Combating Designer Drugs Act of 2011

Madam President, I ask unanimous consent that the order for the quorum call be rescinded.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 am going to speak for 2 or 3 minutes in a brief introduction, and then turn it over to my colleague from Louisiana. We are both very excited and enthusiastic to present to the Senate and to Congress work that has been underway for almost a year.

As you know, next week on April 20, we will be marking the 1-year anniversary of the Deepwater Horizon explosion, which killed 11 men-- they are still in our thoughts and prayers, and their families to this day--injured dozens of others and shocked millions with the explosion that occurred a year ago next Wednesday.

There are many steps our Nation has to take and must take to respond to that horrific incident. Senator Vitter and I are on the floor today to introduce the Restore the Gulf Coast Act of 2011, which we believe is one of the most important things that needs to be done in response to this incident.

It was frankly long overdue even before this tragedy happened, and I will briefly explain. This gulf coast is a very important coast of America.

I know all of the people of our coasts believe they are all important--but we who live on the gulf coast are particularly proud of the coast of Texas, Louisiana, Mississippi, Alabama, and Florida because on this coast not only do we have port and maritime activities, which is true of every coast, we also support the Nation in hosting a very important domestic oil and gas industry, which is primarily offshore, but a great deal on shore, both close and on our marshes.

In addition, we have a very vibrant and robust fishing industry, both commercial and recreational. We have ecotourism and migratory bird routes from the south going north. Obviously this is a flyway for migratory birds and extremely important to wildlife enthusiasts and hunters and fishermen. May I also add--and not let us forget--the tourism industry. So we say proudly in the gulf coast, we are America's working coast. We seek a balance between mining and exploring for and using our natural resources, and balancing that so this coast can be sustainable.

This is a great opportunity for the Nation to do right by the gulf coast. It is a great opportunity for the polluters to step up and do the right thing. It is a great opportunity to give a break to taxpayers because the bill Senator Vitter and I are putting forward--and we hope our other colleagues will join us in--will basically say the fine BP is going to pay--and maybe other contractors as well--that 80 percent of that fine should go to the area where the injury occurred.

I am going to take the next minute to put up this horrifying picture that people will remember because a year ago this is what the site looked like when the Deepwater Horizon exploded and 5 million barrels of oil escaped from this tragedy and marred the beaches and marshes and ocean, and we are still recovering, and will for years.

But because of the 5 million barrels of oil that were spilled, this polluter, BP, and its contractors are going to have to pay a very serious fine to the Federal Government. We believe that fine is best directed to help the environment which was injured and to get the taxpayers off the hook and put the polluters on the hook for picking up this tab, and to do so in a way that is fair to the Gulf Coast States. That is what Senator Vitter will speak about in more detail.

Let me show you one picture, happily. Today, the beaches along the gulf coast--in large measure--look like this, as shown in this picture. This is the way they normally look. Because not only do we drill for oil and gas off of our waters, but our children swim in this water. We recreate and have picnics along the beach. This is the way we would like this beach to look for decades to come.

If we are successful in getting our bill passed through the Congress and signed by the President in the near future, this is possible, along with pictures like this one I show you, which represents a great and proud industry: the shrimping industry on the gulf coast, which supplies fresh seafood for restaurants all over our Nation and, in some cases, the world.

So at this point, let me turn it to Senator Vitter for some more detail. I want to say, it has been a pleasure and I thank the Senator for his support. We want this to be a bipartisan effort. Both the industry and environmental groups are very interested in working with us on this issue. We think it is the right policy for our country.

I yield to Senator Vitter.

Mr. President, I see other colleagues on the floor waiting to speak so I will try to wrap up these remarks in about 5 minutes. But I do want to add a few things and thank my colleague again. He is on the committee that will take this bill into consideration. That committee is chaired by Senator Barbara Boxer. I want to thank her, our colleague from California, the Chair of the EPW Committee, and her staff, who have been working with us very closely over the last year as we fashioned this approach. I think the Senator, of course, will speak for herself, but I think it is in her philosophy that the polluters should pay, not the taxpayer, and that the area that was injured should be the area that receives the response. It is important that the environment that was injured should be first attended to first. That is the essence and nature of our bill.

But to put a couple of other things in the Record, Senator Vitter mentioned this, but it is worth repeating. President Obama has already endorsed this general concept, and I want to thank him for his early leadership on this issue. I had some real reservations early on about the national oilspill commission. I honestly did not think there were enough people representing the industry perspective, only the environmental perspective. But I was happy to see that commission report came out fairly balanced. Both Bob Graham, who is a former colleague of ours from Florida, and Bill Reilly, the former EPA Director under President Bush, came to the same conclusion: that one of the best ways to spend this fine money would be restoring this very important coastal area. This should not just be for the gulf coast but for the Nation. Frankly, the world should take notice and to try to find a path forward for coastal communities to have sustainable economies.

This is an important question, not just for the gulf coast, not just for the east coast, not just for the west coast, but I might say, this might be one of the great questions in the world today. 60 percent or more of the population of the world lives near coastlines. The question of how can people live there productively, safely, and how the environment can sustain them in that growth and development is an important question to get answers to.

Let me say, as a resident of the gulf coast, we do not have enough answers. We do not have enough money to ask questions. That is what this money will go for: some science and technology, some basic research, and, most importantly, some money to restore our coast--to do the right things by this environment.

I want to recognize the entities that support this cause. Secretary Ray Mabus, the Secretary of the Navy added to his portfolio to examine this issue, and he, too, arrived at the same conclusion: that a very excellent and smart way to spend some of these fine moneys would be on these programs.

Just a couple of minutes more to put some facts into the Record; and other Senators from other States--Florida, Texas, Mississippi, and Alabama--can enter their own data.

I think it is important for people to understand, when we talk about the coast of Louisiana, just the coast of Louisiana--this is going to be hard for people to believe, but it is actually true--if you count the tidal miles of Louisiana, which is about 7,000 tidal miles from the tip here, as shown on this map, all the way over to Texas from our Mississippi border--7,000 tidal miles--if you stretch that out, it is the same as going from Miami to Seattle. I need people to get that in their mind.

I know this looks like a little shore because it is not a big shore like California or Florida. But the nature of this shore--because it is not just a beach; it is America's greatest wetlands and marshes--if you stretched it out with all of its inlets and bays and estuaries, it would go from Miami to Seattle.

This area is threatened, and has been for years. Yes, the oil and gas industry, unfortunately, has contributed to some of this damage. But it is also because the Mississippi River flows through here, and it has been dammed and tamed as best as men and women can try to tame natural things. The hydraulics have changed. The sea level has risen. This area is under great threat.

Mr. President, 1,500 square miles have been lost since 1930; 25 square miles of wetlands each year, which means a football field every 30 minutes. This is an urgent matter. There is no loss of land anywhere in the continental United States that has as much threat to it as there is to this coast. We have struggled for years to find a revenue stream to help fix it. We understand the rest of the country says: Why should we fix it? It is not our coast. But what we say back is: This coast is important to the whole Nation. It drains 40 percent of the continent. It is the greatest river system in North America. No one can get wheat out of Kansas or Iowa without coming through this Mississippi River. So there is a national interest.

Seventeen percent of GDP is basically supported and created by this gulf coast economy.

We are also willing to pay our own way as well. Our parishes have taxed themselves. The State has set up a constitutional safeguard, a lockbox--if we had only done that with Social Security. We are happy to have a lockbox for the wetlands money that comes in, so it can only be used for that purpose. So we are very proud of the actions our locals have taken. Now it is time for the Federal Government to act.

A few more statistics: 30 percent of the commercial fisheries in the United States come off this coast, and $1.7 billion in economic impact for recreational fishing--again, over 50 percent of the domestic oil and gas, because we drill for oil and gas here, that keep lights on and electricity flowing in Chambers such as this, in rooms and buildings all over our country. So that is why this is so important.

I am going to add some other statistics for the Record about some of the economic impacts of this. Again, this is an important coast to the country and it is an important effort for the world for us in America to get this right. Think about the drilling that is occurring off the coast of Africa or Brazil or Australia or Israel and what happens. Let's prevent any explosions. Let's prevent these disasters. We are struggling to do that, and the record is pretty good, despite the criticism that comes, and that is a speech for another day.

But the question is, When there is an accident, when this happens, how do we take that penalty money and invest it in the coast so it is more resilient and it will benefit people in every way over a long period of time in a very balanced fashion.

I conclude by urging my colleagues along the gulf coast, from Florida to Alabama to Mississippi and Texas, Republicans and Democrats alike, Members of the House as well, to step forward and join me and Senator Vitter. We are open to ideas and thoughts about how the money should be allocated but within general sets of principles we have outlined today. I wish to, again, thank Senator Boxer whose committee will consider this in the very near future. We are hoping for a hearing in the very near future and then a markup on this bill to move it forward to the President's desk.

Mr. President, I ask unanimous consent to have printed in the Record some further statistics about this horrific spill and our valuable coast.

Mr. President, I am pleased to join my colleague, Senator Klobuchar, in cosponsoring the Combating Designer Drugs Act of 2011. All too often we are confronted with new and emerging drugs that spread quickly on the scene. However, what is most concerning about this new generation of drugs is how quickly these substances are sold and marketed to kids. Although these substances were created for scientific research they are now packaged as innocent products and sold on the shelves of local stores or via the internet.

Recent reports in the media along with increasing calls to poison control centers and visits to emergency rooms reveals that more and more kids are using products laced with substances that are very dangerous. Although these products are currently legal and can be sold in stores and online, many people who use products are under a false impression that these products are safe because they are legal. However, use of these products is anything but safe.

Last month, a teenager from Blaine, MN, died after overdosing on a substance called 2C-E that he and others used at a party. Police report 10 other individuals were hospitalized after using this substance. According to the Drug Enforcement Administration, 2C-E along with its cousins in the 2C family are used for their hallucinogenic qualities. These drugs are marketed as similar to illegal drugs like LSD or Ecstasy and can be used in similar ways. A popular way to pass these drugs off as safe is by labeling them as ``fake,'' but clearly the victims of this drug have suffered very real consequences.

Last month, I, along with Senator Feinstein, introduced legislation to ban the chemicals found in synthetic or ``fake'' marijuana. This legislation came in part from the death of Indianola, IA, resident David Rozga, who committed suicide shortly after smoking a package of K2, a product laced with synthetic marijuana compounds. Since then the Drug Enforcement Administration has identified more substances that are used in a similar way such as 2C-E and others. The Combating Designer Drugs Act of 2011 is part of the ongoing effort to identify drugs that are being marketed as legal, safe alternatives to illegal drugs and places them among their rightful place as dangerous drugs like meth and cocaine. Specifically, this legislation targets drugs found in the 2C family, which were invented for scientific research but never intended to be used for humans and makes them schedule I controlled substances.

Mr. President, the sale and use of synthetic drugs like those in the 2C family represent a new and dangerous trend in drug abuse. We must take strong action to eliminate the ease in which these substances can reach the market before their use gets out of hand. I urge my colleagues to support this legislation to remove these dangerous drugs from our society.

Mr. President, the last reauthorization of the Elementary and Secondary Education Act of 1965 was specifically designed ``To close the achievement gap with accountability, flexibility, and choice, so that no child is left behind.'' Going into the next reauthorization of this law, there has already been much discussion about the extent to which each element of that goal has been achieved. While there is some evidence of a narrowing of the achievement gap between disadvantaged and minority students and their more advantaged peers when it comes to meeting minimum ``proficiency'' goals, the achievement gap among high-ability students has been widening. Some of our most promising students, the scientists, inventors, and problem solvers of the future, are being left behind.

I want to be clear that I am not necessarily talking just about high- achieving students. I am talking about high-ability students with gifts and talents that go beyond simply the ability to master grade level content. There is sometimes a tendency to assume that gifted students are the straight A students and vice versa, the students we needn't worry about because they are doing fine on their own. Sadly, that's far from true. A student may get straight A's because his or her abilities and pace of learning just happen to be exactly matched with the grade level curriculum and pace of instruction. Those are not the students I am talking about. By definition, a gifted and talented students is one who gives evidence of high achievement capability and needs services beyond the standard content provided in the standard way in order to fully develop those capabilities.

In fact, gifted students may significantly underperform. Many high- ability students get poor grades due to boredom. Some drop out of school or exhibit problem behaviors, and gifted students are often well represented in alternative schools. Still, even if they are getting straight A's on content that is not challenging to them, they are still underperforming. That hidden gap between achievement and potential ought to be alarming to all of us who are concerned about our Nation's future economic competitiveness.

On the most recent international tests, students in China topped the charts in math, science, and reading, while U.S. students were in the middle to bottom of the pack. Few American students are reaching the most advanced achievement levels on national and state-level tests, with miniscule numbers of children of color or children from poverty reaching those levels. A dynamic economy needs a steady supply of individuals capable of achieving at advanced levels, yet we rely on imported talent while systematically holding back our brightest young minds here at home.

I would recommend to my colleagues the book Genius Denied by Jan and Bob Davidson of the Davidson Institute in Nevada. It describes the many obstacles faced by some of our brightest students in trying to get an appropriate education. The book tells the story of a boy named Carlos who didn't speak until he was 3\1/2\ years old, but then began to speak in complete sentences like a much older child. His mother had been told he might be autistic or have a learning disability, but when she had him tested, she learned he was actually gifted. He learned to read and write with incredible speed and was able to grasp simple algebra problems. However, in his Kindergarten class, they were learning to add single digits by grouping teddy bears. He was miserable, and despite his natural love of learning, he cried to stay home from school. He was teased for being different and the stress of school got to be so great that his hair started falling out. He began talking about wishing that he was dumb or even dead.

The book also talks about a boy named Tim who is dyslexic and also profoundly gifted. His gifts compensated for his inability to read so he was able to earn normal grades, but his school would not make appropriate accommodations for his learning disability because he was achieving at acceptable levels. School officials also maintained they had no obligation to accommodate his gifts. This left Tim frustrated. His zeal for learning waned because his disability held him back while his gifts went undeveloped, but both went unaddressed by his school because he was not failing. Eventually, his mother was forced to pull him out of the public school and educate him at home.

Many schools have special gifted and talented programs with staff trained in gifted education strategies, but a great many others do not. This leads to the uneven availability of appropriate services. Title I schools are far less likely to have any services for gifted students. Is this because there are no high-ability disadvantaged students? Certainly not. There are high-ability students in every school and low income doesn't mean low ability. It is of course appropriate to ensure that struggling students receive the support they need to achieve to their potential, but when disadvantaged high-ability students go unrecognized and unchallenged, thus falling short of the level of achievement they are capable of attaining, the tremendous loss of human

potential is truly tragic both for the students and for our society.

So should every cash-strapped Title I school hire special teachers with a background in gifted and talented education and start offering gifted education programming? Well, that would be ideal, and would likely help improve the academic achievement of all students in those schools, but a lack of funds need not be a barrier to schools meeting the unique learning needs of their high-ability students. For instance, a report by some of the leading experts in the field at the University of Iowa's Belin-Blank Center titled ``A Nation Deceived: How Schools Hold Back America's Brightest Students'' outlines both the problem of schools systematically failing to support their high-ability students and an almost no-cost solution--acceleration. Simply allowing students to take classes with their intellectual peers, where the curriculum is matched to their ability rather than to their age, often results in better academic results as well as happier, better adjusted students. Also, knowing that all teachers have high-ability students with unique learning needs in their classrooms, there is a great need for professional development opportunities to incorporate the ability to recognize and meet those needs.

Today, I am introducing a bill, with Senator Casey of Pennsylvania, to ensure that Federal education policy no longer overlooks the needs of high-ability students. It's called the TALENT Act, which stands for: To Aid Gifted and High-Ability Learners by Empowering the Nation's Teachers. My bill corrects the lack of focus on high-ability students, especially those students in underserved settings, including rural communities, by including them in the school, district, and state planning process that already exists under the Elementary and Secondary Education Act. It also raises the expectation that teachers have the skills to address the special learning needs of various populations of students, including gifted and high-ability learners. To that end, my bill provides for professional development grants to help general education teachers and other school personnel better understand how to recognize and respond to the needs of high-ability students. Finally, because we have much to learn about how best to address the very unique learning needs of this often overlooked population of students, my bill retools and builds upon the goals and purpose of the existing Javits Gifted and Talented Students Education Act so that we continue to explore and test strategies to identify and serve high-ability students from underserved groups. These strategies can then be put into the hands of teachers across the country.

Meeting the needs of our brightest students, the ones our country is counting on for our future prosperity, is not a luxury, it is a necessity. That isn't a justification for embarking on some sort of new spending and sticking them with the bill, however. Instead, my legislation would accomplish its goals in a cost-effective way by amending existing law to account for the needs of gifted and high- ability learners as well as retooling the old Javits program to have a greater impact. For too long, Federal education policy has been so focused on preventing failure that we have neglected to promote and encourage success. We can no longer afford to ignore the needs of our brightest students and thus squander their potential. My legislation will put our country on track to tap that potential which is so essential to the future happiness of the students and the future prosperity of our Nation.

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 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 call up amendment No. 2111.

I ask unanimous consent that the reading be dispensed with.

Mr. President, this amendment is one that is a bipartisan amendment. Senator Vitter is cosponsoring this with me, also Senators Franken, Shaheen, Kohl, Tom Udall, Tim Johnson, Klobuchar, Merkley, Sanders, and the Presiding Officer, Senator Brown.

This amendment addresses the very same issue that the Senator from Maine was talking about; that is, how do we bring down the price of prescription drugs? How do we get competition into the market for prescription drugs?

We have a circumstance today in which an anticompetitive, anticonsumer practice is engaged in, and our amendment will change the law so that practice can no longer be engaged in. The practice I am talking about is the entering into so-called pay-for-delay settlements between brand-name drugs--brand-name pharmaceutical companies and generic manufacturers.

These pay-for-delay settlements have the effect of delaying timely access to generic drugs. These agreements between companies shield billions of dollars in sales each year from effective competition. The pharmaceutical companies benefit from this lack of competition and they do so at the expense of consumers and they do so at the expense of the Federal Government, since the Federal Government is a very large consumer and purchases a substantial amount of prescription drugs for the military and in other ways.

A preliminary estimate from the CBO indicates that this amendment will reduce direct spending by hundreds of millions of dollars at a minimum. Frankly, I believe it will, in fact, save us billions of dollars annually at the Federal Government level. The CBO also indicates that the amendment will reduce the average cost for prescription drugs and lower the cost of health insurance plans.

Early access to generic drugs is a key to saving money in the health care system. Kaiser Family Foundation has found this. They concluded that spending in the United States for prescription drugs reached $259.1 billion in 2010. That is nearly six times as much as we spent on prescription drugs in 1990. Since generic drugs are on average four times less expensive--or another way to put that is one-quarter of the cost of the brand-name alternatives--they can be a very important source for reducing the cost in our health care system. To actually receive these savings, consumers have to have access to these generic drugs and have access to them in a timely manner.

In 1984, Congress passed the bipartisan Hatch-Waxman Act to create market-based incentives for generic pharmaceutical companies to bring their drugs to market as quickly as possible. The purpose of the law was to incentivize the early generic drug competition while preserving incentives for pioneer companies to develop innovative new medicines. Unfortunately, pay-for-delay settlements between brand-name drugs that already have their products in the market and generic pharmaceutical manufacturers who have not yet brought their products to market have become commonplace, and these agreements, these so-called settlements, have stifled competition and delayed access to generic drugs at a significant cost to everyone who is involved in the health care system.

There is a table I want to put up. It relates to three particular drugs, and I will talk about the second two of these drugs because this gives some context to what I am concerned about.

This second drug is Lipitor. Everybody knows about Lipitor. It is a cholesterol-lowering drug. It is familiar to most people. It is the best-selling pharmaceutical ever in the history of the world.

According to a 2008 New York Times report, a pay-for-delay settlement delayed generic entry into that market--the entry of a generic version of Lipitor--by 20 months. The same report stated the generic version of the drug was estimated to sell for less than one-third the cost of the brand-name Lipitor. It pointed out that the brand-named Lipitor had earned $12.7 billion in sales the year before.

According to a letter sent to the FDA Director Hamburg last year from some of my colleagues in the Senate indicating that the Federal Government was spending $2.4 billion a year on

Lipitor, they estimated that bringing a generic version to market would generate somewhere between $4 billion and $6.7 billion in savings annually to people who are purchasing this drug in this country.

The second example is Provigil. This is a sleep disorder drug. Due to the pay-for-delay settlement entered into there, a generic version of Provigil just came to market this year. Had this amendment we are offering as part of this bill been law, generics very likely would have entered the market 6 years ago with the expiration of exclusivity.

The chief executive officer of Cephalon--which is the brand-name manufacturer of Provigil--is quoted as saying:

We were able to get six more years of patent protection.

That's $4 billion in sales that no one expected.

In other words, the Provigil case represents 6 years and millions of dollars of lost savings to consumers, the largest consumer being the U.S. Government and particularly the U.S. military.

I have a chart that relates to the U.S. military's potential savings from this amendment. This translates this into dollars that are being paid out by the U.S. military as part of the defense budget, which we are going to be passing later this year.

Assuming that a generic version of Provigil would have been released in 2006, the Department of Defense alone would have saved $159 million from this one drug between 2006 and 2011. That is over $150 million from a single prescription drug.

If enacted, this amendment would foster more generic competition, would bring generic drugs to the market sooner, and would do so in a manner that is consistent with the original intent of the Hatch-Waxman Act. Passage of the amendment would significantly cut prescription drug costs for American consumers and help reduce the Federal deficit.

Let me also allude to an article on the front page of the New York Times. I know some of my colleagues take exception to the New York Times occasionally, but this is an article entitled ``New Fervor for Cutting Costs Among Hospitals and Insurers.'' The reporter is Reed Abelson. About three paragraphs into the article, he states:

After years of self-acknowledged profligacy, hospitals,

doctors and health insurers say there is a strong effort

under way to bring medical costs under control.

I was struck by that phrase ``self-acknowledged profligacy in the health care system.'' I think that is what we have engaged in, in the Congress, frankly, is self-acknowledged profligacy in the health care system. This amendment will help to correct that.

The amendment has the strong support of AARP, of Families USA, Consumer Federation of America, U.S. PIRG, Consumers Union, the Center for Medicare Advocacy, AFL CIO, AFSME, Walmart, the National Committee to Preserve Social Security and Medicare, among other groups and organizations.

If my colleagues favor competition, this amendment helps to promote competition. If we want to see reduced costs to the taxpayer for health care, then this amendment helps to reduce the cost to the taxpayer. If we want to reduce what patients and hospitals and insurance companies have to pay for prescription drugs, this amendment helps to do that as well.

I think this is something that is long past time we corrected this problem. This is a great opportunity for us to do so. I believe it is one of the first amendments that will be considered on this legislation. I hope my colleagues will put aside whatever other considerations they might have had in the past and go ahead and vote for this correction in Federal law. This is a problem, frankly, that we passed legislation that provided the opportunity--unfortunately. It was not intended. But an unintended consequence of the earlier legislation that we passed, the Hatch-Waxman Act, was to allow this kind of blocking, these kinds of pay-for-delay settlements to be entered into. We can correct that today. I hope very much we will.

I urge my colleagues to support the amendment, and I yield the floor.

Mr. SCHUMER addressed the Chair.

Madam President, I thank Senator Vitter for his comments and for his strong support of this amendment. I thank all of the other cosponsors of the legislation.

If we are interested in promoting competition in the health care field so that we can keep prices down, then we need to support this amendment. That is exactly what this does.

Under our law in this country, we provide exclusive rights to a company that develops a drug to sell that drug during the time the patent is in effect. But what we are concerned with here is that after that patent is no longer valid, companies are still extending their exclusivity, extending their time when they don't have any competition by entering into these agreements. So we think they can settle their disputes--we don't have a problem there--but they cannot keep other generic manufacturers from coming to the market who also have demonstrated the invalidity of a patent.

If we are worried about the cost of health care to the Federal Government--the Federal Government is paying too much for prescription drugs because of this flaw in the Hatch-Waxman Act that we are trying to correct. If we are worried about keeping prices down for hospitals, insurance companies, and consumers, this amendment will help to do that.

I urge my colleagues to support the amendment.

Mr President, I rise in strong support of the underlying bill we are debating, the Food and Drug Administration Safety and Innovation Act.

This legislation, which has been the model of bipartisanship and effective legislating on the part of Chairman Harkin and Ranking Member Enzi, is critically important to the people of New Jersey and the Nation.

This bill is about more than drug safety. It is about more than protecting patients. It is about improving the approval process to speed access to new lifesaving, life-enhancing drugs and devices, and making sure the FDA is a partner in the production of safe and effective products.

This bill does this and accomplishes several key goals that are critically important to our Nation's health care system. Not only does it reauthorize the key user fee agreements for prescription drugs and medical devices, but it establishes agreements for generic drugs and generic biologic drugs called biosimilars.

Together, these user fee agreements will provide the FDA with the resources necessary to improve the drug and device approval process to more quickly and efficiently bring new products to market. It will enhance communication between manufacturers and the agency to foster a more cooperative environment, and it will allow for better and more thorough postmarket reviews to ensure continued patient safety and product efficacy.

There is more to this bill than the FDA user fees.

It permanently reauthorizes two vital programs that are a lifeline to our Nation's children--the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which are incredibly important to our children. It helps reduce and mitigate the ongoing problem of drug shortages we have heard about throughout the country. It provides for enhancements to the prescription drug supply chain and increases the accountability and transparency of the Food and Drug Administration.

It is good for children. It is good for business. It is good for patients. It makes the FDA a more effective partner in the process, and it demonstrates that we can reach across the aisle and work together to tackle tough issues and find solutions that benefit the people we collectively represent.

This just touches the surface of what this bill will accomplish. However, this incredibly hard work could very easily be unraveled by some of the amendments being considered.

Amendment No. 2107

It seems that, once again, despite the countless times--the countless times--the Senate has rejected the policy my friend from Arizona pursues, he has brought us an amendment that I believe puts Americans at risk, undermines FDA's authority, and would have a devastating ripple effect throughout our country's drug supply by allowing untraceable foreign pharmaceuticals into our country.

This amendment would ostensibly only allow drugs from Canada into the United States. However, nothing in the amendment comes close to ensuring that is the case. In fact, this amendment would easily allow Web-based pharmacies within Canada to provide untraceable, unaccountable drugs from all over the globe into the U.S. market without any FDA oversight whatsoever.

This amendment does not provide the FDA with any additional resources to monitor the drugs coming in from Canada, and even the Canadian authorities have said they cannot be expected to monitor all the drugs coming through their country and into ours. Once one of those drugs hits and causes consequences to some family, then we will all be running and saying: How did we allow that to happen?

The Senate has soundly and repeatedly voted against this type of drug importation because we understand the implications it has on bringing counterfeit and dangerous products into our Nation. As we work to strengthen the FDA, I ask my colleagues to join me in opposing this amendment, which would significantly weaken the agency and put Americans at risk.

Amendment No. 2109

Additionally, I wish to address another critically important issue brought up by my friend from Vermont. The Sanders amendment would lead to a radical change in how our Nation's biotech and pharmaceutical industry achieves the process of bringing lifesaving, life-enhancing drugs into the marketplace.

I certainly respect the passion for the issues he pursues. But there are over 200,000 people in New Jersey who work in the biopharmaceutical industry every day who take pride in the work they do creating breakthrough, lifesaving, life-enhancing drugs, and I take issue with this characterization of an industry which is responsible for some of the world's most important medical breakthroughs that have saved millions of lives. If you are one of those people waiting for one of those drugs to come to the marketplace, hoping that for your mother's Alzheimer's--the Alzheimer's that took my mother's life--we will finally have a breakthrough; that for your husband with Parkinson's, we will finally have a breakthrough; that for your loved one with cancer, we will finally have a breakthrough, you want to see that come to the marketplace.

This industry is responsible for finding the cures and treatments for diseases that kill people and destroy family incomes. This is the industry that has more than 1,600 active clinical trials in New Jersey on drugs to treat cancer, cardiovascular disease, diabetes, HIV/AIDS, mental and behavior disorders, and, especially important to me personally, trials for drugs treating Alzheimer's and other forms of dementia. Families look forward to those breakthroughs coming to the market to help cure their loved ones.

This work is what keeps our Nation competitive and on the cutting edge of medical science, providing billions of dollars in economic impact annually--roughly $900 billion nationally and more than $35 billion in New Jersey--and it provides countless people across the globe with lifesaving medications.

The amendment being offered could have a chilling effect on all this--all the hope for new treatments and perhaps new cures for diseases, having an opportunity for that to be turned around, to stop having those families lose a loved one who succumbs to a disease, ruining countless lives. It has the potential to dry up investment in the next cure and severely curtail the number of high-skill, high- paying jobs and billions of dollars in economic investment in the biopharmaceutical industry.

I know my friend from Vermont wants to prevent fraudulent behavior, and I wholeheartedly agree that bad actors who willfully commit fraud need to be punished, which is why we have the most incredible, stiff civil and criminal penalties in current law to prosecute those who commit fraud. But ultimately taking away the incentives we have in place to attract investment in this important research, especially when the penalties could be triggered by a minor, unrelated offense--the way the amendment is written--is just plain and simple bad policy. It is akin to having the death penalty for a simple assault.

The current intellectual property laws that protect pharmaceutical products provide researchers and their investors with a stable and predictable timeline that allows them to recoup the risky investments in research and development of new drugs.

We only think about the drugs that have success. But remember, out of every 5,000 to 10,000 potential drug compounds identified, only 1--only 1--of those 5,000 to 10,000 potential drug compounds will result in a new medicine on the market.

Do we want the companies not to take the risk of going through all those thousands and thousands of compounds to come up with the one that can be the cure for so many lives and save so much money in the government under Medicare and Medicaid and in our entire health care system? That is risky investing by anybody's standard, so removing incentives is bad policy for the public health of the United States.

This amendment will lead to uncertainty among investors. It will dry up capital. It will further delay access to new medical products. It will pull us back from the cutting-edge research and development that has always made this Nation great.

As I have said--and as my friends who are managing this bill have said--this FDA reauthorization is too important not to pass. So I urge my colleagues to reject these harmful amendments so we can move forward and have an FDA that has the ability to do its job on behalf of the American people to create a process that will be safe but will give us the lifesaving, life-enhancing cures that ultimately will lead to a better life for all of us.

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

Mr. President, it is not the special interests that have caused the Senate countless times to reject this policy. It is an amendment that puts Americans at risk, undermines the FDA's authority, and would have a devastating ripple effect throughout the country's drug supply by allowing foreign pharmaceuticals into the country.

It is not simply about Canada. The Canadians themselves have said they cannot be expected to monitor all the drugs coming through Canada and into our country, and all the Web-based opportunities would allow untraceable drugs to come through Canada into the United States.

This is about the health and security of the American people. That is why time after time the Senate has rejected it. It is why it should be rejected once again.