation that I 
introduced with Senator Grassley to deter the sale of counterfeit 
drugs. The Counterfeit Drug Penalty Enhancement Act, S. 1886, has the 
support of groups such as the Alliance for Safe Online Pharmacies, the 
Easter Seals, and the U.S. Chamber of Commerce. The legislation is 
consistent with recommendations from the Intellectual Property 
Enforcement Coordinator and the administration's Counterfeit 
Pharmaceutical Interagency Working Group. I am pleased that a 
compromise version of this legislation will become law as part of S. 
3187.
  I am also glad that the final bill includes important provisions 
addressing the issue of synthetic drugs. These provisions correspond to 
three bills that the Senate Judiciary Committee passed last year--the 
Combating Dangerous Synthetic Stimulants Act, S.

[[Page 9935]]

409; the Combating Designer Drugs Act, S. 839; and the Dangerous 
Synthetic Drug Control Act, S. 605. I was glad to move these bills 
through the committee last year and to work to try to pass them in the 
full Senate. They address substances commonly known as ``bath salts'' 
and other synthetic drugs that have no legitimate use and can too 
easily be obtained under current law. Bath salts have resulted in a 
number of reports of individuals acting violently in the United States, 
including in Vermont, and have led to injuries to those using them and 
to others.
  I thank Senators Klobuchar, Grassley, Portman, and Schumer for their 
leadership on this issue. I was glad to be able to work with them and 
with Senator Harkin to support including these important provisions in 
the FDA bill and keeping them there in negotiations with the House. It 
is good that we are able to make real progress in this area.
  I am also glad that we are moving forward on this issue in a 
responsible way after appropriate consideration. Adding chemicals to 
schedule I of the Controlled Substances Act has serious consequences 
and is not a step that we should undertake without careful 
consideration. We will continue to study this issue and consult with 
the DEA, FDA, and others going forward.
  I note also that Senator Paul has expressed serious concerns about 
the mandatory minimum sentences contained in the Controlled Substances 
Act, mandatory sentences that are expanded every time we schedule new 
substances. I appreciate those concerns. As more and more of our 
criminal justice budget goes to housing more and more people in prison 
for ever longer periods of time, rather than supporting prevention 
programs and law enforcement which can more efficiently and effectively 
reduce crime, we have to rethink our reliance on mandatory minimum 
sentences, particularly for nonviolent drug offenses. In the future, I 
intend to work with Senator Paul and others on this vital issue.
  Finally, I am pleased that the final FDASIA includes language to 
protect the public's ability to access information under the Freedom of 
Information Act, FOIA. This bill will allow the Food and Drug 
Administration, FDA, to obtain important information about drug 
inspections and drug investigations undertaken by foreign governments, 
while at the same time ensuring that the American public has access to 
information about potential health and safety dangers. This provision 
carefully balances the need for the government to keep some information 
confidential, with the need to ensure free flow of information in our 
democratic society. 
A number of Senators, including 
Senator Harkin and Senator Enzi, 
and a number of open government 
and consumer groups, including OpenTheGovernment.org and Public 
Citizen, worked with me to protect the public's access to FDA 
information in this bill.
  Sending this legislation to the President's desk will save lives. The 
Senate's action will also mitigate the uncertainty facing the FDA 
should these user fees expire. I am pleased to support this legislation 
and urge other Senators to do so as well.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. HARKIN. Madam President, we are about to move to a vote on the 
FDA reauthorization bill, a bill which I have said earlier we spent 
more than 1 year working on in committee. It has had a lot of input 
from Senators on all sides, including industry stakeholders and 
consumer groups. This is the result of a wide collaboration on all 
these issues.
  I wish to respond to a couple things my friend from North Carolina--
and he is my friend--said earlier about the amendment he was concerned 
about on the track-and-trace amendment. The Senator from North Carolina 
talked about speed. He said we were rushing this through. The vote in 
the Senate was 96 to 1. The House vote was unanimous. That doesn't 
happen if a bill is being rushed through. Anybody who tries to rush a 
bill is not going to get 96 votes in the Senate or a unanimous vote in 
the House.
  Again, my friend questioned how hard we tried to get the track-and-
trace provision included in the conference report. I might turn the 
question around and question how hard the Senator from North Carolina 
and the Senator from Colorado worked to get this included. We have been 
working on this bill for over 1 year. My friend, a good member of the 
committee, and his staff has been very much involved in many aspects of 
this bill. So I wonder why the amendment was dropped on our staff 1 day 
before filing the bill at the midnight hour. I might also point out 
that on September 14, 2011, our committee had a hearing on the supply 
chain issue. The record will show that I, the chairman, was the only 
one to raise the issue of track and trace at that hearing.
  Two weeks before markup, Senator Burr and Senator Coburn introduced 
an FDA bill. Senator Enzi's staff and my staff worked for 2 weeks to 
incorporate elements of this bill into the reauthorization. These are 
elements of the bill that were introduced 2 weeks before by the Senator 
from North Carolina, Mr. Burr, and Senator Coburn. So our staff spent 2 
weeks trying to incorporate elements into the bill, and they did. We 
did incorporate a lot of elements. I would point out there was nothing 
that mentioned track or trace that was in that bill that was introduced 
2 weeks before.
  Again, I just say, if this was so important, why wasn't it in their 
bill? If it was so important, why did they wait until Sunday evening at 
6:20 p.m., the day before filing, to get the language? Again, who is 
trying to rush what? We did not try to rush anything, but when we get 
something dropped in our lap at 6:20 p.m. the night before the filing, 
it is hard to build a consensus, and that is what this bill is. We did 
go to conference on this, but this issue involves a lot of different 
players, and we could not get that consensus.
  So I say to my friend from North Carolina, we are still working on 
this. We will work on it in good faith, but we have the State of 
California, we have the pharmaceutical manufacturers, we have 
drugstores, we have consumers, we have a lot of people out there who 
have something to say about this, and we have to build that coalition 
in order to get a good track-and-trace bill through.
  We are now about to vote on the critical FDA bill reauthorizing user 
fees, modernizing FDA's authority in several meaningful and targeted 
ways, addressing the drug shortage problem, streamlining the device 
approval process, enhancing our global drug supply chain authority and 
all the while maintaining and improving patient safety. Because this 
bill will directly benefit patients and the U.S. biomedical industry, 
it is critically important to the agency, industry, and most important 
to patients that we get this done.
  I urge my colleagues to vote for final passage and pass this bill. It 
is the same bill the House passed unanimously. Once it is done here, we 
can send it to the President and get it signed and move ahead with a 
good reauthorization of the Federal Food and Drug Administration.
  The PRESIDING OFFICER. Under the previous order, the motion to concur 
with amendment No. 2461 is withdrawn.
  The question is on agreeing to the motion to concur in the House 
amendment to S. 3187.
  Mr. HARKIN. I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There appears to be a sufficient second.
  The clerk will call the roll.
  The legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Colorado (Mr. Udall) is 
necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from Utah (Mr. Hatch), the Senator from Illinois (Mr. Kirk), and the 
Senator from Arizona (Mr. McCain).
  Further, if present and voting, the Senator from Utah (Mr. Hatch) 
would have voted ``yea.''
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?

[[Page 9936]]

  The result was announced--yeas 92, nays 4, as follows:

                      [Rollcall Vote No. 168 Leg.]

                                YEAS--92

     Akaka
     Alexander
     Ayotte
     Barrasso
     Baucus
     Begich
     Bennet
     Bingaman
     Blumenthal
     Blunt
     Boozman
     Boxer
     Brown (MA)
     Brown (OH)
     Cantwell
     Cardin
     Carper
     Casey
     Chambliss
     Coats
     Cochran
     Collins
     Conrad
     Coons
     Corker
     Cornyn
     Crapo
     DeMint
     Durbin
     Enzi
     Feinstein
     Franken
     Gillibrand
     Graham
     Grassley
     Hagan
     Harkin
     Heller
     Hoeven
     Hutchison
     Inhofe
     Inouye
     Isakson
     Johanns
     Johnson (SD)
     Johnson (WI)
     Kerry
     Klobuchar
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Lee
     Levin
     Lieberman
     Lugar
     Manchin
     McCaskill
     McConnell
     Menendez
     Merkley
     Mikulski
     Moran
     Murkowski
     Murray
     Nelson (NE)
     Nelson (FL)
     Portman
     Pryor
     Reed
     Reid
     Risch
     Roberts
     Rockefeller
     Rubio
     Schumer
     Sessions
     Shaheen
     Shelby
     Snowe
     Stabenow
     Tester
     Thune
     Toomey
     Udall (NM)
     Vitter
     Warner
     Webb
     Whitehouse
     Wicker
     Wyden

                                NAYS--4

     Burr
     Coburn
     Paul
     Sanders

                             NOT VOTING--4

     Hatch
     Kirk
     McCain
     Udall (CO)
  The motion was agreed to.
  Mr. HARKIN. Mr. President, today, with final passage of the FDA 
Safety and Innovation Act and the reauthorization of the FDA user fee 
agreements, we have helped both the FDA and the biomedical industry 
ensure that they can get needed medical products to patients quickly. 
This legislation, now headed to the President for his signature, will 
ensure that the FDA can swiftly approve drugs and medical devices, save 
biomedical industry jobs, protect patient access to new therapies, and 
preserve America's global leadership in biomedical innovation. It will 
keep patients safer by modernizing the FDA's inspection process for 
foreign manufacturing facilities, while also improving access to new 
and innovative medicines and devices. It will reduce drug costs for 
consumers by speeding the approval of lower cost generic drugs and help 
prevent and mitigate drug shortages.
  Finally, by improving the way FDA does business, increasing 
accountability and transparency, U.S. companies will be better able to 
innovate and compete in the global marketplace.
  With the FDA Safety and Innovation Act ready to be signed into law, 
we have taken an important step to improve American families' access to 
lifesaving drugs and medical devices.
  As I have said throughout this debate, the bipartisan process that 
produced this excellent bill has been a shining example of what can be 
achieved when we all work together in good faith. I worked very closely 
with my colleagues on both sides of the aisle, as well as industry 
stakeholders, patient groups, and consumer groups, to solicit ideas and 
improvements on the critical provisions in this bill. We have a better 
product thanks to everyone's input.
  My colleague, Ranking Member Enzi, deserves special recognition, and 
I extend my sincerest gratitude to him. Without his strong leadership 
and cooperation in this open bipartisan process, we would not have the 
exceptional consensus measure we have today. So I thank Senator Enzi 
for his partnership and collaboration throughout the past almost year 
and a half.
  I wish to specifically thank the staff of Ranking Member Enzi, as 
they have devoted countless hours to working with my staff and others 
throughout this process to build consensus for this legislation.
  I thank Frank Macchiarola, Chuck Clapton, Keith Flanagan, Melissa 
Pfaff, Grace Stuntz, Katy Spangler, and Roley Swinehart. I sincerely 
thank them for their tireless efforts and loyal commitment to this 
cause.
  I also thank all of the HELP Committee members as well as other 
Senate Members and their staffs who were thoroughly engaged with this 
process from the beginning as part of the bipartisan working groups. 
Each of you has contributed significantly to this legislation, and I am 
sincerely grateful for your contribution.
  I also recognize Chairman Upton and Representative Waxman, as well as 
their staffs, who worked tirelessly to reconcile the differences 
between the Senate and House legislation.
  Of course, I thank my own staff on the HELP Committee, who have spent 
many a night and weekend with Senator Enzi's staff, other Members' 
offices, and our colleagues in the House working to come to consensus 
on the critical policy issues in this legislation.
  First of all, I thank our staff director Pam Smith, and I especially 
want to note the tremendous work done by Jenelle Krishnamoorthy through 
this last almost 15 months or more, for pulling people together and 
working on weekends. I don't know how she does it, and she still has 
time for the twins. It is remarkable, but she does it, and it is done 
remarkably well, and I thank Jenelle especially for her great 
leadership.
  I also thank Elizabeth Jungman, Bill McConagha, Kathleen Laird, Dan 
Goldberg, Justine Sessions, Kate Frischmann, Elizabeth Donovan, Frank 
Zhang, and Evan Griffis.
  I also thank our former staff director Dan Smith, who left the 
committee as staff director a couple of months ago, but he was very 
much involved in this until the time of his departure.
  I also thank the Congressional Budget Office for their knowledgeable 
and capable team that was willing to work around the clock sometimes to 
estimate the budgetary effect of the legislation.
  We also owe our gratitude to the staff members in the Legislative 
Counsel's Office--specifically Stacy Kern-Scheerer and Kim Tambor. This 
bill is a result of tremendous effort by their team to draft and 
redraft provisions in this measure, as well as address technical issues 
well into the nights and over weekends. I thank them profusely for 
their dedication.
  This bill's final passage is a victory for millions of Americans who 
need medicines or medical devices, a victory that would not have been 
possible without the dedicated work of our Senate family.
  The PRESIDING OFFICER. The majority leader is recognized.

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