Counterfeit Drug Penalty Enhancement Act of 2011

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 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 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.)

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 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 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 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

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

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 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 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 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.

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.

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 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. President, I thank the Senator from Utah for his concluding remarks regarding the amendment that I assume will be offered by the Senator from Illinois, as it is cleared to be offered.

I thank Senator Hatch for his great leadership on the issue of making sure the American people can have access to healthy, life-supporting vitamins, minerals and supplements, without having it go through untold processes and reviews and approvals by the FDA, and all that kind of regulation.

Senator Hatch was the leader on the DSHEA bill when we passed it in 1994. I was happy to work in tandem with him on that. It has proven, through the years, to be a great success for the American people. The American people all over this country take vitamins and other supplements, and they are living healthier because of this.

I say to my friend that I heard the Senator from Illinois on the floor yesterday give an impassioned speech about a very sad case about a young woman who evidently consumed some energy drinks with a lot of caffeine in them and had heart arrest and died. It is a very sad story. But as sad as that is, you can't keep people from abusing things. People also die every year from aspirin poisoning, where they took too many aspirin.

Reasonableness has to enter into this. We have worked together to make sure the labels are good on all of these things, so that people know what is in them. The FDA has the authority--as the Senator said, every Commissioner has said they have the authority to keep dangerous products off the shelf and to remove them from the shelf. They have all that authority. These cases, as I said, that Senator Durbin brought up are very sad, and you wish it were not so. I don't think it lends itself, though, to overturning what has been working now for 17, going on 18, years and working well for the American people.

I join the Senator from Utah, and I hope the amendment might not come up. But if it does, it does. I am sure there will be some debate on it. I join with the Senator from Utah in urging all Members of the Senate to vote that amendment down. If it comes up, I will move to table that amendment. Hopefully, we can approach this in a much more judicious, responsible, thinking manner.

I say to my friend from Utah--and I know he agrees--we are not taking the position that nothing has ever been changed. We have changed DSHEA in the past to make it work better. We did it after due deliberation, committee hearings, and going through the process to see what it means in terms of access to these products by the American people, to make sure we keep the intent of DSHEA there.

Again, I am more than willing, as chairman of the committee--and the Senator used to be chairman of the committee at one time, and then ranking member--we are always willing to look at these things and have a hearing on them and get more information. Again, I thank the Senator from Utah, who has been a great leader on this issue.

Mr. President, how much time does this side have on the bill?

I reserve the remainder of my time on the bill. If the Senator from Illinois wishes to bring up his amendment, we can bring it up.

Mr. President, again, I understand I have 24 minutes left.

I will make a short general statement about the bill. I talked about it in the past. I want every Senator to know that we are now on the FDA reauthorization bill. This is reauthorizing the prescription drug user fee, the medical device user fees, and then we are authorizing a new program, the generic drug user fee, biosimilar user fee, and so we are on the bill now. There is 30 minutes for debate on each amendment that has been listed. Senators know who they are and what the amendments are.

I want to make it clear that the unanimous consent we just adopted says that all debate time will expire at 2 p.m. tomorrow. So I say to Senators, if you want to take your 30 minutes and debate your amendment, now is the time to do it. If you wait too long, 2 o'clock will come tomorrow, you won't have the time, and you will be limited to 1 minute. There will be 2 minutes on each amendment after that. Those who have amendments and wish to discuss them, you are guaranteed at least 30 minutes, but all time runs out at 2 p.m. tomorrow. If you want to talk on your amendment and make your point, now is the time to do it this afternoon.

I yield the floor.

Mr. President, how much time remains on this amendment?

Mr. President, I just want to say, first of all, that I have the greatest respect, as he knows, for the Senator from Illinois. He is one of the true consumer champions in the entire Congress and has been for all of his time here. So it is kind of hard to argue against the Senator when he is such a champion of consumers. But on this issue I think we part a little company.

I want to make it very clear that under DSHEA, supplement labels must already disclose their ingredients--must disclose their ingredients. Even when a product is reformulated, if the supplement contains new ingredients, then the label must reflect that change. These were all added to the bill. We added that for consumer protection.

Now, again, it is not as though FDA doesn't know what is out there. Under current law, supplement manufacturers have to biannually register their products. There is a biannual registration requirement right now. So the concern is that FDA just doesn't have the resources to do anything. I have tried--and the Senator knows because he is on the Appropriations Committee--to get more funds for the FDA to do this, but we haven't been able to get the funds necessary for the FDA to even do what jobs they are supposed to do now.

I repeat for emphasis sake that every FDA Commissioner--those appointed both by Democratic or Republican Presidents--have said the DSHEA gives them adequate authority to keep dangerous products off the shelves. So the authority is already there. What the FDA needs is the resources. That is money. That means appropriations. Quite frankly, I don't see that happening this year--that we are going to give them any more. We are just going to give them more of a burden, and I think it will give a false sense of security to people because FDA simply won't be able to do that.

Lastly, as the Senator did say, we do have a voluntary program for ingredients and things with the dietary supplements with the National Institutes of Health that is already in place. That is coupled with the biannual reporting requirements plus the fact every dietary supplement has to have the ingredients listed on the label. So there is plenty of consumer protections out there. It is just that we can't protect a consumer who doesn't want to follow directions, who doesn't want to follow the guidelines listed on the labels themselves. I don't know how to protect people from that. Sometimes we just have to continually tell people to follow the directions. If they follow the directions, they will be fine.

That is why I think this amendment is ill-timed. I said to the Senator, and I mean this, that the Senator from Utah and our committee would be more than happy to have hearings again to flesh it out a little more and to see just what might be possible. But I come down to this as the bottom line: The FDA needs more money and they need more personnel to do this job.

I yield the floor.

Just one minor correction I would make, and that is under the DSHEA law, the FDA must approve any health claims made by any dietary supplement or vitamin. The only health claims they can make are structure function claims, but they have to be approved by the FDA. I just wanted to clear up that point.

I would also say further that I honestly don't know of any vitamin or supplement that is out there in the market that is dangerous if taken as directed--if taken as directed. As I said, anybody can abuse things. But if taken as directed, I, quite frankly, don't know of any supplement out there that is dangerous. Quite frankly, if taken as directed, they help maintain people's health and keep them healthy rather than being injurious to their health.

I yield the floor.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Again, Mr. President, I have to ask, how much time remains on the bill for both sides?

Mr. President, I object. How much time is left on the Sanders amendment?

Will the Senator from Oklahoma withhold? We have some people who want to speak. Once the time has run, then we automatically move on to another amendment and could bring up the Senator's amendment at that point.

There is 10 minutes in opposition to the amendment.

Senator Mikulski was here earlier. She wants to speak on this amendment. If we just wait 5 minutes?

I am sorry, I was wrong. I thought the Senator wanted to speak on the Sanders amendment. She wanted to speak on the underlying bill itself?

The Senator just seeks 5 minutes?

Since it is my time, I yield the Senator from Maryland 5 minutes on the underlying bill.

Mr. President, how much time is remaining on the Sanders amendment?

I will yield myself a couple of minutes.

I join with my colleague Senator Enzi in opposition to the Sanders amendment. We are all disturbed by a lot of what we are reading and these big settlements. I know the recent one a couple of weeks ago on Abbott Labs where part of the prosecution case was actually that this was part of their business model. Then they had to settle it. So this is all very disturbing.

However, that cries out more for, perhaps, looking at the criminal charges and perhaps strengthening some of those things but not taking away exclusivity. If you do that, a lot of times you could take away exclusivity from someone who just committed a misdemeanor. A lot of these settlements were misdemeanor charges where no intent was shown.

A lot of times, if you did this, you might penalize someone who maybe had done something wrong in the past, and now maybe they have new leadership, a new company, and reformed themselves, and now they have to lose their exclusivity? You would not want to do that.

Third, if you do this--I think Senator Enzi pointed this out correctly--if there is no reason to settle, then people are going to go to the wall in terms of defending themselves, and DOJ doesn't have all that kind of personnel and the time to do that. I think we would then have an even worse situation of people committing fraud because then they would know they would not have any reason to settle it whatsoever. Settlement is a good tool to be used by prosecutors to get cases to justice, to make sure consumers are made whole, and to let people know they are being watched. That is what they do.

I think the Sanders amendment, while maybe well-intentioned--I know it is well-intentioned. I know the Senator has all good intentions of what he wants to do. But I think it goes too far and is not the right solution to that problem. So I would oppose Senator Sanders amendment also.

I yield the floor.

Would the Senator yield for a question?

I think the Senator is making a lot of common sense. The only question I would ask is--and I don't know a lot about this. I haven't read the GAO report. But if, in fact, every employee says, I know they are going to get me on this timeliness. So it is the balance of safety and quickness, safety and expediency. In other words, we try to get a balance. We want devices and drugs approved as quickly as possible, but we don't want to jeopardize safety. Those are the two things we always try to balance here, safety being the foremost. We want things to be safe.

My question is, by enshrining this into law rather than in the administration, would this somehow put more undue pressure on reviewers and others to do something quickly and jeopardize the safety aspect?

Madam President, I join Senator Enzi in thanking Senator Burr for being not only a very valuable member of our committee but I would say the Senator's fingerprints are a lot on this bill we have before us. He has worked very hard on this bill and I think helped to improve it every step of the way over the last year.

I was looking through the list of different things here. Senator Burr was one of the leaders in our working group on the supply chain, which we have in this bill to make sure those things coming from other countries have good manufacturing practices on them and we can keep track of them.

The provision of clarifying the ``least burdensome'' standard on clinical data for device approval was also the result of the Senator's hard work. The Senator was also in the working group on the GAIN bill regarding antibiotic incentives for getting more incentives for new antibiotics. And there was a Burr-Coburn bill regarding enhanced reporting requirements for FDA, and that basically is also included in the bill we have in front of us.

So in every respect, the Senator from North Carolina is a great member of our committee, a very valuable member of our committee. As I said, we are looking at the amendment he has now brought up, and I am sure, as Senator Enzi said, we will be talking about this in the next few hours and going into tomorrow. But I again want to pay my respect to the Senator from North Carolina and thank him for all the hard work he has done on this bill.

I yield the floor.

Madam President, an inquiry: Is the Senator bringing up-- --no, the Senator does not have an amendment pending.

The Senator wishes to speak on which amendment?

Madam President, how much time is remaining on the Grassley amendments, the amendments offered by the Senator from Iowa?

How much time does the Senator wish to take?

I would ask that 10 minutes of the time in opposition to the Grassley amendment be allocated to the Senator from Minnesota.

I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, how much time remains on the two amendments offered by the Senator from Maryland?

Mr. President, I will speak on the time available for the amendments.

Amendment No. 2125

First of all, amendment No. 2125 will help ensure that health care providers, patients, and payers better understand the benefits and risks associated with drugs, especially with respect to those drugs by underrepresented subpopulations.

I believe this is an important and noncontroversial amendment. I hope we can support this amendment.

Amendment No. 2141

On the other amendment, No. 2141, which is the small business report, I think it is important FDA give small businesses a helping hand. I understand each FDA center has a small business office and that each of FDA's five regional offices has a small business representative. This report the FDA would have to submit on the basis of the amendment offered by Senator Cardin would provide Congress with more information about how FDA uses its resources for small businesses to help encourage small companies.

Again, I think this is another valuable addition to our bill and, hopefully, we can support that amendment also. So I thank the Senator from Maryland for his offering these two amendments and for what I consider to be improvements to the underlying bill.

I thank him very much for that.

Mr. President, again, I would say to the Members who may be in their offices that we still have some extra time before we will be adjourning this evening. Again, I would advise Senators that by at least 2 p.m. tomorrow, when the bell rings, we will be moving to voting, if not before then. So any Senator who has an amendment to bring up and who wishes to talk about it, I wish they would come to the floor and do that now.

Mr. President, I yield the floor.

Mr. President, I ask unanimous consent that the time during the quorum call be divided equally.

Mr. President, I rise in opposition to the amendment offered by the Senator from Kentucky, and I oppose it for several reasons.

I believe I am in the court of equity now: I come with clean hands because I am one of the authors of the Dietary Supplement and Health Education Act, along with Senator Hatch, in 1994. We worked in tandem over a period of a couple of years to get the legislation through. A lot of compromises were made at that time, not only here in the Senate but also with the House when we went to conference. I believe the right balance was struck, and I think it has proven its worth over the years.

We have done some minor modifications to it over the years. As I have often said, when we write laws around here they are not chiseled in stone for all eternity. These aren't the Ten Commandments, they are laws, and sometimes they need to be modified and changed a little bit, usually tweaking. But this amendment basically turns the whole law that we had since 1994 on its head.

We have a process now where the FDA regulates the supplements as foods. These are foods, not drugs. So as

we hammered out this agreement, supplements can make nutrient, structure, function claims without any FDA preapproval. If they want to make a health claim, then it has to be approved by FDA, and FDA has to find that it is supported by appropriate scientific evidence. Under this amendment, substances that today are considered drugs and used to treat diseases as serious as cancer or HIV could be marketed without any rigorous FDA review that we have heard from many speakers here today is the gold standard of drug regulation throughout the world. It would turn our current system of drug regulation on its head. It would be a huge setback for health. It would foster a system rife with potential for health fraud. The big losers would be patients.

Frankly, as someone who is a strong supporter of the Dietary Supplement Health and Education Act, and I would say along with Senator Hatch one of its protectors for all these years, I daresay the amendment offered by the Senator from Kentucky would destroy DSHEA. It would destroy it and I don't want to see it destroyed because I think it is doing a lot of good for a lot of people in this country. It is working well. Consumers have access to a wide range of safe products. There is no reason to upset its success, because this amendment would do that.

To think that somehow you could go out and make any health claim you want? Back to the days of snake oil salesmen: ``This elixir will do everything, it will cure every ailment you have and turn the clock back 20 years on your age.'' People would buy it, and what was it? It was 80-percent alcohol and 20-percent water or something like that. They made all these crazy claims. We are going to move to that kind of system now? And the only recourse would be to take them to Federal court and then have a trial and go through all that and then, OK, then they appeal it and finally you find out, OK, the court says no, there is not enough scientific evidence to warrant it so you have to take that product off the market.

We are going to do that for every one of the thousands and thousands of different products that are out there? What a mess this would be. First of all, the Federal courts would not have the wherewithal to do every one of those. Second, who has the money to take all that to court? And it would literally destroy--bring down an industry that has done well in this country. The dietary supplement industry, the vitamins and minerals industry in this country, has done a great job and I do not want to see it ruined. This would ruin it.

Last, the Senator from Kentucky talked about increasing the mens rea, the mind; you know, in law school, what your mental condition, what your thought processes were--what was your intent. It would increase it. It would need to be shown to enjoin or prosecute serious violations of the Food, Drug, and Cosmetic Act. I find this amazing. This idea that we need to make it harder to enforce a public health protection statute, not easier, is deeply troubling. I see no legitimate reason to do this.

The goal of this amendment is clearly to render the FDA virtually incapable of addressing industry abuses. I think this amendment would have deleterious effects on the Dietary and Supplement Education Act, and the industry, and also on the FDA's ability to regulate prescription drugs. You can say just about anything about what your health claims would be on any kind of product and the only recourse, as I said, would be to go to Federal court.

Again, this is a consensus measure. We have built a very broad bipartisan support for this FDA user fee bill. It is must-pass legislation. We cannot jeopardize that consensus.

For those reasons, I oppose the amendment offered by the Senator from Kentucky.

Mr. President, I suggest the absence of a quorum.

Mr. President, I ask unanimous consent the order for the quorum call be rescinded.

Mr. President, how much time remains on the amendments offered by the Senator from Maryland, Senator Cardin?

Mr. President, I ask the Senator from Colorado, how much time does the Senator seek?

I ask 10 minutes of the time from amendment No. 2141 be yielded to the Senator from Colorado.

Mr. President, I join Senator Enzi in thanking Senator Bennet for being a very valuable member of our committee and for all of the great work the Senator did on this bill. His fingerprints are all over this bill, and, as he pointed out, it is a great bill. There was great bipartisan support.

I thank the Senator for all of his work in our working groups, especially the drug supply chain. This is a key part of this bill. The FDA will have the authority and the wherewithal to go back up the chain to where these drugs come from. The Senator was the first one to point out to me at the committee hearing that I think about 80 percent of all of the ingredients that go into our drugs in this country come from outside this country, but we had no real idea on where and how, and now we can insist on good manufacturing practices. So I would say this singular addition to this bill can be traced right back to the Senator from Colorado, and I thank him very much for his leadership on this issue and in helping us to get this bill to where we are today. I thank the Senator.

I would like to yield 10 minutes off of the opposition of the Grassley amendment 2121 to the Senator from Minnesota.

Mr. President, as the Senator said, his amendment would amend the Controlled Substances Act to make any substance containing hydrocodone--Vicodin--a schedule II drug. As he said, this is presently a schedule III drug. The most significant difference is, for patients, schedule II drugs are not allowed to be refilled. That is the key to the amendment.

I applaud the Senator. I have great concerns regarding the increased abuse of prescription drugs. According to the Centers for Disease Control and Prevention:

Overdoses involving prescription painkillers are at

epidemic levels--

Epidemic levels--

and now kill more Americans than heroin and cocaine combined.

That is a quote from the Centers for Disease Control and Prevention.

According to CDC, more than 40 people die in America every day from overdoses involving narcotic pain relievers such as hydrocodone.

For this reason, I applaud Senator Manchin for his amendment and the efforts he has undertaken to reschedule this drug. It is the most frequently abused narcotic and that is a strong reason to reschedule it into section II.

Again, I thank the Senator for this amendment. At the appropriate time I will ask for its adoption. Again, I thank the Senator from West Virginia. This is a great amendment. It improves the bill. It is widely accepted, and the Senator has been on the right track on this issue for a long time. I applaud him for doing this and, believe me, a lot of people in America are going to thank the Senator for getting this drug rescheduled to cut down on the terrible overuse of this drug in America. I thank the Senator very much.

If the Senator would withhold the unanimous consent request.

We have a number of amendments we are putting together, and at the appropriate time I will make sure that happens.

Mr. President, I ask unanimous consent to set aside all pending amendments in order to call up Reed amendment No. 2126, and I ask that the clerk report the amendment by number.

Mr. President, I further ask unanimous consent that the following amendments be agreed to en bloc: Cardin No. 2125; Cardin No. 2141; Grassley No. 2121; Grassley No. 2129; Manchin No. 2151, as modified; and Reed No. 2126.

Mr. President, we are finished with business for today. We do have some more amendments to be called up and voted on tomorrow. I understand we are coming in--I do not know exactly what time has been set for the morning, but after the leaders' time has been used, we will be back on this bill.

Again, I remind Senators and their staffs that we have until 2 p.m. for their amendments to be brought up and to be debated. The sooner we get to those in the morning, the better off we will be.

So as soon as the leader time is exhausted tomorrow morning, we will be back on our bill.

So, Mr. President, I suggest the absence of a quorum and ask unanimous consent that the time in the quorum call not be taken off our bill.

Madam President, I ask unanimous consent that the pending amended be set aside so that I may call up amendment No. 2125.

Madam President, I ask unanimous consent that that amendment be set aside so I may call up my amendment No. 2141.

Madam President, I rise to discuss the FDA Safety and Innovation Act, the bill now under consideration here in the Senate.

I applaud Chairman Harkin and Ranking Member Enzi for their leadership in moving this critical legislation through the HELP committee, and now to the Senate floor.

As an agency of the Department of Health and Human Services, the FDA has as part of its broad mission to protect Americans' health by assuring the safety of drugs, biologics, medical devices, our Nation's food supply, vaccines, tobacco, cosmetics, and animal food and drugs. Every single day, every single American depends on the vital work of FDA's employees.

There is a second key element to the FDA's work--helping to speed innovations to the marketplace through the drug, biologic, and medical device approval process. It's that component of the FDA's mission that we are addressing this week--reauthorizing the user fees that help fund the approval process.

I'm proud of the FDA's workers--the majority of the agency's more than 11,000 employees are based at its headquarters in Silver Spring, MD. It's

there that the process of medical innovation, which begins at NIH with basic research, is completed as lifesaving drugs and medical devices are approved for use.

A recent report from the IMS Institute for Healthcare Informatics found that in 2011 ``medicines with new mechanisms of action were launched in greater numbers than in prior years, with many representing significant breakthroughs and first-time therapies became available to treat several types of cancer, multiple sclerosis, hepatitis C, and cardiovascular conditions.''

At the same time, we know that greater resources are needed for the agency to be able to fulfill its mission in a timely and effective manner. For all of our Nation's investment in health care research, additional new medicines will not reach patients promptly unless the FDA has the necessary funds to perform its regulatory duties.

That's why the user fee amendments are so important. This 5-year reauthorization bill is Congress' opportunity to improve and update the regulatory process, and augment appropriations so that the agency can achieve its goals.

The purpose of the user fee program is to reduce the time in which FDA can review and make decisions on marketing applications. Lengthy review times affect drug and medical device manufacturers, who face delays in bringing their products to market, and more importantly they affect patients, who face delays in receiving needed treatments and cures.

The bill reported out of committee will move us forward. It will reauthorize the prescription drug user fee program, PDUFA, through October 1, 2017.

This is necessary so that the Federal Goverment can continue to collect application, establishment, and product fees from drug companies to support the review process for the next five years.

It will also reauthorize the medical device user fee program, MDUFA, through 2017 as well, and in an effort to ensure that the FDA's personnel needs are met, it would authorize a streamlined hiring of employees. Additionally, the Critical Path Public-Private partnerships, which are so important in encouraging medical product innovation, are reauthorized through 2017.

Two new user fee programs are established in the bill for generics and one for biosimilars. It's estimated that the monies generated from the generic user fee program will enable the FDA approval time for generics to be shortened from the current time frame of 30 months to 10, speeding savings to patients and to all taxpayers, as Medicare, Medicaid, and CHIP programs will reap considerable cost savings.

The base bill takes key first steps toward resolving the vexing issue of drug shortages. I want to acknowledge Senator Klobuchar's work in this area.

All of us have heard from our community hospitals and physicians about the anguish they feel when they cannot secure medicines necessary to treat the patients in their care. I certainly have, and I have also heard from patients themselves who cannot fathom how such shortages could occur.

Carey Fitzmaurice of Bethesda, who is undergoing treatment for ovarian cancer, wrote to me:

My doctor put me on Doxil and carboplatin to try to get rid

of some tumors. Doxil was chosen because of recent research

showing that it works especially well in those patients with

the BRCA gene, like me.

I had four treatments with both drugs and was responding

very, very well. I have now missed three doses of Doxil due

to the shortage. I am ``treading water'' with the Carbo but

am frustrated that I am no longer making progress towards

remission. Then there is all of the stress involved with the

shortage--not knowing if there is anything I can do, or what

will happen next or how long I will be in treatment.

I am trying to continue to be a wife and mother and to hold

down a job. This shortage is adding insult to injury. I

wonder why we are being asked to raise money to find cures

when we can't even get access to the cures that exist now.

Carey is one reason why I am a cosponsor of Senator Klobuchar's bipartisan bill, the Preserving Access to Life Saving Medications Act, and I am pleased that the bill's early notification requirement provisions are included in the PDUFA bill we are considering today. It also requires the Secretary to establish a task force and create a strategic plan to address shortages.

This is also an urgent matter because shortages affect the ability to conduct clinical trials. Senator Rockefeller and I worked together some years ago to get Medicare beneficiaries coverage for the routine costs associated with clinical trials.

As a result of Senator Brown's work on the Affordable Care Act, insurance companies now must also cover the routine costs of trials. Access to trials often means the difference between life and death for cancer patients, and the availability of trials has enormous implications for the effectiveness of treatments for all patients going forward. There are more than 150 cancer clinical trials being conducted now at the NIH Clinical Center in Bethesda.

But the impact of shortages on clinical trials has not received a great deal of attention outside the research world. It is an extremely important issue for Medicare beneficiaries, who have the highest rates of cancer incidence. Cancer trials do not usually use placebos.

Rather, they compare standard of care drugs, versus, or in combination with, the experimental drug.

Doctors face difficult choices when the standard of care drug is in short supply. They must decide whether to use the limited supply of an existing drug to treat new patients, or use it in clinical trials to help find a cure for those who are seeking new therapies. Cancer trials have been delayed, limited the number of patients enrolled in the trial or stopped the trial entirely because there is simply not enough of the standard of care drug.

So I am pleased that the bill contains language requiring the Secretary's strategic plan to considering the impact of drug shortages on research and clinical trials.

The Finance Committee held hearings on drug shortages earlier this year as well, and we learned that the majority of shortages are found in the generic drug market. Some are due to a lack of raw materials, while others occur because the drugs yield lower profits than newer generics, and the interest in continuing to market those drugs is no longer there.

The notification language in this bill is a good start, but I believe it should be strengthened to better ensure compliance, and so I have cosponsored Senator Blumenthal's amendment establishing civil monetary penalties for manufacturers who knowingly fail to notify the FDA of shortages for essential medicines.

I express my appreciation to Senator Pryor for his leadership on nanotechnology. I am pleased to join him in this effort and am hopeful that the language we have sponsored can be included in this bill.

Nanotechnology has become increasingly indispensible in our daily lives--everything from cellphones and MP3 players, to packaging of our snack foods, to cancer treatments in development employ the use of nanotechnology.

As this burgeoning technology continues to power more of our consumer products and drive job creation in America, it is essential that we fully assess, understand, and address any risks that it may pose to safety, public health and our environment.

By soundly assessing the safety of nanotechnology and developing best practices, the Nanotechnology Regulatory Science Act of 2011 will further job creation, public safety and growth in the industry.

Our bill would establish a program within the FDA to assess the health and safety implications of using nanotechnology in everyday products, and develop best practices for companies using nanotechnology. This new program would bring more highly-skilled research jobs to Maryland.

FDA's laboratories and research facilities at its consolidated headquarters are ideally suited to conduct the scientific studies required under the bill.

The USDA's Beltsville Agricultural Research Center, BARC, is similarly equipped to provide innovative scientific technology, training, methods development, and technical expertise to improve public health.

Lastly, I urge my colleagues to support language addressing the lack of available information on the benefits and adverse effects of drugs and medical devices for minority populations.

Today, warnings and safety precautions are included as part of the initial approval by the FDA. The Agency

may also require them post approval--after the drug has been approved and sold for months or years. We know that additional side effects or risks may become known once a product is in the market and a much larger, diverse patient population is using it.

Ideally, a detailed conversation between physician and patient about the risks versus the potential benefit of taking a drug would always take place in a timely and informed manner. However, this is not always the case and is especially true if the warning is added after drug is initially prescribed and been on the market for an appreciable time period.

The randomized controlled trials used by the FDA when reviewing new drug applications, while the gold standard for examining efficacy, do not necessarily reflect the overall population for a variety of reasons.

For example, members of minority groups are generally underrepresented in clinical drug trials even though they are disproportionately affected by diseases such as diabetes, hypertension, colorectal, prostate and cervical cancer, stroke, congestive heart failure, acute coronary disease, and asthma.

We know that there are racial and ethnic differences in responses to pharmaceuticals, and they may not become known until the drug is in wide use, certainly beyond the constraints of a controlled clinical trial.

In today's world, post-approval surveys and studies are becoming more prevalent, and our ability to discern the effect of a drug over time on a variety of patient types is significantly improving. This information should be made available in a variety of ways to ensure that it reaches physicians, payors and patients, and I have filed an amendment that would greatly improve access to this information.

It would build on the current HHS ``Strategic Action Plan to Reduce Racial and Ethnic Health Disparities'' by directing the Secretary to develop a communications plan to ``address the best strategy for communicating safety alerts, changes to the label or labeling of drugs, including black box warnings, biological products or devices, health advisories, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication.''

This amendment has the support of the chairman and the ranking member, as well as the FDA and BIO, and I urge the Senate to adopt it.

Mr. President, PDUFA reauthorization is essential to furthering the Nation's health, bringing the medical innovations conceived by researchers and entrepreneurs into practice, and creating jobs. I look forward to working through the process to improve this bipartisan legislation.

Again, I thank and congratulate Senator Harkin and Senator Enzi for their incredible work in bringing forward this bill that is so important to the public health of our Nation. We are dealing with the safety of drugs, biologics, medical devices, our Nation's food supply, vaccines, cosmetics, and the list goes on and on. It is critically important that we have the proper authorization so that the FDA has the resources it needs to advance innovation into the marketplace, products that fall within the jurisdiction of the FDA.

We know that the basic research has gone on at NIH. To get products to market, it is important that the FDA have the resources in order to move the process forward. I am proud of the 11,000-member workforce headquartered in Silver Spring, MD, for the FDA. They work very hard. This reauthorization legislation of the user fees will give them the tools in order to get the job done. I am particularly impressed that this is a 5-year reauthorization bill that will give them predictability, which is needed in order to get the job done.

I applaud Senator Harkin and Senator Enzi. We don't see enough of these bills moving forward with the type of process our leaders have brought forward. They have resolved a lot of the issues, and we thank them for that. They have brought us a bill that enjoys broad bipartisan support and is in the best interest of our Nation. I am proud to support this legislation, and I thank them for the manner in which they have proceeded in committee and now on the floor.

Also, I point out that this bill deals with the drug shortage issues. I applaud the occupant of the chair, Senator Klobuchar, and her efforts in dealing with those issues. We need more effective notification of potential shortages so that we can take appropriate action to make sure the people of this Nation have an adequate supply of medicines.

Let me share with my colleagues a letter I received from Carey Fitzmaurice of Bethesda, MD, who is undergoing treatment for ovarian cancer. She wrote:

My doctor put me on Doxil and carboplatin to try to get rid

of some tumors. Doxil was chosen because of recent research

showing that it works especially well in those patients with

the BRCA gene, like me.

I had four treatments with both drugs and was responding

very, very well. I have now missed three doses of Doxil due

to the shortage. I am ``treading water'' with the Carbo but

am frustrated that I am no longer making progress towards

remission. Then there is all of the stress involved with the

shortage--not knowing if there is anything I can do, or what

will happen next, or how long I will be in treatment.

I am trying to continue to be a wife and mother and to hold

down a job. This shortage is adding insult to injury. I

wonder why we are being asked to raise money to find cures

when we can't even get access to the cures that exist now.

That is a frustration that is out there on drug shortages. I am very pleased that this legislation will move us in the right direction in answering that question.

It doesn't only affect those under active treatment, it also affects a number of clinical trials. There are currently about 150 clinical trials at NIH involving cancer and trying to find answers and cures for cancer. The problem is that on these clinical trials they don't use placebos, they use the current drug therapy that is known for the treatment against an experimental process. If there are not enough drugs available to treat people for the current protocols, how can those drugs be used in a clinical trial. As a result, we are finding it very challenging to move forward with the clinical trials that are needed. This legislation recognizes that concern and specifically deals with it. I congratulate the committee leadership for addressing that issue.

I also will mention one other issue: nanotechnology. I congratulate Senator Pryor for his leadership in this area. Programs at FDA to access health safety facts and using nanotechnology in everyday products is something we need to do. This legislation advances that. I point out that I am proud that the lab facilities at the FDA are fully capable of dealing with the challenges presented by nanotechnology. This legislation acknowledges that.

We also, in Maryland, are proud of the Beltsville Agricultural Research Center, which will advance nanotechnology and the impact it has on everyday products and safety. Those issues will be addressed also by the underlying bill. We very much appreciate the leadership of the committee.

Let me talk for a moment about the two amendments I have brought forward. Amendment No. 2125 deals with safety warnings, particularly as they affect the minority community. Clinical trials don't always represent the diversity of our community. We know there is underrepresentation of minorities within clinical trials. Quite frankly, when the FDA gives approval, they give approval to the known risks, as I am sure you are all aware, but it doesn't always represent the impact on all communities. We also know there are racial and ethnic differences in response to pharmaceuticals, and they may not become known until the drug is in wide use, certainly beyond the constraints of a controlled clinical trial. So we do have the initial approval of FDA that includes the known risks, but we also have the capacity under FDA to do postapproval warnings. My amendment deals with that aspect.

Health and Human Services has a strategy to deal with minority health and health disparities. It is called the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities. We also now have an institute at the National Institutes of Health that deals solely with minority health and health disparities. We have a commitment to do a better job as a nation in dealing with minority health disparities. This amendment would help us move forward in that regard.

One particular drug that is used to treat an inflammatory disorder has been determined by several studies to have a mortality risk that is three times higher for African-Americans than the general public. However, it is still widely prescribed, and ads for the product on the Internet and on television prominently feature African-American actors.

This is an area in which the National Medical Association and many other groups concerned about the quality of minority health have focused on for years. Beyond the black box warning, which is the most serious warning that can be issued about the side effects of approved drugs, there are other concerns about products that are marketed for the overall population that may have side effects, but the specific data has not been developed yet to warrant a black box warning.

The amendment I have offered directs the FDA to develop communication plans to address the best strategy for communicating benefits and risks, safety alerts, changes to the label or labeling of drugs, including black box warnings, biological products or devices, health advisories, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including a variety of means of electronic communication.

I might point out this amendment has the support of the FDA and BIO, and it is budget neutral. So I would urge my colleagues to support this amendment to advance the commitment we all have made to deal with reducing and hopefully one day eliminating minority health disparities in our health care system. It is totally consistent with the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities at the Department of Health and Human Services.

The second amendment I have brought forward, amendment No. 2141, deals with small businesses. This is a very appropriate amendment, as it is being considered during Small Business Week. We all acknowledge the importance of small business in the growth of our economy. Two out of every three new jobs are created through small business. We get more innovation through our small businesses on a per-employee basis than we do through larger companies. It is critically important small businesses be energized if our economy is going to rebound, as we know it needs to.

This is particularly true as we deal with innovation in drug development or medical devices. My amendment deals with the issues of coordinating the work between the FDA and small business. It provides a listing of the staffing levels at the small business offices of the FDA so that we know the capacity we have and we can evaluate that. It is our responsibility to do that. It provides an overview of the status of partnership efforts between the FDA and the SBA. We want the two agencies, the Food and Drug Administration and the Small Business Administration, to be working in concert to advance the cause for small businesses as well as the mission of the FDA.

My amendment provides a summary of all outreach efforts to small businesses and small business associations. It details the number of small businesses receiving protocol assistance. It shows the number of unsolicited and solicited grant applications to small businesses, again, so we can evaluate that. Most importantly, it calls for the examination of existing barriers, particularly as it relates to the generic drug shortages.

It is interesting that with regard to the fee schedule, the FDA has the authority to do waivers as it relates to brand names. We know a lot of the generics are where we have our shortages because of the economics of the circumstances. But the SBA has limited ability to waive the fee structure as it relates to the general development of generic drugs. My amendment would ask the SBA to report back to Congress on what impact that has on small businesses being innovative in developing generic drugs to help us generally with less costly drugs that are available for treatment, but also to make sure we deal with the drug shortage issue, which I alluded to earlier.

This amendment is also supported by Senator Landrieu, the chairman of the Small Business Committee, on which I have the pleasure of serving. I urge my colleagues to support both amendments I have brought forward. I believe they only enhance the strength of the bill before us and are totally consistent with the work of the chairman and the ranking member of the committee.

With that, Madam President, I would again urge my colleagues to support both amendments and to support the underlying bill.

I yield the floor, and I suggest the absence of a quorum.

Mr. President, I rise to discuss my amendment that would repeal the costly and counterproductive medical device tax in President Obama's health care law. In the mad scramble to find money to pay for his $2.6 trillion health spending law, the President and his Democratic allies created a number of new taxes that serve no purpose other than to fuel this new spending. Economically, these taxes are a disaster. They will undercut job creation, and they will increase costs for patients.

The new 2.3-percent tax on medical device manufacturers, which kicks in at the beginning of next year, is particularly onerous. For that reason, last year I introduced legislation to repeal it. That bill, the Medical Device Access and Innovation Protection Act, S. 17, has been cosponsored by 25 of my colleagues.

They understand that all of ObamaCare needs to go. The President's health care law is now over 2 years old. It is not aging well. Even before ObamaCare became law, the American people made themselves absolutely clear they wanted nothing to do with this Washington takeover of the Nation's health care system. The President and his advisers refused to face reality, telling reluctant Democrats all

was well in spite of the tea party townhalls.

According to the President and his congressional Democratic leadership, as soon as the legislation became law, Americans would come to embrace the wonderful benefits bestowed on them by the Department of Health and Human Services. It has not quite turned out that way.

Poll after poll shows that substantial majorities of Americans continue to oppose the law and favor its full repeal. A majority of Democrats think the law is unconstitutional. In a matter of weeks, the Supreme Court might issue a coup de grace to President Obama's misguided adventure in big government.

Whatever the Supreme Court does, I want to be clear about something. All of ObamaCare needs to go. It needs to be pulled out root and branch. The entire thing needs to be repealed. That said, some part of the law stand out for their wrongheadedness. The individual mandate and Medicaid expansions are flat out unconstitutional.

The IPAB, the CLASS Act, the Medicare cuts, and the employer mandate all deserve honorable mention for being bad public policy. Among the most counterproductive parts of the law are its over $500 billion in new taxes and penalties.

The medical device tax sits at the top of the list of foolish new ObamaCare taxes, and my colleagues who have supported S. 17 and this amendment understand the critical importance of eliminating it. I thank in particular my colleagues, Senator Brown from Massachusetts, and Senator Toomey from Pennsylvania, who have spoken on this issue and understand completely the devastation this tax will create for patients and for employers who provide good jobs for communities in their States.

Thanks to ObamaCare, medical devices will get hit with a $28 billion tax. So we are clear about what these medical devices are, they include surgical tools, bed pans, wheelchairs, stethoscopes, and countless other products that patients and doctors rely on every day. Surgical masks, gloves, blood pressure monitors, scissors, needles, cribs, trays, lights, stents, pacemakers, scales, scalpels, inhalers, and ankle, knee, and hip braces, and a lot more.

The cost of all of those products is going up thanks to this tax. Somebody is going to have to pay for it, and that someone is the already overburdened American taxpayer and middle-class breadwinner.

The President and his supporters seem to think we can simply tax corporations and individuals with impunity and face no adverse economic consequences. Yet economists understand when we tax these companies, employees will pay for it in lower wages, the unemployed will pay for it with a job that was never created, and patients will pay for it with higher health care costs.

Whatever our economic circumstances, this tax is bad news. But it is particularly foolish given the precarious state of our economic recovery. The President once liked to tout all of the jobs created or saved by his over $800 billion stimulus bill. Yet by supporting the medical device tax, the President and his allies have shown a real disregard for good high-paying American jobs.

Medical device companies employ nearly half a million people. They pay a salary that is nearly 40 percent higher than the national average. These manufacturers are small businesses we must be cultivating if our economy is going to recover and we are going to be successful in bringing down unemployment.

Roughly 80 percent of medical device companies have fewer than 50 employees; 98 percent have fewer than 500 employees. ObamaCare's $28 billion tax hike on these manufacturers will do nothing to improve health care, but it will do plenty to undercut the viability of these companies that provide good wages and good opportunities for American families.

According to one recent analysis, the medical device industry provided jobs to 409,000 employees in 2009. Yet this tax could result in job losses in excess of 43,000. It will hit certain States harder than others: California, Florida, Illinois, Massachusetts, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Wisconsin, and my State of Utah. The presence of medical device manufacturers is significant in all of these States.

This new tax will roughly double the device industry's total tax bill and raise the average effective corporate income tax to one of the highest effective tax rates faced by any industry in the world. The President and his allies frequently attack industries that choose to move their operations overseas. But they do not seem to grasp that their policies are driving these industries to do just that. With the onset of this new tax, U.S. device manufacturers are increasingly likely to close plants in the United States and replace them with plants in foreign countries.

According to another report by the Lewin Group, the medical technology industry contributes nearly $382 billion in economic output to the U.S. economy every year. President Obama, in the middle of a weak economy, facing high rates of joblessness, has decided to attack that industry. It is bewildering to me. An industry that pays workers on average $84,156 has become a victim of the President's desire to pay for his new health spending law or, better put, those workers and the families they support become the victims of the President's health spending law.

In my own State of Utah, the device tax is an issue of great importance. There are over 120 medical device companies in Utah. As the Utah Technology Council wrote in a letter to me, these companies ``are a vibrant part of the Utah economy providing high-paying, high-tech jobs for citizens of our great state.''

They certainly are all of that, and they are under assault as a result of this tax, targeted for nothing other than their success and the fact that they were a so-called stakeholder that could pay a so- called fair share to subsidize the President's health spending bonanza.

I ask unanimous consent that letter be printed in the Record.

Just yesterday, the Governor of Utah, the Honorable Gary Herbert, sent a letter to Congress addressing the negative impact this tax will have on our State. He wrote:

As a Governor of a state with a significant concentration

of medical technology manufacturers, I believe this tax could

harm U.S. global competitiveness, stunt medical innovation

and result in the loss of tens of thousands of good paying

jobs.

Now, there is little doubt the President's medical device tax, one that unfortunately received the vote of every Democrat in the Senate, will do just that--kill jobs and undercut our economy.

I ask unanimous consent that Governor Herbert's letter be printed in the Record.

The President's health care law is a travesty. The American people know it. They think it is fundamentally illegitimate, unconstitutional to its core, and enacted over the deep and loud objections of citizens and taxpayers.

All 2,700 pages of that law must be stricken from the U.S. Code one way or another. Eliminating its medical device tax is absolutely essential. It is critical for our States, for our economy, and for America's families and workers. I ask my colleagues join the repeal effort, and I thank my colleagues who have already joined as cosponsors.

I would like to briefly touch on one other issue that is of great importance to me and to the people of Utah and others all over the country. Over 150 million Americans regularly consume dietary supplements as a means of improving and maintaining their health.

The passage of the Dietary Supplement Health and Education Act, or DSHEA, in 1994 brought clarity, predictability, and a better understanding of what the FDA expected from industry and vice-versa. DSHEA provides an appropriate structure that balances the risks and benefits to consumers, with continued access and affordability.

Unfortunately, my colleague from Illinois, Senator Durbin, has filed an amendment to the current bill that would undo that well-balanced approach. As the author of DSHEA, along with my dear friend and colleague, Senator Harkin in the Senate, I strongly oppose his amendment. It would require facilities engaged in the manufacturing, processing, packing, or holding of dietary supplements to register with the FDA, provide a description with a list of all ingredients, as well as a copy of the labeling for each dietary supplement product. Additionally, the facilities must also register with respect to new, reformulated, and discontinued dietary supplement products.

While I appreciate my colleague's commitment, his amendment is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks authority to regulate these products. This is simply not the case. Previously FDA Commissioners, including Drs. Jane Henney, Mark McClellan, Les Crawford, and Andy von Eschenbach, as well as the former Deputy Commissioner, Dr. Josh Sharfstein, have all agreed DSHEA provides an appropriate and sufficient level of oversight of this industry.

Under DSHEA, Congress set out a legal definition of what could be marketed as a dietary supplement and safety standards that products have to meet. It allowed the FDA to develop good manufacturing practice standards and clarified what types of claims could be made. It provided the Secretary of Health and Human Services with the authority to impose an immediate ban on any dietary supplement that poses an imminent risk to public health.

DSHEA already provides the Secretary with enforcement tools of seizure, injunction, or criminal prosecution for ingredients that pose an unreasonable risk of illness or injury, are poisonous or deleterious, contain unapproved drugs or food additives, or fail to meet good manufacturing practice standards.

Furthermore, under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a manufacturer, packer, or distributor whose name appears on the label is required to report a serious adverse event related to the use of a supplement within 15 business days to HHS; submit any related medical information received within 1 year of the initial report within 15 business days; maintain records related to each report for 6 years; and permit inspection of such records.

To me, that sounds like a whole lot of regulation. The FDA already has a tremendous amount of regulatory oversight and enforcement tools when it comes to dietary supplements. Yet instead of urging FDA to use its current enforcement authority to find and punish those companies that are not following the law, Senator Durbin's amendment serves to punish all responsible companies with its overreaching mandates.

Finally, I would be remiss if I did not mention another obvious point. Senator Durbin's amendment would have the devastating effect of piling on more work for an underfunded agency already struggling to keep above water with its current core responsibilities.

Now, let me just say this: Before we passed DSHEA, there basically was no regulation over this industry. We brought together, Senator Harkin and I, the whole dietary supplement industry to get behind DSHEA. They are behind it. It took over 10 years to get the good manufacturing practices completed by FDA--more than 10 years, as a matter of fact. But we provided for them in that agreement. We provided all the tools that are necessary to supervise and regulate dietary supplements. To now add other obligations

onto this industry is just plain not right, and I hope my colleagues in the Senate and the House of Representatives will recognize this is an overreach and not put up with it. We are not going to put up with it. I will be voting against Senator Durbin's amendment, and I urge all of our colleagues to do the same.

At this point, I pay tribute to my colleague, Senator Harkin from Iowa. Senator Harkin worked tirelessly on this bill along with me. We worked all the way through the Senate on a number of occasions on various things. We have improved the bill from time to time. We have gone along with the improvements. We have done everything we can to protect the American citizens with everything that should be done. Nothing further needs to be done.

This is an industry that deserves support, not condemnation. Senator Harkin has been there every step of the way. He is a champion for the dietary supplement industry, as am I, and a lot of others in this body. I think it is time to quit trying to overregulate everything to death and cause costs to go up by leaps and bounds. Dietary supplements are not inexpensive today, although they are a lot less expensive than they would be if we keep piling on these regulations.

Frankly, we believe we have all of the necessary language in the law today to protect the American public regarding dietary supplements. We have given the Food and Drug Administration all the authority they need, and every FDA Commissioner has met with me, as I recall, since DSHEA was passed in 1994, and has said they have enough tools to be able to supervise this industry properly and they don't need anything more.

To make a long story short, again, this is an overreach by a colleague, sincere though he may be, and as important as he believes it to be. I hope he will withdraw his amendment so we don't have to go through this again. If he won't, I hope our colleagues on both sides of the aisle--and this is a bipartisan effort--will rise and say we have had enough of this and let's vote these kinds of amendments down.

I yield the floor.

I thank the Senator from Iowa. I know Senator Durbin is sincere, but, my gosh, there is enough regulation and regulatory authority in this bill, including the amendments we have added voluntarily, to resolve any problem that exists. Frankly, I hope everybody will vote against the Durbin amendment.

Mr. President, I ask unanimous consent to speak for 15 minutes in morning business and not to take time away from the debate on the bill.

Mr. President, I have had a conversation with them----

Mr. President, next week Americans are going to spend time honoring and commemorating the men and women who died fighting for our great country. Memorial Day is a day to reflect on and give thanks to the sacrifices made by those who made the ultimate sacrifice. It is also a day to look forward and to think about what we all can do to help our veterans who sacrificed so much and who deserve our support when they come home.

So I come to the floor today to discuss an issue that, quite frankly, defies common sense. The high rate of unemployment among recently separated veterans is an issue that continues to make the transition home for veterans harder than ever. Despite the fact that our veterans have the leadership ability and the discipline and technical skills to not only find work but to excel in the workforce of the 21st century, our veterans continue to struggle.

Despite the skill and talent and training of our veterans, statistics continue to paint a grim picture.

According to the Department of Labor, young veterans between the ages of 18 and 24 have an unemployment rate that is nearly 20 percent. One in five of our Nation's heroes can't find a job to support their family, doesn't have an income that provides stability, and doesn't have work that provides them with the self-esteem and pride that is so critical to their transition home.

We know this should not be the case. We shouldn't let the skills and training our Nation's veterans have attained go to waste. That is why all of us joined together to overwhelmingly pass my VOW to Hire Heroes Act here in the Senate late last year. Among many other things, that law would provide tax incentives to encourage businesses to hire veterans; it makes participation in the transition assistance program mandatory for most separating servicemembers, and expands the education and training we provide to transitioning servicemembers.

Thanks to that legislation, we have been able to take real concrete steps toward putting our veterans to work. The tax credit is working, and VA is set to begin accepting applications for a retraining program that will benefit unemployed veterans ages 35 to 60 and help them get back to work.

But that bill is only that, a first step. Today I am here to talk about the next step, and that step is to build partnerships with private businesses, large and small, all across our country, to hire our Nation's heroes. Recently I was up in New York where I participated in a lively roundtable discussion hosted by the Robin Hood Foundation. This discussion on veterans employment was moderated by Tom Brokaw on the USS Intrepid and brought together people of various backgrounds, including former Chairman of the Joint Chiefs ADM Mike Mullen, and Housing and Urban Development Secretary Shaun Donovan, to talk about this important issue.

What is very apparent is that there is momentum to build public- private partnerships. What is also apparent is there is a lot of room for improvement in this area.

I want to first make clear that a lot of companies across the country are far ahead of the curve. In fact, many private sector companies have already joined our efforts in addressing this critical issue. J.C. Penney, one of America's largest retailers, and Joseph Abboud, a men's clothing company, partnered with Iraq and Afghanistan Veterans of America to launch the Welcome Home Joe--Thanks A Million Program.

To prepare veterans for job interviews, this program has provided 5,000 veterans with certificates to purchase business attire. For the last decade, we have expected our brave men and women in uniform to prepare for the battlefield. In the process, they have become accustomed to wearing combat boots and battle dress uniforms. Now they are expected to wear a suit and tie for job interviews--something that sometimes seems pretty foreign to them. But thanks to this program, thousands of transitioning veterans can now hang up their battle dress uniforms and dress for their next challenge.

Other companies such as Schneider National, one of America's largest

trucking companies, are realizing the skills our veterans have gained over the last decade of work are directly applicable to their business. Schneider National recognizes that a veteran who has driven a 7-ton truck across Afghanistan's dangerous and rugged terrain is more than qualified to drive a freight truck across our Nation's roads. In addition to providing many veterans with new jobs, Schneider National also provides newly separated veterans with on-the-job training through their military apprenticeship program. As part of that program, veteran employees are eligible to earn a monthly educational benefit check from the VA in addition to a paycheck. Schneider National serves as a great example of how companies can hire veterans who have proven they can perform on the job but lack proper certifications for civilian employment.

The U.S. Chamber of Commerce also should be commended for launching its Hiring Our Heroes initiative which has sponsored 150 hiring fairs in 48 of our States. At one of these recent hiring fairs, General Electric, the employer of 10,000 veterans, launched its veterans network transition assistance program. As part of that program, General Electric has vowed to hire 1,000 additional veterans every year for the next 5 years and provides job-seeking veterans with one-on-one mentoring sessions. Those sessions help transitioning veterans improve resume writing and interviewing techniques so they can capitalize on the skills they have developed during their military service.

That is just a fraction of the work being done by our Nation's employers. There are many success stories at big companies such as Home Depot and small companies such as General Plastics in my home State which has created a pipeline to hire veterans at its aerospace composite factory. All of these companies are not only examples of success stories but they have also created a roadmap about how best to find, hire, and train veterans. It is our job to make sure those lessons are being heard.

Today I am here on the floor to lay out a few things that all businesses, large and small, can do to bring our Nation's heroes into their companies. First, get the word out to companies to educate their human resources teams about the benefits of hiring veterans and how skills they learned in the military translate to the work a company does. I can't tell my colleagues how often I hear from veterans who tell me the terms they use in interviews and on resumes fail to get through to the interviewer.

Second, help our companies provide job training and resources for transitioning servicemembers. This is something I have seen done at large organizations such as Amazon and Microsoft, but also at smaller companies in conjunction with local colleges. In fact, the most successful of these programs capitalizes on skills developed during military service but also utilizes on-the-job training.

Third, let business leaders know how important it is to publicize job openings with our Veterans Service Organizations at local military bases so we can help connect veterans with jobs, and to work with local one-stop career centers.

Fourth, develop an internal veterans group within our companies to mentor recently discharged veterans.

Finally, if possible, please reach out to local community colleges and universities to help develop a pipeline of the many veterans who are using GI bill benefits to gain employment in a particular area.

If we can spread the message on just a few of these steps, I am confident we will be able to continue to build on the success we have had in hiring veterans.

There is one other even more important step we have to take to ensure that businesses are taking, and it has to do with the difficult issue that some potential employees face. I have heard repeatedly from veterans that they do not put their military service on their resume because they fear it stigmatizes them. They fear that those who have not served see them all as damaged or unstable. We have to understand what mental health challenges are and what they are not.

As we seek to employ more veterans, we need future bosses and coworkers to understand that issues such as posttraumatic stress or depression are natural responses to some of the most stressful events a person can experience. We need them to understand that these illnesses do not afflict every veteran and, most importantly, we need to understand that for those who are affected by these illnesses, they can get help, they can get better, and they can get back to their lives. We need to let businesses know if they have a veteran who is facing some challenges, we should do the right thing and encourage him or her to get help. They need to know it is OK to reach out. Help them take advantage of the excellent mental health care the VA is capable of providing. The veteran will be better and they will be an even stronger member of a company's team.

Those are some steps our employers can take, but we also need to make sure our veterans are taking steps to stand out as candidates. Unfortunately, too often our veterans don't see how the skills they learned in the military translate from the battlefield to the working world. One of the biggest reasons for that is often our veterans don't understand the vernacular of the working world.

A few weeks ago I was home in Washington State talking about this issue when I met a woman named Anne Spurte. Anne is a veteran. She helps other local veterans find work through an organization called The Unfinished Mission. Anne told me how often she has heard from veterans who told her they were not qualified for the jobs they had seen on line or in the paper. Repeatedly they told her they didn't see how their experiences mattered to employers in the area. So one day in front of a whole group of veterans, Anne pulled out this job advertisement from Boeing for a position as a fabrication specialist. Anne could once again sense that the veterans who sat there and read this ad thought they weren't qualified for this manufacturing job that is listed in Boeing's space exploration division. But then Anne concentrated all the attention of the veterans in the room on the competency and qualifications section that was listed on that job advertisement and she asked all of them: Did you spend time in the service working together to remove obstacles to help a team accomplish its goals? Did you work to fully involve others on the team in decisions and actions? Were you held responsible? Did you demonstrate your commitment to the team? Around the room, all of these veterans' heads were nodding as she read verbatim from the Boeing job announcement. Every veteran understood they had the core skills employers at Boeing were looking for, but they just didn't realize it.

What Anne made those veterans come to understand was that their skills were being lost in translation, and what many of them needed to do was simply articulate their experiences in a way that employers could understand.

So today I want to reiterate to all of our veterans that no matter what branch you served in or when you served or how long you served, the skills you learned are valuable and it is up to you to make sure employers see that.

Our veterans don't ask for a lot. Oftentimes they come home and don't even acknowledge their own sacrifice. My own father never talked about his time fighting in World War II. In fact, I never saw his Purple Heart or knew that he had a wallet with shrapnel in it from when he was hit or a diary that detailed his time in combat, until after he died and my family gathered to start sorting through his belongings. But our veterans shouldn't have to ask. We should know to provide for them.

When my father's generation came home from the war, they came home to opportunity. My father came home to a community that supported him. He came home to college and a job--a job that gave him pride and helped him start a family and one that ultimately led to me starting my own.

That is the legacy of opportunity we have to live up to for today's veterans. Together, working with the private sector, we can ensure that the brave men and women who have worn our uniform have that real opportunity. We can make sure they get a fair shot from America's employers, that they are not measured by fear or stigma but by what they can do, what they have done, and what they will do.

I thank those companies that are leading the way as our veterans transition from military service to the civilian workforce. The Veterans Affairs' Committee, which I chair, has a Web site with a list of some of those companies that are contributing to this effort. I would encourage all of our colleagues to visit that Web site and suggest companies that can be added to our list. I look forward to working with all of them, and many more of our Nation's businesses, on this important next step in bringing our veterans home to opportunity.

As we celebrate our fallen heroes on Memorial Day next week, let's all keep thinking about how we can make sure our veterans are getting everything they need after they have given so much.

Before I yield the floor, I wish to take a moment to acknowledge a young Marine reservist, an Afghanistan combat veteran, who has been working part time on my Veterans' Affairs Committee staff for the last year. Carlos Fuentes is a hard-working, well-liked young man who graduated from American University earlier this month. He has helped our committee get a better understanding of what our veterans are facing when they are looking for work, and I want to thank him for his continued service to our Nation. I need my colleagues to know that Carlos is going to be getting married this weekend and I wish him and his bride many happy years to come.

Thank you, Mr. President. I yield the floor and I suggest the absence of a quorum.