Michael Enzi

Mr. ENZI

Mr. ENZI. The heart of the debate is how to construct a regulatory framework so that biologic drugs can be safely available under an accelerated pathway. It is more difficult to approve biosimilars than to approve generic versions of typical drugs. The balance we are trying to find is a compromise that promotes access with innovation, while also maintaining the high standards of safety at the Food and Drug Administration. Biologics are complex molecules modeled after key processes occurring daily within the human body. One analogy is that if a typical drug was a 3 bedroom, 2 bath starter home, a biologic would be a skyscraper. The size, scope and complexity are completely different. The nomenclature is, too. As key scientists stated at our HELP Committee hearing on this topic, these are not generic biologics but biosimilars. With many drugs, we can describe their structure with a high degree of precision--but not with follow-on biologics. You can't make an exact ``copy'' of a biologic, like you can for most typical generic drugs. For example, if I was to try to build the skyscraper of a biologic without the blueprints, as any generic company would need to do to create a follow-on biologic, I would have to ensure that every copy was identical or there could be fatal results. Because of this, science must be an essential part of any safety standard. One piece out of place would cause the entire structure to fall. But to be clear, a safe pathway for an accelerated approval process for biologics, that also preserves innovation, is possible. It is not just me who believes it--the FDA, generic and pharmaceutical industries have all said so as well. I have been working across party lines with Senators Hatch, Kennedy and Clinton to develop legislation that does just that. Our staffs have been working tirelessly on this topic: individually meeting with experts and stakeholders; and as a group, talking with experts from the United States and global leaders. After all, we want the same end result--legislation that ensures medicines are safe and affordable, and that medical innovation continues to flourish. I have a track record of working across party lines to build consensus and find common ground on tricky legislative issues. I know that with a little more time, and through regular order, we will develop a bipartisan package that accomplishes our common goals. I concur with the chairman and am committed to moving a bipartisan bill through the HELP Committee in the near future with the goal that it can be joined with the conference on the FDA Revitalization Act.

Mr. ENZI. Mr. President, I, too, encourage people to get their amendments to us, so we can talk about the amendments. The amendment process is a difficult thing around here because it doesn't allow for some of the tweaks noticed by people who have expertise in that area. If we get to talk about them first, sometimes there can be modifications to them before they are put in. We want to move this along and have some things to vote on at 4 o'clock today. I hope everybody will cooperate on it. I thank Senator Kennedy and his staff and my staff who have been working together with anybody who has an amendment. They were working at 3 and 4 o'clock this morning on different things, trying to get them ironed out so that it would be possible to move the bill forward. Mr. President, what's wrong with limiting exclusivity for blockbuster drugs? It is the exact opposite of what we should do. The whole point of the law is to leverage the large adult market for the benefit of the smaller kids' market. The effect of the cap will be to discourage companies from studying the effects of the most-widely used drugs on kids. Seventy-five percent of the drugs are not being studied under the current incentive. We need more studied, not less. Are not companies only studying blockbuster drugs that make the most money, not the drugs needed most in kids? No. According to a Tufts University study, only about 10 percent of drugs with pediatric exclusivity are blockbusters. GAO says most products obtaining exclusivity have annual sales of less than $200 million. Do companies get to choose the drugs they study? What is to stop companies from ``cherry picking'' to make money, not help kids? No drug is eligible for pediatric exclusivity unless FDA requests, in writing, a pediatric study of the drug. FDA's decision is based on whether more information about safety and efficacy for children is necessary. Doesn't the Duke/JAMA study demonstrate that 6 months of additional exclusivity is a windfall? It's been said that a cynic is someone who knows the cost of everything, and the value of nothing. That applies here. The Duke/JAMA study concluded that the financial benefit of exclusivity for blockbuster drugs often exceeded the cost of the pediatric study. This completely misses the point. This law is not about micromanaging drug company profits. It's about helping kids. In fact, the very last sentence of the study reads: ``Clearly, however, the greatest return of the exclusivity program is the benefit derived in obtaining new information relevant and applicable to the care of children, and this benefit should not be compromised.'' Companies can spend only a few million dollars on a study and get many millions in return. Shouldn't the reward be equal to the amount spent on studies? The incentive is designed to raise the priority of pediatric studies among all the competing research priorities for drug development within companies. Just covering the cost of the studies will not do it--the drug company knows it can put those same dollars into the development of a drug for adults that will earn much higher profits. Incentives work by making pediatric study more attractive than other studies for drug companies. Aren't windfall profits unfair? No. The benefits to kids, and to society in general, from pediatric studies far outweighs the cost. What are workability issues with the exclusivity cap? FDA says the cap has ``serious workability issues.'' It is unclear how FDA will obtain the right type of sale data or how the data's accuracy can be verified. FDA would spend lots of time litigating the validity of exclusivity decisions, and less time making drugs safe for kids. Why shouldn't we restrict excessive drug company profit? The problem is not excessive profits. The problem is that most drugs aren't tested for kids. It is wrong to play the politics of drug pricing at the expense of kids.

Mr. ENZI. Mr. President, I will have a lot more comments on this bill at a later time. In light of the comments by the Senator from North Dakota about the importance of reading the bill, I wasn't sure that I had read the most recent copy of it. I think I have the most recent copy of it now. It is a fascinating 140 pages that is being attached to our 300-page drug safety bill. The reason I am checking it is because in the past we have noticed some strong implications for safety problems with drug importation, and I want to make sure we are not opening the door for even more safety problems. I had hoped that the bill on safety wouldn't have to get into the safety of imported drugs, but I can see that is not the direction we are going. I am more than happy to address it. I am fascinated by the discussion today because the people who normally are talking about free trade are now talking about some restrictions. That would be my side of the aisle. Those who normally rail at any kind of opening of the market to anyplace outside of the United States are the ones who are supporting this bill. It is kind of a reversal of situations. I have heard the Senator from North Dakota talk about the way the Canadian Government is subsidizing the grain in that country and how that gives them an unfair advantage in the United States market and how we have to be sure that doesn't happen. Yes, the Canadian Government subsidizes. Yes, the Canadian Government gives an unfair advantage to their citizens. On drugs, the Canadians do some interesting things, too. They are a very small, limited market compared to the United States. Sometimes in business when you are trying to price things, you say: I could pick up a little bit more in the market if I changed my price a little bit. But I am only willing to go after the fringe in order to do that. That is kind of what has happened in Canada. Canada has made it a little more difficult for the drug companies because they say: We are going to negotiate the price. I love that word ``negotiate.'' Normally that means there is a little give and take on both sides and some advantages that are picked up on both sides in order for the outcome that is derived. In terms of pharmaceuticals, usually ``negotiation'' is the code word for ``price fixing.'' That is what they have done in Canada. They have fixed the price. If you want to be able to sell your drug up there, they will tell you what bid you better come in at and they are willing to have various pharmaceuticals bid against each other for the right to enter that fringe market, a small portion of what is in the United States but a potential customer. If you can cover your costs and pick up a few more sales, perhaps you can increase profits. It is a little accounting trick, but it happens. But they negotiate the price. There are five drugs for heart that do similar things. They make the five drugs for heart bid against each other. That means one or two of them will win the bid. If your doctor prescribed one of the other three in Canada, you are out of luck. The decision by the doctor is taken away because you will get a good price on the pharmaceutical that may not be quite right for you, but it will be cheaper than what you could have gotten. That is not the way we work it in the United States. We try to have competition between all of the different products and hope that brings the price down. There is some positive indication that it does bring the price down. We have the Medicare plan D. When they did the calculations on how much that was going to cost, it was considerably higher than what it actually came in at when there was competition among the providers, who in some cases represent more people than Medicare or Medicaid or the veterans and negotiate prices, but they negotiate realizing that we are forcing them to provide all of the pharmaceuticals, not just one or two out of five. If they are providing a plan, they have to provide for the prescription drugs. When I was doing hearings across Wyoming, I had a little surprise almost at every meeting that I had to explain Medicare Part D. That was somebody saying: I can't get the prescriptions I really want. I was doing all of this promotion before Part D even went into effect. So I knew something was wrong with that kind of a response. It occurred to me that maybe those were veterans. We negotiate the price on drugs for veterans. That means when the Government is doing it, they have to say: You know, I don't think your price is low enough so we are just not going to make that available to our people. Did you know that a whole bunch of veterans are taking prescriptions under plan D because they can't get what they want under veterans? It is an interesting situation. When you negotiate these things, you change some of the dynamics and you do not make everything available. I don't think we in the United States are going to settle for just having some, although if we can tap the cheap one in Canada where they fix the price, that will lend an advantage to people in the United States. I am ready to admit that. I am ready to admit if we didn't have restrictions on ethanol and subsidies in this country, we would bring in a whole bunch of ethanol from Brazil. But we are going to protect the ethanol. Again, it is a different group of people who are talking about that than are talking about drug importation. Let me get back to drug importation because that is important. The Senator from North Dakota several times--in fact, all the time--used to say ``where are all the dead Canadians'' when he was talking about safety. That is what my colleague from North Dakota used to come down to the Senate floor and say when he was talking about importation. He always asked that question. It may have escaped the notice of those of us in this body that he didn't ask that question anywhere in yesterday's debate or today's debate. Why not? Because two summers ago, five people in Hamilton, Ontario, died from taking counterfeit Norvasc. Norvasc is a blood pressure drug taken by millions upon millions of people who rely on it for their health and well-being. Since so many people take it, it is a target for counterfeiters looking to make a quick buck. I know he did say that counterfeiting is going to happen anyway. Probably. It happens in virtually every industry, and there are some countries that actually specialize in it. But imagine opening an opportunity for counterfeiters, an opportunity for them. In the portions of the bill I have gotten through already, I know there are some pretty tight restrictions on who can be an exporter and who can be an importer and how packages will be labeled and all of those sorts of things. It is a marvelous effort to try to tighten it up so that what you buy is what you think you are getting. But how many of us, when the program was to first start, would know what to look for or even who to order from in order to be sure the drugs we are getting are safe? How do you do that? It is a tremendous opportunity for counterfeiters. We already have a problem with counterfeiters. There is no way you can write off the counterfeit argument. I ask unanimous consent that I be able to show some three-dimensional objects on the Senate floor, the same as the Senator from North Dakota.

Mr. ENZI. One of the things we are trying to do is keep the debate on the children's amendment so we can get a conclusion to the children's amendment before time deadlines come up. So if those who wanted to speak on other issues can reserve their time until later, that would be very helpful.

Mr. ENZI. It might be helpful if I explained the provision you are discussing, as my office has received many calls as well and I believe the callers are not informed about this matter. Subtitle B of title II of S. 1028 establishes the Reagan-Udall Foundation for the Food and Drug Administration. That simple purpose of that nonprofit Foundation is to lead collaborations among the FDA, academic research institutions and industry designed to bolster research and development productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make the development of those products more predictable and manageable.

Mr. ENZI. Yes, we took great pains to make certain there would be no conflict with DSHEA. Regarding foods, and dietary supplements are generally regulated as foods, the general directive of the Foundation is to identify holes in the evaluation of food safety and identify ways to address those deficiencies through collaborative research with industry.

Mr. ENZI. I agree with Chairman Kennedy's assessment.

Mr. ENZI. Mr. President, I move to lay that motion on the table. The motion to lay on the table was agreed to.

Mr. ENZI. Mr. President, I rise today in support of this amendment by Senator Allard which would strike a cap on pediatric research incentives for blockbuster drugs with more than $1 billion in annual sales. That sounds like a lot. We are going to quibble here about whether they get 3 months of additional time or 6 months of additional time. They have had 6 months of additional time. Incidentally, this is one time per drug. This is not every time they can come up with a child's use they can extend another 3 months or 6 months; this is one time on any drug, they can get an extension of 6 months. Now we are going to decide that a company that comes up with a really great drug is only going to get 3 months versus 6 months because they make $1 billion in annual sales? Three months' worth would be $250 million in annual sales, and that sounds like a lot, but when you figure out what is profit out of that, it is a much smaller number. I congratulate Senator Dodd for originally coming up with this incentive. He came up with the idea for 6 months, and it worked. You have seen the chart that shows how dramatically there was an increase in the number of drugs that were studied for kids and how proper doses were derived for kids. The Allard amendment ensures that pediatric studies that are essential to our children's health and well-being will continue to take place, that they will continue the same as they have with the same incentives and the same requirements. Under current law, in exchange for performing a pediatric study, a manufacturer can receive an additional 6 months of market exclusivity, one time per drug. This is a powerful incentive to ensure pediatric studies are completed. The substitute amendment we are debating today limits this exclusivity to just 3 months, and I am concerned that this will reduce or limit the number of pediatric studies. Senator Allard's amendment would revert back to current law. If we support and pass the amendment of Senator Allard, we go to current law, so manufacturers can receive the additional 6 months of market exclusivity. Before incentives, there were very few pediatric studies. In the 7 years before Congress authorized incentives, only 11 pediatric studies were completed; 7 years, 11 studies--embarrassing. But at least 132 pediatric studies were completed, and more are ongoing. The current incentive system works. This is not an abstract policy issue. Pediatric drug studies can mean the difference between life and death for our children. For example, initial research indicates that Viagra, which is a blockbuster drug, can work miracles for children with pulmonary fibrosis, a rare and potentially fatal lung disorder. Viagra seems to relax and expand blood vessels in afflicted children's lungs. Incentives spurred Pfizer to perform studies that are now underway and could save approximately 28,000 children who might otherwise die or suffer greatly. Without powerful incentives, such studies might not get done. The Democratic witnesses at the HELP Committee's--the Health, Education, Labor, and Pension Committee--recent hearing agreed that caps are a risky experiment. The number--zero incentives, 11 studies; strong incentives, 132 studies--that speaks for itself. Reducing incentives will certainly reduce the number of pediatric studies. We should not undercut a system that is proven to help kids and then say we are improving the program. I don't think so. I strongly agree we need to do everything we can to make health care more affordable and accessible, but harming a worthwhile program that saves kids' lives is the wrong way to do it. It is wrong to play the politics of drug pricing at the expense of our kids. We should protect these incentives which are proven to work. Again, I congratulate Senator Dodd for coming up with the idea of providing these incentives. I wish to note for the record it was at 6 months that we provided that. I ask that you support the Allard amendment. I yield the floor.

Mr. ENZI. However, there is much more work to be done. This amendment is a good first step on the road to a comprehensive response to food safety. In March 2005, Senator Kennedy and I announced that we were working to develop a comprehensive response on another FDA issue, which is drug safety. The bill on the floor this week is a direct result of that announcement and that pledge to work together. So when I pledge today to work to develop a comprehensive response on food safety, you can have some sense that I do mean that. I want my colleagues to work quickly and diligently to get this amendment to the point where we can accept it. I know we have it scheduled for a vote at the moment, too. Madam President, I yield the floor.

Mr. ENZI. I thank the Senator from Louisiana for his patience on this amendment, and also his understanding that he would work with my staff and the staff of Senator Kennedy to see what can be done to make our drug supply safer. I appreciate that. I also thank him for all the efforts he has made on behalf of the Louisiana turtle farmers, which was a new industry to me--although they have been exporting turtles all over the world for years--for the work he did drafting and putting together a mechanism for eliminating salmonella in turtles so they can be, once again, pets in the United States.

Mr. ENZI

Mr. ENZI. Mr. President, I rise to speak about the Student Loan Accountability and Disclosure Reform Act which I, along with Senators Alexander, Burr, Isakson, Allard and Murkowski, am introducing today. In this era of rising college costs, it is more important than ever to make sure that the colleges, lenders and guaranty agencies that provide loans to help students pay for college operate in a fair, accountable and transparent manner. In fiscal year 2007, the Federal Government, through the Federal Family Education Loan, FFEL, and Direct Loan programs is expected to back and provide $65.9 billion in new loans to students and their parents for attendance at over 6,000 schools. The FFEL program accounts for about 79 percent of new student loan volume. There are approximately 3,200 FFEL lenders. Thirty-five State and private, nonprofit guaranty agencies back the FFEL loans. Overall, the programs are expected to provide financing to 14.3 million students and their families this year. These students and their families are depending upon us to protect them from those individuals who are using the financial loan programs to benefit themselves to the detriment of students. The focus of this bill is to make colleges, lenders and guaranty agencies accountable, by prohibiting lenders and guaranty agencies from offering inducements, and colleges from accepting them, and by requiring disclosures to students, their families and the public. There are a lot of ethical, hard-working financial aid administrators and lenders who have spent their lives helping students go to college. It is a shame that a few bad actors have cast a shadow over the whole student loan industry. However, in light of recent revelations about the behavior of a few college officials and a few lenders, it is clear that we need to take steps to protect students and their families from any actions and arrangements that are not fully disclosed. A key part of this bill is a Code of Conduct for institutions of higher education. It prohibits colleges and their employees with responsibility for student financial aid from receiving anything of value from any lender in exchange for advantages sought by the lender. The prohibition applies not only to gifts and trips, but to compensation for service on advisory boards and consulting contracts. Colleges are prohibited from designating ``preferred lenders.'' However, they may collect information from lenders, at the college's invitation or upon the request of a lender, including interest rates, payment of origination and other fees, discounts, services and terms and conditions of the loans, and the lender's contact information, on a standard electronic template. All templates submitted will be made available to current and prospective students and their families. Colleges will provide students and parents with a guide that enables the students and parents to do their own evaluation of the loan products, benefits, and services offered by the lenders. An annual attestation of college compliance by a high level college official with the Code of Conduct is required. The bill expands prohibitions on guaranty agencies and lenders, including provisions that prohibit the offering of any premiums, payments, prizes, and tuition payments. Guaranty agencies are precluded from performing any services for colleges without compensation. Lenders may not provide information technology equipment at below market value. Both lenders and guaranty agencies are prohibited from sending unsolicited electronic mailings to potential borrowers. Finally, the recent revelations of questionable relationships between colleges and lenders have led to new calls to eliminate any areas of potential conflicts of interest. For this reason, it is time to phase out the ability of colleges to act as lenders in the FFEL program, a provision commonly referred to as ``school-as-lender.'' Higher education is crucial to maintaining America's competitiveness. Education at all levels, including lifelong education opportunities, is vital to ensuring that America retains its competitive edge in the global economy. In this global economy, learning is never over and school is never out. If students and families are to make informed decisions about how to pay for college, they must have clear, accurate, comprehensive information on which to base their decisions. We must help and protect the 14.3 million students and their families who will seek student loans this year to pay for the education they need. Therefore, we must maintain the integrity of the student loan programs. Let's fix the system and restore the confidence of students that they are being treated fairly from the beginning, and through the time they are repaying their loans and realizing their goals. I want to thank Senators Alexander, Burr, Isakson, Allard, and Murkowski for joining me in this effort. Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. ENZI

Mr. ENZI. Mr. President, I rise to speak about the Student Loan Accountability and Disclosure Reform Act which I, along with Senators Alexander, Burr, Isakson, Allard and Murkowski, am introducing today. In this era of rising college costs, it is more important than ever to make sure that the colleges, lenders and guaranty agencies that provide loans to help students pay for college operate in a fair, accountable and transparent manner. In fiscal year 2007, the Federal Government, through the Federal Family Education Loan, FFEL, and Direct Loan programs is expected to back and provide $65.9 billion in new loans to students and their parents for attendance at over 6,000 schools. The FFEL program accounts for about 79 percent of new student loan volume. There are approximately 3,200 FFEL lenders. Thirty-five State and private, nonprofit guaranty agencies back the FFEL loans. Overall, the programs are expected to provide financing to 14.3 million students and their families this year. These students and their families are depending upon us to protect them from those individuals who are using the financial loan programs to benefit themselves to the detriment of students. The focus of this bill is to make colleges, lenders and guaranty agencies accountable, by prohibiting lenders and guaranty agencies from offering inducements, and colleges from accepting them, and by requiring disclosures to students, their families and the public. There are a lot of ethical, hard-working financial aid administrators and lenders who have spent their lives helping students go to college. It is a shame that a few bad actors have cast a shadow over the whole student loan industry. However, in light of recent revelations about the behavior of a few college officials and a few lenders, it is clear that we need to take steps to protect students and their families from any actions and arrangements that are not fully disclosed. A key part of this bill is a Code of Conduct for institutions of higher education. It prohibits colleges and their employees with responsibility for student financial aid from receiving anything of value from any lender in exchange for advantages sought by the lender. The prohibition applies not only to gifts and trips, but to compensation for service on advisory boards and consulting contracts. Colleges are prohibited from designating ``preferred lenders.'' However, they may collect information from lenders, at the college's invitation or upon the request of a lender, including interest rates, payment of origination and other fees, discounts, services and terms and conditions of the loans, and the lender's contact information, on a standard electronic template. All templates submitted will be made available to current and prospective students and their families. Colleges will provide students and parents with a guide that enables the students and parents to do their own evaluation of the loan products, benefits, and services offered by the lenders. An annual attestation of college compliance by a high level college official with the Code of Conduct is required. The bill expands prohibitions on guaranty agencies and lenders, including provisions that prohibit the offering of any premiums, payments, prizes, and tuition payments. Guaranty agencies are precluded from performing any services for colleges without compensation. Lenders may not provide information technology equipment at below market value. Both lenders and guaranty agencies are prohibited from sending unsolicited electronic mailings to potential borrowers. Finally, the recent revelations of questionable relationships between colleges and lenders have led to new calls to eliminate any areas of potential conflicts of interest. For this reason, it is time to phase out the ability of colleges to act as lenders in the FFEL program, a provision commonly referred to as ``school-as-lender.'' Higher education is crucial to maintaining America's competitiveness. Education at all levels, including lifelong education opportunities, is vital to ensuring that America retains its competitive edge in the global economy. In this global economy, learning is never over and school is never out. If students and families are to make informed decisions about how to pay for college, they must have clear, accurate, comprehensive information on which to base their decisions. We must help and protect the 14.3 million students and their families who will seek student loans this year to pay for the education they need. Therefore, we must maintain the integrity of the student loan programs. Let's fix the system and restore the confidence of students that they are being treated fairly from the beginning, and through the time they are repaying their loans and realizing their goals. I want to thank Senators Alexander, Burr, Isakson, Allard, and Murkowski for joining me in this effort. Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. ENZI

Mr. ENZI. Mr. President, I wish to thank the Senator from New Hampshire, Mr. Gregg, for the tremendous effort he put into this bill. He spent years on the committee. He became chairman of the committee. He used those years with the institutional memory and the experience with a great deal of diligence and creativity which he has always used on that committee to provide us with fuller explanations and wording for several of the provisions that are in this bill. I thank him for helping us to perfect those and the diligence he always has on all of the issues we bring up in the committee. I also appreciate the work he has done on Internet safety. This is not something he just developed now. He has been working on it for at least 3 years that I am aware, to make that as safe a system as possible if we ever have to put it into place. I am hoping we will not have to have that full debate at this time and appreciate his submitting it in case we need to have that debate. I also appreciate the explanation he gave on the follow-on biologics. It is a hard thing for people on the committee who have been through a number of hearings to understand. I am sure the public as a whole has an even greater difficulty with it. But it is a whole new phase of medications. By the name, ``biologics,'' it is alive. That makes it a lot more complicated than a set of chemicals that are ground up and put together in a particular order. Even with the chemicals that are ground up and put together in a particular order, if they aren't done quite right, they would not dissolve and people do not get any benefit from them. That is why we are doing the bill. Then we will be working on biologic similars to see if there is some way that that can be done effectively and safely. I thank the Senator for his comments and his tremendous work. I yield the floor.

Mr. ENZI. Madam President, I thank the Senator from Massachusetts for his comments. I'll make a slight addition to what he said. For some, it may not look as if there is a lot of progress being made, but I assure you there is a lot of progress being made. One of the secrets to our committee operation--which used to be one of the most contentious committees in the Senate, and now it works productively on issues such as this to get things done--is that we recognize if somebody brings an amendment to the floor and we have not heard about it before, it creates difficulty. When the amendment is filed, we don't have a real good process for amending an amendment. Technically, we can, but it requires a lot of time and votes. In the meantime, it polarizes people. Instead, we take a look at them, talk about them, and we use the body of knowledge we have gained from a lot of hearings on the issue to show where there could be inconsistencies and problems with the amendment. We get the problems ironed out so the amendment can have a logical chance for inclusion if it adds to what we are doing. That is what is going on as we are speaking. The Kennedy staff and the Enzi staff, and those Senators with amendments are meeting together and working out difficulties. We will accept many of them. Some of them are already in the substitute bill we have. So a lot of progress has already been made on this bill. We want to get the remaining things cleared up. We would like to get it done tonight and tomorrow, if possible. I think we are getting a long way down the list now on problems that people had with it, and we are getting those cleared up in a way that I think both sides can agree on. So that is why this is not quite as controversial as some people might expect or perhaps even want. I thank the Senator from Massachusetts, Mr. Kennedy, for all his cooperation on this and the tremendous effort of all the staff. We need people to come down with amendments, particularly if they have something new that we have not heard about. I yield the floor and suggest the absence of a quorum.

Mr. ENZI. Madam President, I am going to make even briefer remarks than the Senator from Massachusetts did. One of the questions I had been asked over the weekend was: Why hasn't the President already vetoed the supplemental appropriations bill? He promised he would veto the bill because it has all this extra spending in it, with directions on the war from people who really are not even involved in administering the war. Of course, what I found out is the bill has not even been sent to the President yet. He cannot veto a bill until he receives a bill. So to chastise him for not having already vetoed the bill when there is a hold card keeping him from being able to veto the bill I think is unconscionable. Hanging on to that bill and not getting it there so the decisions can be made on it one way or the other just is not right. That is not the way to run the Senate. It is not the way to run the country. And it is not the President's fault if he does not have the bill to make the decision. There can be a lot of debate on what that decision ought to be made and how to carry them out. I am certain the President will veto the bill; he has been very clear on that. There is a differing philosophy on how a war ought to be run. There are a lot of people throwing in the towel. It is kind of hard to win at anything if your opponent knows the point at which you are going to give up. That is where we are in this battle, with the complete direction to give up, to throw in the towel, to say what has been done over there has not done any good, won't do any good, and to keep calling it a civil war. It is not a civil war. It is a religious war that is brewing. There is a tremendous difference. It is a religious war that involves the entire Middle East, not just Iraq. And in preparation, for what the other people in the Middle East have heard said on the Senate floor, armies are gearing up in Saudi Arabia and Syria and Israel and Iran, ready to move into the vacuum that would be caused by a U.S. departure. That will not be the first time there has been a religious war in the world. If we do not step in, it would probably be the first time we had the chance to stop a religious war and did not help. So we could leave, have a regional religious war, and then try to decide what we are going to do about that. Religious wars are not easy things to solve. We have seen that with Kosovo with religious genocide. We got to see what happened in Kosovo. We helped out in Kosovo just as we are helping in Iraq. So, Madam President, I hope we would actually debate the Food and Drug Administration bill, which is what we were set out to do this week. I hope people who have amendments would bring the amendments to the floor.

Mr. ENZI

Mr. ENZI. Madam President, this morning there have been a couple of topics brought up. The bill before us, of course, is the reauthorization of the Food and Drug Administration, several important parts of the Food and Drug Administration, and a new section on drug safety to give the Food and Drug Administration a few more tools for their tool box. So I will stick to that topic instead of addressing the one more recently brought up. I have some very strong feelings on that and some very strong opinions on how America ought to be involved in the war and what the consequences are of us pulling out. However, I want to stick to the topic of the day, which is our pharmaceutical supply. Most Americans who turn to imported drugs do so because of the cost. We need to answer a lot of questions before we open our borders to imported drugs to be sure we don't endanger consumers or jeopardize research or jeopardize the development of new lifesaving products. Senator Dorgan, of course, introduced a bill last year. He made the statement that miracle drugs provide no miracles for those who can't afford them. I don't think there is anybody in this Chamber who couldn't agree more with that statement, but I am sure they would agree that a counterfeit or tainted drug is unsafe at any price. As we consider the issue of drug importation, the safety of our citizens must be our primary concern. As ranking member of the committee charged with public health, it is certainly mine. You will find the focus of the bill that is before us to be on safety. I think everything in the bill leads to safety. I don't want to come up with a countersituation now that might put people at risk. I am reminded we are going to have a little bit of debate on the safety of our food supply--we talked about that a little bit last night--because there is a crisis with pet food, in particular, but even some potential for human consumption, partly because of the pet food, partly because of some other possibilities. There are some kids dying in China because they have melamine in their food. This is a product that is added to food to increase the appearance of protein. If you add that to grains or other things, you can get a higher protein count, and usually the protein count relates to the price you get. The more protein, the higher the price. I was talking to the Senator from Colorado, Mr. Allard, who is a veterinarian, and he was pointing out this morning that if you take a fingernail, that is 100 percent protein. If you take the liver, that is 100 percent protein. One of the differences is if you grind liver up and you put it in food, it is digestible. If you grind a fingernail up and put it in food, it isn't digestible at all. So you are not getting any protein out of it. So kids have died in China who thought they were getting sufficient food, and they weren't. The cause of death was starvation. One of the countries that could be getting drugs to the United States would be China. If they are fooling with our food supply, do you think they would hesitate a minute to fool with our prescription drug supply? It worries me a lot. There is a lot of risk that is involved in this. The Senator from North Dakota held up two bottles. The bottles were identical. One was cheaper in Canada than the same bottle in the United States. In a minute, I will go into how that price difference happens. I could hold up two bottles that would look exactly the same. One would appear to come from Canada, but it might very well come through Canada from Saudi Arabia, have exactly the same packaging, labeling, colors, seals, even the same look of a pill. But one of the things we found out from some of these drugs that have come from other countries through Canada is that they don't work. If you grind them up, they have exactly the same chemicals in them, but it isn't just the chemicals that do it, it is the way they are put together that makes it possible for them to solve a medical problem. If they are put together wrong, they may not even digest. If they don't digest, similar to a fingernail, you don't get the benefit from the drug. If you don't get the benefit from the drug, you shouldn't pay anything for it. In fact, there ought to be some pretty severe action taken against the person or country or company that produced that kind of a drug. We are not able to do that. The Food and Drug Administration is charged with watching our borders and the things that come in to see if the drugs that come into this country are legitimate. There are warehouses full of drugs they have found that are not legitimate. So it is a matter of safety, and we are concentrating on the safety portion of this bill. So I am hoping we will save the drug importation question for a separate debate of its own. We know each one of us takes a risk every time we take a drug, but Americans who buy prescription drugs in Canada and other countries or purchase drugs from Internet pharmacies that operate outside the United States are taking an even greater risk by obtaining their prescription medicine from pharmacies and Internet sites that don't always meet the high standards we require here at home. Here is where my concern lies. We already have a problem with counterfeit and substandard drugs in the United States. Concern about the quickly growing counterfeit market is not limited to the United States. In Europe, dangerous counterfeit drugs are already a problem, and the problem is growing as the European Union expands. In addition, we have little knowledge of the extent of counterfeiting in Asian markets such as India, Pakistan, and China, other than that it may be the best. Now, prior to legalizing an untested, drug importation project on a large scale across our Nation, we must consider any new vulnerabilities in our drug distribution system, especially since those vulnerabilities could be massive in size. I know we all share the same goals. We want to ensure that drugs are safe, effective, and will not compromise the integrity of our Nation's prescription drug supply or our world-leading pharmaceutical research, and we want it to be at the lowest possible cost. Similar to many Americans, I am concerned about the high and rising cost of prescription drugs. However, I doubt the importation of drugs from other countries will solve that problem all by itself. We better be certain about exactly what we are doing and how we are going to do it. We have had some hearings on that. We have also gotten some phone calls from the Canadian Minister in charge of the program who has said: Do you realize that if America suddenly started buying its drugs from Canada, we would have to prohibit Americans from doing it. We are a small country. We could not take the amount of orders we might possibly get because we do have price fixing. We talk about negotiated prices and we talk about that in the context of Medicare drugs. Congress passed and the President implemented Medicare Part D that actually came in considerably lower in cost for drugs for American seniors than what we or the Government Accountability Office had ever anticipated--dramatically lower. Why? Because of competition. How does a country negotiate drug prices? Well, the way Canada did it was they said: If there are five drugs that treat heart problems, we make a bid for one drug against another drug. If there are five heart drugs, they all don't do the same thing. Some doctors would prescribe one and others would prescribe another. But if you are going to negotiate prices, you make the five bid against each other and you pick one or two, and you tell the rest of them they can't sell their drugs there, that the Government would not have any part of it. This eliminates choices. Then there is another little caveat that some of the countries add to that which says: If you don't come in with a low enough price, we are going to give your patent away and you would not get anything for it. We have some real patent issues if we are going to have people investing in the research to get new drugs passed and approved, and we should take a little look at the process that you have to go through to get a drug approved. It is about a $1 billion project to get a drug approved. They don't do that because they are wanting to donate $1 billion; they are doing it because they expect there will be some profit on the other end of selling the drug. Otherwise they wouldn't go through all that research, all the trouble, all the clinical trials, and then turn it over to people for free. They give away quite a few drugs, but that is to people who can't afford them. There is a lot to the fact that we have more pharmaceutical companies developing more drugs than anywhere else. I am pleased that through our committee we found out there are over 650 clinical trials happening right now on various cancer drugs. That is just in the area of cancer: 650 drugs in the pipeline. That is a lot of billions of dollars being spent for us. Every once in awhile somebody mentions the high cost of insurance. That is something else our committee is working on. I think we have some potential for making some good changes there. But one thing I always remind people of is I could get them 1980 insurance prices if they would settle for 1980 treatments. Then they start to realize how many things that have been invented since 1980 that make a difference in our life and in our longevity. I don't know of anybody who wants to settle for pre-1980 treatments, but they are cheaper. In any importation discussion, it is critical we limit imported drugs only to those that have been approved by the FDA. It is important to understand how small differences between drugs can mean big differences in patient health. We are talking about a drug safety bill on the Senate floor this week. We all acknowledge that there are drug safety problems that must be addressed. It makes no sense to open up our borders when we don't have things quite right here at home. Imagine trying to handle the world's drug safety when we are having some problems handling drug safety in the United States. Furthermore, we should not tell companies with whom we must do business how much they have to sell and at what price they have to sell it. Those are mandates I strongly believe will ultimately limit consumer access to drugs. So I look forward to a spirited discussion. I think it will answer some of my questions about the legislation and will hopefully inform us all on the best direction we can take from here. There are possibilities for solutions on drug importation. I hope it will be a separate discussion from how the Food and Drug Administration administers the safety of pharmaceuticals and medical devices and particularly when they concern children. We actually forced the pharmaceutical companies and the medical device companies to pay to have their products tested and reviewed. That is what a big portion of this bill is about: how they will pay for having the products tested and reviewed. That needs to be reauthorized before September, or it expires. That would mean a lot of additional costs on the taxpayer if we don't do those two parts. There is also a portion on that which deals with pharmaceuticals for children. It is important that tests be done with the pharmaceuticals to be sure they are safe for children and in what dosage they are safe for children. There is a portion of the bill which gives incentives to companies that will go to that extra length to see which of the drugs can be used for children as well. That is another potential for a fascinating discussion over the next couple of days. I compliment the Members who have been working on that. Many are on the HELP Committee and have been looking into this with as much depth and detail as I have seen on any bill we have ever done. I have also seen as much cooperation between both sides of the aisle as I have seen on any bill we have done--working together to find a way to take care of the concerns and make sure we are improving the safety but also making it possible for people to get the pharmaceuticals and get them as quickly as possible. It doesn't do any good to have a miracle drug and not be able to get it on the market. It doesn't help to have a miracle drug with some problems and, because FDA doesn't have the tools to change some of those problems, they have to pull it off the market and take it away from some people who really rely on that drug. That is what this bill does essentially. I think in the substitute, or managers' amendment, that will be coming out, many of the difficulties people have will have been worked out. People are working on them as we speak. That is why the managers' amendment has not been laid down. It has been vetted with all Members who are interested and working on this, and there has been incredible cooperation. I hope people will continue to work with us. I do not want anybody to think this bill is a complete answer to safety. It doesn't cover some topics. That is because we are still working on some topics that are not developed to a point yet where they can be done. One is this drug importation. It is being looked at, hearings are being held, and we are trying to find out some way prices can be lowered in the United States. Another problem is biosimilars. There is a whole new area of drugs that has come out because the genome has been unlocked and proteins can be developed which can be used as medication which will solve some of those genetic problems. Those are called biologics. There are people who would like them to become generics right away because that would bring the cost down. Again, we want to make sure we have a bill that takes care of the safety of the biosimilars, to be sure they truly are similar and will have the same effect. The Europeans have been working on that for a while. We have looked at their model and a number of Senators--again from both sides of the aisle--have been working on that problem. Senator Clinton and Senator Hatch have been very involved in that, providing guidance from both sides of the aisle. We appreciate their efforts on it. I do not expect that to be a part of this bill. There are a number of tobacco issues, and our committee has a lot of concern on that. There are some bills which would provide a different way of doing that--maybe put the regulation of tobacco under the jurisdiction of the FDA. I hope that will not be a part of this bill. That is not ready yet, either. We have a lot of parts that are ready, and particularly the user fees need to be done before a deadline that is coming up. I really appreciate the cooperation we are having in making sure we can meet the deadline and have an FDA that is even more responsive and has more tools in their toolbox to make sure the drugs out there are safe and that there is a system for making sure safety is maintained and if there is a problem, that it can be corrected with some of the new tools in the toolbox. I thank everybody for their cooperation and patience. I yield the floor.

Mr. ENZI

Mr. ENZI. Mr. President, I rise at this moment to support the substitute that has been put into S. 1082, the Food and Drug Administration Revitalization Act. I have said a lot about this important bill, and I do intend to say more. The most important thing I can say right now is this is the product of a lot of bipartisan work by members of the Senate Committee on Health, Education, Labor, and Pensions. We have a great process that wound up with a work in progress, which wound up with this substitute bill. Now we do have one major outstanding issue to figure out; that is, the direct consumer advertising for prescription drugs. I do believe we will work something out, but we are not quite there yet. So I would ask my colleagues' indulgence to work that out, and I hope I have the assurance of the chairman that we will engage in a serious dialog about the various provisions that are included in that direct consumer issue. That will be a real key to finishing up. I congratulate the Senator from Massachusetts, Mr. Kennedy, for the outstanding way he and his staff have worked with all the Members on our side of the aisle to clear up. As he said, in some cases, clarifications were needed, and in some cases it was the expansion of wording; in some cases, a reduction in wording. But, at any rate, we got it to where I think both sides understand and agree on many of the issues that are included. I hope we can have other amendments brought to the floor so we can debate them and get them worked out. Of course, it would be nice if any Senator thinking about offering an amendment would share their idea with us prior to filing it. We might be able to save some time that way and make sure debate flows in an orderly process. We are trying to keep the bill to relevant amendments.

Mr. ENZI

Mr. ENZI. I thank particularly Secretary Leavitt and those people on his staff. We had discussions over the weekend. They had some suggestions for changes. We asked for more detail on those changes. We also asked for them to be prioritized. I was pleased they were delivered within a matter of a very short period of time. That shows people in Government can work together and that they do work on the weekends to get these things done. A lot of people think when we go into recess for a weekend, all work around here stops. But there are dedicated staff who put their best effort into getting together and working together, sometimes in very tense situations and long hours, mostly through the night--last night. Then they have to draft what has actually been decided. It is a very difficult process. We owe them a great deal of credit. I want the American people to know that, too. I yield the floor.

Mr. ENZI. Madam President, I wish to thank the Senator from Massachusetts, Senator Kennedy, for his outstanding presentation on what is in the bill. I rise to speak about S. 1082 as well. It is a comprehensive bill to enhance drug safety and provide key resources to the Food and Drug Administration--the FDA--for the review of new drugs, for the review of medical devices, and to ensure that drugs and devices for children are safe and effective. It has been a long and careful road for this bill. The Senate Committee on Health, Education, Labor and Pensions embarked on a top-to-bottom review of the FDA's drug safety and approval process over 2 years ago. This bill is the culmination of our review and the input of hundreds of stakeholders. I wish to speak for a few minutes discussing why the drug safety components and the changes that are being made are so critical to restoring the peace of mind to Americans who want to be assured the drugs they purchase to address illnesses and chronic medical conditions can be relied on and trusted. ``Bipartisan'' is a word that is kind of thrown around in this Chamber a lot, and sometimes it means that one person from one party joins several people from the other party. For Senator Kennedy and me, bipartisan means you actually work together to find out what the problem is, what the potential solutions are, and how you can meet those needs. I mentioned it has been a long process--over 2 years--and it is still a work in progress--and we are making progress. We held hearings on the FDA. A lot of those hearings were held in the heat of the moment, when certain drugs were having problems, and we recognize that is a problem. One of the problems with Congress is we usually see that if it is worth reacting to, it is worth overreacting to. We have always taken a very careful view in our committee to make sure that was not the case. Other committees held hearings on the FDA, even though the FDA is under the jurisdiction of our committee, and we have no problem with that. We have taken the suggestions we have gotten through those hearings and considered them for this legislation. Then we drew up a list of principles, and we took that to the stakeholders to see what all the people involved thought about the principles we had. Then we did the tough part. We drafted the details. It is easy to sell concepts, but details are tough. Until you have those details put down in writing and have people look at every word that is in them, you can't tell whether you have a bill. But we went through that process. We took it back to the stakeholders. We redrafted. We filed the bill. We had more hearings. This year, we have had more hearings on FDA, and we have had a markup. That is when all the Committee Members are offered a chance to request or suggest amendments to the bill. We probably had about 50 amendments and we worked on the 12 major categories of amendments. Some of those were worked into the bill as part of the markup. Some of them have been put into the manager's amendment. I mentioned this is a work in progress. We are still looking at some of those, figuring out what is needed and how to get there. I appreciate the cooperation we have had from the Members with their suggestions and the staffs of the Members with their suggestions, because throughout the last weekend, there were hours and hours and hours spent by Senator Kennedy's staff and my staff and the interested Senators and their staffs to arrive at the best possible solution. We are not there yet. We are close. That is the way we work on bills--a long process with decisions being made up to the last possible moment so that we can have the best possible solution for the people of this country. That is bipartisan. It was mentioned there have been some hearings on food safety. Recently, there has been some real criticism of the FDA on food safety. We held hearings on food safety. I don't want the people of this country to think it is all bad. In fact, I was amazed that three Federal agencies have to work together on a food problem. The CDC, the Department of Agriculture, and the Food and Drug Administration have to work together because each of them has a role in discovering whether there is a problem. I was amazed to find out that with as few as 50 cases spread out across the whole United States, they can diagnose and determine there is a problem and get products off the market. If you are not amazed with that, you are not paying attention. We have agencies that work together, and they work together in critical times to solve problems for the people of America. They can notice, with a real small sampling--when you consider the millions of people in this country, the millions of people who are being fed every day,--they can recognize a problem with the food supply and get the harmful product off the market. It would be nice if they could prevent that. They are working on that. But when you consider the number of producers in this country and other countries, they have a tremendous job, and we have to be sure they have the tools to do that job as well. But that is a job that is in addition to the drug approvals. This bill concentrates on the drug approvals. Vioxx was one of the triggers of these discussions. As we saw with Vioxx, the FDA doesn't have enough tools to deal with newly identified risks when those risks become evident after a drug has been on the market for some time. Most of the FDA's current authority is based on information and plans available at the time of approval. They have a massive job determining if a drug is ready to go to market. What is amazing is that once they have given that approval, their options are very limited. Now, that creates a little bit of a dilemma for them. They don't know everything that will happen with that drug. Yes, it has been through clinical trials. What is a clinical trial? It is a controlled study of people taking the drug, and sometimes people who are not taking the drug--a controlled study. Once that drug is approved, it goes out to the whole market--not controlled people, not people that we know what other drugs they are taking or what other kinds of things they are doing. That can have a different result than under a controlled situation. The FDA's choice has been to take the information and approve the drug and then monitor the drug, but have relatively few tools after that point. What can be the result of that? The FDA can say let's really be careful before we approve this because we will have expended our toolbox. They have said: If you will give us a bigger toolbox for after the approval, we can approve the drugs quicker. We can have some assurance that because of the controlled study things will be fine. But we won't have to worry quite as much about preapproval because we will have tools after approval--tools for quick recognition of additional problems as it goes out to the major markets. We need to have that happen if we are going to have safe drugs in this country. We have always relied on that, and we expect that. The FDA, for the most part, has delivered. So much more needs to be done to clarify the FDA's authority, to give them the bigger toolbox so that FDA can proactively react to additional safety information whenever that safety information is discovered. That is the purpose of this underlying legislation. The FDA does have some authority to manage the risks of drugs--for drugs such as novel cancer therapies approved under subpart H for accelerated approval. Is that faster approval? The FDA has the authority to apply restrictions on distribution and use for those drugs at the time of approval to provide further safeguards against misuse and adverse reactions. However, if such a risk is determined after the drug is on the market, the only option FDA has now is to pull the drug from the market, disrupting patient care. Some of the people who have that drug are deriving a tremendous benefit from it and are not having the adverse reaction and would feel hurt if it is pulled away from them as the only option that the FDA has. The FDA does not want to disrupt patient care. The FDA just wants to protect patients. Those who need the protection they want to help; those who don't need the protection ought to be able to get the continuing patient care. The option now, I repeat, is to pull the drug from everybody. Then, of course, they can put it back on the market so it can apply those special risk management tools. We have chosen to give the FDA in this bill the authority to impose those restrictions after a drug comes on the market, too, so there is no disruption in patient care. The bill also makes several key improvements to how patients get their information through advertising and labeling. The changes ensure that patients get access to new and changing information in a timely manner. As Vioxx made clear, FDA has very little authority to require labeling changes postmarket. Those changes are primarily negotiated and they don't have any time limits on the two parties coming to agreement to the labeling change. Now, we have included provisions that ensure that those discussions between the FDA and a drug manufacturer come to a close, rather than relying on the FDA's ``nuclear option,'' which is pulling the drug from the market. It hurts a lot of patients and disrupts their care. Imagine a system that gives the FDA, through sound science and remarkable innovation, the tools to get drugs to the market quickly and efficiently, especially when lives are on the line and people need new drugs and therapies. Imagine a system that gives the FDA new authority to take swift, appropriate, and decisive action to ensure patient safety and protect consumers when new information comes to light to expose unexpected risks. We can make this a reality with the passage of this bill. FDA doesn't have a current mechanism for active, routine surveillance of potential safety problems. Thus, it cannot as readily detect safety problems after a drug has been put on the market--short of a catastrophe. FDA has minimal authority to require additional observational studies or clinical trials after the product is already on the market. FDA cannot even make companies finish studies they have agreed to pursue concerning safety impacts on patients. Given the current FDA limitations, I strongly felt it was necessary to correct those problems and ensure that FDA has the right tools and toolbox to address drug safety after the drug is on the market. That is why this bill creates the risk evaluation and mitigation strategy, or REMS. The REMS gives FDA a full toolbox of options for dealing with potential safety problems, even if they are discovered after a drug is first marketed. I hope you are noticing a trend. With this new toolbox, FDA has the ability to identify side effects after the drug is marketed through active surveillance. FDA also has the authority to request a separate study or clinical trial to learn more about a particular potential safety problem. FDA can also obtain timely label changes for the first time under the new REMS system. How does this all work together? A house cannot be built without a foundation. Routine, active safety monitoring using large linked databases--what I like to call ``health IT for drug safety''--is the foundation. Risk evaluation and mitigation strategy, or REMS, is the house. I thank the Senator from New Hampshire, Mr. Gregg, for all of his work on health IT for drug safety and his emphasis on being able to have the right surveillance and the right triggers to be able to put these things into place at an appropriate time. In designing that house, you can have a small, simple house, or you can have a big fancy house. The size and complexity of your house should match your needs. The REMS is customizable, buildable to address whatever risks are present for the drug in question. The REMS allows you to build an addition for your house if your family grows, for example. You can also move into a smaller home if you find you don't need so much space. Let's talk about how this would work. Let's say drug A treats high blood pressure, has very few side effects. Therefore, the label and use of routine, active safety monitoring will be enough to manage the risk. Drug A doesn't need a REMS. However, drug B, which also treats high blood pressure, has serious side effects, including occasional liver failure. The label and use of routine, active safety monitoring is not enough to manage the risk. Therefore, drug B needs REMS. The REMS will include extra warnings on the label, perhaps periodic letters to doctors to remind them of the risks, and require testing and a system to test patients for liver enzyme levels before they are allowed to fill a prescription. As I said, not every drug needs a REMS. However, every drug will need a very active FDA with all of the necessary tools to identify and quickly manage additional risks. Like everyone else, when I purchase a product for myself, my children, or my grandchildren, I want the assurance that the product is safe and beneficial. This bill gives the FDA the necessary resources and tools so that moms and dads are able to trust that product at the pharmacy counter and know that it is safe and effective. As I mentioned, this bill is still a work in progress. There are a dozen amendments, several of which have been in the managers' amendment, and several are still being worked on. We do want faster drug approval, but we want assurances that as the whole population becomes a clinical trial, connections can be made quickly to any problems without the need to pull the drug off the market and away from those who could benefit. I will have more to say about other potential things that will not be in this bill that I think would complicate the bill or maybe be adverse to what we are trying to do in the bill, and some of them that have not had enough study yet. I will comment on those as they come up, if they come up. At this point, I yield the floor.

Mr. ENZI

Mr. ENZI. I also request unanimous consent, on behalf of one of my staff members, to have the privilege of the floor during discussion on this important bill. That will be David Schmickel.

Mr. ENZI

Mr. ENZI. Mr. President, I would like to speak about community spirit. In the Senate, we work day in and day out to pass good policy that will provide for the safety, security, and health of the Nation, but we are not alone in our effort to make our country better. In fact, we are but a small part. There are great events taking place every day in our country that are examples of neighbor helping neighbor, people who do not wait and do not ask for help but take it upon themselves to act. I would like to tell you about one such example that has been going on for years in Wyoming right in the small community I call home. When people think about my hometown of Gillette, WY, many images come to mind--sagebrush as far as the eye can see, coal trucks, and cattle herds. We have deer, antelope, and some buffalo in the neighboring community of Wright. Our kids are great basketball players, and we work hard to get the methane gas and minerals that power this country. The list goes on. But after living in Gillette for more than three decades, what stands out about home are the people themselves, their character, their sense of community, and how they come together to help each other. And then there is the crawfish. Yes, I said crawfish. This week, Gillette will be kicking off a 24-year tradition of flying in 10,000 pounds of crawfish for the annual Crawfish Boil. The event raises money for local families with medical hardships and was started in 1983 by the Society of Petroleum Engineers. The event raised $117,000 last year to help people get medical treatment. This weekend we hope to top that number. Wyoming may be small in population, but our families know how to help each other out more than any other State in the Nation. Wyomingites do not just rely on government for help--they talk to neighbors, they come up with a good idea, they organize, and they follow through. The crawfish feed is an example for the Nation on how to pull yourself and your neighbor up by the bootstraps and have fun doing it. Gillette not only raised $117,000 at last year's Crawfish Boil, the Festival of Trees raised $51,500 for hospice and lifeline services, the Chili Cook-Off raised $28,800 for the Council of Community Services, the Black Cat Ball raised $26,000 for the Hospice Hospitality House, the Chuckles for Charity event raised $24,000 for the Gillette Area Refuge, and the Rotary Ball raised $40,000 for education and other programs in Gillette. Mr. President, $287,000 in 1 year, in one community with roughly 25,000 residents. I could not think of a better place to call home.

Mr. ENZI

Mr. ENZI. Mr. President, I wish to speak about the importance of supporting and passing the America COMPETES Act. It has been 50 years since Sputnik was launched by the Soviet Union. The United States was quick to react with a flurry of activity and investment to spur innovation. Its launch also had a dramatic impact on education in this country. Students wanted to be the best and wanted to prove that the United States was a better and stronger country. Today the need is just as great, but we don't have a catalyst, like Sputnik, driving the need. The need is driven by our economy and companies that need bright and innovative workers. This need is driven by the competition the United States now faces from across the globe. Last year I was in India and saw firsthand what Thomas Friedman discusses in his book, ``The World is Flat''. It does not take long to figure out that by numbers alone, India has to educate only 25 percent of its population to have more literate and educated people than the total population of the United States. This trip reinforced my belief that we need to ramp up our efforts in the areas of education and labor to keep our country competitive. Add to this perspective the fact that China has 20 percent of the world's population and has sharply increased the proportion of its college-age population participating in higher education from 1.4 percent to over 20 percent in just a generation. It should not be surprising that a substantial portion of our workforce now finds itself in direct competition for jobs with highly motivated and often well- educated people from around the world. Unless we pay attention to these facts, this competition will only increase in the future. Here are a few of the facts that I find paint a compelling picture and show why this legislation is needed: Business is spending billions each year to train new employees and remediate the educational skill gaps of those already in the workforce. The American workforce is aging--77 million baby boomers are set to retire over the next several decades. Reading proficiency among 12th graders has declined to the point where just over one-third of them are even considered proficient readers. In addition, 47 percent of those with a college degree are not considered proficient readers according to the most recent National Assessment of Adult Literacy. Only 68 of every 100 ninth grade students graduate ``on time,'' in other words, within 4 years. America's high school graduation rate is among the lowest in the industrialized world, and the impact on our minority students has been especially severe, where this rate hovers around 50 percent. Nearly one-third of entering college freshmen need at least one remedial course. The United States has one of the highest college enrollment rates, but a college completion rate average to below average among developed countries in the world. Four out of every five jobs will require postsecondary education or the equivalent, yet only 52 percent of Americans over the age of 25 have achieved this level of education. Seventy-five percent of today's workforce will need to be retrained just to keep their current jobs. Median earnings of a high school graduate are 43 percent higher than those of a nongraduate and those of a college graduate are 62 percent higher than those of a high school graduate. Two-thirds of the 7 million worker gap in 2010 will be a skilled worker shortage. If our students and workers are to have the best chance to succeed in life and employers to remain competitive, we must ensure that everyone has the opportunity to achieve academically and obtain the skills they need to succeed, regardless of their background. To accomplish this, we need to build, strengthen, and maintain our educational pipeline, beginning in elementary school. We must also strengthen programs that encourage and enable citizens of all ages to enroll in postsecondary education institutions and obtain or improve their knowledge and skills. The decisions we make about education and workforce development will have a dramatic impact on the economy and our society for generations to come. This legislation is the product of bipartisan negotiations and input from members of 3 Senate committees--the Senate Commerce, Energy, and HELP Committees. Work on this legislation began last year in response to the ``Rising Above the Gathering Storm'' report, the ``Innovate America'' report, and the President's American Competitiveness Initiative. I want to thank all those who worked on this bill for their hard work and dedication and commend them for the collegial manner in which this bill was crafted. This bill includes provisions that improve math, science, and critical foreign language education in our Nation from elementary school through graduate school. It supports improvements to teacher preparation, establishes stronger links between graduate schools and employers, provides funding to support students trained at the doctoral level in science, technology, engineering, and mathematics, and enhances Federal programs that support students in graduate school. It should come as no surprise that I particularly support the education components of this bill. Education at all levels, including lifelong learning opportunities, is vital to ensuring that America retains its competitive edge in the global economy. In this global economy, learning is never over and school is never out. Every American can and should be part of our Nation's success. The education and skills of today and tomorrow's workforce were a high priority for me even before I became chairman and now the lead Republican of the Health, Education, Labor, and Pensions Committee. The America COMPETES Act is a good starting point, but we need to do more. Maintaining America's competitiveness requires that all students have the opportunity to continue to build their knowledge and skills. We need to find ways to encourage high school students to stay in school and prepare for and enter high-skill fields such as math, science, engineering, health, technology, and critical foreign languages. For many, including those at the cutting-edge of science, technology, engineering, and mathematics, acquiring a postsecondary education or training will be the key to their success. Therefore, I remain committed to reauthorizing the Higher Education Act. Individuals in the workforce often need retraining to keep up with our fast-paced economy. Businesses also need help in finding well- qualified individuals to meet their needs. The Workforce Investment Act and the system created to support it provide those needed services. We must reauthorize the Workforce Investment Act this Congress. Finally, our children need a strong foundation of knowledge to succeed in both education and knowledge. The No Child Left Behind Act provides funds to States and local school districts to support our neediest and most disadvantaged students. Those students need a hand up in order to succeed in the future. I look forward to working with Chairman Kennedy to reauthorize the No Child Left Behind Act this year. Fifty years after Sputnik, the United States is in another equally important race that will define our leadership. This race is fueled by innovation, education, and skills. Its success is measured by jobs and prosperity for American families. It is a race we cannot afford to lose. I ask my colleagues to support the passage of the America COMPETES Act.

Mr. ENZI

Mr. ENZI. Mr. President, today I wish to speak in opposition to the bill currently before the Senate. First I would like to briefly review the status of the new Medicare law that Congress passed in November of 2003. That landmark legislation enacted the first major benefit expansion of the program since 1965 and placed increased emphasis on the private sector to deliver and manage benefits. It created a new voluntary outpatient prescription drug benefit to be administered by private entities. The legislation also expanded covered preventive services and created a specific process for overall program review if general revenue spending exceeded a specified threshold. I am pleased to be able to report that this new program is working. All across the country, seniors are expressing their approval of the new benefit. In my State of Wyoming, the new Part D prescription drug benefit has been a huge success. Last year, I traveled around Wyoming and visited with seniors in Cheyenne, Douglas, Sheridan, Casper, Powell, and Rock Springs. I talked to folks all over the State and told them about the new program as I encouraged them to sign up for it. I also talked to a few of the pharmacists in Wyoming that worked so hard to make this program a success. I believe I can speak on behalf of many of my colleagues in saying thank you to the thousands of pharmacists throughout the country that did so much to implement this great program. Today, about 89 percent of Wyoming seniors are receiving prescription drug coverage, an increase of 16 percent from last year. They remember what it used to be like when they tried to get their prescription medications and they don't want to go back. I have received hundreds of calls and letters from Wyoming seniors who like the way things are and don't want Congress interfering with their prescription drug plan because it is working for them. Five separate surveys show that more than 75 percent of all beneficiaries are satisfied with the way the program works. Not only are about 90 percent of seniors now receiving prescription drugs, the program is costing less than originally expected. When is the last time a government program cost less than was estimated? I came to Washington in 1997, 10 years ago, and I don't know that I have ever seen a government program that spent less money than we expected. Private competition is working better than we envisioned and it is saving seniors and the government more and more money every day. Why should we change that? For some reason my colleagues on the other side of the aisle have decided they need to ``fix'' a program that isn't broken. We have implemented a plan that is working and before we change it, we need to be sure about what we are doing and the effect it will have on the program and the impact it will ultimately have on seniors from coast to coast. The bill now before the Senate would strike the noninterference clause from the Medicare law. The ``noninterference'' language in the Medicare law prevents the Federal Government from fixing prices on Medicare drugs or placing nationwide limits on the drugs that will be available to seniors and the disabled. I support this language 100 percent. Decisions on what drugs should be available should be made by seniors and their doctors, not by some central committee in Washington. Under the Medicare Part D law, each prescription drug plan has its own list of preferred drugs. Each plan's list is different--some are broader, some are narrower. Each list, however, has at least two drugs from each therapeutic class of medications and everyone can find a plan that is advantageous to them. The ``noninterference'' bill before us is not only unnecessary, but it could also prove to be harmful to the health of our nation's seniors. The ``noninterference'' language protects seniors and the disabled from having the government decide which drugs their doctors can prescribe. It maintains the sacred relationships that seniors have with their doctors, who know best about what particular drugs are right for their patients. Patients support this language, and they want us to maintain it. I would like to repeat, we have already implemented a plan that is working. Yet the majority party wants to ``fix'' the Medicare drug benefit. It is ironic to me that they use the word ``fix''--fix is exactly what this bill will lead to, the government ``fixing'' prices on drugs. It is not a bill about negotiating prices; it is a bill about fixing prices. As most Americans know, the Government doesn't negotiate in the Medicare program. It sets the prices that the Government will pay doctors and hospitals for serving seniors. Setting the price is the same as price controls. And we saw what happened in the 1970s when we tried to control the price of gasoline. Do you remember the long lines at the gas pumps? Trying to control the price of gasoline was a complete disaster. Let's not experiment with giving government the ability to control the prices of prescription drugs. Despite what some folks are reporting, the nonpartisan Congressional Budget Office has said over and over again that removing this language would not save the Government or seniors any money. It wouldn't save money because the Medicare prescription drug plans will have strong incentives to negotiate drug price discounts that would be as low--or lower--than anything the Government could negotiate. Additionally, many plans represent more people than Medicare, Medicaid, or the Veterans Administration, so the plans have greater purchasing power than the Government. To effectively negotiate, you need competing products, or you have to be willing to do without one of the products on which you are negotiating. How many times does the Congressional Budget Office have to say that this bill will not save the Government any money before it starts to sink in? When will my friends on the other side of the aisle acknowledge that this bill will not save any money? We do, however, know of something that will save the Federal Government and seniors money--competition among private plans. What has been proven to reduce costs--especially for seniors with low incomes-- is the new Medicare drug benefit that we passed in 2003. The competition among private plans is driving the cost of the program down. The average monthly premium has dropped by 42 percent, from an estimated $38 to $22--and there is a plan available in every state for less than $20 a month. So let me suggest letting competition work to drive the prices even lower instead of instituting government price controls that have failed in the past. Also, because the program has choice, if the price of one plan goes up, beneficiaries can switch plans. It is important to remember that sometimes the prices will go up, because medical costs will go up as long as new technologies are invented that allow people to live longer, healthier lives. Democrats want to change Part D to resemble the drug benefit program of the Veterans Administration. In the VA system, the Government sets a price on a drug it can get at the cheapest rate and limits or restricts access to those it can not get at cheap rates. As a result, the VA benefit excludes three out of four drugs available through Part D. Changing the Medicare Program to be as restrictive as the VA system is completely illogical. Another thing about the VA system is that it can take a long time for new drugs to be included on the formulary--sometimes as long as 3 years. Let me repeat that. It can take as long as 3 years for new, life-saving drugs to be included on the VA formulary. Lastly, the VA owns the whole system, so you have to order your drugs from them or you have to fill your prescriptions at one of 350 government-run facilities nationwide. In contrast, seniors signing up for a Medicare prescription drug plan can choose their plan based on the pharmacy they want to use to fill their prescriptions. As a result of all of these things, more than 1 million retired veterans have signed up for Medicare in the last year. I talked to many veterans in Wyoming and they all told me that they signed up for Medicare Part D so they could finally get the drugs they needed that they couldn't get from the VA. Unfortunately, my colleagues on the other side of the aisle want to make the Medicare Program more like the VA program. They want to take away a senior's ability to choose. The real thing we should be talking about is how we can change the VA program to be more like Medicare Part D. The mark also contains a few other provisions relating to the comparative effectiveness of prescription drugs--a study that determines whether drug A is better than drug B at treating a disease. The mark also contains a provision authorizing consideration of comparative clinical effectiveness studies in developing and reviewing formularies under the Medicare prescription drug program. No surprise here, but the Congressional Budget Office stated no savings will result because of this section. This is the first step of a dance the Democrats want to do called ``cutting in on the relationship between doctors and patients.'' Decisions about what drugs patients should take should be made by doctors and patients. I think we should keep the Government out of the exam room. To close, I would just like to remind folks of a few key points: (1) The Medicare Program is working. More seniors are getting the drugs they need at lower costs. (2) The bill before the Senate tries to ``fix'' something that isn't broken. (3) This bill will take away the choices seniors have about the drugs they use. (4) The Congressional Budget Office has stated several times that this bill will not produce any savings. (5) The bill tries to make the Medicare Program more like the Veterans program, but the Veterans program has fewer choices than the Medicare Program)--that is why over one million veterans have signed up for the Medicare Program. We don't need meddling for the sake of meddling or a new system conjured up for political convenience. Let's stop wasting the time of this important body and move to a bill that can actually do some good for the American people. Mr. President, I yield the floor.

Mr. ENZI

Mr. ENZI. Mr. President, today I commend the University of Wyoming Cowgirls on winning the 2007 Women's National Invitation Tournament. On March 31, 2007, the University of Wyoming women's basketball team won this exciting national tournament by defeating the University of Wisconsin team by a score of 72-56. They made it to the final by defeating Kansas State in triple overtime. This historic win was the first WNIT championship for the Cowgirls and was witnessed by a record crowd of over 15,000 fans at the University of Wyoming Arena-Auditorium. But as any Cowgirl fan can tell you, this victory was the result of months of hard practice, courageous leadership by the players and coaches, and a commitment to excellence both on the court and in the classroom. The teamwork and discipline demonstrated all year by the Wyoming Cowgirls allowed them to be successful on game day. And we do not have to look far to see examples of this success: This year, the Wyoming Cowgirls won the most games in program history, including thrilling late-game comebacks and overtime wins. Equally as important, however, they earned the respect of women's basketball programs across the Nation. I am proud to stand here today on the floor of the Senate and congratulate the University of Wyoming Cowgirls on a championship season and recognize the student athletes, coaches, faculty, and fans who were essential in achieving this great victory.