Thomas Coburn

Mr. COBURN

Mr. COBURN. Certainly.

Mr. COBURN

Mr. COBURN. Madam President, as we debate the important issue of drug safety, I want to address the safety of one drug in particular: RU-486 or mifepristone. This drug was approved in 2000 under a special pathway, subpart H drug approval that is reserved for drugs that treat severe or life-threatening illnesses. Subpart H approvals generally require a special ``restricted distribution'' approval process. Unfortunately some drugs, RU-486 for example, approved under subpart H have caused serious adverse health events in women. Every drug approved under Subpart H is listed on the Food and Drug Administration's Web site. The vast majority of drugs listed combat HIV or specific types of cancer. One governs the use of thalidomide in treating leprosy. These drugs are supposed to relate to the treatment of life-threatening illnesses. One example of a subpart H approval makes a mockery of the regulatory process by an expedited approval of two extremely risky drugs for abortions. Pregnancy is not an illness and certainly not one that is life-threatening in the first 7 weeks, unless it is a tubal or ectopic pregnancy in which case RU-486 abortions are absolutely contraindicated. RU-486 was inappropriately approved in 2000. RU-486 was approved using special ``subpart H'' regulations to address problems for ``certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses . . .'' and under restricted distribution conditions due to serious hazards presented by the drug; for example, severe hemorrhage and ectopic pregnancies. This was an inappropriate approval of RU-486 as pregnancy is not normally a life-threatening condition. Today many health care providers do not follow the limited distribution requirements of RU- 486's approval. RU-486 has put women's lives at risk. To date there have been six North American deaths related to the use of the RU-486 abortion regimen: five Americans and one Canadian have died from septic shock stemming from infection by the anaerobic bacteria Clostridium sordellii. Five other international deaths have been related to RU-486. RU-486 causes serious safety issues. More than 1,000 adverse event reports--232 hospitalizations, 116 blood transfusions, and 88 cases of infection--have been submitted regarding RU-486 and are significant because they confirm that large numbers of mifepristone patients require surgical intervention for infection, hemorrhage, complications from ectopic pregnancy, and incomplete abortions. While lives have been lost from the use of RU-486, not a single case has been documented where RU-486 has been used to save a woman's life. RU-486 is not always effective and when it is not the consequences are dire. I recently learned of a woman who was given RU-486 after she had a seizure. Her physicians assumed that the seizure was life- threatening to the baby she was carrying and gave her RU-486 for a therapeutic abortion. RU-486 was not effective in her case and the woman carried the baby to term. When the baby was born at a low birth weight, it also suffered from failure to thrive. That baby has had three subsequent brain surgeries due to hydrocephalus. The baby also suffers from idiopathic lymphocytocholitis--an inflammatory disease of the colon, which is extremely rare in children. It is clear that RU-486 not only is unsafe in women, but it is also not completely effective. And when it is not effective, the results are devastating. I appreciate the desire to effect safer drugs through this bill. Senator Kennedy and Senator Enzi have done a great deal of work in designing the REMS scheme for certain drugs to ensure that they can be safely and effectively used. Under the risk evaluation and mitigation system, REMS, provisions of this drug safety bill, a drug that has previously been approved under subpart H is deemed to have a REMS. Every REMS is subject to a periodic review. Therefore, RU-486 is deemed to have a REMS and is subject to periodic review. I am pleased that the amendment offered by Senator DeMint was accepted by the full Senate. Senator DeMint's amendment sets a ``date certain'' REMS assessment for RU-486 to properly evaluate its drug safety risks in women. Women in this country deserve to know the safety risks associated with RU-486.

Mr. COBURN. Madam President, I appreciate the attention to drug safety on the part of Senators Kennedy and Enzi. The drug safety problems our nation experienced surrounding Vioxx and the SSRIs demanded that we take a serious look at the FDA. I appreciate the hundreds and hundreds of staff hours that have gone into working on this legislation both before and after the HELP Committee markup. When the Health, Education, Labor, and Pensions Committee marked up this legislation, I strongly opposed it. I appreciate the willingness of Senators Kennedy and Enzi to listen to my concerns and take action to address them. Many of the changes I requested are included in the final product that we vote on today. This bill has come a very long ways since its consideration in the HELP Committee. Instead of requiring a risk evaluation and mitigation strategy, REMS, for every drug, a REMS may only be requested when there is a scientific reason for one. In giving new regulatory authority to the FDA, we must be extremely cautious that we do not hurt access to new and innovative prescription drugs. I appreciate that the concept, introduced by Senators Gregg, Burr, and myself, to establish a surveillance system for adverse prescription drug events has been included in this legislation. This will now allow cooperation with academic institutions that have the expertise to evaluate the signals from that surveillance system and ensure that both patients and doctors have the information they need to make decisions about the risks and benefits of medical drugs. As a practicing physician, I know that it is impossible to ever completely eliminate drug risks. The right approach is to provide accurate risk information and preserve the doctor-patient relationship. I appreciate the progress made in the bill towards this end. I appreciate the willingness of Senators Kennedy and Enzi to work with me on preserving the doctor-patient relationship. The FDA's job is to approve drugs as safe and effective--not to dictate which doctors can prescribe which drugs to which patients. Medicine is not just a science; it is also an art. This legislation will ensure that patients have access to potentially lifesaving drugs that might not otherwise be approved because of known adverse events caused by the drug. This legislation establishes that the agency will not limit or restrict distribution or use unless a drug has been shown to actually cause an adverse event. I also appreciate the efforts of my colleague Senator Roberts in preserving the right to commercial free speech, as intended by the Constitution, in direct-to-consumer, DTC, advertising. While I am not a big fan of DTC, I am a big fan of the Constitution. I am pleased that a compromise was reached to remove the ban on DTC from this bill and instead ensure that drug companies are held accountable if their advertisements are false or misleading. I appreciate the willingness of Senators Kennedy and Enzi to accept an amendment that will provide a date certain for a safety evaluation of the drug RU-486. The two user fee agreements for prescription drugs and medical devices, PDUFA and MDUFMA, have been negotiated between industry representatives and the FDA. The industry indicates what it will pay for faster drug approvals and the FDA commits to achievable performance goals. I appreciate the work of FDA Commissioner Dr. Andrew von Eschenbach in crafting fair and reasonable proposals for both prescription drug and medical device companies. It is critical that we focus on public health and safety, and also hold the FDA accountable for improved agency performance goals. Maintaining timely and efficient patient access to lifesaving and life-enhancing medical drugs and devices is a win for the industry, doctors, and patients. I look forward to seeing how the new performance goals in both the PDUFA and MDUFMA agreements will both help keep the pipeline of innovation moving forward and improve communication and understanding between agency staff and manufacturers. I can vote in favor of this legislation today because of the enormous progress made. However, there are some workability issues with both the Best Pharmaceuticals for Children Act and the Pediatric Research Improvement Act. These issues need to be resolved so that the FDA has the authority to do its job quickly and effectively. The Best Pharmaceuticals for Children Act, BPCA, has generated more clinical information for the pediatric population than any other legislative or regulatory effort to date. I am concerned about this reauthorization of the Best Pharmaceuticals for Children Act because chips away at incentives that have been getting real results for kids. I am also concerned that part of the bill, pediatric medical devices, would authorize $30 million in demonstration grants for improving the availability of pediatric devices. While this has a worthy goal, more accountability is needed for this program to ensure that such grants are used for helping save the lives of children. Additionally, the bill's sponsors failed to do their homework in examining existing Federal programs. The fact is, the National Institutes of Health already has a program for this purpose. In order to preserve a heritage for our grandchildren, Congress needs to do the hard work of taking an inventory of existing programs before we authorize new ones. Again, I appreciate the enormous amount of work that has gone into improving this legislation. It is critical that in addressing drug safety that we do not harm access to new and lifesaving medical technologies.

Mr. COBURN

Mr. COBURN. Mr. President, I want to chime in for a minute on this amendment, and I want to set a little background. Why do we want to import prescription drugs? What is the reason behind it? The reason is that there is not a true international market in pharmaceuticals. Senator Stabenow quoted a figure of $29 billion worth of Government research. That is not quite accurate. There is $29 billion that goes to NIH, but that is not all related to drug development. Probably half of that is. So we do have a great investment in drugs. There is no question that the American consumer subsidizes the pharmaceuticals of almost every other nation in this world. So the purpose behind this amendment is a good one. I would draw attention to the fact that Senator Brown and I passed a drug reimportation bill in the late 1990s that became law, and President Clinton signed it. Donna Shalala, however, under the same guidelines, refused to carry out that mandate--that bill is still on the books, by the way--claiming there was nothing they could do that would make them safe and that they could assure they were safe. I am going to vote for this amendment, and I think it is right that we should develop a worldwide market on pharmaceuticals, but I am not sure we are going to accomplish this. Having authored the first bill on drug reimportation when I was a Member in the House, what I have seen is that the problem is much bigger than what we are attacking. I find it kind of peculiar and strange that we haven't gone a little further. What really needs to happen is we need to tell all our friends around the world that tell the pharmaceutical companies what price they will pay for drugs, we need to tell them what price we will pay for their products. As soon as we did that, guess what. There would be a worldwide market on pharmaceuticals. We may get there through reimportation, but I don't think so. I think it is going to get squeezed down. I think greed conquers technological difficulty almost every time. So I think this is a good step, but if we really want to solve this problem, let us put an amendment on the floor which says that any country that essentially fixes the price on pharmaceuticals, their products coming into our country will have their prices fixed. Can you imagine if we were to tell BMW what they are going to get for a BMW 531, or Volkswagen what they are going to get for one of their vehicles, or Toyota what they are going to sell a car for? That is essentially what they are doing to the pharmaceutical industry in this country. I believe this is a good amendment, and I am supportive of reimportation, but I don't believe it solves the problem. I don't want the American people to think that if we pass this, all of a sudden the price of drugs is going to come down. It will not. It is great that we are doing it, but we are not going far enough. We need to ask the administration to carry out the strength of their ability through Executive orders to create true competition throughout the country and throughout the world on pharmaceutical prices. Regardless of all the precautions and the well-thought-out plans of Senator Dorgan--and I know Senator Brown has worked on this for years, as has Senator Stabenow and Senator Vitter and several others--I believe they will get around it. I believe they will sign contracts for fixed quantities of drugs, and then the countries that have the potential to take a drug that was produced here or produced by a manufacturer that is based out of this country, they will limit the amount of drugs that are available to them based on the contract they sign for the number of drugs. So we will have made everybody feel better, but we will not really have created a worldwide market for pharmaceuticals. That is what I think we have to do. I would like to put out to the author of this amendment, as well as the sponsors, that we ought to think bigger on how to handle this because what we really have is one industry where there is not true free trading. We are not ever going to get the benefits, we are not ever going to relieve the burden of the American consumer, who is paying to subsidize drugs in Germany, in England, in France, and in Japan, we are not ever going to take that burden off until we really create a true worldwide market in pharmaceuticals. I am just hesitant to believe this is going to accomplish it. Like I said, I am going to vote for it. I believe it is a step in the right direction, but I think we need to be more bold. If we really believe in the benefits of international free trade, then we should do whatever is in our power to insist it become an international market for pharmaceuticals. That way, the pharmaceutical companies won't have to use the only market there is in our country to subsidize the variable costs and the research that they contribute to a lot of the drugs that come today. So I am supportive, I think it will pass, but I would reach out to the other Members who are interested and say: Let's do something bigger. Let's do something that will really fix it and do it fairly quickly. We will have a thriving pharmaceutical industry that way. It truly will be based on competition. Intellectual properties that are truly researched and supported by the country--we as Americans, if we have done that, we will get the better benefit from it if we have a true international market. I think the drug companies would like to see that as well. I understand they are trying to get return on invested assets. I believe it is important that everyone has a fair price for a pharmaceutical and that people make money when they sell a pharmaceutical. But we have to have an international market, and we have to solve it that way. I thank Senator Brown for allowing me the time, and I yield the floor. Amendment No. 985

Mr. COBURN. Mr. President, I rise to speak for a minute in support of Senator Allard's amendment. I also want to recognize Senator Dodd's work, and I believe he truly cares about us getting pharmaceuticals to children. But I think the bill as written today has some very great risks for our children. I practice medicine. I can remember 25 years ago, for so many of the drugs, we did not know what we were doing as they related to children. We had sometimes great outcomes and sometimes poor outcomes as to the availability and knowledge of pharmaceuticals for children. We have a system that started 10 years ago that has been highly successful. Mr. President, 144 drugs have now been studied in kids. We know what we are doing with 144 drugs. With 25 of those drugs, we now know not to use them for children. How did we get there? We created an incentive that said: We will give you a 6-month patent extension if you will study pediatric indications and do a study on pediatric patients for this drug. It worked. As a matter of fact, it worked great. Now, I am having trouble understanding, as a physician, the therapy Senator Dodd wants to put on this. He is back to practicing medicine the way we did pediatrics 25 years ago with his amendment. I certainly hope he is right if he wins because there are going to be a lot of children in trouble if he is not. What his amendment actually says is, if you made $1 billion off a drug, you only get a 3-month extension. I can see how we could look and say they are making too much money. But only 1 out of every 10 drugs we studied in pediatrics was a blockbuster drug. So what is happening with these high-profile drugs they are making a lot of money off of is they are the things that are funding the other 130 studies of drugs that are not blockbusters, that are not profitable. So what Senator Dodd has put in this bill--and I know it is well- meaning--is to limit that profitability, hoping drugs will become more reasonable, and gambling--a very risky gamble--that the research on pediatric drugs will continue with that 3-month extension. He may be right. But as someone who cares for kids in my own practice, I am not willing to take that gamble. I am not willing to say: What if he is wrong? What if the studies go from 144 to 15? Now that we are seeing all these new drugs coming out, we are not going to have a study for kids? We are going to take away opportunities for young children to have the benefits of a new drug because they are not studied? Or we are going to use the drugs anyhow, even though they are not indicated and we do not know what we are doing, in a hope--not in a knowledgeable, scientific way but in a hope we are doing some good? We have a system that has worked very well. Senator Dodd was supportive of that system. I do not know that he is right. He could be right. But the question will be: What if he is wrong? What if the next 100 drugs that come out for maladies that could have an application for children--especially some very small used drugs, specialty drugs for chemotherapy, and have a very low incidence of usage in kids--what if they are not available? What if they are not made available? How many children are not going to get that drug? Now the system is paying for 90 percent of the studies on drugs that aren't the blockbusters, and we are going to cut the incentive in half. It may work. I don't know where the knowledge is, the scientific inquiry, or the study that says that going from 6 months to 3 months is the right amount. What about 2 months? What about 1 month? What about 5 months? We don't know. So what are we going to do? We are now going to go back and practice on pediatric drug studies the way we used to practice on children. We are going to guess. What the Allard amendment says is: We are not real happy there is this amount of tremendous profit, but we do understand that the profit off the blockbuster drugs is actually paying for 90 percent of the studies on nonblockbuster drugs for kids, that we are going to take away that incentive. It is really comforting as a physician to know now what I didn't know before in terms of giving a kid a medicine and knowing how it is going to be metabolized, knowing its half-life, knowing it is different in a child and being able to dose it correctly, and confidently saying to a parent: I have given you something that is going to fix your child, that is going to cure this illness, and I know you are not going to have a side effect from it. What we have done has worked. Why would we mess with it unless we know? I have listened to this debate. I don't see anybody telling me how we know we are not going to disincentivize further drug studies. If somebody can show me that, then I will be happy to vote against the Allard amendment. But there is not anybody who can show me scientifically that we are going to have another 144 drugs studied if we cut this in half. Maybe we will, maybe we won't. I can't see into the future, but I am cautious enough to know I love the progress we have made. If we change this, if we change it--and it sounds as if, from the debate here, the Allard amendment isn't going to be approved--we better darn sure know what we are doing, and we better darn sure say that taking money away from drug companies in terms of extending patents is not going to have a negative impact in terms of positive benefits. I am not the greatest defender of the drug companies. I authored the first bill that was signed by President Clinton which allowed reimportation of drugs into this country. Why did I do it? I think we need to have a worldwide market on pharmaceuticals. We don't. We have a controlled market everywhere except in this country. The American taxpayers end up subsidizing the research and subsidizing the profits. But I also recognize that some of these drugs' profits are the very things that allow me to now give comfort to a mother and a father when they have a very sick child. I hope Senator Dodd has the wisdom to know that he has done it just right and that there is not going to be one cancer chemotherapeutic agent that wasn't studied in children because it is not a blockbuster drug, and now that we are going to cut it to 3 months, that there will still be an incentive to make sure that the next child with a sarcoma or the next child with an aplastic anemia or the next child with a leukemia that is resistant to bone marrow transplant or anything else is going to be able to have the medicine. We are going to go back to the way we practiced medicine 10 or 12 years ago. We are not going to know, and we are going to shoot from the hip and pray and hope. What we have today is we don't have to pray and hope anymore. We now have the studies. I don't know the answer to it, and I am not saying Senator Dodd is wrong, but I think a legitimate question to ask is, What if he is wrong? What if he is wrong? How many children aren't going to have drugs? How many children are going to have a drug complication? How many children are going to have a drug interaction? How many children's lives aren't going to be saved because we decided the drug companies are making too much money and we are going to tell them how much they should make? Mr. President, I yield the floor.

Mr. COBURN. I have no objection.

Mr. COBURN. Reserving the right to object.

Mr. COBURN

Mr. COBURN. Mr. President, I request the yeas and nays.

Mr. COBURN. Mr. President, I ask unanimous consent that the pending amendment be set aside, and that amendment No. 921 be called up.

Mr. COBURN. Mr. President, what you just heard was a denial that we need oversight and that people shouldn't be accountable for how they spend Federal dollars. The fact is, this is one program and one meeting. This doesn't stop meetings. This doesn't stop any legitimate function. This was a golf tournament and a meeting for 2 days that cost $46,000 of Federal funds. I will tell you, NOAA does not have any conflict of interest rules presently in their guidelines. So what the Senator is saying is, leave it the way it is today. Let's don't change it. That is exactly the problem, because this didn't come through the Commerce Committee. They would have fixed it, as Senator Stevens fixed the fishery boards. Instead, what we are trying to do with this is to fix the same thing Senator Stevens did with the fishery boards. Because it didn't come through committee, that didn't get attached. Now that we want to attach it on the floor, we don't want to have that done. The fact is, there is no oversight catalyst with these grant programs. By defeating this amendment, we are going to continue saying there is none. If you don't like this amendment, then fix it in conference. There is no reason why we shouldn't hold these grants to the light of day. There is no reason why they shouldn't be transparent. Everything in this Government should be transparent. There is nothing in these grants that is fiduciary or private that shouldn't be exposed. The fact is, if you are going to take money from the Federal Government, the American people ought to know what you do with it. What we are saying is, we don't want that to happen. That is what defeating this amendment means. It means more secrecy, less transparency. It means, by the way, if there is a financial conflict of interest, don't worry about it, we don't want to hold them accountable. I understand the resistance, but the American people won't understand the resistance. The real problem we are faced with is our Government is so big and into so many things that we don't know where it is being handled right or wrong. This is one small step to say there shouldn't be a conflict of interest. There ought to be reporting, there ought to be oversight, which there is not. We ought to be asking the GAO to oversee it and to look at it. That is all it does. Mr. President, I will rest with the will of the body on that amendment.

Mr. COBURN. I believe you all still have time.

Mr. COBURN. Mr. President, let me describe what has happened. There was an earmark which NOAA believed they did not have the responsibility to oversee, since it was an earmark, in terms of rehabitating oyster beds. We have seen from the investigations so far that it has been highly ineffective. But more importantly, what we have seen is conflicts of interest in terms of the board that manages the program and the ownership of the companies that are given the grant money. I won't go into the details. Senator Mikulski is in agreement that they should be oversighted and looked at and conflict of interest should be eliminated. This amendment is very simple. It just says that ought to happen and there ought to be a review, there ought to be a prohibition of use of NOAA funds for meetings. There is $46,000 yearly going out for a meeting out of this grant money with no real concern. There is no conflict of interest requirement in the grant authority- making process at NOAA. So this amendment simply sets out that we ought to have basic conflict of interest rules of engagement in the grant- making process with NOAA. I reserve the remainder of my time.

Mr. COBURN. I thank the Senator for his comments. I would note that the House didn't find it hard to eliminate ATP on their component piece of legislation that will be matched up with this and, in fact, last year we eliminated ATP in the funding cycle on the appropriations side. I know there are some positive things about the program, but overall it is a poor investment for the Federal taxpayer. Mr. President, I yield the floor at the present time, and I reserve the remainder of my time.

Mr. COBURN. Mr. President, I am somewhat perplexed. We had a debate on Medicare Part D. The debate was about corporate welfare. I find it hard to believe that we want to continue to fund General Electric and IBM and Intel and all these other companies with taxpayer money after we have claimed we do not want to do corporate welfare. Tell me where in that process--if the Senator from New Mexico would care to put his sign back up--this money is? Tell me why an IBM needs money at that stage. Tell me why a General Electric needs taxpayer money at that stage, money that is going to go to them. They have all the resources. IBM just announced they are buying back 10 percent of their stock. They have plenty of cash. They are buying back their stock. Tell me why, in a time when we have a $300 billion deficit, $300 billion we borrowed from two generations from now, that we should give a penny to IBM, corporate welfare to enhance anything. They have all the resources they need. Tell me why we should give a penny to General Electric or Intel or any of those large companies that consume 30 percent of this money. If we want to have an Advanced Technology Program, why wouldn't we say, yes, we will do it, but you have to be at a certain size. You have to truly not be able to access the capital markets. They have no problems accessing the capital markets for research. So what we are doing is taking from two generations from now and giving it to the richest corporations in this country and making ourselves feel good because it wouldn't happen otherwise. It will happen otherwise. That is what markets are all about. I will be happy to have the Senator respond to my question.

Mr. COBURN. Mr. President, it has come to mind that NOAA, when they do the grants, lets the grantee set the terms of oversight. I ask unanimous consent to have printed in the Record from NOAA's official Web site their financial assistance application for their grants where they ask the grantee what kind of oversight they want rather than setting it up themselves.

Mr. COBURN. Mr. President, we passed the Fisheries Act, the Magnuson- Stevens Act, which was reauthorized this year in which Senator Stevens undertook, correctly, the responsibility of eliminating conflicts of interest and created oversight on the fisheries boards. We have recently had notification and seen some pretty significant abuse within NOAA of some of their grant processes. All this amendment says is, we are going to add some accountability and transparency to the National Oceanic and Atmospheric Administration grants program. I refer my colleagues to a Baltimore Sun article which has been prominent in that newspaper over the last couple of weeks where over $10 million in a grant has failed to demonstrate results. It is riddled with conflicts of interest, and it has had little to no oversight from NOAA. Before we expand NOAA, one of the things we ought to do is make sure there are no conflicts of interest, financial or otherwise, in the grant process. I ask unanimous consent to have printed in the Record both articles outlining this situation, as well as a Stanford study on other areas of NOAA where there is a lack of informed consent and a lack of conflict of interest rules for NOAA.

Mr. COBURN. Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.

Mr. COBURN. I call up amendment No. 922.

Mr. COBURN. Mr. President, the claim of Senator Bingaman that a point of order will lie against this is wrong. Paragraph 7, rule XVI only requires the Appropriations Committee to list the unauthorized programs. He made my point: 20 percent of our appropriations are unauthorized from expired or sunsetted programs. It won't stop anything if it is a good program. I contend with Senator Domenici that he thinks this is a great bill, but the only way we are going to know is the results of the bill. So based on what we think, not on what we know, is the reason this bill should be sunsetted so that it forces us to go back and look at what we might think we know today but didn't know and change it. It is about putting discipline into our body. It is about forcing us to do the work the people told us they wanted done when we came here. It requires us to not be fortune tellers, to not be seance dwellers, but to, in fact, look at the facts after 3 years, see what it has accomplished, and forces us to make the changes. The Senator knows quite well that on most of the programs we haven't done that. That is one of the reasons we had a $350 billion deficit. That is one of the reasons we had $200 billion that we spent on wasteful, duplicated, or fraudulent programs last year out of the $1 trillion we spent in the discretionary budget. What I am trying to do is force us to do the hard work of relooking. I agree, does that make it hard? Yes. Nobody said it was going to be easy. But I would want any Senator in this body who says they know the outcome of this bill to put something behind that and say we don't need to relook at it. That is the question. This is a disciplinary force that says we have to come back and look at it. Let me remind my colleagues again. There are great ideas in this legislation. I don't doubt that for a minute. This didn't go through the committee process. This wasn't made available for amendments. On an $80 billion authorization--which is what it is going to be if we guess at the sums that are authorized for this bill--to not have it go through either committees of jurisdiction and come to the floor, and we are going to spend this kind of money and we are going to think rather than know it is going to work, and to say we should not look at it I find really ironic, and I feel pretty sure most of the American people would think we can't know for sure. It is a commonsense amendment and will cause us to do what is necessary. Amendment No. 922 Mr. President, I ask unanimous consent to set the pending amendment aside.

Mr. COBURN. Mr. President, this is a sunset amendment. It is very plain, very straightforward. It says, can we be assured that we have, with absolute certainty, all the wisdom, facts, and knowledge we will need 4 years from now as to the viability of the programs expressed in this bill? It is one thing the American people would like to see us do--relook at, on a regular basis, what we authorize to make sure what we are doing still has application. As a matter of fact, the biggest problem I have noticed in our Government is that we don't do oversight, we don't review and reassess, except in very rare instances. This amendment is very simple. It just says that in 4 years, we are going to look at it again. We are going to sunset the bill, and probably a year before that Senator Alexander and his companions will come back, relook at it, tweak this, make the changes they need to make, and then have the America COMPETES Act again 4 years from now. The key component of what it does is it forces us to look at it because it is going to expire, it is going to run out of gas. What happens now is that we pass things and don't ever look at them again. I believe the Senator from Tennessee, as well as the Senator from New Mexico, would agree that we fail to do proper oversight in this body. That is one of the very lacking components of the job. It is hard work, oftentimes not fun, but it is very important to the future of this country. Some people will say that we should not sunset this, that the implication is that we know now what we are going to need to know 4 years from now. But, in fact, we sunset a lot of things, from the PATRIOT Act, to the tax bills, to the Ryan White health care bill, to Defense bills, to veterans bills. I put forward that we need more sunsets because of the discipline it will force on us as representatives of the American people to do what is in their best interest, with the knowledge we have on hand at that time. I don't know whether this amendment will pass, but it is a great judgment for the American people to look at us and say are we serious about doing the business or are we so arrogant or elitist that we think we know now absolutely what we need to know 4 years from now. I had a good debate with Senator Durbin on the previous bill the body considered. One of his suggestions was that I should have offered a sunset to that legislation. I think that is a great suggestion. I think it is equally apropos that we do it on this legislation. It gives us the benefit of our experience over the next 3 years, it allows us to have the hearings in the committee and the committee work we need to do--as a parenthesis, this bill didn't go through any committees, didn't have the pleasure of the Commerce or HELP Committee--and allows us to look at and see what we have been doing and whether it is effective, whether or not the American people actually get good value for the money over what we intend them to do. That is our real obligation. It is not to create an America COMPETES Act, it is not to pass a piece of legislation, but, in fact, it is to make sure that whatever we do, the American taxpayer dollar gets a great accomplishment for that. I reserve the remainder of my time and will listen to the opposing points of view on this amendment.

Mr. COBURN. First, I ask unanimous consent that the pending amendment be set aside and that my amendment No. 918 be called up.

Mr. COBURN. Mr. President, in consultation with the managers of the bill, they have granted me some time to bring up three additional amendments that I believe are important as we look at the bill. Amendment No. 918

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

Mr. COBURN

Mr. COBURN. Mr. President, I ask for the yeas and nays.

Mr. COBURN. I yield back my time.