David Mitchell Rozga Act

Mr. President, I rise to speak in support of the amendment offered by the Senator from Arizona.

Nuclear Submarine Fire

Before I do that, I want to recognize and acknowledge the tremendous and outstanding and remarkable work done by the crew at the Portsmouth Naval Shipyard and the local firefighters from numerous departments from the State of Maine, as well as from New Hampshire, because of the fire that occurred on the nuclear-powered submarine at the shipyard last evening, which was burning for more than 9 hours.

It was the extraordinary teamwork and coordination among all of the crews, as well as the firefighters and departments from both States, that managed to put out the fire. It is now smoldering. I offer my commendations and congratulations to those who did the exceptional and outstanding work, which exemplifies the kind of teamwork that already occurs at that shipyard. I wanted to offer my recognition to that extraordinary work in a very difficult circumstance.

Amendment No. 2107

I rise in support of the amendment offered by the Senator from Arizona, Senator McCain, in authorizing a very limited drug importation program, whereby Americans can purchase medications from accredited online Canadian pharmacies. I am supporting this amendment, as I have in the past. In fact, we have had broader amendments offered on the floor of the Senate for almost more than a decade with respect to allowing importation of prescriptions from other countries that offer more competitive prices.

I applaud Senator McCain, who obviously has been a very valuable ally in

this effort for many years. But he proposed a very limited approach to address those who have concerns with the idea of importing prescription drugs. I, for one, cannot understand why there is such a fundamental concern about this issue because, first of all, Americans have been facing tremendous increases in prescription drug prices for far too long. I think it is at a point at which Congress should address this issue, and precisely on this particular piece of legislation that is before us today. It could not be more appropriate to have this amendment offered on this legislation.

In 2010, AARP found that retail prices for the most popular brandname drugs increased 41.5 percent, while the Consumer Price Index rose just 13 percent. In other words, the cost of prescription drugs rose more than three times as much as the inflation rate. That is completely unacceptable.

What has occurred as a result of this trend? First of all, American consumers are increasingly choosing to risk living without taking critical medications. According to the Commonwealth Fund, in 2010, 48 million Americans did not fill a prescription due to high costs. That represents an increase of 66 percent since 2001.

If the Senate and the overall Congress were to adopt the McCain amendment, it would allow Americans to purchase safe medications at a lower price than they are available for us in this country. We could begin to turn this disturbing trend around. I know people in Maine deserve access to affordable drug prices. Millions of Americans, and certainly those in Maine, have purchased drugs from Canada safely, at a significant savings over the years. They have had to go to great lengths in order to purchase lower price medications. They have taken bus trips to Canada to purchase that medication because that was the only way they could have access to the prescriptions they so desperately need. The McCain amendment builds on that foundation.

If we look at this first chart, Mr. President, an April 27, 2012, survey comparing average Canadian drug prices against major U.S. retail pharmacy prices, we find the average U.S. price for a 90-day supply of Nexium, which is a common blood thinner, is $560 in America but only $265 in Canada. So Americans are paying twice as much for Nexium as Canadians do. I think that is simply outrageous. Why should American consumers pay twice as much for a medication that so many Americans depend upon?

Here is another example of a drug that is a blood-thinning drug that is also very crucial in this process, and that is Plavix. That costs $585 in the United States versus $398 in Canada for a 90-day supply. So, again, American consumers are paying 50 percent higher costs for the same prescription drugs as Canadians do.

Then let's look at the very popular anticholesterol medication Lipitor. This chart illustrates, again, what Lipitor costs the American consumer. The cost is $478 in the United States as compared to $278 in Canada for a 90-day supply.

So for patients who are already trying to make ends meet in this very difficult economy by rationing their medications, splitting their pills, or even skipping medications entirely, why would we deny them access to safe drug products at these dramatically lower prices? That is why I have cosponsored Senator McCain's amendment. It would allow Americans to import medication from accredited Canadian pharmacies from a list approved by the Secretary of Health and Human Services. These accredited pharmacies must commit to ongoing quality assurance programs and product testing to determine the safety and efficacy of these products.

This amendment is more narrowly focused than even the one that our former colleague Senator Dorgan and I had offered previously. This provides a pathway to a more limited approach for Americans to access affordable medications. In fact, there has been a very recent study conducted by Roger Bate of the American Enterprise Institute entitled ``Unveiling the Mystery of Online Pharmacies: An Audit Study.'' Let me quote from him as to what he discovered:

If some foreign Web sites sell safe prescription drugs with

substantial price discounts, but American consumers are

guided to buy from U.S. Web sites only, the FDA could

potentially discourage price competition between the U.S. and

foreign pharmacies and, thereby, reduce drug affordability

within the United States. The danger of reducing price

competition depends on whether consumers can distinguish

trustworthy Web sites from the vast pool of foreign Web

sites.

So here we have the documentation by a very significant study that talks about how Americans can access these affordable medications. We shouldn't be discouraging price competition, as this study illustrates. That is one of the points I have been arguing over the years; that the real problem in this country with respect to prices for prescriptions is that we don't have competition within the industry and competition for those medications.

Americans have learned that citizens in other countries use the very same medications as we do. They are made in the very same plants. Yet they pay less. We talk about injecting greater free market competition in the health care marketplace as a way of achieving greater affordability, and this amendment attempts to address that very issue. As we look at what other countries do, when we are talking about accessing cheaper medications, we know in Canada that is the case, and it is certainly true in other industrialized nations.

I should add, in fact, they pay 35 to 55 percent less for their drugs because of the higher prices Americans pay, which is about $90 billion more for prescription drugs every year than we would otherwise. I think that is totally unacceptable. Why should American consumers be paying 35 to 55 percent more or nearly $90 billion more than consumers in other countries for the very same medications? It simply doesn't make sense.

According to former Pfizer CEO Hank McKinnell--looking at the quote on this chart:

Competition is good medicine for economies. . . . Name an

industry in which competition is allowed to flourish--

computers, telecommunications, small package shipping,

retailing, entertainment--and I will show you lower prices,

higher quality, more innovation, and better customer service.

There's nary an exception. Okay, there's one. So far, the

health care industry seems immune to the discipline of

competition.

When we last considered the legislation I introduced along with former colleague Senator Dorgan, we allowed importation only from Canada, the European Union, Australia, New Zealand, and Japan, and the Congressional Budget Office estimated the Federal Government would save almost $20 billion--$20 billion--if we allowed the importation of those medications. So we know for a fact allowing drug importation generates considerable cost savings to the government, to individuals, and businesses that provide health insurance coverage to their employees.

The bottom line is where nations institute safe, regulated trade in pharmaceuticals they achieve results. When Sweden entered the European Union system of trade, they saw a reduction of 12 to 19 percent in the price of traded drugs. In fact, Europe has had parallel trading for more than 30 years and has never had an incident.

Industries see the advantage in being a part of the global market when it comes to manufacturing costs. For example, according to a Pew study in 2011, the number of prescription drugs made at non-U.S. sites doubled between 2001 and 2008. That means they doubled at a sizable increase with respect to the number of prescription drugs that are made at non-U.S. sites. There are more than 50 plants where our medications are manufactured, and not all of those facilities are even inspected-- not even inspected. Yet those are medications we use in this country because they are manufactured at other plants in other countries. As I said, there are more than 50 countries in which we have our prescriptions manufactured.

So let me see if I have this straight. It is fine for some foreign countries to manufacture drugs in their own plants for the U.S. market, ship those drugs here where the American people are given the privilege of paying higher prices than anywhere else in the world, but somehow we can't safely import those very drugs into the United States directly. It simply doesn't make sense.

The American taxpayer is underwriting more than $30 billion of research--basic and applied research--at the National Institutes of Health alone, so consumers in all those other

nations are benefiting from the investments the American taxpayer is making with respect to research. That U.S. research produces these medications and these prescriptions that other nations pay 35 to 55 percent less for than the American consumer. The American taxpayer is paying more for those drugs, as I said, and also paying more of their tax dollars for the research that is ongoing at the National Institutes of Health. It simply doesn't make sense.

With all of the additional profit, industry invests nearly equally in R&D in the United States and in Europe and is increasingly moving research to low-cost Asian countries. So paying the world's highest prices for drugs doesn't ensure us more research, but it decreases our access to drugs. So that is the contradiction that Americans confront each and every day when they are purchasing their medications at a much higher cost than consumers in other countries.

The amendment that is offered by the Senator from Arizona is allowing importation solely from Canada, and it is for online pharmacies based on a list that has been drafted by the Department of Health and Human Services. That is a very prescribed, targeted, limited approach to allowing American consumers to benefit from those lower priced drugs that are offered in Canada.

It is very important we take this step. It is important for American consumers who otherwise are not going to be able to afford these medications when they are paying two to three times more than their counterparts in Canada, for example. The prices are rising five times more than the inflation rate year after year, so the compounding effect is significant and overwhelming for most American consumers and families. So what I hope is we will support the amendment that has been offered by Senator McCain.

Some have suggested that providing support for the McCain amendment will hinder efforts to quickly move on the underlying legislation for the FDA. That concern is certainly not persuasive because the McCain amendment is a very narrowly focused approach. It represents a good- faith effort to find common ground. It has included strong safety- related measures and is done under very limited circumstances so the American consumer can take advantage of the lower prices I have demonstrated today with regard to some of the commonly used drugs, such as the anticholesterol medication Lipitor and the drug-thinning drugs such as Plavix. It is explicitly designed to make it more broadly acceptable to those who might have concerns in taking the approach of drug importation.

We must create a more competitive, more affordable health care system for the American people. The prescription drug market needs competition. Competition will lower prices. For some reason, even though we are underwriting all of the research that benefits consumers in so many other countries, and even though our medications are manufactured at other plants in 50 countries, the American consumers are paying up to 55 percent more than their counterparts around the world. It simply doesn't make sense. In fact, I would suggest it is outrageous.

So that is why I am supporting this amendment. We need to take this limited, modest first step that I think goes a long way to addressing any reservations anyone might have in this Chamber with respect to the issue of importation. I hope we will allow American consumers to benefit from the much lower prices, especially during these very difficult economic times. This is a first step toward a larger system of safe, regulated drug importation.

I commend the Senator from Arizona for offering this amendment, and I hope the Senate will adopt it.

I yield the floor.

Mr. President, I rise today, along with Senator Warner, to reintroduce legislation that provides greater technical resources to the Commissioners of the Federal Communications Commission. Such resources are essential to making sound regulatory decisions and being a more effective technical agency--especially in this era of rapid innovation in the industries under the Commission's jurisdiction.

Specifically, the FCC Technical Expertise Capacity Heightening or ``FCC TECH'' Act would allow Commissioners'' to appoint a staff member--an electrical engineer or computer scientist--to provide in- depth technical consultation, and commission a study by the National Academy of Sciences on the technical policy decision-making process and the availability of technical personnel at FCC. The study would include an examination of the FCC's technical policy decision-making, current technical personnel staffing levels, and agency recruiting and hiring processes of technical staff and engineers, and make specific recommendations to improve these areas.

Over the past several years, I have shared the concerns voiced by the technical community and even some Commissioners themselves about the lack of technical resources and expertise at the FCC. Such concern is warranted. In 1948, the FCC had 720 engineers on staff; today, it has fewer than 270--an astonishing 63 percent reduction--even though the FCC now must face more technical issues concerning the Internet, advanced wireless communications, commercial cable & satellite industries, and broadband. It should be noted that engineering staff currently only accounts for a dismally low 14 percent of the FCC's workforce--in 1948 that figure was more than 50 percent.

A December 2009 report by the Government Accountability Office (GAO- 10-79) provides additional evidence of the need for this legislation. The GAO concluded that ``weaknesses in FCC's processes for collecting and using information also raise concerns regarding the transparency and informed nature of FCC's decision-making process.'' Furthermore, the report found the ``FCC faces challenges in ensuring it has the expertise needed to adapt to a changing market place.''

So in a time when citizens are demanding more effective and efficient government and zero government waste, taking such steps as prescribed by this legislation will ensure the FCC is adequately equipped legally and technically to properly craft policy. It should be noted this legislation does not require new staff--it just makes better use of them. In addition, streamlining FCC processes and rulemakings will make sure the Commission keeps pace with the dynamics of the industry it oversees, which is important in order for U.S. companies to continue to be competitive in this global economy.

In a letter I wrote to Chairman Genachowski last year, I highlighted several outstanding spectrum proceedings that I urged the Commission to conclude. The proceedings I mentioned had a common characteristic that concerned me--all of them had been open for three years or longer, and another related proceeding had been pending for well over a decade. This regulatory delay and uncertainty due to the Commission's inaction adversely affects American businesses, which request technical waivers or file petitions to better compete domestically and internationally, and suppresses innovation and the jobs associated with it. We must make sure the Commission is a catalyst to innovation and jobs, not an inhibitor.

Even the general public is aware of the significant technical deficit that exists at the Commission and the importance of increasing its technical aptitude--one of the top public recommendations on the FCC's reform website, reboot.fcc.gov, is to ``require at least one FCC Commissioner to be an engineer.''

This Administration has stressed the importance of innovation being a vital component in our economic recovery, so allowing a shortage of technical

staff to exist at an agency responsible for regulating very technical industries that will be the main drivers for innovation is counterintuitive. The President has also placed a major emphasis on science, technology, engineering, and mathematics, STEM, education in order to enhance our nation's competitiveness and economic wellbeing in the global economy yet, engineers only constitute 14 percent of the FCC's workforce and, it is my understanding, there is only one engineer in a senior management role at the Commission today--the government's technical expert agency.

This legislation enhances technical resources at the FCC so it will be better equipped and more agile to address the ever-changing technical landscape from a regulatory perspective. If it isn't, our nation's technical leadership in this area will continue to erode and it will be even more difficult to lay the proper policy foundation necessary to meet future telecommunications needs. It is also an essential component to execute the FCC's recently released National Broadband Plan, which includes several technically complex initiatives.

Last Congress, several technical organizations expressed support for the legislation--the Institute of Electrical and Electronics Engineers, Society of Broadcast Engineers, Association for Computing Machinery, and the Association of Federal Communications Consulting Engineers. Also, prominent individuals in this field, such as Vint Cerf, and former Senior FCC Technical Officials Dale Hatfield, Dave Farber, and Robert Powers support the legislation.

In the past, Chairman Genachowski has stated ``the country expects the FCC to be an expert agency.'' Being an expert agency starts with having the technical expertise to comprehensively understand and examine the issues that are within its jurisdiction and also acting on those issues in a timely manner. If it doesn't, our nation's technical leadership in telecommunications could continue to erode due to regulatory bottlenecks that are created at the Commission from unresolved proceedings and petitions. Removing the bottlenecks that exist through streamlining processes and removing bureaucracy will reduce government expenses and waste over the long term.

This bill takes steps toward properly addressing glaring technical deficiencies at the Commission, which left unaddressed could continue to hamper American innovation and competitiveness. This is absolutely critical given how rapidly technologies are changing and the implications that regulation could have on the underlying technical catalysts of innovation. That is why I sincerely hope that my colleagues join Senator Warner and me in supporting this critical legislation.

Mr. President, I rise to introduce legislation with Senator Merkley that will provide the President of the United States with emergency powers to aggressively reduce the Federal Government's demand for energy.

The Strategic Petroleum Demand Response Act will be an additional tool to address rapidly rising energy prices by reducing our country's demand for oil. The political instability in the Middle East reminds us that this region, which holds the largest reserves of oil in the world, has had profound implications on our country's economy by dramatically affecting the price of oil. Although the attention has been on potential supply disruption, our country also consumes nearly 17 million barrels of oil per day and through aggressive measures the Federal Government can lead our country in reducing its energy bill, curtailing its consumption of oil, and reducing the price of oil for consumers.

As we encounter these price spikes, some have called for a release of oil from our country's strategic petroleum reserve. The fact is prior to releasing our country's strategic reserves we must develop policies that prioritize the Federal Government's consumption of these critical oil supplies. The Federal Government can reduce nonemergency travel, reduce congestion on the roads by providing flexible work hours, decrease the use of oil in heating and cooling buildings, and work with local and state governments to cut consumption as well. We must develop a strategic petroleum strategy that reflects the fact that prices are dictated by both supply and demand and the Strategic Petroleum Demand Response Act will address the demand side of the equation.

Since the start of the year the price for West Texas Intermediate has increased by 16 percent and the week of February 28 encountered the second highest net increase in gasoline prices in our country's history. While I strongly believe that we need to develop specific long-term strategies that build on the success of fuel economy standards and reduce our consumption of oil, this legislation will allow the President to take immediate and decisive action to address any energy crisis through both supply and demand.

Mr. President, I rise today to introduce bipartisan legislation along with Senators Landrieu, Merkley, Brown of Massachusetts, and Enzi, titled the Small Business Contracting Fraud Prevention Act of 2011.

In the past year, the Government Accountability Office, GAO, has identified vulnerabilities and abuses in virtually all of the SBA's contracting programs, including the 8(a) Business Development Program, the Historically Underutilized Business Zone, HUBZone, program, and the Service-Disabled Veteran-Owned small business, SDVOSB, program. Our legislation attempts to remedy the spate of illegitimate firms siphoning away contracts from the rightful businesses trying to compete within the SBA's contracting programs.

As Ranking Member of the Senate Committee on Small Business and Entrepreneurship, I take very seriously our responsibility of vigorous oversight. That is why, last December, Senator Landrieu and I sent a letter to the SBA highlighting the recent press headlines and GAO reports of fraud and abuse that have plagued the Agency's contracting programs. That letter stated unequivocally that our Committee's first priority this Congress is ensuring that ALL of the SBA's contracting programs are running efficiently, effectively, and free of exploitation. Adopting this critical small business legislation is an effective first step at ensuring all small businesses are competing fairly and honestly within the Federal marketplace.

As recently as Saturday March 12, the Washington Post, as part of an ongoing investigation, published an article titled, ``DC insiders can reap fortunes from federal programs for small businesses.'' This article states ``Government officials were not monitoring contracts for compliance with rules.'' The report exposes a glaring deficiency in contract oversight. Moreover, an SBA spokesperson is quoted as saying the SBA ``long ago transferred that authority to the Pentagon and other agencies.'' This hands-off attitude is unacceptable, and as I told the SBA Deputy Administrator at a recent Small Business Committee hearing, the ultimate authority for monitoring fraud lies with the SBA.

This legislation contains recommendations both from the SBA Inspector General and the GAO for combating these reports of fraud and addresses vulnerabilities in the Service-Disabled Veteran-Owned small business program, the HUBZone program, and the 8(a) program. Additionally, the bill will work to change the culture at SBA to make the process of suspensions and debarments more transparent.

In order to effectively execute the small business contracting programs, the SBA needs a comprehensive framework to provide effective certification, continued surveillance and monitoring, and robust enforcement throughout the SBA's contracting portfolio. This bill aims to increase criminal prosecutions as well as suspension and debarments for businesses found to have attained contracts through fraudulent means, and requires the SBA to submit a report to Congress annually detailing the specific data on all suspensions, debarments, and cases referred to the Department of Justice for criminal prosecutions.

To that end, the SBIR bill we are now debating on the Senate floor, includes stringent oversight and fraud prevention measures, requiring Inspectors General of participating Federal agencies to establish fraud detection measures, coordinate fraud-related information sharing between agencies, and provide fraud prevention related education and training to agencies administering the programs, among other initiatives.

As a senior member of the Senate Commerce Committee, I worked with the Chairman, Senator Rockefeller, in developing this language following a 2009 committee investigation and hearing on the subject of fraud in the SBIR program. My amendment goes even further and provides the SBA more stringent oversight capacity across all the SBA contracting programs. It is SBA's duty to utilize every fraud prevention measure at its disposal and this amendment puts the tools in place to punish the bad actors that have infiltrated the SBA contracting programs.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

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

I ask unanimous consent to be recognized for 10 minutes and that the time be taken from the Burr amendment and equally divided.

Madam President, we have three counties in Delaware. The

southernmost county is called Sussex County. Several years ago, I was privileged to visit a Methodist Church there and speak as a lay speaker to try to encourage people to become mentors.

The minister that day was a great old guy, Reverend Reynolds. He is now deceased, but he said to me that day these words, and I have never forgotten them. He said, ``The main thing is to keep the main thing the main thing.''

That is what he said. ``The main thing is to keep the main thing the main thing.''

At first I wasn't sure what he was talking about, but the more I thought about it I thought: Boy, this guy is smart. And if I am smart, I will keep the main thing the main thing.

For us in the Senate and in Congress, the main thing for the voters of this country is they want us to work together--well, maybe the two main things are they want us to work together--they want Democrats and Republicans to work together--and they want us to get things done. One of the things they want us to get done is to create what I call a nurturing environment for job creation and job preservation. They want us to do things that are going to help encourage the creation of jobs and the preservation of jobs.

Little known to a lot of folks across the country, we actually have been doing some of that in the Senate for much of this year, and we have worked productively across party lines to pass a series of bills that I think do help create a more nurturing environment for job preservation and job creation.

Just a couple examples, if I could: One, the reauthorization of the Federal Aviation Administration to establish a new source of additional revenues to modernize and update airports across the country, to bring the air traffic control system of our country into the 21st century where we had kind of an analogue system, and to bring it into the digital age.

Patent reform was another significant step forward earlier this year, where we said enough of this patent patrol--people who come in after someone has filed for a patent and say: Oh, no, that was my idea, and just botch things up and drag things out in the courts. Under patent reform legislation, if you are first to file, you are first to file, and that is your patent. Also provided in the same legislation are the resources needed in the Patent Office to more expeditiously process patent applicants.

Free-trade agreements. One of our roles as the government is to try to make sure we have access to foreign markets. If our goods and services are being closed out in those foreign markets, then we have to open them up. We agreed by a broad bipartisan proposal this year--three of them, actually, three free-trade agreements--one with South Korea, one with Colombia, one with Panama negotiated originally by the George W. Bush administration and embraced by the Obama administration, which is now the law of the land, to make sure when businesses have the opportunity to export, the barriers that have maybe kept them out in the past are knocked down or eliminated, and to make sure if American businesses need financing and help to finance their exports, that they have that kind of help through the Export-Import Bank, which we have reauthorized and extended into the future.

Another one that we worked on this year together, a bipartisan bill and supported by the President, is something called the JOBS Act. What it is all about is trying to make sure companies have better access to capital, and if a small or medium privately held company wants to go public, to make sure they can do it through something called an IPO onramp as opposed to just trying to jump into it and get it done all at once. Or for companies that want to stay privately held, for them to be capped at 1964 levels, 500 shareholders, to say they can go up to 1,000, 2,000 shareholders to enable them to have that access to capital to continue to grow and to create jobs.

Other examples of bipartisan legislation we worked on, in one case the Transportation bill--land transportation: roads, highways, bridges, and transit--we passed a good bill in the Senate, paid for, to help over the next couple of years to meet our transportation needs and make sure the 3 million people who are working on transportation and transit projects across the country don't basically get laid off in a month or two. We passed a good bill. I give a lot of credit to Senators Boxer and Inhofe for helping to lead the bipartisan approach.

Also, 7 or 8 million jobs depend on the Postal Service. The Postal Service is in tough straits, running out of money and losing $125 million a day. We are hoping that the House of Representatives will pass the bill--they need to--so we can go to conference and help fix that problem. But there is good bipartisan legislation here to effect positively 7 or 8 million jobs that depend on the Postal Service. All that stuff, in terms of the American people wanting us to work together, and we have been. Those are just a couple examples.

In terms of actually doing things that help create jobs and preserve jobs, every one of the items I just mentioned does create a more nurturing environment for job creation and job preservation. In the coming weeks, we also want to work on agricultural legislation--a bipartisan bill, again, out of the Agriculture Committee that will save billions of dollars on the deficit side. It will also help to strengthen our agricultural economy.

We need to get to work on a national flood insurance update, and that legislation helps to bolster the home building industry in this country which is struggling, as we know, and we have the opportunity for those things that are on our to-do list, to get them done.

Today the Senate is considering another bipartisan piece of legislation, as we know, the Food and Drug Administration Safety and Innovation Act, affectionately known by its acronym. I don't like acronyms, but I love this one. It is called PDUFA. So it is the FDA and how we make sure the FDA has the resources they need to do their job. As the other bills passed by the Senate I just talked about, this bill helps create a more nurturing environment for those businesses to thrive. Those businesses include the pharmaceutical business and businesses that make and sell medical devices. But just as important, this bill helps to ensure that Americans get access to lifesaving medications and medical devices that are developed in this country as soon and as safely as possible.

This bill reflects a strong bipartisan, bicameral effort, for which Chairman Harkin and ranking member Mike Enzi deserve enormous praise, and I praise them even though they are not in the Chamber right now. They have done great work, and I thank them and their staffs for bringing it to this point today.

The legislation builds upon the successful current user fee programs. For a number of years, the companies have paid a user fee if they want the FDA to approve a drug or medical device, and we are making progress to actually have more resources for the FDA to do this than we used to. But they need some additional help, and this legislation would do that, paid for by the industries that are seeking the consideration of their new pharmaceuticals and their new medical devices.

The legislation also adds important new user fees for generic and biological drugs. The user fees are paid, again, by the prescription drug and medical device industries to help cover the FDA's costs for reviewing new drugs and medical devices.

What this means is safer drugs and a speedier process to bring new and less expensive drugs and medical devices to markets for consumers, and I think it is a win-win for just about everybody.

As a result of the FDA legislation affectionately known as PDUFA, the FDA's drug review times have already been cut in half. That is good. If these user fees, these user programs are not reauthorized, though, the FDA would have to lay off, I am told, about 2,000 employees, which would put them back in the ditch, if you will, and begin to delay approval of new drugs. We don't want to see that happen. That would threaten patent access to new therapies, as well as pharmaceutical and medical device industry jobs, and America's global leadership in biomedical innovation.

This bill also makes medicines safer for millions of children, improves the FDA's tools to police the global drug supply chain, and reduces the risk of drug shortages. There are a number of amendments that are being offered to the bill--we have voted on a couple of

those--and one of the amendments that we will be voting on, I believe, a little later this afternoon is legislation that would, in my view, weaken or contaminate our country's supply of prescription drugs and put our patients and our health care system at risk.

Some of my colleagues have proposed to include a measure in this bill that ostensibly would lower prescription drug prices. This amendment, in my view, however, is not without unintended consequences, and we always have to be careful of those.

I ask unanimous consent for 3 more minutes equally divided.

Unfortunately, it would open our borders to increased numbers of contaminated and adulterated drugs.

The proposal to import drugs from Canada would allow drugs to be imported wholesale, often from illegal Internet pharmacies with no protection against abuse or contamination.

Also, though this measure is supposed to be about importing drugs from Canada, in truth it would allow drugs to come from countries that don't have the kind of strong inspection and policing of prescription drugs that we have in the United States.

Instead of going down that road, we should work to increase the FDA's abilities to protect and regulate our drug supply. While doing so, we should reject any proposals to import drugs from Canada that undermine our ability to ensure that prescription drugs are safe and effective.

One last thing I want to mention is there is an amendment that is going to be offered today--or maybe already has been, but I am going to mention this anyway--that deals with generic drugs and concern about the ability for larger pharmaceutical companies to work with and pay off, buy out the generic drug companies so they don't bring their generic version of the name-brand drug to market. I just want to say that we need to be careful what we are doing here.

I came out of the Navy and came to this Congress in 1983 as a freshman Congressman. In 1982, 20 percent of the prescriptions being filled in this country were generic drugs. This year, 80 percent of the medicines or prescriptions that are being filled are generic. One of the well-intentioned amendments to have been offered today is one that says we are not making enough progress toward allowing the generics to grow. Say that again?

We have gone from 20 percent generic penetration in 1982 to, today, 80 percent. I would suggest that we should declare victory, and as time goes by, even that 80 percent will become 85 percent or 90 percent. But we have come a long way. As a result of that, people who need to buy medicine can find a generic version of almost any medicine that is being sold in this country. I think the system is working just fine, and we ought to allow it to continue to work.

In closing, the main thing is the main thing. The main thing is to keep the main thing the main thing.

For us, the main thing is to work together. We are in a whole host of ways--including under the great leadership of Senator Harkin and Senator Enzi--working to make sure our pharmaceutical industry is vibrantly strong, the medical device industry is vitally strong, but also that patients are not disadvantaged, that they are actually advantaged by all of that.

So responding to folks in Delaware and Iowa and across the country, we are working together. We are not just working together on a couple of things but on a whole host of things, a whole litany of provisions and laws and proposals that do what: help us to create a more nurturing environment for job creation and job preservation. That is a good thing. That is a very good thing.

I thank Senator Harkin for giving me a chance to say a few words and for the great work that he and Senator Enzi have done. I am happy to follow their leadership here today.

Mr. President, I rise in opposition to the McCain amendment No. 2107, which would facilitate the importation of prescription drugs from Canada. We are not talking about bus trips of seniors to reputable brick-and-mortar pharmacies right across the border. We are talking Canadian Internet pharmacies, which may not even be in Canada, which pose a significant threat to American patient safety.

This amendment would require the Food and Drug Administration to allow individuals to import prescription drugs into the United States from Canada, notwithstanding any other provision of the Federal Food Drug and Cosmetic Act.

Drugs that supposedly come from Canada can originate in any country in the world, and merely be shipped to the United States from Canada. Canadian law does not prohibit the shipment of drugs from any country into Canada and then into the United States. They do not care.

In 2005, FDA conducted an investigation of drugs that American patients thought they were ordering from Canada. Eighty-five percent of the drugs represented as coming from Canada actually came from 27 other countries. A number of drugs were found to be counterfeit.

A letter from Assistant Deputy Minister of Health, Canada, to the U.S. Surgeon General again said that Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future.

The pending amendment would allow importation from Canadian Internet pharmacies. Canadian Internet pharmacies openly acknowledge they obtain most of their drugs from other countries. The specific language of the pending amendment gives rise to the additional safety concerns. For example, it will not prevent the importation of drugs that need special handling, such as refrigerated or photosensitive drugs. It would not prevent the importation of special drugs, such as those inhaled during surgery or administered intravenously.

The pending amendment would not require Canadian wholesalers that would be involved in the importation to be licensed or registered in any way. There would be a list but not a licensing or registration. Do we want anyone, even someone under investigation or with a suspended or revoked license, to be in the business of importing drugs, given the well-known risks?

FDA advises consumers that some imported drugs, including those that bear the name of U.S.-approved products, may, in fact, be counterfeit versions that are unsafe or completely ineffective. You know, they can have all of the ingredients to it, but if it is not put together the right way, it will not even dissolve as it goes through the body, and therefore there would be no benefit from that drug, even though it looked like the real thing, it tasted like the real thing, it went down like the real thing. But if it is not the real thing, it can cause some real trouble with people's health.

This is not a hypothetical concern. Last year Homeland Security Secretary Napolitano testified that counterfeit drugs are a growing problem. Two months ago, FDA testified about the dangers of purchasing counterfeit, unapproved, or diverted prescription drugs on line. My colleague Senator Mikulski has highlighted the growing involvement of organized crime in this area. Prescription drug counterfeiting can be dramatically more profitable than narcotic smuggling. Imported drugs pose additional dangers because their labels may lack important information or warnings.

FDA advises consumers that an imported medication may lack information allowing patients to be promptly and correctly treated for dangerous side effects.

We know imported drugs pose severe risks to American patients. The FDA and the Department of Health and Human Services have repeatedly said they cannot assure the safety of imported drugs. A side-by-side amendment that we used to put on this all the time was that you could import drugs as long as the Secretary of Health and Human Services said it was safe. Well, there hasn't been a Secretary of Health and Human Services who has been willing to sign that drugs imported from anywhere--even Canada--are safe.

FDA's Web site advises consumers that imported drugs--including drugs imported from Canada--may not have been manufactured under quality assurance procedures designed to produce a safe and effective product. That is the FDA Web site.

The Federal Food, Drug, and Cosmetic Act represents over 100 years of lawmaking to protect the public health. It gives the FDA authority to make sure drugs are properly approved, manufactured, labeled, shipped, handled, and stored, that factories are inspected, and that numerous other protections are in place for American patients. Adopting this amendment would endanger American patients, and I therefore urge my colleagues to oppose it.

There is a lot more that could be said. I have been saying this for years and trying to find a way it could be done. At the present time, the safety of it makes me oppose this particular amendment. They keep revising the amendment. It is still online and everybody knows how things online can be redone. They talked about putting an official seal on each Web site, but I know fourth graders who can duplicate any seal you can put on the Internet. Any list can be changed--and who checks lists, anyway? The problem is not knowing where the drugs come from that go through Canada to the United States. If they are counterfeit, they can sell them for less. The Canadian secretary of health also doesn't want to be the pharmaceutical supplier to the United States. They have a little different system up there. It is a way of driving prices down, which is something we would not stand for in the United States, a mechanism where they have to bid on the drugs. The people who make hard medicine bid against each other, and your doctor might prefer the one that doesn't win the bid. That is how they drive the price down. It is probably something we would not allow in the United States.

I ask my colleagues to oppose the amendment.

I yield the floor.

Mr. President, while I agree with much of what the Senator has said, I hope this doesn't encourage other partisan diatribes to come to the floor when we are on a bipartisan bill and trying to solve getting necessary pharmaceuticals to the market as soon as possible. We have a limited time of debate, and we need to stay on the subject. So I hope others are not encouraged to come down to counter anything they may have heard or to make different charges.

We have some time left on Bingaman and some others, but I hope we can move forward on the bill.

I yield the floor to the Chair.

Madam President, I rise today to oppose the amendment addressing the patent settlements for generic claims.

I am sympathetic to the intent of the sponsors of this amendment. I believe that some drug patent settlements may be improper and could be unfairly increasing drug prices for consumers. If that is in fact happening, we should stop the bad settlements and encourage the ones that work.

The problem with this amendment, however, is that its scope is much broader and could lead to unintended consequences that could harm consumers and increase costs. That is why I must oppose it. The amendment uses a machete when a scalpel might solve the problem. Not all patent settlements are abusive. They do not all lead to higher costs. In fact, some settlements can actually expedite generic drugs coming to market. According to

one recent study by RBC Capital Markets, patent settlements helped expedite 24 of the 37 most recent generic drug approvals.

The amendment would allow competing generic manufacturers, in certain cases, to share the 180 days of exclusivity provided under the drug patent law known as Hatch-Waxman. This period of exclusivity was intended to create a market incentive for generic manufacturers to be the first to file a generic drug application with FDA.

The amendment is intended to discourage generic manufacturers from reaching settlements with brand manufacturers to delay generic competition. Unfortunately, it may also have the unintended consequence of discouraging generic competition generally.

The Hatch-Waxman statute, which first established our current system of brand and generic drug approvals, was a careful compromise of competing interests. It struck a balance between encouraging research and development of new cures and promoting competition to lower costs. By all accounts, this law has been a success. Our Nation leads the world in the creation of new drugs and therapies that improve the lives of countless patients across the world. At the same time, generic drugs have promoted competition and lowered costs to American patients. According to one recent estimate, generic drugs have saved the American health care system over $930 billion over the last decade.

This amendment would disrupt that system and reduce the incentives that currently encourage manufacturers to file generic drug applications with the FDA. Allowing competitors to share the 180 days of exclusivity will undermine the market incentives for manufacturers to make such filings. It will also create uncertainty about whether generic manufacturers will ultimately be able to recoup their investments and could mean that there will be fewer generic drugs.

That is why the generic drug manufacturers oppose this amendment. While I genuinely appreciate the desire to prevent abusive settlements, I believe that we must be very careful in disrupting a system that has worked so well for patients and consumers.

We should hold hearings in the HELP Committee to hear from all of the stakeholders who have a role in this system. We need to learn how any proposal will impact the incentives to encourage competition. We also need to learn how any proposed solutions will affect settlements and patent litigation.

This is clearly an important and very complex issue, but this amendment could have serious and detrimental consequences for patients. This is why I would urge my colleagues to oppose this amendment.

I yield the floor.

Madam President, I yield 3 minutes to the Senator from Tennessee.

Madam President, I yield 5 minutes to the Senator from Ohio.

Madam President, I ask unanimous consent that when we begin the next vote, Senator Paul, who has 7 minutes left on his item, be given 2 minutes so he may explain his bill in exchange for those 7 minutes.

Madam President, I yield the Senator from Kentucky the time he is already entitled to.

Mr. President, I would oppose this amendment. We do need to combat health care fraud, but this amendment goes too far in several aspects. First and most important, it would discourage any settlement agreements. People would fight it to the death if they are going to lose their exclusivity.

Second, as drafted, the amendment would require companies to forfeit exclusivity anytime there is a civil or criminal liability under the Federal Food, Drug, and Cosmetic Act. It is disproportionate. This could be triggered by a misdemeanor. In addition, such liability may not reflect fraud. The amendment would discourage the development of new cures for patients. If manufactures know they could lose exclusivity for even minor infractions, they will not invest the millions of dollars necessary to create new lifesaving therapies for patients.

I ask that the Senate oppose the amendment.

I yield the floor.

Mr. President, I rise today to introduce the Earthquake Insurance Affordability Act. This bill makes important changes that will increase availability and reduce cost of catastrophic insurance for homeowners in California and other earthquake-prone Sstates.

The tragedy and devastation of the recent 9.0 earthquake in Japan was a real wakeup call for many of us. You see, the people of Japan are keenly aware of the risks of earthquakes. Every year, thousands of people participate in earthquake drills, and their building codes are the most advanced in the world. Japanese seismologists have the most sophisticated technology and monitoring systems. But all of this did little to protect them from an earthquake of this magnitude.

The people of California and much of the West Coast face a similar risk. The United States Geological Survey predicts a 99.7 percent chance that a magnitude 6.7 earthquake will strike in California in the next 30 years. The agency also predicts a 46 percent chance that a magnitude 7.5 percent or higher earthquake will strike California in the next 30 years.

The 2008 ShakeOut Scenario conducted by the US Geological Survey and FEMA modeled a 7.8 earthquake on the southern San Andres Fault. Though that quake was only 1/10th the size of the recent event in Honshu, Japan, FEMA estimated that a 7.8 earthquake in Los Angeles would result in 2,000 deaths and an economic loss of $213.3 billion.

The simple fact is that we cannot prevent earthquakes, so we must be prepared in the event one does occur. That is the only way we will be able to respond and recover quickly.

That is why I am introducing the Earthquake Insurance Affordability Act. This legislation allows non-profit state-run disaster insurance programs to receive federal guarantees if they need access to credit in the aftermath of a catastrophic disaster. Access to credit is critical in the immediate aftermath of disasters because the market will likely be disrupted and private institutions will be reluctant to lend the large sums necessary to facilitate a quick and meaningful recovery.

This Federal guarantee will be limited. The Secretary of Treasury must certify that recipients of each of the loan guarantee are able to repay debts within a reasonable timeframe. Moreover, my legislation ensures that the cost of the program is born by state programs, not the federal taxpayer. The Congressional Budget Office has estimated that my bill comes at no cost to the taxpayer.

But this legislation is about more than just access to credit--it will guarantee homeowners have access to affordable earthquake insurance coverage. This means homeowners will be able to quickly rebuild in the aftermath of an earthquake.

This legislation is necessary because most homeowner insurance policies do not cover earthquakes. In California, for instance, most homeowner insurance policies cover fire damage but not damage caused by earthquakes.

As a result, homeowners are often put in the position of either having to purchase expensive supplemental insurance or leaving their homes uninsured against these risks.

In order to help promote coverage for these risks, many states and the Federal Government have set up supplemental insurance programs that offer this coverage at affordable rates.

At the Federal level, the National Flood Insurance Program offers flood insurance to residents living in flood plains where private insurance is unavailable or too expensive.

Similar State-level programs exist in California, Florida, Texas, and other states to help residents protect their homes against catastrophic disasters. In my state, The California Earthquake Authority, CEA, was set up after the devastating 1994 Northridge earthquake to make earthquake insurance more affordable.

Unfortunately, many of these programs are not fully utilized. The California Earthquake Authority insures 70 percent of homeowners who purchase earthquake insurance in my state, but only 770,000 homeowners in California opted to buy such insurance. That means only 12 percent of Californians will be covered up if an earthquake hits.

The reason for such low use in that premiums and deductibles remain too high for the average consumer. A policy covering a $400,000 home and $60,000 of its contents costs an additional $1,105 per year, and that's on top of normal homeowners insurance. Even worse, with such high deductibles, policyholders must suffer near total collapse before they receive any payout. For most, this just isn't a good deal.

The reason for high-cost, high-deductible policies is that the CEA is forced to spend nearly $200 million each year to purchase reinsurance. This ensures that in the event of a major catastrophe, the CEA will still be able to pay out all of its claims. It is good policy for the CEA to incur this expense, and I commend their responsible business practices.

However, since 1994 the California Earthquake Authority has paid $2.5 billion in reinsurance premiums and only received back $250,000 in claims. It doesn't take a savvy businessman to see this isn't a good investment. But with minimal changes to federal law, the CEA and other state-run insurance programs can drastically reduce the

need for expensive reinsurance and substantially decrease the cost of their products.

The Earthquake Insurance Affordability Act makes these changes, allowing programs like the California Earthquake Authority to access sufficient capital following a disaster.

Let me be clear: this is not a bailout or a handout for states. The California Earthquake Authority is independent from the state and financially stable.

This bill would increase insurance coverage in California and the rest of the country and help consumers deal with losses that will occur when the next major disaster strikes.

Over the first 5 years this legislation is in effect, nearly half a billion dollars in reinsurance costs would be saved and passed along to consumers.

The California Earthquake Authority could cut premiums by 30 percent or deductibles by 50 percent.

This could result in at least 700,000 new California homeowners purchasing earthquake insurance.

Following major disasters, the federal government spends millions of dollars, and often billions, cleaning up the mess.

Katrina cost FEMA $7.2 billion.

The Northridge earthquake cost FEMA $7 billion.

Hurricane Andrew cost FEMA $1.8 billion.

By enacting the Earthquake Insurance Affordability Act and increasing the number of individuals with insurance, the cost of disaster recovery to the Federal Government could be substantially lower.

This is because FEMA cannot make payments to individuals who have insurance coverage. Therefore, every family that purchases earthquake insurance as a result of this bill, is one less family that FEMA may have to support when disaster strikes.

The bottom line is this: the next big earthquake is coming and we are not prepared for it. Families need to make sure they have earthquake preparedness plans, and homeowners need to evaluate the best ways to protect their homes. Structures need to be strengthened and all new buildings must be built to the highest standards. The Federal Government must also do its part, to help facilitate this preparedness.

The Earthquake Insurance Affordability Act will make great strides to help our country prepare for a major earthquake, and it does so without burdening the federal taxpayer. I urge my colleagues to quickly adopt this critical piece of legislation and help us better prepare for tragedy.

Mr. President, today Senator Kyl and I are introducing two bills that will assist with alleviating the costs of illegal immigration for State and local governments--the SCAAP Reauthorization Act and the SCAAP Reimbursement Protection Act of 2011.

We are joined by Senators McCain, Schumer, Boxer, and Hutchison.

Immigration is a federal responsibility, as is securing the Nation's borders. When the Federal Government fails to prevent illegal immigration, as it has for some time now, it needs to take responsibility for the consequences of this failure.

However, the burden of incarcerating illegal aliens who commit crimes in our country has fallen largely to the States, and it weighs heavily on them, especially during this time of economic uncertainty. Last year, the State of California spent an estimated $1 billion to incarcerate criminal aliens.

Understanding the expenses that States and localities bear, Congress enacted the State Criminal Alien Assistance Program, SCAAP, in 1994 as part of the Violent Crime Control Act. The program was designed to help reimburse States and local governments for the costs of incarcerating criminal aliens, and was last reauthorized in 2006 as part of a Department of Justice Reauthorization bill. The SCAAP Reauthorization bill that I am introducing today will reauthorize the program for an additional four years, until fiscal year 2015.

The second bill that we are introducing today is necessary to fix a switch in interpretation by the Justice Department.

Prior to 2003, the Department of Justice interpreted the SCAAP statute to include reimbursement to States and localities for incarcerating undocumented criminal aliens who have been accused or convicted of State and local offenses, and have been incarcerated for a minimum of 72 hours. However, in 2003, DOJ changed its interpretation, and began limiting reimbursement to the amount States and localities spend incarcerating convicted criminal aliens for at least 4 consecutive days.

Reimbursing States and localities only for the costs when a criminal alien is convicted and incarcerated for 4 consecutive days significantly undermines the goal of SCAAP that States and localities should not bear the burden of a broken Federal immigration system. The actual costs of this failed Federal system begin when these aliens are charged with a crime, transported, and incarcerated for any length of time.

This narrow interpretation by the Justice Department is even more devastating because SCAAP is consistently under-funded. The President's fiscal year 2012 budget request for SCAAP represents a 59 percent reduction below the fiscal year 2010 level and is far short of meeting the actual reimbursement costs of most States. As a result, SCAAP only reimburses States for a fraction of the costs of incarcerating criminal aliens. In 2009, Los Angeles County alone spent $116.6 million to house undocumented felons and received only $15.4 million in reimbursement payments.

The SCAAP Reimbursement Protection Act of 2011 will fix this problem by making it clear that States can be reimbursed for the full costs of incarcerating aliens who are either charged with or convicted of a felony or two misdemeanors.

When the Federal Government does not reimburse States and local governments for the costs of incarcerating criminal aliens, it is at the expense of local services and law enforcement. American communities simply cannot afford to shoulder the weight of our immigration policies.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

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

Mr. President, I understand the Republican leader is about to come to the floor to give his leader remarks.

I just wish to let Senators know we are moving ahead on the bill. Senator McCain just brought up his amendment and spoke about it. I know there are some who want to speak in opposition to the McCain amendment. We still have amendment No. 2111 by Senator Bingaman to be called up. We have two amendments, No. 2146 and No. 2145, by Senator Portman that need to be called up. I ask Senators to please come over and call up their amendments so we can debate them and move ahead to expeditiously voting on those amendments and final passage of the bill.

I see the Republican leader is on the floor, and I yield the floor.

Recognition of the Minority Leader

Mr. President, I ask unanimous consent that the time in quorum calls be evenly divided on the McCain amendment.

Mr. President, I again say we are rapidly coming to a close. Again, the sooner we can get to voting, the sooner we will close out the business for the day and probably for the week.

I again would point out that we have Senator Bingaman's amendment No. 2111 yet to be called up. Senator Portman has two amendments--Nos. 2146 and 2145. Those basically are the only ones left to be brought up. So I would urge them to come and others who have indicated they want to come and speak on the amendments that are pending. The McCain amendment, the Sanders amendment, the Murkowski amendment, the Durbin amendment, and the Paul amendment are still pending. People have indicated they want to come over and speak on these various amendments. I would hope they would do so, so we can perhaps get to voting on the amendments and final passage of the bill sooner rather than later.

With that, I suggest the absence of a quorum.

Mr. President, prior to Senator Bingaman bringing up his amendment, I ask unanimous consent that the following amendments be in order and made pending: Leahy No. 2142, as modified, with the changes that are at the desk; Portman No. 2145, as modified, with the changes that are at the desk; and Portman No. 2146, as modified, with the changes that are at the desk.

Amendment 2146, as modified, filed by Senator Portman, places a number of synthetic drugs within schedule I under the Controlled Substances Act.

I am glad that those bills and, therefore, the substance of this amendment have already been given careful consideration by the Senate Judiciary Committee. That gives me comfort in including this amendment among those to which the managers of the bill consent.

Absolutely.

It is too bad that so much progress has been blocked by so few in this Congress. I am glad that the Food and Drug Administration Safety and Innovation Act may provide an opportunity to make progress on this important issue.

Mr. President, I ask unanimous consent that the following pending amendments be agreed to: Leahy No. 2142, as modified; Portman No. 2145, as modified; and Coburn No. 2131; and that the Coburn amendment No. 2132 be withdrawn.

Mr. President, it is my understanding that we are ready to act on the Portman amendment No. 2146, as modified.

Mr. President, I yield the floor.

Mr. President, I concur with Senator Enzi on that, to stick to the bill.

I ask unanimous consent, notwithstanding the previous order, the Senate proceed to votes in relation to the following amendments at 12 noon with all other provisions of the previous order remaining in effect: Bingaman amendment No. 2111, Murkowski amendment No. 2108, and Paul amendment No. 2143.

Mr. President, I would modify my unanimous consent request to have the vote start at 12:05.

Madam President, first I ask for the yeas and nays.

Madam President, I inquire what the next vote would be on?

Madam President, I ask that that vote be a 10-minute vote.

Regular order, please.

Madam President, parliamentary inquiry.

There is a lot of commotion going on. I want to know where the time is coming from for the Senator from Tennessee.

Madam President, how much time is left on the bill?

How much time does the Senator from Tennessee need?

OK, that is fine.

I will, too, if he needs it.

Madam President, if I may inquire of the Senator how much time she wishes.

I yield 6 minutes off the bill.

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

Madam President, I suggest the absence of a quorum, and I ask unanimous consent that the time during the quorum call be taken off of the Burr amendment and be equally divided on both sides.

Madam President, I appreciate the remarks made by my good friend from Delaware. I thank him and his staff for their input on this bill. Again, this bill is the work of a lot of different people, and I want to thank the Senator from Delaware for helping us get to the point where we have a good consensus bill.

Madam President, is there any time remaining on the Burr amendment?

Madam President, I yield 6 minutes off of the McCain amendment, on our side, to the Senator from New Jersey.

Madam President, I yield 6 minutes to the Senator from West Virginia, again off the opposition to the McCain amendment time.

Madam President, how much time remains on the McCain opposition?

Madam President, I yield myself that time and a couple of minutes off the bill.

Madam President, I wish Senators to know that we will start voting here in 9 or 10 minutes, and these will be 10-minute votes.

The first vote will be on the amendment offered by the Senator from Kentucky, Mr. Paul, followed by Senator McCain's amendment, Senator Sanders' amendment, Senator Durbin's amendment, and then final passage.

By an earlier consent, all of those votes will be 10-minute votes. I wanted to make sure that people knew what the lay of the land was here.

We are rapidly approaching the final passage of this bill. We have had great cooperation from all Senators on both sides in moving this legislation forward here on the floor. We have had good debates. They have not been drawn out endlessly, but we have had good debates and a good airing of the amendments on the bill. I thank all Senators for that, and hopefully we can move rapidly to wrap up this bill and move on.

This bill is the product of 18 months of very hard work by Senator Enzi and all of the Senators on our committee on both sides of the aisle. It is a true compromise and bipartisan bill. As I mentioned earlier, it has the support of a broad spectrum of stakeholders, from the pharmaceutical companies to pharmacists to consumer organizations, across the broad spectrum who support this bill, and it is necessary that we get it done. That is why we have urged everyone to expeditiously get this done before the break period coming up for Memorial Day so the Food and Drug Administration won't have to start sending pink slips out to people this summer, and so there will not be any disruptions. It will allow them to get on with the business of making sure we get drugs and devices to patients expeditiously but safely, making sure our drugs and our devices are safe.

It is a good bill, and it is the result of a lot of hard work by a lot of people, so I hope we can move these amendments rapidly and move to final passage this afternoon.

I yield the floor.

Madam President, I yield myself as much time as I may consume off the bill.

Madam President, we are rapidly approaching a vote on the Paul amendment, and I know the Senator wants to have a couple of minutes to speak on that.

I rise in opposition to the Paul amendment. I oppose it for several reasons. Perhaps the most important reason is that this is a drug bill. This bill deals with drugs and devices. It does not deal with food. We dealt with dietary supplements and vitamins and things such as that in the food safety bill that we passed 2 years ago and that bill, again, was a consensus bill that has been through the committee structure. We brought it to the floor and had a lot of debate on it. We made modifications at that time to the whole area of vitamins, minerals, and supplements, and that is the proper place to address it, not on a bill such as this. This bill is a bill on drugs, not on supplements and food, so that is the most important reason.

I will make that same argument on the Durbin amendment. That should not be here because this is a drug bill.

On substance, I would say this bill kind of turns food law on its head. It would allow supplements to be sold with claims to cure any disease, such as AIDS or cancer, without any kind of FDA review whatsoever. I take a backseat to no one in terms of my support for the vitamin, mineral, and supplement industry and their products. Senator Hatch and I were the two people who put through the DSHEA bill, the Dietary Supplementary Health and Education Act in 1994. If I might say, we have sort of been protectors of it in working to make sure it has been implemented correctly since that time.

But the Paul amendment would go way too far. It is not consensus policy. In fact, it is strongly opposed by even the dietary supplement industry. I would note that the Natural Products Association, United Natural Products Alliance, and the Council on Responsible Nutrition, all three are big umbrella groups that oppose the Paul amendment. This would open this industry to snake oil salesmen.

Again, those of us who want to make sure people have unfettered access to safe products and to good, nutritious vitamins, minerals, and supplements, the last thing we want to see is people in their garages mixing it up and selling it as snake oil. This is not good for America, it is not good for people who want to take vitamins and supplements and minerals for their own health. It would throw this thing open and turn the clock back 50 years or more where anybody could make any claim they want and the FDA would have no way of reviewing it whatsoever.

I will move to table the amendment at the appropriate time, but I urge all Senators to oppose the Paul amendment.

I yield the floor.

Madam President, I move to table the amendment by the Senator from Kentucky and ask for the yeas and nays.

Mr. President, first of all, this is a drug and device bill, not a food bill. We addressed food issues in the food safety bill 2 years ago. That doesn't solve the problem Senator Durbin talked about. This bill is a very delicate balance. We have worked on this for 18 months. Stakeholders all over the country, consumers, the pharmaceutical industry, and pharmacists all support this bill. This would upset that delicate balance.

I say to the Senator that every supplement has a label, the ingredients, and the potency, by law, on every single item sold as a supplement. This is a drug bill, not a food bill.

Mr. President, I think we are under a time agreement on the bill; is that correct?

I wish to proceed under my leader time.

Mr. President, today we will once again attempt to prevent student loan interest rates from going up. This problem could have been solved literally weeks ago, but our friends on the other side were not interested in solving the problem; they wanted a scapegoat more than a solution.

So this afternoon we will vote on two different ways of addressing the issue. The Democratic plan is designed to fail. In order to cover the cost of a temporary rate freeze that both parties actually want, they propose to divert $6 billion from Medicare and to raise taxes on small businesses, hurting the very companies we are counting on to hire today's college graduates. They have known for months that we would not support this tax hike and that it couldn't pass this Chamber or the House of Representatives. It has already failed, but they are proposing it anyway, for a second time.

If our Democratic friends would allow it, the chairman and ranking

member could write a bill that could actually pass. But since passage isn't their goal, our friends on the other side huddled behind closed doors, out of sight of the public and the press, and produced the tax hike instead of letting the committee actually do its work.

We already know how this story is going to end. We know exactly, already, how the story will end. So why are the Democrats forcing us to vote on their failed proposal yet again? Because, as I have said, they are more interested in drawing our opposition--of trying to create a bad guy--than in actually solving the problem.

When it comes to college graduates today, the bigger issue is the President's economic agenda which has created an environment in which most of them can't find a decent job. So I can understand why our Democratic friends want to change the subject, but if we are actually going to do something to solve the problem, we are going to need to get past the political theatrics.

If Senate Democrats reject the bipartisan fix the House already passed--one that doesn't raise taxes or divert a single dollar away from Medicare and is an offset they have used themselves before--then I hope they will turn around and work with us on a bipartisan fix that doesn't tax small businesses--a proposal that is actually designed to pass and become law.

But let's be clear about something. The real issue isn't the fact that certain students are going to see an interest rate hike because we will address that concern; it is that so many young people today can't find a job that will enable them to pay off their loans in the first place. That is the much larger problem. The solution is a progrowth agenda that would make it easier for U.S. businesses to hire, not a tax hike that will actually make it harder for them to hire.

In the short term, Republicans are ready to work to offer this temporary relief, but we are still waiting on the Democratic leadership to propose a solution of their own that can actually pass either one or two Chambers of Congress.

I would, once again, urge the President to get involved. If the President has time to run around to late-night comedy shows and college campuses talking about this issue, then he can pick up the phone and work out a solution with Democrats in the Senate.

Last week at the White House, I pressed the President to get involved in order to prevent the student interest rates from going up--a goal we all share. Think about it. If the President wants to pass this bill so badly, then why on Earth hasn't he picked up the phone and called the chairman or ranking Republican of the relevant committee? As with so many pressing issues, the President has not led on this issue. He has campaigned on it, but he has not worked to actually fix it.

The American people are tired of the posturing and the games. It is time for the President to lead. It is time for Senate Democrats to stop the political theater and to find a real solution.

Thanking Senator Enzi

Mr. President, on another matter, I wish to take a moment to thank my good friend, the senior Senator from Wyoming, Mike Enzi, for the work he has done shepherding the FDA bill through the markup and across the Senate floor. This is an incredibly complex piece of legislation that strikes a difficult balance of protecting consumers while avoiding the stifling regulation that slows the process of bringing lifesaving drugs and devices to market.

Throughout a lengthy process, Mike has shown the command of complex topics, steady leadership, and interest in his colleagues' priorities that have characterized his tenure at the HELP Committee. For that, those of us on this side of the aisle would like to thank him very much.

Honoring Our Armed Forces

Specialist David W. Taylor

Mr. President, I wish to address one other matter. I have a sad task today of informing my colleagues that a valued and honorable Kentuckian who enlisted in the U.S. Army has fallen in the performance of his duty. On March 29, 2012, SPC David W. Taylor of Dixon, KY, died from injuries sustained in an accident at an ammunitions supply point in Kandahar Province, Afghanistan. He was 20 years old.

For his service in uniform, Specialist Taylor received several awards, medals, and decorations, including the Army Commendation Medal, the Army Good Conduct Medal, the National Defense Service Medal, the Afghanistan Campaign Medal with Bronze Service Star, the Global War on Terrorism Service Medal, the Army Service Ribbon, the Overseas Service Ribbon, the NATO Medal, the Parachutist Badge, and the Overseas Service Bar.

After his tragic death at entirely too young an age, one of Specialist Taylor's commanders, Sergeant Addington, delivered a tribute to his fallen brother in arms. This is what he said:

When his country called for young lives to offer themselves

up for the preservation of freedom, young David Taylor

answered the call and said, ``Here am I, take me.''

Specialist Taylor was my soldier, my battle buddy, and my

friend. He was a fast learner and my greatest student. He

sacrificed himself so we might be free.

Before he was a soldier, his mother Sarah Taylor recalled that David was a compassionate, dedicated young man. From a young age, he was always looking for ways to help others. Sarah says of her son: ``One Christmas he had received a large amount of gifts.''

David asked his parents ``if he could give some of his gifts to a classmate of his who he knew would not receive many items.''

David was a great athlete who played football and soccer and ran track. He loved to hunt and hunted turkey and deer, but his real passion was for duck hunting. He had many friends, was the life of the party, and he was popular with the girls. David ``would change outfits multiple times before going to school, as his hair and clothes had to be perfect,'' Sarah says.

David was also very dedicated to physical fitness. He worked out multiple times a week to stay in shape. Perhaps that is because young David knew his body was his instrument, and he had made up his mind to join the military by age 14.

David's high school did not have an ROTC program, so David worked hard to graduate 6 months early and eagerly enlisted. He skipped both the prom and graduation to take up his more important pursuit, enlisting in January 2010. He even waived his signing bonus saying, ``It is every young man's duty to serve.''

David planned to make the military his career and hoped to go into the medical field. He dedicated himself to the military handbook and doing everything ``by the book.'' He went on to serve as a paratrooper in a parachute infantry regiment, one of the most demanding specialties in the Army.

LT Eric Fitzgerald was Specialist Taylor's platoon leader. He says:

David was one of the most outstanding paratroopers in the

whole platoon, just striving to be the best. When you wanted

something done, when you wanted it done right, you went to

Taylor for it.

CPT Brian Bifulco, David's company commander, concurs:

It was evident since the day I met him that David had all

the qualities desirable in a paratrooper: Smart, aggressive,

committed, and reliable. He displayed them readily in

everything he did.

David maintained his rigorous workout schedule in the Army by following the Crossfit physical fitness programs 5 to 6 days a week so he could excel at the Army's physical fitness test. He could run his 2- mile fitness test in a full minute faster than anyone else in his platoon. Specialist Taylor was assigned to D Company, 2nd Battalion, 508th Parachute Infantry Regiment, 82nd Airborne Division, based out of Fort Bragg, NC. He deployed to Afghanistan for Operation Enduring Freedom in February of this year for what would be his first and only deployment.

David's fellow soldiers from his platoon named the small gym in their Afghanistan outpost in his honor as a remembrance of David's commitment to excellence. Nearly every soldier in the platoon wears a metal bracelet honoring Specialist Taylor. SFC Russ Kelley had this to say:

For many of the guys, this is the first friend they've ever

lost to combat. They wear the bracelets to remember.

At this time we are thinking of SPC David W. Taylor's family and his friends as I recount his story for the Senate, including his mother Sarah Taylor, his grandmother Laura Klutey,

and many other beloved family members and friends. David was preceded in death by his father Kevin Taylor.

David's mother Sarah says David loved the Army and was excited to be in Afghanistan.

Sergeant Addington remembers:

David seemed to live for the job, and while others would

whine and complain in the field, David would just sling up

his hammock and settle in. He was at home in the woods, a

natural outdoorsman.

David, who grew up in the woods, fit in perfectly. He

seemed born to do this job, and I felt sorry for any Taliban

that he was bound to run into in Afghanistan. The Taliban got

lucky this time.

Even if that is the case, the tragedy of Specialist Taylor's death is certainly not lucky for anyone else, most of all not for the family he has left behind or his friends and fellow soldiers.

I know it is small solace in place of what they have lost, but I want them to know this Senate holds SPC David W. Taylor in the highest regard for his service on behalf of our country. We are honored, just a few days before Memorial Day, to recognize his enormous sacrifice on behalf of this Nation.

I yield the floor.

Mr. President, I rise today with Senator Graham to introduce the Sunshine in Litigation Act of 2011, a bill that will curb the ongoing abuse of secrecy orders in Federal courts. The result of this abuse, which often comes in the form of sealed settlement agreements, is to keep important health and safety information hidden from the public. As we recognize Sunshine Week, this bipartisan, commonsense measure is an important step to improving transparency in our

courthouses by requiring judges to consider public health and safety before permitting secrecy agreements.

This problem of court secrecy has been occurring for decades, and most often arises in product liability cases. Typically, an individual brings a cause of action against a manufacturer for an injury or death that has resulted from a defect in one of its products. The injured party often faces a large corporation that can spend a virtually unlimited amount of money defending the lawsuit, prolonging the time it takes to reach resolution. Facing a formidable opponent and mounting medical bills, a plaintiff often has no choice but to settle the litigation. In exchange for the award he or she was seeking, the victim is forced to agree to a provision that prohibits him or her from revealing information disclosed during the litigation.

Plaintiffs get a respectable award, and the defendant is able to keep damaging information from getting out. But the American public incurs the loss because they remain unaware of critical public health and safety information that could potentially save lives.

This concern about excessive secrecy is warranted by the long history of tobacco companies, automobile manufacturers, pharmaceutical companies, medical device manufacturers, and others settling with victims and using the legal system to hide information which, if it became public, could protect the American people from future health and safety harms. Surely, there are appropriate uses for such orders, like protecting trade secrets and other truly confidential company information, as well as personal identifying and classified information. This legislation makes sure such information is protected. But, protective orders are certainly not supposed to be used for the sole purpose of hiding damaging information from the public, to protect a company's reputation or profit margin.

One of the most famous cases of abuse of secrecy orders involved Bridgestone/Firestone tires. From 1992 to 2000, tread separations of various Bridgestone and Firestone tires caused accidents across the country, many resulting in serious injuries and even fatalities. Instead of owning up to their mistakes and acting responsibly, Bridgestone/Firestone quietly settled dozens of lawsuits, most of which included secrecy agreements. It wasn't until 1999, when a Houston public television station broke the story, that the company acknowledged its wrongdoing and recalled 6.5 million tires. By then, it was too late. More than 250 people had died and more than 800 were injured as a result of the defective tires.

If the story ended there, and the Bridgestone/Firestone cases were just an aberration, one might argue that there is no urgent need for legislation. But, unfortunately, the list of abuses goes on. There is the case of General Motors. Although an internal memo demonstrated that GM was aware of the risk of fire deaths from crashes of pickup trucks with ``side saddle'' fuel tanks, an estimated 750 people were killed in fires involving trucks with these fuel tanks. When victims sued, GM disclosed documents only under protective orders, and settled these cases on the condition that the information in these documents remained secret. This type of fuel tank was installed for 15 years before being discontinued.

More recently, the world's largest automaker, Toyota, has faced a barrage of litigation relating to its recall of over 8 million cars due to sudden unintended acceleration problems, causing more than eighty deaths. After years of lawsuits, Congressional oversight hearings, and Toyota's efforts to keep settlements and product information secret, a California Federal judge finally made public thousands of previously sealed documents, noting that ``the business of this litigation should be in the public domain.'' Had a judge been required to weigh the public's interest in health and safety, as this legislation would require, perhaps we would have known more about the risks sooner and some of those lives could have been saved. Until we put the public interest on par with the interests of private litigants, public health and safety will remain at risk.

This very issue is currently before a Federal judge in Orlando, FL. There, the court is faced with deciding whether AstraZeneca can keep under seal clinical studies about the harmful side effects of an antipsychotic drug, Seroquel. Plaintiffs' lawyers and Bloomberg News sued to force AstraZeneca to make public documents discovered in dismissed lawsuits. In 2009, the court unsealed some of the documents at question, but denied requests to release AstraZeneca's submissions to foreign regulators and sales representatives' notes on doctors' meetings. Despite a recent $68.5 million settlement, continued efforts to unseal crucial documents proved unsuccessful. This is exactly the sort of case where we need judges to consider public health and safety when deciding whether to allow a secrecy order.

We are mindful of the risks to public health and safety that court secrecy orders can pose in the wake of last year's horrific BP oil spill in the Gulf of Mexico. As the parties continue to fight over crucial documents, injured parties continue to accept secret settlements. We can only hope that information vital to public health and safety, which could protect against the next disaster, is not being shielded from us as well.

The examples go on and on. At a 2007 hearing before the Senate Judiciary Committee Subcommittee on Antitrust, Competition Policy and Consumer Rights, Johnny Bradley Jr. described his tragic personal story that demonstrates the implications of court endorsed secrecy. In 2002, Mr. Bradley's wife was killed in a rollover accident allegedly caused by tread separation in his Cooper tires. While litigating the case, his attorney uncovered documented evidence of Cooper tire design defects. Through aggressive litigation of protective orders and confidential settlements in cases prior to the Bradleys' accident, Cooper had managed to keep the design defect documents confidential. Prior to the end of Mr. Bradley's trial, Cooper Tires settled with him on the condition that almost all litigation documents would be kept confidential under a broad protective order. With no access to documented evidence of design defects, consumers continue to remain in the dark about this life-threatening defect.

In 2005, the drug company Eli Lilly settled 8,000 cases related to harmful side effects of its drug Zyprexa. All of those settlements required plaintiffs to agree ``not to communicate, publish or cause to be published . . . any statement . . . concerning the specific events, facts or circumstances giving rise to [their] claims.'' In those cases, the plaintiffs uncovered documents which showed that, through its own research, Lilly knew about the harmful side effects as early as 1999. While the plaintiffs kept quiet, Lilly continued to sell Zyprexa and generated $4.2 billion in sales in 2005. More than a year later, information about the case was leaked to the New York Times and another 18,000 cases settled. Had the first settlement not included a secrecy agreement, consumers would have been able to make informed choices and avoid the harmful side effects, including enormous weight gain, dangerously elevated blood sugar levels, and diabetes.

There are no records kept of the number of confidentiality orders accepted by State or Federal courts. However, anecdotal evidence suggests that court secrecy and confidential settlements are prevalent. Beyond Bridgestone/Firestone, General Motors, Toyota, Seroquel, BP, Cooper Tire, and Zyprexa, secrecy agreements have also had real life consequences by allowing Dalkon Shield, Bjork-Shiley heart valves, and numerous other dangerous products and drugs to remain in the market. And those are only the ones we know about.

While some judges have already begun to move in the right direction by giving serious weight to public health and safety, we still have a long way to go. The Sunshine in Litigation Act is a modest proposal that would require Federal judges to perform a simple balancing test to ensure that in any proposed secrecy order in a case pleading facts relevant to public health and safety, the defendant's interest in secrecy truly outweighs the public interest in information related to public health and safety.

Specifically, prior to making any portion of a case confidential or sealed, a judge would have to determine--by making a particularized finding of

fact--that doing so would not restrict the disclosure of information relevant to public health and safety. Moreover, all courts, both Federal and State, would be prohibited from issuing protective orders that prevent disclosure to relevant regulatory agencies.

This legislation does not prohibit secrecy agreements across the board, and it does not place an undue burden on judges or on our courts. It simply states that where the public interest in disclosure outweighs legitimate interests in secrecy, courts should not shield important health and safety information from the public. Since last Congress, we have made changes to make absolutely clear that this would apply only to those cases with facts relevant to public health and safety, and to ensure that there is no undue burden on judges or our courts. The time to focus some sunshine on public hazards to prevent future harm is now.

I urge my colleagues to support this important legislation.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.