VISN Reorganization Act of 2012

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, I ask unanimous consent to speak as in morning business.

Mr. President, 11 years ago, I introduced the DREAM Act, which is legislation that would allow a select group of immigrant students with great potential to contribute more fully to America.

The DREAM Act is not an amnesty bill. It would give students a chance to earn legal status in America, and there are standards they would have to live up to: No. 1, they came to the United States as children; No. 2, they have been long-term U.S. residents; No. 3, they have good moral character; No. 4, they have graduated from high school; No. 5, they either serve in America's military or complete 2 years of college.

The DREAM Act also includes important restrictions to prevent abuse. Under the DREAM Act, no one would be eligible for Pell grants or any other Federal grants when they go to school. Individuals who commit fraud under the DREAM Act, who lie, misrepresent their status, would be subject to tough fines and criminal penalties, including a prison sentence of up to 2 years. It is serious. No one would be eligible for the DREAM Act unless they arrived in the United States at least 5 years before the bill becomes a law. There is no exception and no waiver for this requirement.

My colleague from Florida, Senator Marco Rubio, on the Republican side of the aisle, said in a recent speech that the DREAM Act is not an immigration issue, it is a humanitarian issue. I might add that I think it is an issue of justice.

Thousands of immigrant students in the United States were brought here as children. They didn't make a decision at the age of 2 to come to America. It was not their decision to come here, but they grew up here, went to school here, and they stood in classrooms across America pledging allegiance to the only flag they ever knew. They sang ``The Star-Spangled Banner'' before baseball and football games, believing they were part of America.

The fundamental premise of the DREAM Act is that we should not punish children for their parents' actions. It is not the American way. Instead, the DREAM Act says to these students that we are going to give them a chance. These Dreamers, as I have come to know them, don't want a free pass. They just want a chance to earn their place in America. That is what the DREAM Act would give them.

The DREAM Act isn't just the right thing to do, it would make America a stronger country by giving these talented young people the chance to serve in our military and contribute to our future. Tens of thousands of highly qualified, well-educated young people would enlist in the Armed Forces. That is why we end up with the support of people such as General Colin Powell, who has given his life to the military and the security of America. He says the DREAM Act is the right thing to do for the future of America.

Studies have found that DREAM Act participants would contribute literally trillions of dollars to the U.S. economy during their working lives.

One might wonder how an idea like that ends up becoming a bill and being debated not only on the floor of the Senate and the House but becoming a subject of debate in the Presidential contest now going on. It started with a phone call to my office about 11 years ago from a woman named Duffy Adelson. Duffy is the director of the Merit music program in Chicago. The Merit music program is an amazing program which offers to children in the public schools of Chicago an opportunity to learn to play a musical instrument. That program goes to the poorest schools and asks children if they are interested, if they would like to have an instrument and a chance to learn. Children sign up and amazing things happen. These kids--100 percent of them--end up in college. That is what that one life experience of learning to play music can do.

She called me about a young girl. She was a Korean who had been brought to America at the age of 2. Her mother and father became citizens. Her two siblings, a brother and a sister, were born here and were automatically citizens, but she was not. She joined the Merit music program and turned out to be an accomplished pianist, to the point where, when she was graduating high school, she was being offered scholarships to the best music academies in the United States.

When her mom sat down with her to fill out the application, there was a little box that said ``citizenship.'' She turned to her mom and said: So what do I put there? Her mom said: I brought you here at the age of 2 on a visitor's visa, and since you were a little baby, I didn't file any more papers. I don't know what you should put there. The girl said, What are we going to do? Her mom said: We are going to call Durbin.

So they called me and my office checked the law and the law turned out to be pretty harsh. The law said this 18-year-old girl--who had never lived, to her knowledge, in any other place but America--had to leave America for 10 years and then apply to come back. That didn't seem right. She came here at the age of 2. She had done nothing wrong. So I introduced the DREAM Act.

Well, here is the rest of the story about this young lady, whose name is Teresa Lee. Teresa Lee did go to the Manhattan School of Music, and when she went there she turned out to be as good as the Merit music program thought she would be. She progressed to the point where she literally played in Carnegie Hall. She found a young man, fell in love, got married, and she became a citizen by virtue of that marriage. She is now working toward her PhD in music. She is a brilliant young woman.

There was a talent that would have been lost to us and lost to the future if we had followed the strict standards of the law at that moment. But we didn't. We gave her a chance and she proved herself. She proved she is a quality individual.

When I introduced the DREAM Act, it was a bipartisan bill. There were Republican Senators who actually debated as to who was going to be the lead sponsor of the bill because they thought it was such a good idea. The DREAM Act has had a history of broad bipartisan support. When I introduced it with Senator Orrin Hatch of Utah, he was chairman of the Judiciary Committee and was the lead Republican sponsor. When the Republicans controlled the Senate, the DREAM Act was reported by the Judiciary Committee on a 16-to-3 bipartisan vote. And on May 25, 2006, 6 years ago this week, the DREAM Act passed the Republican-controlled Senate on a 62-to-36 vote as part of comprehensive immigration reform.

That bill, unfortunately, did not pass, and, unfortunately, the Republican support for the DREAM Act has diminished over the years. The last time the DREAM Act was considered on the floor of the Senate in 2010, the bill had already passed the House and received a strong majority vote there, but only eight Republicans supported it in the House and only three Republicans in the Senate. A bill which had been so bipartisan and so popular was now becoming, each time we called it up for a vote, more partisan. The bill hasn't changed, but politics had changed.

The vast majority of Democrats in the House and Senate continue to support the DREAM Act. But the reality is we cannot pass the bill without substantial support from my colleagues on the other side of the aisle. That is why I have always said I am open to working with anyone--Republican or Democrat--who is interested in working in good faith to solve this problem. I will never close the door on the possibility of providing assistance to these DREAM Act students.

I have come to the floor almost every week for the last several years to tell the story of another young person who would qualify under the DREAM Act. Today I want to tell you the story of Sahid Limon. Sahid was brought to the United States from Bangladesh in 1991 at the age of 9. He grew up in Durham, NC. His dream was to become a doctor. He attended Southern High School--a prestigious magnet school for young people interested in health care. He was a member of the National Honor Society and won his high school's Diamond in the Rough Scholarship award. One of Sahid's teachers said:

In the classroom, he was kind, very respectful, and

responsible. He showed great interest in a career in

medicine. In the medical community, through shadowing

experiences, he was professional, highly motivated, and

caring with patients.

Sahid didn't learn about his immigration status until his senior year in high school. He went on to graduate from East Carolina University with a bachelor's of science in biology, with a concentration in microbiology. And understand, he didn't qualify for any Federal loans or any Federal grants. It wasn't easy to get through college under those circumstances.

During college, Sahid volunteered at underserved rural areas in North Carolina and it made a big impression on him. In his application for medical school, he wrote:

I was surprised to see that so many people would line up

during a cold winter morning, just to know if they were

healthy or not. Seeing their dedication and patience

influences me every day to work my hardest in order to meet

my personal goal of becoming an exceptional physician.

That was 7 years ago--2005. Today, Sahid is 30 years old. He has been unable to attend medical school because of his immigration status. Since he graduated from college, he has volunteered with a health clinic in Raleigh that serves low-income patients, he has tutored elementary school students to help develop their interests in science, but his personal dream of becoming a doctor has not become a reality.

Some of my colleagues have criticized the DREAM Act because people under the age of 35 are eligible. They say only children should be eligible for the DREAM Act. But this ignores the obvious. Every year we wait, those children grow a year older. In order to qualify for the DREAM Act, an individual must have come to the United States as a child, as Sahid did. Today he is 30. That doesn't change the fact he was brought here when he was 9 years old. It doesn't change the fact he has lived in the United States virtually all his life. And it doesn't change the fact he should not be punished for the choices his parents made. Sahid was 19 years old when the DREAM Act was first introduced. Why should he be penalized because I can't pass the bill? I keep trying, but Congress doesn't get it done. Does that mean his life should be wasted?

Last year, Sahid was arrested by immigration agents and placed in deportation proceedings, despite the fact he has lived in the United States for 21 years, since he was 9 years old. He was held in a county jail with violent criminals. Sahid has never committed a crime in his life. Sahid sent me a letter, and here is what he said about the experience of being in jail and facing deportation:

I lived my life by the law, did everything by the books,

never committed any crime, and somehow ended up in jail for

something I had no control over as a child. What would I do

if I was sent back [to Bangladesh]? I barely speak the

language, and I don't know how to read or write. How am I

supposed to start my life from scratch in such a place

without the knowledge of the language or the culture?

Well, my office learned about Sahid's case. We contacted Immigration and Customs Enforcement and asked them to consider his request that his deportation be placed on hold. The Obama administration placed a stay on his deportation proceedings. However, it is only temporary. It doesn't give him permanent legal status, and he is still at risk of being deported sometime in the future. The only way for Sahid to be permitted to stay in the United States permanently is for us to do something to pass the DREAM Act--to change the law.

In his letter to me, Sahid explained what the DREAM Act meant to him:

The DREAM Act means being able to be home. Regardless of

where we go . . . we all yearn to come back to our home. To

me, North Carolina is that home . . . I watched live on C

SPAN [in 2010] as the bill passed the House, but failed to

pass the Senate. To most of the Senators, it's just another

bill that was rejected. However, to someone like me, whose

life not only depends on something so crucial, but my future

literally hangs in line, it's absolutely devastating to

witness such a rejection. I hope this is the year that

politics is set aside, and all of the representatives can

work together for a solution.

Sahid is right. Those of us who are fortunate enough to serve in Congress have an obligation to set politics and party aside and do the right thing. This isn't a Democratic issue or a Republican issue. We are going to be a stronger and better country if we give Sahid a chance to earn his way to American citizenship.

This is not just one example, one person. There are literally thousands like him waiting for their chance. The DREAM Act would give Sahid and other bright, accomplished, and ambitious young people like him the opportunity to become tomorrow's doctors and engineers, teachers and soldiers. Today I ask my colleagues again, as I have so many times before, to support the DREAM Act. Let's give Sahid and so many other young people like him the chance to contribute more fully to the country they call home. It is the right thing to do, and it will make America a stronger Nation.

Financial Regulation and Reform

Mr. President, 2 weeks ago, we were given a cautionary lesson about the need to ensure that our Nation's banks are carefully regulated. We are still learning the details about the $2 billion bad bet made by banking giant JP Morgan Chase. But what we have learned is disturbing. Apparently, the London office of this Wall Street giant crafted a credit derivative trading strategy that spun out of control over the course of 6 weeks. At the center of the strategy was one single trader who was nicknamed ``the London whale.'' One trader, 6 weeks, $2 billion gone.

It is not clear how widely the repercussions of this trading loss will extend, but this incident clearly is an important reminder to all of us that we cannot afford to take a hands-off regulatory approach to the giant financial institutions on Wall Street. These institutions drove this Nation to the brink of economic disaster just a few years ago. If they are simply left to their own devices, it could easily happen again.

We need reasonable financial regulation that will ensure transparency, competition, and choice. We need to prevent Wall Street banks from fixing the rules and setting up rigged schemes that line their own pockets and hang Main Street America out to dry.

Two years ago, Congress passed, and the President signed, the Dodd- Frank Wall Street Reform and Consumer Protection Act. This legislation took on the challenge of placing a reasonable regulatory framework on Wall Street. It is a tough challenge. Wall Street and the banking industry have enormous resources and enormous power, and they are not afraid to use it--not only on Wall Street but on Capitol Hill.

In the days to come, we are going to see important regulatory efforts proceed on issues such as the Volcker rule, which deals with the big banks' ability to make bets with their customers' money. It is important we pursue this regulatory effort diligently. We cannot let the big banks use their threats and scare tactics to water down reform and to preserve business as usual. There is too much at stake.

I want to talk today about another part of the Wall Street reform that passed 2 years ago, a provision that the big banks hate as much as any other. I am talking about the provision I wrote dealing with interchange fees, or swipe fees. The swipe fee is a fee that a bank receives from a merchant, like a restaurant or a retailer, when the merchant accepts a credit or debit card

issued by the bank. That fee is taken out of the transaction amount. If your bill is $50 at the restaurant, that includes the fee the restaurant is paying to the bank and credit card company called the swipe fee--the interchange fee.

The vast majority of bank fees are very transparent and competitive. Chase, Bank of America, Wells Fargo, and the rest set their own fee rates and compete for business based on the fees they charge. But that is not the case with these swipe fees--the interchange fees--that affect credit and debit cards. The big banks know competition and transparency help keep fees at a reasonable level, and make it harder to make big money off of fees. That is why they set up the swipe system--the interchange system--to avoid competition and transparency.

The big banks decided, rather than each of them setting their own swipe fees, they would designate two giant card companies--Visa and MasterCard--to set the fees for all of them. That way, each bank could get the same high fee on a card transaction. No competition. Then the banks buried this swipe fee under layers of complexity within debit and credit transactions. Most consumers, and even most merchants, still have no idea how much they are being charged on a swipe fee.

This system helped the card-issuing banks do very well over the last 20 years. U.S. swipe fee rates became the highest in the world, and they kept going up even as the cost of processing transactions went down. Debit swipe fees alone--just debit cards--brought the banks over $16 billion in the year 2009. That is the interchange fee paid by the merchants--and ultimately by the consumer--to the banks and credit card companies when people use a debit card.

Of course, banks don't need all this debit swipe fee money to conduct debit transactions. The actual cost of a transaction is very low, a few cents. But the banks, looking for more revenue, exploited the swipe fee system to charge far more than they could ever justify. It doesn't have to be this way. Many other countries--Canada, European countries, and others--have vibrant debit card systems with swipe fees strictly regulated or prohibited altogether. In the United States, debit swipe fees used to be tiny, until Visa took over the debit card market in the mid 1990s using tactics that I think bordered on violations of antitrust.

By 2010, the U.S. swipe fee system was growing out of control, with no end in sight. There were no market forces serving to keep fees at a reasonable level. Merchants and their customers were being forced to subsidize billions in windfalls to the big banks. That is when I introduced an amendment to the Wall Street reform bill that, for the first time, placed reasonable regulation on swipe fees on debit cards.

The reason I picked debit cards is--some of us are old enough to remember something called a checking account. Those checking accounts are still around, but checks are becoming rare. Most people do their checking transactions with a piece of plastic called a debit card. The money comes directly out of their bank accounts just as the check removed money directly from their bank accounts. That is why the debit card is a different transaction than the credit card.

My amendment said if the Nation's biggest banks are going to let Visa and MasterCard fix swipe fees for them, then the rates must be reasonable and proportional to the cost of processing the transaction. There would be no more unreasonably high debit swipe fees for big banks.

My amendment also included a nonexclusivity provision which aimed to stop Visa from taking over the debit card market entirely. This provision says there needs to be a real choice of card networks--real competition.

The regulatory steps my amendment proposed were modest. Most other countries have gone a lot further in regulating their credit and debit systems. But if you have listened to the banking industry and card companies, you would have thought my amendment would be the end of the world as we know it. They made outrageous claims, that regulation and swipe fees could kill the debit card system, devastate small and community banks, and particularly be an end to credit unions and cause banks to raise their fees on customers.

My amendment passed the Senate with 64 votes and was signed into law, and it has been 8 months since the swipe fee reform took effect. It turns out all the scary scenarios threatened by the banks have not come to pass.

First, the banks claimed it was impossible for Visa and MasterCard to establish a new tier of regulated swipe fee rates. As it turned out, creating this two-tier system was easy. There were already hundreds of rate tiers, so adding another one wasn't difficult.

The banks then claimed that small banks and credit unions would be hurt by reform--even though all institutions with assets of less than $10 billion were exempt. As it turned out, small banks, community banks, and credit unions have actually thrived since this reform took effect. Why? Because under my amendment, small banks and credit unions can continue to receive high interchange fees from Visa and MasterCard--higher than the big banks that control about 60 percent of the issuer market. And, those big banks have been so heavy-handed in their response to swipe reform that they have driven their customers-- many of them--straight into the arms of the community banks and credit unions.

Credit unions in particular are flourishing after the passage of swipe fee reform--a reform which they actively opposed. Last year, 1.3 million Americans opened new credit union accounts. That was up from 600,000 the year before. More than twice as many people as before opened credit union accounts, and credit unions now have a record number of members across the Nation--almost 92 million overall. So much for the prophecy by the credit unions that this change in the law would be the end of them. It has turned out to be the best thing that has ever happened to them.

I know the Washington lobbyists for the small banks and credit unions still like to complain about this reform. These lobbyists have spent so much time fighting reform they are just not going to change their positions. But the facts are clear--if they will just be honest enough to admit it. Small institutions have thrived since this reform took effect.

How about consumers? The big banks tried last year to recoup their reduced swipe fees by charging $5 monthly debit fees on their cardholders. Do you remember that? Do you remember when Bank of America said it was going to go up to $5? Do you remember what they said all across the nation? Bye-bye, Bank of America. We will go somewhere else. Within a matter of a month or two Bank of America backed off of it.

Finally, consumers were coming alive. They were awakened to the reality that they could shop too. This is a free market--underline the word ``free.'' If you don't like the way your bank or any institution is treating you, go shopping. That is part of America. The banks had never run into that before. People just waited, unfortunately, for the latest fee increase. People don't wait around anymore. They pick up and move.

Unlike swipe fees, the big banks' $5 debit fees were transparent and customers had a range of competitors to choose from. So they moved. Transparency and competition worked.

Consumers are also benefitting from savings passed along by merchants. After swipe fee reform took effect in October, we saw a massive level of retailer discounting that extended beyond the usual holiday season discounts. According to USA Today--an article from May 11--a number of individual merchants are offering debit card discounts for items such as gas, furniture, and clothing.

USA Today also pointed out that despite the banks' threats, free checking accounts for consumers have not disappeared. USA Today reported that in the second half of 2011, 39 percent of banks offered checking accounts with no monthly maintenance fee, up from 35 percent for the first half of the year. Also, of those banks that charge checking maintenance fees, the average fee fell in the second half.

This is what is known as competition. What is wrong with that? That American families and consumers go shopping for the best bank deal. It is happening because swipe fee reform has created new competition. I think competition is a good thing.

It is important to note that the savings of swipe fee reform to merchants and consumers actually should be even greater than it is. When the Federal Reserve was writing its rule to implement my amendment, the banks lobbied them to set a swipe fee cap at a level significantly higher than the 12 cents that the Fed established in its draft rulemaking. Predictably, Visa, MasterCard, and the big banks took advantage of this watered-down regulation they had lobbied for. Visa and MasterCard promptly jacked up their swipe fees to the 24-cent ceiling set by the Fed.

Here is what has happened. Swipe fees have traditionally been charged as a percentage of the transaction amount plus a small flat fee. This meant the small dollar transactions used to incur fees of much less than 24 cents. Now, with Visa and MasterCard's rate increases, businesses that primarily deal with smaller transactions--coffee shops, fast-food restaurants--are paying far more in swipe fees than they did before.

This is not a flaw in the law we passed, which wisely required reasonable and proportional fees. Rather, it shows the danger of watering down the regulations to implement the law. The banks and card companies lobbied the Federal Reserve for a loophole which they immediately raced through. This is something we need to fix going forward. It can be fixed.

I am pleased the modest swipe fee reform we enacted in 2010 is off to a good solid start: more competition, customers and families moving across America for the best treatment they can receive from their bank or their credit union. But already the big banks and card companies are plotting to undo all these reforms and get that money back, the billions of dollars which they were taking in under the unregulated swipe fee regime. Visa, in particular, has crafted new fee schemes in its continuing effort to monopolize the debit card market. In fact, Visa recently disclosed that the U.S. Justice Department has opened a new antitrust investigation into anti-competitive aspects of Visa's newest fees.

I continue to be concerned that the giant card companies-- particularly Visa--are becoming too big and too powerful. These companies have gained an enormous amount of control over the way Americans can use their money. They set up the fee systems, they dictate the security standards, and they make a fortune by taking a cut out of every transaction they handle, far beyond the cost of processing. There is no regulatory agency that directly supervises the actions of these card companies, and we can't afford to simply trust these companies to do what is in our Nation's best interest or to watch out for consumers.

That, again, is why the Consumer Financial Protection Bureau created by the Dodd-Frank law is such a critically important agency. It is virtually the only agency at the highest levels of our government that is solely devoted to consumer protection when it comes to financial products.

In the weeks and months to come, I will continue to work to ensure that the debit and credit card systems have competition, transparency, and choice, and that there is a framework for reasonable regulation. I know the big banks and card companies are going to continue to fight it. They have a lot of money on the table. But I believe reasonable regulation is the right way to move forward, and I will continue to work for it. Our economy, our small banks, our credit unions, our merchants, and our consumers are benefitting from this important change in the law.

Mr. President, I yield the floor.

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

Madam President, dietary supplements have become a common health aid in medicine cabinets all across America. More than half of us in America use dietary supplements, including this Senator, who, for a variety of reasons, takes a multivitamin tablet every morning. In spite of their popularity, many people would be surprised to learn the Food and Drug Administration doesn't know how many dietary supplements are actually being sold in the United States. Most people don't know if a dietary supplement ingredient presented serious health concerns, the Food and Drug Administration doesn't have the information to track down products containing the harmful ingredient. We assume if it is for sale in America, some government agency has taken a close look to make sure that product is safe and that we know what is inside it and that it wouldn't harm an innocent customer. It turns out that may be true when it comes to prescription drugs and over-the-counter drugs, but the dietary supplement world is a much different world, with minimal regulation.

I have an amendment which I will be offering to ensure the Food and Drug Administration has the information it needs to respond quickly and efficiently when safety concerns arise concerning dietary supplements. This amendment would require dietary supplement manufacturers to give the Food and Drug Administration the name of each supplement they produce, along with a description, a list of ingredients, and a copy of the label. It is not an onerous requirement, but for the first time the Food and Drug Administration would literally have a catalogue of all the dietary supplements being sold to Americans all across the Nation. With this information, the FDA would be better equipped to protect consumers' health and to work with manufacturers to address any problems should they arise.

A 2009 report by the Government Accountability Office found the Food and Drug Administration is limited in its ability to respond to safety concerns because dietary supplement manufacturers don't always provide basic information, such as product names or lists of ingredients. This commonsense amendment I am offering is supported by the Consumers Union, and it would provide the Food and Drug Administration the basic information it needs to protect the public.

Trust me. It will be opposed by certain interest groups. But I heard opposition almost 10 years ago when I introduced a bill to require dietary supplement manufacturers to report serious adverse events, such as hospitalizations or deaths, to the FDA. The need for mandatory reporting of adverse events was demonstrated by injuries and deaths across the country caused by the popular and dangerous dietary ingredient ephedra before it was banned in the United States in 2004. One of the victims was 16-year-old Sean Riggins from Lincoln, IL--30 miles from where I live in downstate Illinois. He died in September 2002. Sean was a high school student, and he died from a heart attack after he took something called Yellow Jackets. It was supposed to be an energy boost, and he was headed off to play football. It contained ephedra and it killed him.

Shortly before his death, Metabolife--the largest manufacturer of supplements containing ephedra--claimed to the public they had no ephedra-related adverse event reports, period. However, a lawsuit was filed, and they were required under that lawsuit to disclose their records.

In October of 2002, under pressure, Metabolife gave FDA over 13,000 ephedra-related adverse event reports. People had taken their substances with ephedra and had gotten sick or worse.

In 2006 I worked with Senator Orrin Hatch of Utah and Tom Harkin of Iowa to pass the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which mandates reporting of adverse events to the Food and Drug Administration. It stands to reason if there is a drug for sale in the United States--a dietary supplement in this case--that causes a problem, we should know about it. If it is causing a problem in a lot of different places, the Food and Drug Administration, through these reports, will discover it.

Since the law took effect in 2007, dietary supplement adverse event reports submitted to the FDA have increased sevenfold, from 368 in 2007 to 2,473 in 2011. The FDA is using these reports as part of a surveillance system to signal potential safety issues and, in some cases, to take regulatory action. Mandatory reporting of adverse events was an important step to help protect consumer safety, but we need to do more to ensure the FDA and consumers have the information they need.

Madam President, the sad reality of this amendment and this issue is that it takes a tragedy to catch our attention. Someone has to be seriously hurt or worse before Members of Congress and others will take notice and do something.

I recently learned about the tragic death of this beautiful young 14- year-old girl. Her name was Anais Fournier from Maryland. Anais was an honor student. She liked to read vampire novels. She watched chick flicks with her mom, and she had a passion for writing. Last December her life was cut short when she went into cardiac arrest. What caused it? Caffeine toxicity. She drank two 24-ounce Monster Energy Drinks in less than 24 hours, and it took her life.

The American Academy of Pediatrics recommends that adolescents, such as 14-year-old Anais, consume no more than 100 milligrams of caffeine every day. But in less than 24 hours, Anais had consumed 480 milligrams of caffeine. That is the equivalent of 14 12-ounce sodas with ordinary caffeine content. Of course, she did it with two drinks--Monster Energy Drinks.

A recent report by SAMHSA shows energy drinks pose potentially serious health risks. I might just say that in the Senate today, as I am speaking, are members of Anais' family. We want to

join them in mourning her loss and hope that her life will at least give us notice there are things we can do to spare other families the grief their family has gone through. Wendy Crossland is her mom, her sister Jade is here, her grandfather Dick and grandmother Faith. They have come here today because they are hoping the Senate will hear about this amendment and that we can take it up and pass it.

Anais' case is not the only one. Emergency room visits due to energy drinks have increased tenfold between 2005 and 2009 from 1,128 in 2005 to 13,114 ER visits in 2009. Energy drinks target kids with flashy ads and names like Monster and Rockstar and Five Hour Energy Drink, but there are serious concerns about the high level of caffeine in these beverages and the herbal ingredients that act as stimulants and contain additional caffeine.

But here is an interesting thing. If you walk in--as I have--to an ordinary gas station--whether it is in New Hampshire or in Illinois-- and you see the cooler with the drinks in it, and then you see others on counters, you might assume, well, they are all subject to the same level of regulation. But that is not true. If we are talking about ordinary beverages--sodas--they are characterized as food, and they are subject to certain limits by the FDA. However, if you look at the fine print--and you better look closely, because it is very tiny--you may find this is being characterized and described as a dietary supplement.

By putting those two words on the label, the product escapes regulation. So we limit the caffeine in an ordinary soda pop, for example--a cola--but when it comes to the dietary supplement side of the story, there are no limitations. That is why this poor young girl was a victim because of the huge amount of caffeine that was consumed in the name of a dietary supplement.

The FDA has the authority to regulate caffeine levels in beverages and to require beverage manufacturers to prove the additives they put inside that can or bottle are safe. But most energy drinks avoid FDA oversight by calling their products dietary supplements.

I defy anyone to walk into a store and look at all the things they can buy and pick out the ones that are regulated by the FDA and those that are not. They are going to have to study long and hard and look closely at the labels to figure it out.

Is that fair to consumers? Is it fair to families and parents that we don't have even basic oversight and regulation of products that can literally harm or take the life of a beautiful young girl? The amendment I am offering would ensure the FDA knows about all of the energy drinks being sold in the United States and can provide information about ingredients that could help the agency address potential safety concerns.

Most dietary supplements available today for sale are safe, and they are used by millions of Americans as part of a healthy lifestyle. Some ingredients may be safe for the general population but may be risky for kids, pregnant women, or people with a heart condition or who are taking certain prescription drugs.

Furthermore, in spite of the many responsible dietary supplement companies, sadly, there is a murky market space out there where some bad actors are selling potentially dangerous products--some of them imported into the United States--which literally do not even disclose their ingredients in an accurate way. This amendment will take an important step in protecting public health by requiring dietary supplement manufacturers to submit basic information to the FDA that would help the agency identify safety issues and respond more quickly.

No one wants to hear of the death of another 16-year-old who loved to play football or a young girl such as this wonderful young 14-year-old girl who loved watching movies with her mom. We can help prevent these tragedies by requiring that better information is reported to the FDA when these dietary supplements go on the market.

Madam President, I yield the floor.

Mr. President, I would like to speak as in morning business for 15 minutes.

Mr. President, today I rise to discuss the National Flood Insurance Program, which is a program we are now trying to reauthorize in the Senate. Senators Johnson and Shelby have shepherded this bill through the Banking Committee. I have a ton of respect for both of those Senators and the work of the Banking Committee because they worked very hard to get it to the floor, to get it ready. In fact, it expires on May 31. If for some reason we cannot work out something here in the next couple of days, I sincerely hope we will extend this on at least a short-term basis--for another, say, 30 days--to give us time to work this out. The National Flood Insurance Program is too important to mortgages and commercial real estate, et cetera, to let it lapse. If we cannot work it out, I hope we can get a 30-day extension. I support that effort.

We need to reauthorize this legislation, this program, but we need to do it in the right way. Several Senators over the course of the last few months have stated objections to S. 1940. Here are mine. I have listed some of mine in a letter we sent to the chairman and ranking member last month or so--November 15, 2011. We listed several objections and concerns we had with the bill. There were 13 Senators from 9 States who signed this letter going to Senators Johnson and Shelby. Again, we appreciate their efforts, but we have to do this the right way.

Let me run through three or four or five of my concerns about this legislation and tell my colleagues why I cannot support it in its current form and why I do support an extension but why, in the end, if the bill stays the way it is now, I cannot support it. I hope many of my colleagues will join me in the effort of not supporting this legislation as it is currently drafted.

Let me start with the bill itself, S. 1940. The primary objection I have is in section 107 of the legislation. It is titled ``Mandatory Coverage Areas.'' Basically what it does is it redefines ``special flood hazard areas.'' This may not sound very exciting or very fun to people, but this is critically important.

I am showing a map here on the floor today. All of these counties in the dark green--there are 881 counties total that have levees in their counties. To my understanding, well over 50 percent of the U.S. population lives somewhere near a levee. They may not realize it because the levees work and they don't have floods, but if you see this map, you can see the levees all over the country. If you are a Senator representing one of those States, I strongly encourage you and your staff to look at section 107 of the legislation.

Here is part of it, 107(b):

Residual Risk Areas--The regulations required by subsection

(a) shall require the expansion of areas of special flood

hazards to include areas of residual risk that are located

behind levees or near dams or other flood control structures,

as determined by the Administrator.

Subsection (c) says:

Mandatory Participation in National Flood Insurance

Program--

(c)(1) In General--Any area described in subsection (b)

[the one I just read] shall be subject to the mandatory

purchase requirements. . . .

Then go down to (c)(3):

In carrying out the mandatory purchase requirement under

paragraph (1), the Administrator shall ensure that the price

of flood insurance policies in areas of residual risk

accurately reflects the level of flood protection provided by

any levee, dam, or other flood control structure in such

area, regardless of the certification status of the flood

control structure.

So regardless of whether these levees and dams are certified--in many cases by the Corps of Engineers, in other cases by private engineering firms--regardless of whether they are certified, the people behind those levees are going to be required to purchase flood insurance.

Let me read that one more time:

The regulations required by subsection (a) shall require

[there is no wiggle room there] the expansion of areas of

special flood hazards to include [these] areas. . . .

This is a great expansion of this program. I want to talk about the expansion in just a moment, but let me say that the folks in these areas--I know it is certainly true in my State of Arkansas--the people in these areas currently pay for flood protection. In most cases, what they do is, through some sort of local levy or local tax--it is different in different places, but somehow, someway, they pay to build and maintain these levees. They are paying out of their pockets right now to make sure they do not get flooded. What this bill does and what FEMA would do under this bill--they would be required to do it, wouldn't have any wiggle room--what they would be required to do is make them pay again; not only have to pay for their own levee, they have to pay for flood insurance for floods that will never happen in their

areas because these levees are certified. Again, this is 881 counties, 50 percent of the U.S. population.

Over half the counties in Arkansas have levees. There are over 1,200 dams in our State. I don't have the number of dams for everybody all over the country, but it is over 1,200 in my State, so you can multiply that over how many dams you might think there are in the United States. It is a huge number, and it will affect over half the people in the United States.

I mentioned that these folks are already paying for their own flood protection through local levies. Now, also, according to this law, they are going to have to pay for insurance. In addition to that, to rub salt in the wounds, what they are going to have to do is their local counties are going to have to pass an ordinance that FEMA has written and it is going to restrict the land use. In many cases, that ordinance will diminish the property values, diminish the ability for them to do economic development in their communities.

If we can just take one example of something that happened last year, last year we had terrible flooding in the midsection of the country. Many of you remember that. The Corps of Engineers ended up having to blow the levee at Bird's Point. That is part of the Corps of Engineers' Mississippi River and tributary system.

By the way, we have to thank the Corps of Engineers and praise them for the engineering they have done on the river. I know there have been a few problems over the years. Some obviously happened in Katrina. But overall the Corps of Engineers designed things that work. Certainly when you look at last year, the 2011 flood of last year, in the Mississippi River, one of the longest rivers in the world, certainly the longest in North America, there was more water that flowed through the gauging stations from Cairo, IL, to Natchez, MS, than in any flood in recorded history. The flow at Cairo, IL--the confluence of the Mississippi and the Ohio--was over 2 million cubic feet per second. That was running through the Mississippi River right there. At Helena, AR, it was running at 2.3 million cubic feet per second.

In some locations--the Corps of Engineers is in the process of determining this; they are not ready to say it yet--in some locations up and down the Mississippi River system, they are considering whether this actually was not a 100-year flood or 250-year flood, this was actually a 500-year flood, the largest flood in history.

All of this Mississippi River--MR&T, we call it, Mississippi River and tributary system--all that has cost our taxpayers $32 billion since its inception, but just in the flood last year, it saved taxpayers $110 billion in damages. That is a great return on investment. We need to honor that return on investment. We need to not charge people additional flood insurance for areas that do not flood. They maybe had the 500-year flood up and down the Mississippi or maybe in certain parts of it, and there was not 1 acre of ground that went underwater. It was a new flood of record. Ten million acres of land were protected, 1 million structures were protected, and, again, it prevented $110 billion of property damage. There were no lives lost, and not 1 acre was flooded. The system worked exactly according to plan.

Now this bill comes in and says: Well, even though we just had the 250-year or the 500-year flood, still we want to make all these people up and down the Mississippi in all these counties--not all the people but in certain parts of these counties, depending on what the flood maps say--we want to require them to pay for flood insurance when it is never going to flood there.

I want my colleagues to know that this provision, section 107 in the Senate bill, is not in the House bill. I think the reason it is not--I can't speak for the House, of course, but I think the reason it is not is for the reasons I am saying right here. We know it is not going to flood in these areas. This is the Corps of Engineers. This is the best levee system in the world, and it is keeping these folks safe and dry when the floods come.

Also, I wanted to say the House does not have section 107 in their bill. It never did. There is a House amendment offered by Congressman Cardoza who took out a requirement to show these areas are on their maps, and that vote passed 261 to 163. So not only can we get consistent with the House because we can get rid of section 107, but we can also get rid of other specific parts of this legislation that will be more consistent with the House.

Here is a map of the Mississippi River, the area I am talking about. We can see the States of Louisiana, Mississippi, Arkansas, Tennessee, Missouri, and a little bit of Kentucky and Illinois is in there as well. But this large blue area is what they call the historic floodplain. Before man came, before people started building levees, before they started draining swamps and trying to manage the land, this is the area that would flood.

One thing important to know about this is that a lot of this area in light blue has some of the richest farmland in the world. The reason it is so rich is that for centuries or eons or however long it was, this river would flood periodically and put this very rich soil out there. That is one reason why in this part of the country they can grow almost anything. That soil is great.

This is a huge industry for the area, and it is important we keep it going. It is also critically important for U.S. trade and the U.S. economy. This is the breadbasket, so to speak, of the United States right here. We have that area growing food and fiber for everyone. It is critical we keep that going.

Once the Corps of Engineers gets control of the Mississippi River-- this is what it looks like now when it floods. This is now the floodplain. If you go back to last year when it flooded so badly, this is what it looked like, with one exception; they blew out this one little area in Birds Point to give a little bit of relief. Again, that was by design and that worked.

The first problem I have with the bill is section 107. Another problem is the general expansion of what this bill does to the National Flood Insurance Program. One of the things buried in the bill that a lot of people may not see is in section 118. Section 118 talks about how the Administrator needs to establish an ongoing program under which they review and update and maintain National Flood Insurance Program rate maps in accordance with this section, et cetera, et cetera. Then they go down their criteria of what they need to look at.

It says here ``all populated areas and areas of possible population growth located not within''--not the 100-year floodplain. The current law is the 100-year floodplain. What this plan says is the 500-year floodplain. We don't have a map of that because the Corps of Engineers has not finished mapping and FEMA has not accepted all the maps yet. We don't know exactly what that is going to look like, but I am going to say it is going to look something like this here. It is a good bet that a lot of people in this light blue area are going to have flood insurance.

Based on the flood we had last year, they are never going to get flooded, not in 100 years, and certainly not in 500 years. They are not going to get flooded, but this says they must purchase flood insurance. This is a huge expansion of the program. It has a big impact not just on homeowners, which is obviously very important. They are not going to be able to get a mortgage if they are in a floodplain.

What this law says in the committee report is that notice will be provided to property owners in the 500-year floodplain to inform them of their flood risks, which may lead to more owners protecting their property through flood insurance.

Mr. President, I would ask to have 5 more minutes to wrap up.

Mr. President, what this says in the committee report is that the 500-year flood notation should be sent out to everyone so everyone knows this property is in a 500-year floodplain. The problem is folks are not going to be able to get mortgage insurance, they are not going to be able to do real estate development; commercial real estate is going to hurt from that. They are not going to be able to have economic development projects in these areas because of the floodplain notation.

Also on page 8 of the committee report it talks about how they are going to spend about $400 million annually in

doing this mapping. Well, if they are going to map out the 500-year floodplain, that is a lot more map than the 100-year floodplain. They can save quite a bit of money by doing that.

The bottom line is these levees are designed correctly, they are built correctly, they are maintained correctly, and they are certified that they are safe. What is the point of people having to get flood insurance in that area when it is not required right now?

I also think this legislation requires a huge conflict of interest for FEMA. It is not FEMA's fault; they are not asking for this. It is what the Congress is trying to do. Basically under this law FEMA would write the regs, they will draw the lines, they will control the timing, they will set the standards, they will update the maps, they will maintain the maps. If there is an appeal, they would have to go to FEMA. They also set the rates, they collect the money, and they spend the money. Everything is done by FEMA.

Obviously FEMA is going to have an interest to make sure this program is adequately solvent and funded, and obviously they should. They have control of every aspect of this, with no checks and balances in the system. There are going to be millions of people who will pay in to make this solvent, I guess, but it will never need flood insurance.

With that, I wish to say I hope my colleagues who represent these States, when they look at section 107, will see what I see and we can all work together to either take out section 107 completely or get the 30-day extension so we can have time to take it out in the next few days.

Order Of Procedure

Mr. President, I ask unanimous consent that the majority leader be recognized at 4 p.m.

Thank you, Mr. President.

I yield the floor.

Madam President, I wanted to speak about an amendment which I intend to offer once we do get on this Food and Drug Administration Safety and Innovation Act. This is an important amendment. I want to advise my colleagues and all who are listening about it so they can, hopefully, look into it and wind up supporting it.

This is an amendment that Senator Vitter has worked with me on, as well as Senators Franken, Shaheen, Kohl, Tom Udall, Tim Johnson, Klobuchar, Merkley, Sanders, and Sherrod Brown. The amendment has the strong support of many organizations that are focused on the cost of prescription drugs.

Here is a list: AARP, AFL CIO, Walmart, Families USA, Consumer Federation of America, U.S. PIRG, Consumers Union, Center for Medicare Advocacy, AFSME, National Legislative Association on Prescription Drug Prices, the Alliance for Retired Americans, various other companies and organizations--the New Mexico Pharmacy Association strongly supports this legislation.

This amendment addresses the root cause of anticompetitive, anticonsumer settlements that are entered into between brand-name and generic pharmaceutical manufacturing companies. The effect of these settlements they enter into is to delay timely access that consumers would have to generic drugs. This practice is commonly referred to as pay for delay. It costs American consumers and it costs the Federal Government billions of dollars each year in higher drug costs.

According to the Federal Trade Commission, in 2010, pay-for-delay agreements, limiting access to affordable generic drugs, protected $20 billion in sales from brand-name pharmaceutical companies. That was at the expense of consumers who would have been able to pay much less for those same drugs.

Ensuring access to affordable medication is an essential aspect of addressing the growth in health care spending. Prices for brand-name prescription drugs have continued to outpace inflation, and overall spending on prescription drugs has also increased sharply. These statistics are amazing to me. The Kaiser Family Foundation found that in 2008, spending in the United States for prescription drugs was $234.1 billion. That is nearly six times what it was in 1990.

Since generic drugs are, on average, one-fourth of the price of their brand-name alternatives, they can be an important source of affordable prescription drugs for many Americans. But to actually achieve the savings for consumers, those generics have to reach market 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 express purpose of that law was to incentivize early generic drug competition while preserving incentives for pioneer companies to develop innovative new medicines. Instead, the pay-for-delay settlements that our amendment tries to address--these pay-for-delay settlements between brand-name and generic pharmaceutical manufacturers have become commonplace.

These settlements stifle competition. They delay access to generic drugs at significant costs to consumers and to the Federal Government. In these settlements, the first filer generic drug company agrees to delay market entry in exchange for monetary or other rewards. This has the effect of blocking all subsequent generic filers in coming to market.

This is a complicated issue. I would like to take a few minutes to explain how these agreements work under existing law and also how our amendment would solve this problem as we see it.

Under current law, first-to-file generic drug applicants are rewarded with 180 days of market exclusivity. Exclusivity is awarded only to generic companies that are the first to file. It is not available to subsequent filers even if they successfully invalidate a patent and are ready to come to market immediately. So subsequent generic filers can only enter the market after the first generic filer has enjoyed its 180 days of market exclusivity.

So under the pay-for-delay settlements, the first filer generic company essentially parks its exclusivity; that is, it blocks all other generic manufacturers from coming to market until 6 months after the market entry date. This is true regardless of the strength of the patent or the readiness of subsequent generic filers to come to market.

So this means under pay-for-delay settlements, first filer generic companies receive a reward from brand-name companies for delaying market entry, usually a cash reward, a very substantial amount. They also get a reward from the current statute, this 180-day exclusivity period, and brand-name companies get to extend their monopolies beyond what was originally intended under the Hatch-Waxman legislation.

Consumers are left footing the bill and left with no option but to buy the more expensive drugs and to keep buying it, even after the generic should have come to market.

``Pay for delay'' settlements also typically include an agreement that the first-filer generic company can accelerate its entry into the market in the event that a subsequent filer invalidates the patent in question. In such cases, the subsequent filer triggers the first filer's exclusivity. Put simply, there is no incentive for subsequent generic filers to fight to invalidate weak patents and come to market as soon as possible, even when they believe strongly that they would win their case in court. In other words, whereas the original intent of Hatch-Waxman was to reward companies that were the first to file and actually bring their drugs to market, currently the reward goes to the first company to submit the necessary paperwork. Bringing the generic drug to market immediately has become an option that can be negotiated away.

To fix the ``pay for delay'' problem, the law needs to be changed so that first filers who enter into ``pay for delay'' settlements can no longer block generic subsequent filers who successfully challenge patents from entering the market and bringing affordable drugs to consumers. The amendment we are offering provides this solution or this fix in the following three ways:

First of all, the amendment grants the right to share exclusivity to any

generic filer who wins a patent challenge in the district court. This means that if a subsequent filer successfully challenges a patent, even after a first filer has entered into a ``pay for delay'' settlement with a brand-name company, that subsequent filer has a right to share exclusivity with the first filer. This provision provides an incentive for subsequent filers to challenge patents and stimulates competition.

Second, the amendment we are offering maximizes the incentive for all generic challengers to bring products to market at the earliest possible time by holding generic settlers to the deferred entry date agreed to in the settlements they have signed.

Third, our amendment creates more clarity regarding litigation risks by requiring brand-name companies to make a decision to litigate a patent challenge within the 45-day window provided for in the Hatch- Waxman Act. This ``use it or lose it'' provision enhances market certainty by eliminating the option for brand names to litigate patent challenges well after a generic has come to market.

Finally, I think it is important to point out that the amendment we are offering does not interfere with the rights of the parties to settle their patent litigation if they choose to do so.

There have been numerous antitrust experts and consumer groups that have identified the Hatch-Waxman Act's structural flaw--the one I have been describing here--as the source of the ``pay for delay'' problem and have called for a legislative solution. In addition, in 2003 Senator Hatch himself expressed concern that the flaw remained despite an attempt to fix it by including a ``use it or lose it'' provision in the Medicaid Modernization Act of 2003. Senator Hatch emphasized that the law should be changed to reward, and not penalize, generic companies that successfully invalidate a patent and are ready to come to market.

Let me further underscore the need for this amendment with some concrete examples.

I have a chart here that I think will make the point I am trying to make. This table shows three drugs included in ``pay for delay'' settlements. And this is just three; there are many of these settlements entered into each year. The delay to market in years for each of the three drugs--the three drugs are Altace, Lipitor, and Provigil--the delay period the settlements called for in one case is 2 years; in another case 1\1/2\ years; and in the other 6 years. The estimated lost savings to consumers is here.

Let me describe each of these a little bit. The first drug is King Pharmaceutical's Altace. A generic version of Altace was delayed for 2 years at an estimated cost of $637 million to consumers under a ``pay for delay'' settlement. In 2007, Lupin invalidated a patent covering Altace. Lupin could not launch, or bring their generic to market, despite being the party responsible for invalidating the patent and opening the market early. Instead, the first filer, Cobalt, accelerated its entry into the market and benefited from 180 days of exclusivity. Lupin was left with no reward despite the fact that they had been the one that succeeded in the litigation to invalidate the patent.

The second is a cholesterol-lowering drug familiar to most of us. It is the best-selling pharmaceutical drug in the history of the world, Lipitor. According to a 2008 New York Times report, Pfizer and generic manufacturer Randbaxy Laboratories agreed to a settlement delaying generic entry into the market by 20 months. The same report stated that the generic version of the drug was estimated to sell for less than one-third of the cost of the brand-name Lipitor, which had earned $12.7 billion in sales the year before. A letter sent to FDA Director Hamburg last year by some of my colleagues in the Senate indicated that the Federal Government was spending $2.4 billion a year on Lipitor and that a generic version was expected to generate $3.97 billion to $6.7 billion in savings annually.

The final example on the chart here is Provigil, which is a sleep- disorder drug, a generic version of which could have come to market as early as December of 2006. However, due to ``pay for delay'' settlements, a generic version of Provigil just entered the market this year instead of in 2006.

In addition, in October 2011, a subsequent generic filer, Apotex, invalidated a patent covering Provigil. Because the first filers in this case settled their patent litigation with the brand company 6 years prior, Apotex could not begin selling generic Provigil despite its court victory. Even the CEO of Cephalon, which is the brand-name manufacturer of Provigil, is quoted as saying--this is the CEO of the brand-name company--this:

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 tens of millions of dollars in lost savings to consumers. One of the largest of those consumers is the U.S. military. As this chart illustrates, this is an estimate of the effect of this settlement--the so-called ``pay for delay'' settlement--related to Provigil on the Department of Defense. Assuming that a generic version of Provigil would have been released in 2006 with expiration of exclusivity, the DOD would have saved $159 million for this drug accessed by almost half a million soldiers between the years 2006 and 2011. Had our amendment, the Fair Generics Act, been the law--and we have introduced it as a stand-alone bill--had the Fair Generics Act been the law, generic versions of Provigil would very likely have been available 6 years ago. The first filers, knowing that the patent was weak and that subsequent filers could invalidate it and come to market themselves, would have fully prosecuted the patent fight instead of just settling it as they did.

As these examples illustrate, by granting shared exclusivity rights to any generic challenger that wins its patent case or is not sued by the brand company, our amendment will end the ``pay for delay'' problem and move us closer to the original intent of Hatch-Waxman. That original intent was more competition, greater access to affordable drugs, and substantial savings to the U.S. Government and American consumers.

I hope that when we get the opportunity to offer this amendment and consider it on the Senate floor and have a vote on it, my colleagues will support this amendment. It will be a substantial step forward for American consumers and will help us greatly in our effort to reduce the cost of prescription drugs for Americans.

I yield the floor.

Mr. President, I ask unanimous consent that my remarks be placed in the appropriate place in the Record and that I be permitted to finish my remarks.

Mr. President, we find ourselves in the midst of a Presidential election. In years past it might be expected that during a Presidential election, politics would take precedent over policy. That is not right then and it is certainly not right now. Our Nation faces serious problems--immediate problems--and we cannot wait to tackle them until after the election.

We are over $15.7 trillion in debt, and before the end of the year it will be over $16 trillion. We have a Tax Code that is unmanageable and a burden on conscientious taxpayers. If the Congress and the President fail to act, we have a tax increase coming next year that will dwarf any in our Nation's history. We cannot afford to wait another 7 months to get our fiscal house in order, and we need to act now.

President Obama at least claims to understand that we cannot wait to address this fiscal crisis. He remarked recently that the fact this is an election year is not an excuse for inaction. Unfortunately, other than talk, the President and his liberal allies have done nothing to address either our rising debt or the fiscal cliff we are quickly approaching, both of which are significantly hindering our economic recovery and job growth.

Last week President Obama's budget received zero votes in the Senate. For the second year in a row every Republican and every Democrat who voted on the President's budget voted against it. Remarkably, not one Democrat voted for the serious Republican budgets offered by my friend Chairman Paul Ryan, and my friends and colleagues Senators Toomey, Paul, and Lee.

While he talks a big game, President Obama has shown little interest in lighting a meaningful path toward balancing the budget, reforming the Tax Code, and reducing the tax burden on working families and small businesses.

Instead, President Obama seems to have a single-minded focus on his reelection. While he attempts to scare up votes in swing States, Americans across the country are suffering due to President Obama's failed economic policies. The people of Utah and the people across the country are naturally growing restless. They look to Europe and see the consequences of out-of-control spending and taxes. Yet even with the example of Europe, the President and his friends resist meaningful spending cuts at every turn, and his liberal allies have done everything they can to mislead the public about the responsible intentions of Republicans to reduce wasteful government spending.

Just as critical for our economy is the President's failure to do anything to address the tax relief that will expire at the end of this year. If the President allows current tax relief to expire, the result will be at least a $4 trillion tax increase on the American people. We can call this a fiscal cliff; we can call it ``taxmageddon,'' as others have done. Whatever you call it, it will be a disaster for the middle class. It will be a disaster for small businesses that will be the engine of our economic recovery. One thing we hear time and time again from businesses is that uncertainty holds them back from investing, expanding, and hiring. A robust recovery will require permanent progrowth tax policy.

Given the continued jobs recession and weak economic growth, we need those policies now. Economic growth slowed to 2.2 percent last quarter. For 39 consecutive months the unemployment rate has remained above 8 percent, but that only tells part of the story. There are 12.5 million Americans unemployed, and of those more than 5.1 million workers have been looking for work for 27 weeks or more. There are 7.9 million Americans who are working part time for economic reasons, and another 2.4 million have only a marginal attachment to the labor force. Close to 2 million college graduates are unemployed.

Growth slowed to a tepid 2.2-percent rate in the first quarter, and we already saw business cut back investment as business investment spending declined 2.1 percent in the quarter. Yet the President and his Democratic allies seem content even in this environment to sit on the sidelines as ``taxmageddon'' approaches and threatens even greater harm to our economy.

The coming tax increases will be, without any exaggeration, the largest tax increases in American history, and the possibility of these tax increases is creating enormous uncertainty. The so-called business tax extenders expired at the end of 2011. Will there be an R&D tax credit in 2012? Will there be an exception from subpart F for active financing income after 2011? Families and businesses do not know if the 2001 and 2003 tax relief will be extended beyond 2012. That creates tremendous uncertainty for anyone planning on buying a home, saving for college, investing in a new business, or hiring a new worker. Will passthrough organizations be taxed at 35 percent or 39.6 percent? Will dividends be taxed at 15 percent or will dividends be taxed at 39.6 percent, as President Obama has proposed? Will there be a death tax that hits family businesses and farms with a maximum rate of 55 percent, or of 35 percent, or something else? What will happen to the alternative minimum tax? Will it be patched? Will it be reformed? Will it be repealed? Will it be replaced with higher taxes somewhere else?

The President and the Senate Democratic leadership have shown no willingness to answer these questions and provide the certainty our economy craves. The adverse impact of these tax increases on economic growth is unquestioned. But don't take my word for it. It has been reported that Federal Reserve Chairman Ben Bernanke recently discussed with Senate Democrats the significance of ``taxmageddon.''

In short, the coming tax increases will be so large that Chairman Bernanke apparently warned that monetary policy would not be capable of offsetting the resulting decline in economic growth.

Last month the Fed's policy-setting committee repeatedly warned in minutes of their meeting that fiscal uncertainty has negative effects on consumer and business sentiment, on household spending, durable goods, business capital expenditures, and on hiring.

The former Director of President Obama's Office of Management and Budget concluded that what he estimates to be a $500 billion tax increase

would be so large that ``the economy could be thrown back into a recession.''

According to Barclay's Capital, this fiscal cliff could reduce our GDP by 3 percent.

In addition to these looming tax hikes, budget cuts from the sequester that followed from the administration's failure to arrive at a budget are set to hit as well. According to the magazine ``The Economist,'' the Congressional Budget Office has found that the combined effects of the sequester and the expiring tax relief would add up to 3.6 percent of GDP in fiscal year 2013. Federal Reserve Governor Duke has reportedly indicated that the combined impact of the expiring fiscal policies at the end of the year could amount to around 4 percent of the Nation's economy.

No economy can sustain such a hit without being hurled into recession. Yet instead of addressing this fiscal cliff--tax increases that will harm all of America's families--the President seems content to pursue misguided micropolicies that target the so-called rich in the name of so-called fairness.

I wish to make two points about the President's obsession with redistribution of wealth. First, the American people do not care. The American people do not want government bureaucrats in Washington figuring out who gets what. They don't want politicians spreading the wealth around. They don't want self-anointed arbiters of how much income is fair. What they want is the opportunity that comes with economic growth. They don't want a handout. They don't want their industries vilified for engaging in free enterprise. They want a job. And nothing is more fair than giving every American the chance to make something of himself or herself. That requires Washington getting out of the way, not getting more involved.

Second, the American people seem to understand that the President's promise that he will only tax the rich is a sucker's bet. With his health care law, he already repeatedly broke his campaign promise not to raise taxes on families making less than $250,000 a year. The people of Utah, my home State, and the rest of the other States know that the Democrats' thirst for more spending will require much more than taxes on the wealthy. If President Obama and his Democratic allies get their way, all taxpayers are going to be looking at bigger tax bills.

President Clinton was honest on this point recently. He rejected President Obama's politically convenient claim that he would only tax the rich, and called for across-the-board tax increases: This is just me now; I'm not speaking for the White House. I think you could tax me at 100 percent and you wouldn't balance the budget. We are all going to have to contribute to this, and if middle-class people's wages were going up again, and we had some growth in the economy, I don't think they would object to going back to tax rates from when I was President.

There we have it. Tax increases on everybody. President Clinton can claim that he does not speak for the White House, but the American people are not fooled. They see where the President's policies are leading. Our debt and deficits are unsustainable, but the President has shown no inclination to address them through spending reductions.

There is only one other option available to President Obama and it is one that he and his party have shown to be their preferred policy for decades: higher taxes to pay for more spending. Utahns and Americans all over the country know that the failure to address ``taxmageddon'' is a very real threat. We cannot put this discussion off any longer. It is time for our President to lead.

To that end, last week I, along with 40 of my Republican colleagues, sent a letter to our colleague and friend from Nevada, the Democratic leader, asking for him to address this fiscal cliff in short order. Today we received a response. I have to say I am disappointed. While there is a great deal of political posturing about evil millionaires and big corporations as well as repeated attacks on the tea party and the citizens who support its goals of smaller constitutional government, there is no acknowledgment of the fiscal cliff we are fast approaching. This response seems to confirm what we already know: President Obama and his liberal allies would prefer to put off the discussion of this fiscal cliff. They do not want to address ``taxmageddon.'' I am fairly certain their preference would be to get to the other side of the election and then have tax hikes set in not only for their caricatured evil corporations and individuals but for the middle class as well.

But I am confident that the markets and the American people are not going to allow this to happen. We cannot afford to delay action that will prevent ``taxmageddon'' and steer us away from the coming fiscal cliff.

The likelihood of ``taxmageddon'' and the uncertainty it creates is an anchor around our economy. Americans young and old, unemployed and underemployed, want this anchor thrown off now. We cannot wait until next year or even a lameduck session. The economy is slowing, job growth is lagging, and businesses are cutting back investments. The uncertainty caused by ``taxmageddon'' is contributing to the lackluster economic recovery. American families and businesses are not going to invest in the future if the future holds a $310 billion tax increase next year alone. The best thing we can do to jumpstart our economy is to turn the wheel away from the fiscal cliff sooner rather than later.

Mr. President, I yield the floor.

I note the majority leader has appeared on the floor and I believe he has a procedural motion. I yield to him.

Order of Procedure

I would be happy to.

Mr. President, I rise today in support of the Food and Drug Administration Safety and Innovation Act, which is pending before the Senate this week.

This legislation will give the FDA, through five agreements made between the agency and industry, the resources to approve additional drugs and devices every year for their safe and effective use. Without these agreements, the FDA, starting in October, would lack these resources which are necessary to approve new drugs and devices, and they would also lack resources to monitor the safety and efficacy of those drugs already on the market. This would result in a reversal of decades of work modernizing our drug and device approval and safety programs.

I am particularly pleased that for the first time, the generic pharmaceutical industry will provide the agency with $1.5 billion over 5 years for faster product reviews. In fact, the essence of the legislation is that the industry is actually providing resources for the monitoring and for the approval of drugs. Getting generic drugs onto the market sooner will help lower costs for individuals and families as well as for the Federal and State governments.

This measure would also significantly improve FDA's regulatory authority, including its ability to help prevent drug shortages and to partner with the private sector to develop new medications to treat life-threatening diseases that have become resistant to antibiotics, which is a very important measure included within this legislation.

I wish to recognize especially Chairman Harkin and Senator Enzi for their very thoughtful, very deliberative, and extremely important work. They have represented through their committee work the model of what we should be doing here collaboratively and on a bipartisan basis to advance important measures for the American people. Both of them deserve great accolades for their work today. I hope we can follow through and bring their work to conclusion.

I wish to particularly thank both of them, Chairman Harkin and Senator Enzi, for including provisions pertaining to pediatric drugs and devices that I authored along with my colleagues Senator Alexander, Senator Murray, and Senator Roberts, another bipartisan effort to improve the health of children throughout this country.

Until 1997--15 years ago--80 percent of drugs were used off-label to treat children. Doctors were treating children without fully understanding the appropriate dosage requirements or the potential for any dangerous side effects. This frustrated pediatricians and angered many families, but those sentiments were largely ignored by the industry until Congress stepped in.

With the passage of the Best Pharmaceuticals for Children Act in 1997 and the Pediatric Research Equity Act in 2003, 427 drugs have been relabeled with important pediatric information. Now 46 percent, rather than 80 percent, of drugs are being used off-label in children, but that number is still too high. The legislation before the Senate makes critical improvements to these laws so we can further lower this percentage. It would make these two acts--BPCA and PREA--permanent, like the laws that govern the approval of drugs for adults. It would also provide the certainty that the pharmaceutical companies believe is necessary to continue to wisely invest in the appropriate use of drugs in children.

The legislation will also help ensure pediatric studies are planned earlier in the drug development process and completed sooner. Currently, a disappointing 78 percent of studies that were scheduled to be completed by September 2007 are either late or were submitted late. While Congress, the FDA, advocates, and the industry agree that a pediatric study should not hold up the approval for a drug for use in adults, drug companies should not be allowed to get away with submitting unrealistic study plans to the FDA for approval or failing to complete a required study once they are profiting from these drugs on the market.

The legislation that is before us would also require pharmaceutical companies to work with the FDA early in the process of developing these drugs to create a reasonable and sensible plan for studying the products in children. It would also, for the first time, provide FDA with an enforcement tool that will deter companies from neglecting their obligation to complete these studies on time.

Our bill also responds to the need for pediatric medical devices--not just pharmaceuticals, but devices--in children, which can lag 5 to 10 years behind those manufactured for adults. The pediatric profit allowance for Humanitarian Use Devices has proven to be a very effective incentive. Three new devices have been approved for their use in children in the last 3 years. This is an incredible increase as a result of this incentive.

This policy has shown much promise and I am pleased to see it continue in this bill, along with the Pediatric Device Consortia Grant Program, which has assisted the development of 135 proposed pediatric medical devices in just over 2 years.

The Food and Drug Administration Safety and Innovation Act would also extend this Humanitarian Use Device incentive to manufacturers of devices for use in adults with rare conditions. While it is my hope this policy is equally effective in spurring developmental devices for use in adults as it is for children, I am concerned that it could impact the development and the marketing of devices for use in children. I plan to monitor this policy closely should it become law, but I have full expectations that both noble objectives can be achieved.

There are some children, however, who do not receive the full benefits of BPCA and PREA.

I am pleased the Senate bill begins to address this problem for pediatric cancer patients and children with other rare diseases. It calls on the FDA to hold a public meeting to discuss ways to encourage the development of new treatments for this population. Indeed, for some pediatric cancers, the treatment has not changed in many decades. For other rare diseases, an effective treatment has yet to be found. I look forward to receiving a recommendation that might stem from this important meeting, as well as working with my colleagues to respond to their needs with reasonable and sensible policy.

I am truly pleased these pediatric provisions have drawn the support of 24 organizations, including the American Academy of Pediatrics, also including the Pharmaceutical Researchers and Manufacturers of America. I think this stakeholder support is very important not only to the ultimate passage of the legislation, but for its effective implementation.

There is another provision I would like to talk about; that is, this bill contains provisions which would require the FDA to decide whether to update the labeling requirements for tanning beds.

Every day 2 million Americans visit a tanning salon. Seventy percent of these are women. According to the World Health Organization, the risk of deadly melanoma increases by 75 percent when the use of tanning devices begins before the age of 30.

So this is a particular concern with young women beginning to use-- and younger men--beginning to use these tanning devices. Yet the warning labels on tanning beds have not been updated in over three decades and are often placed far from view.

In 2007 my colleague, Senator Isakson of Georgia, joined me in requiring the FDA to study the labeling standards for tanning beds and make recommendations about how these standards could be improved. In its report, the FDA found that tanning bed labels could be clarified and located in a more prominent location. But the agency has yet to act. It is my hope the FDA will heed its own advice and update the labeling requirements for tanning beds.

Similar to the outdated labeling requirements for tanning beds, sunscreen testing and labeling standards have also been over three decades in the making--three decades. Last year I was pleased when the FDA finally took action. However, just last week the agency announced it would be extending the implementation of these new standards by 6 months, until December. Consumers will have to go another summer without knowing whether they are truly protected from the Sun's harmful UVA and UVB rays.

I have filed an amendment to make sure there are no future delays. I look forward to working with my colleagues to see that this amendment is accepted as part of the final FDA legislation which I hope is passed very quickly by the Senate.

I again want to thank Chairman Harkin and Senator Enzi for their extraordinarily effective and collaborative work on the Better Pharmaceuticals and Devices for Children Act, which is included in this bill.

Student Loan Interest Rates

Just for a moment, let me raise another pending issue which is of critical importance. In 40 days, as I think many of us recognize, student borrowing rates for college will double unless we act. We have seen both sides of the aisle--colleagues from both sides--come down and say we cannot let this happen. Well, we cannot let it happen. That means we have to take action to prevent the doubling of interest rates on Stafford loans.

Unfortunately, last week we had a series of budget votes, which most of my Republican colleagues supported, which would have, if they had passed, mandated the doubling of the student loan interest rate. So I think we have to move away from this debate and actually pass legislation which would prevent the doubling of student loans by July 1. I hope we can do it promptly, certainly before July 1.

Also, I hope we find an effective offset. What the Republicans have suggested is using the Prevention Fund. The President made it clear he would veto the legislation if it included that offset. Also, what should be clear that using resources to prevent disease is not only helpful to the American public, but it is also probably one of the most practical ways we are going to be able to begin to bend that very important cost curve going forward.

This Prevention Fund is going to help everyone, but it is going to particularly help middle-income families who are struggling with medical bills, who are struggling to find insurance, the same families who are struggling to pay the cost of college for their children. It makes no sense to me to take from one program that will largely

benefit working families to pay for another program that will benefit working families.

We have an offset which is an egregious tax loophole that allows lobbyists, financiers, et cetera, to create subchapter S corporations to essentially avoid their payroll and Medicare taxes. I think that is an appropriate way to pay for this support for students' education. If there are other ways beyond the prevention fund, I certainly am happy to listen to them. If there are other principled ways to avoid doubling the interest rate for student loans, let's talk about them. Let's get them on the Senate floor and let's debate them.

I yield the floor