Judd Gregg

Mr. GREGG

Mr. GREGG. I thank my colleagues for allowing me to go forward at this time. Madam President, I yield the floor and make a point of order that a quorum is not present.

Mr. GREGG

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 President, I ask unanimous consent the order for the quorum call be rescinded.

Mr. GREGG. Mr. President, I rise to speak today on this FDA bill that has been brought forward by Chairman Kennedy and Senator Enzi. I begin by thanking them for their cooperative, collegial, and inclusive approach over the last couple of weeks to get this bill in a form that makes it much more effective, accomplishing the goals we all have. Senator Kennedy and Senator Enzi for a long time have been great advocates of making sure we have a strong and effective FDA. Senator Kennedy, of course, has been involved in this for many years and has played a huge role in the success of the FDA, which is, as we know, one of the extraordinarily successful agencies in the Federal Government. It gives the American people confidence, when they go into a grocery store and purchase food or when they go into a pharmacy and purchase a pharmaceutical product or have a prescription filled, that they are going to receive goods which are safe and effective and that they are not going to be at risk of harm as a result of adulteration, fraud, abuse, or misuse of those goods. It is one of the most amazing successes of our Federal Government in the area of protecting consumers. It arose out of the early 1900 period when there were serious issues relative to food safety in this country, and has evolved into clearly one of the finest agencies, not only in our Government but in the world. It is respected around the world as the gold standard for protecting American citizens and citizens who use the products made by American companies. This bill builds on that success. I congratulate the Senator from Massachusetts and the Senator from Wyoming for doing such a strong job of building on that success. This bill continues the effort to make sure we have a prompt but safe procedure for getting drugs approved in this country, something called PDUFA, which basically allows drug companies to pay a fairly significant portion of the cost of the approval of new drugs, which has expedited dramatically the rate of approval of new drugs. That means pharmaceuticals and biologics come to the market, which help people, which save lives, which basically makes life better. That is the good news. In addition, there is, for devices, the MDUFMA proposals, which deal with devices, medical devices the way we deal with pharmaceuticals, setting up a fee system for the approval of medical devices. This is something, when I was chairman of this committee, I had the good fortune to be involved in developing. These two initiatives are the essence of how we maintain a vibrant drug and medical device approval process in this country. It is absolutely critical they be reauthorized, and this bill does it in an effective way. In addition, the bill takes on a number of other issues which are timely and appropriate. The most significant, from my perspective, although there are a lot of significant ones here, is the issue of drug safety and how we make sure the drugs which do come to the market are safe. This involves not guesswork but finding out what the science is and what happens when people start using these drugs and medical devices. The concept behind that in this bill is that we should set up a regime that basically collects information from all sorts of different sources. There are literally thousands of different sources, but there are some very big ones that we develop information about the reactions people have when they take drugs. We have the tremendous database of the Medicare system, for example. We have the tremendous database of provider groups, such as the Kaiser Permanente fund out in California. These different provider groups have a huge amount of information on what is happening when somebody takes some form of medication. But what happens is that information, although it is collected, is not effectively screened and is not effectively evaluated. What this bill does, essentially, is create a regime that allows us to more effectively, first, collect the data; second, when there are red flags popping up on that data that say there is a reaction here or reaction there or something occurs here that was not expected, that information becomes more visible under this regime and more available; and then, third, if it is clear there is something that is not going right here, that there is a series of aberrations nobody expected, then it sets up a process where we take that information out and we give it to selected groups of specialists in the academic and private world who have the ability to evaluate that information and tell us what is going on. There are centers at MIT and I believe at Duke, for example, that do exactly this. The idea, of course, is to first collect the information effectively; second, make sure when those aberrations or red flags start to show up they are noted; and, third, when there is a certain critical mass of information that reflects something that may not be correct or is out of kilter, it makes sure we have that information evaluated in a very science-based, professional way by people who specialize in this and who have the ability to do it--something which FDA does not have the resources, necessarily, to do right now. With that information in hand, with that science in hand, then you can make decisions. This bill creates a new regime for making those decisions--as to what a company must tell people or tell providers when they are using these different drugs and medications. But it will be a science-based decision, and that is the key here. All of this will key off of science that is hard and that is effectively reviewed and evaluated in order to come to the conclusion that certain actions must be taken in how you distribute this medication and how you communicate what the implications of this medication are. So this new safety and surveillance regime, which is known as mining the information, and then pulling it together and taking advantage of it, validating it and integrating it--this new regime is at the essence of the safety concerns which are involved in this bill. It is very positive. It opens a new world of review in the area of pharmaceuticals and medicines, a postmarket review process which will be based on science and which will be very healthy to the system as a whole. I congratulate and thank both Senator Kennedy and Senator Enzi for evolving this process in this bill. In addition, there is the pediatric language in this bill. There is the BSE program, which is the program which basically rewards companies that are willing to go out and do extra research to see how a drug might affect a child. Historically, drugs will be brought to the market and you would never know--because all the clinical exams have been done on adults--how they would affect children. Some of these drugs, obviously, if given to a child, could have a significant negative impact and, if given in the wrong doses, might have an extraordinarily adverse effect. Some could actually be very positive if given in the right dosage. So it became a guessing game as to when these pharmaceuticals, when these medications, were good for children, in many instances. As a result, doctors and prescribers simply didn't know whether to make them available, in many instances, to children. This BSE pharmaceutical procedure said essentially, We will give you, the producer of this pharmaceutical, of this medication--we will give you an extra 6 months of exclusivity in exchange for your testing this and making sure it will work effectively, or finding out if it will not work effectively, on children. The practical effect of that, of giving that incentive, has been that hundreds of new drugs have been made available to children which were not available before. This has had a very positive impact on children and the ability of children to get pharmaceuticals. With the BSE program, we also developed a program called the Pediatric Research Equity Act, which essentially takes the opposite approach from the BSE program. It creates a mandate where, in certain instances, certain medications have to be tested on children. They have to go through a process of seeing if they will work for children. The two together basically work in tandem and the idea is they will feed off of each other, and you will create an atmosphere out there where the two different approaches--one basically being a carrot and the other being a stick--will lead to better medications being available for children. It has worked amazingly well. The key to this, of course, is to keep these two in tandem. In order to accomplish that, they both, in my opinion--and fortunately in the opinion of the chairman and the ranking member of the committee now, at least--have to be on the same wavelength. They have to be dealt with the same way relative to things such as their sunsets, when they get reviewed and when they don't get reviewed, because if you were to have one sunsetted at a different time than the other or one sunset and the other not sunset, you wouldn't get an effective review of the two together, and they both work, as I said, together. This bill makes sure they are treated the same way in that area, and that is a major step in the right direction toward making sure children get proper pediatric care. There is still going to be an issue tomorrow, I understand, on exclusivity, which is going to be brought up by another Senator; that is, the length of the exclusivity that is necessary in order to get pharmaceutical companies to pursue proper research on children is an issue. But I happen to think what we have now has been shown to work, and why fix something that is not broken, in my opinion. So I believe we should stay with what we have for the 6- month exclusivity period. In addition, there are a number of other issues floating around this bill. This bill, obviously being a major health care bill, attracts a lot of other concerns. One of them that I have filed as an amendment-- but I don't intend to bring it up unless we move into the issue of reimportation, which may be brought up on the floor--is the question of safety of Internet pharmacies. I believe very strongly, when somebody goes on line and purchases a pharmaceutical product over the Internet-- which is happening more and more often as people become more comfortable with dealing with the Internet on a variety of different levels, but certainly senior citizens as people age into their senior citizenship years who had been dealing with the Internet for quite a few years and are comfortable with it--I believe it is critical we have in place a system which allows people, when they look at the site on the Internet, to know whether that Internet pharmacy is selling the product they say they are selling and whether the product they say they are selling has received FDA approval. The problem we have here is a lot of these pharmacies will represent that they are selling some sort of pharmaceutical good and it turns out that product is, in many cases, adulterated or inappropriately made, in which case people end up getting a pharmaceutical product which is bad for them. In some cases it can actually lead to death. So it is critical that we have a way so when somebody goes on the Internet and looks at a site on the Internet, they know that Internet pharmacy they are looking at is legitimate and the products they sell are legitimate and have been through the FDA approval process. In order to accomplish that, we need to set up a whole new regime, basically, and we need to pay for it. This amendment which I have put in accomplishes that. It essentially gives the FDA the authority to review pharmacy sites on line, to meet with the people who have set up those sites, to make sure to set up a certification process where they are guaranteed the sites are meeting the conditions of selling pharmaceutical products or medications which have met the FDA approval, and then to put sort of a Good Housekeeping seal on that site, which is tamperproof, which says this site has FDA-approved products. It would be a huge step forward in safety for American citizens using Internet pharmacies. It is complicated, though, in its enforcement. It is simple to state but complicated to enforce because it means the FDA needs the resources to deal with these sites and also to deal directly with these pharmaceutical Internet sales places which may be somewhere other than the United States. Second, you have to have in the United States a point at which you can deal with the site if something goes wrong, a responsible representative on the ground in the United States who has the economic wherewithal to basically bond the site, for all intents and purposes. Setting up that type of regime will be expensive. The language of this amendment puts in place a fee system which allows that to be paid for so we can be assured that the FDA has the resources necessary to review these sites and accomplish this goal of making sure these Internet pharmacy sites are safe for Americans to use. I think this would be a tremendous step forward in safety for all Americans, especially as we move toward a much more Internet-oriented purchasing process in this country. Another issue which is going to be discussed here, and which I understand from the chairman may be held over for conference or come into play in some area, is a crucial issue of follow-on biologics or similar biologics. We know we can produce a generic pharmaceutical and do it with a fair amount of predictability. We know that if a generic company brings on a pharmaceutical product which has run its course, it has proper patent coverage, that that generic is going to be safe and effective and be essentially the same thing as the pharmaceutical because they are chemical compounds. In the biologics area, this is not the case because you are dealing with a much more complex process of producing the biological medication. It is a fermentation process, it involves proteins, it involves mutation of proteins, which depends to a great extent on a huge number of factors which are very uniquely identified with the way that that vat of medication was evolved through the process. Anyone who has been to one of these facilities can see how complex it is to maintain consistency, even within the facility that is producing the medication. If you stepped out of that facility and tried to reproduce that medication, the complexities would even be more difficult to replicate. It is critical that as we move into this biologic area, we understand we are not dealing with generic pharmaceuticals. You know, when you put the title ``generic pharmaceuticals'' on something that is sort of a motherhood term, that is a good idea. It is a good idea if it works. But if you put the generic title on biologics, you are probably going to mislead a lot of people and, in the process, potentially produce medicines which can be extremely harmful or could not accomplish the purposes. So as we move down this road of looking at biologics and how we give the opportunity to produce similar biologics to people after the patent life has run, we have to be very careful that we don't oversimplify the exercise in the name of getting something, as ``motherhoodish'' as generics; rather, we have to make sure we put in place a process which allows those biologics, when they are produced as similar biologics, to have been properly reviewed to be sure they accomplish what they claim they are going to accomplish. This means that almost in every instance of an individual biologic, you are going to have to have clinical trials for the similar biologic. There are going to be very rare instances where you can actually bring to the market something that doesn't go through clinical trials in this area, in my opinion, and you have to be very sure that you demonstrate safety and effectiveness of the similar product before you step into this arena of awarding the authority to go ahead and sell that product in the market generally. You will also need very aggressive postmarket surveillance in this area because you do not know, in many instances--you hope you know, but you do not necessarily know--how individuals will react to taking this type of medication, which is developed as a similar medication, as versus the basic medication which is trying to be replicated. This area of biologics is a complex one. It should not be rushed into. I know there is a great desire to step forward and say: We have a huge victory for the American people, we can now have generic biologics. But if we rush into this exercise and create a process with approval which does not adequately account for the significantly, the exponentially more complex process of bringing online a biologic when compared to a chemical pharmaceutical, then we will not have done our job as policy people but will simply have given ourselves a good press release and in the end probably have given ourselves a very dangerous process relevant to protecting the American people in the area of biologics. As we move down this road of generics, I do hope we will move in a way that understands there is a significant difference in pharmaceuticals and that those differences are going to require a much more detailed and a much more complex approval process than we presently have in moving in the generic pharmaceutical area. Those are some of the concerns I have relative to other issues that might be brought up in this bill. But I do again wish to congratulate the Senator from Wyoming, I wish to congratulate the chairman from Massachusetts for once again bringing to the floor a very strong piece of legislation, which will significantly improve the capacity of the FDA to continue its extraordinary record of protecting the American people relevant to food and drug safety. I yield the floor.

Mr. GREGG

Mr. GREGG. Mr. President, the Food and Drug Administration, FDA, plays a major role in ensuring that the American people have access to the safe and effective medicines that they need. In fact, FDA-regulated products account for about 25 cents of every consumer dollar spent. At the heart of all FDA's regulatory activities is a judgment about whether a product's benefits to users will outweigh its risks. These judgments must be science-based to allow the agency to provide the most health promotion and protection at the least cost to the public. As we work on FDA legislation this year, we need to keep that science-based mission at the forefront of our decision making. Last week, the HELP Committee reported S. 1082, the Food and Drug Administration Act, FDARA. The bill couples must-pass reauthorizations of the Prescription Drug User Fee Act, PDUFA, and the Medical Device User Fee and Modernization Act, MDUFMA, with tour additional pieces of legislation that I am unable to support at this time. It is my hope that we can continue to work in a bipartisan way to improve this bill as it moves to the floor. The Prescription Drug User Fee Act, PDUFA, first enacted in 1992, gives the FDA the authority to collect user fees from pharmaceutical manufacturers in order to enhance their ability to ensure timely access to safe and effective medicines. By reducing the length of review time required to approve a drug, PDUFA has clearly been a success. Following the success of PDUFA, Congress enacted the Medical Device User Fee and Modernization Act; MDUFMA in 2002. Like with prescription drugs, MDUFMA funds have been essential to reducing the length of time of the approval process and other improvements critical to the success of the device review process. This year, both the PDUFA and MDUFMA reauthorizations have been negotiated between the FDA and industry and are worthy of support. In fact, I believe these agreements improve both programs and will improve the safety of these products in the marketplace. If we do not renew these programs by September 30, we risk losing this essential source of funding and patients will face longer review times and diminished access to much needed medicines and devices. However, the Kennedy-Enzi language also includes provisions on drug safety and pediatric medicines and devices. All are important issues, but each title of the bill includes provisions that I believe could do more harm than good. Originally, drug safety legislation was intended to address legitimate concerns many had about how long it took FDA to identify unexpected complications after a drug was approved and to provide FDA with additional authorities to act in those instances. The Kennedy-Enzi language attempts to address the length of time it can take to identify problems by including language that directs the FDA to establish an active surveillance system. This is essential to addressing any potential problems with postmarket drug safety. I strongly support this in concept but feel the language needs to be strengthened to ensure that the FDA has the direction it needs to implement a robust system in an expedited timeframe. Information collected must be standardized, and the overall system should be validated. Without these and other important benchmarks included in my Safer DATA bill, we are essentially setting the FDA up for failure. While not going far enough on drug surveillance, the bill goes too far on providing FDA with new authorities. The Kennedy-Enzi language imposes new requirements on manufacturers to develop Risk Evaluation and Mitigation Strategies, REMS, and gives the FDA the authority to require them in both the preapproval and postmarket settings. Importantly, the standards by which FDA can impose REMS are very broad and lack specific requirements through which this standard is triggered. This gives the FDA excessive discretion on imposing REMS on manufacturers even when a drug has a low risk profile. While clearly the FDA needs new authorities, it is critical to strike a balance, and I fear the Kennedy-Enzi language has gone too far and will slow the approval of new medicines and thereby reduce access. Instead, the language should be modified so that REMS only applies when the Secretary determines that the new active surveillance system has signaled a risk. At that point, FDA should have the authority to require manufacturers to judiciously minimize risks without encumbering drug availability or interfering with drug research, development, and delivery. Any expansion of FDA authority should respect this approach. The Kennedy-Enzi language also gives the FDA the authority to require prereview of direct-to-consumer advertising, specific drug advertising disclosures, and a 2-year moratorium on direct-to-consumer advertising. As drafted, these provisions raise a variety of first amendment issues, specifically the 2-year ban on advertising. Much can be done to ensure that consumers receive information that is not false or misleading without banning patient access to health care information. The Kennedy-Enzi language also includes three separate pediatrics bills: the reauthorization of the Best Pharmaceuticals for Children Act, BPCA, the reauthorization of the Pediatric Research Equity Act, PREA, and the Pediatric Medical Device Safety and Improvement Act. To encourage the study of more drugs in the pediatric population, BPCA as originally enacted as part of the Food and Drug Administration Modernization Act in 1997, and reauthorized in 2002, grants an additional 6 months of patent life to a product or pediatric exclusivity in exchange for the voluntary studies of prescription drugs conducted on children. Since its enactment, BPCA has been viewed as a highly successful program and has produced at least 132 completed studies, leading to at least 115 pediatric label changes. Under the Kennedy-Enzi language, the pediatric exclusivity would be capped at 3 months if annual sales for all drugs with the same active ingredient are over $1 billion in any year. This cap for ``blockbuster'' drugs unfairly segments patent protection regimes by making more successful drugs subject to reduced incentives. Our health care system needs to enhance research into children's drugs, not reduce the incentives for manufacturers that produce them. Simply put, the current program is working, and imposing a ``cap'' on the pediatric exclusivity award will reduce the incentive to conduct pediatric studies and, however formulated, would significantly complicate the administration of the program. Enacted in 2003, PREA gives the FDA authority to require pediatric studies on the same approved indication of a certain drug in adults. BPCA and PREA work hand in hand to encourage the further study of prescription drugs in pediatric populations. It is because of the great success of these two programs that I am pleased that the bill requires both programs to be reauthorized together in 2012. This joint sunset date allows for further reauthorizations to continue to balance the incentives and authorities that drive pediatric study. One troubling aspect of the BPCA and PREA reauthorizations is the creation of an internal review committee. Nobody would argue that pediatric populations should not get special consideration within the inner workings of the agency; however, as drafted, the internal review committee conflicts with the current staff functions of the FDA. The Pediatric Medical Device Safety and Improvement Act aims to improve the process for approving pediatric medical devices and encourages research, development, and manufacture of pediatric devices through demonstration grants and incentives. It modifies the human device exemption for medical devices to allow manufacturers to earn a profit for HDE-approved pediatric devices but maintains the requirement that a humanitarian use device is limited to one that treats and diagnoses diseases or conditions that affect fewer than 4,000 individuals in the United States. This is a good policy, which will help foster the development of pediatric devices. Unfortunately, the bill also expands FDA's authority to require companies to conduct postmarket studies of adult devices, even in circumstances in which the manufacturer has no intent to market the device to pediatric populations. Forcing companies to conduct studies on their products for unintended and unapproved use diverts resources that could be used for further innovation, research, and development. Of additional concern is that at this time, many provisions of the bill have never been scored by CBO. The provisions in this bill have a significant impact on the FDA and require a number of changes at the agency that will require significant dollars. Because PDUFA and MDUFMA are based on negotiations between industry and the administration, any changes that impact that careful compromise need to be fully vetted and understood. Unfortunately, at this time we do not have that information. It is clear to all that there are numerous complicated issues involved. Some provisions provide a great benefit, while others may have graver consequences than even the bill's sponsors would intend. It is my hope that as we deal with these issues, we can do so in a manner that is science based and favors patient access over regulatory burden. I ask that the following statement of HHS Secretary Leavitt be printed in the Record.

Mr. GREGG

Mr. GREGG. Mr. President, I believe it is appropriate to respond to the assistant leader on the Democratic side relative to his commentary because this is obviously an issue of significance, probably the most significant issue we face as a nation today in the area of concern for our citizens who are carrying the burden of service and who wear the uniform of America. I do think it is a touch cynical for the other side of the aisle to come to the floor of the Senate and say they are going to support the troops, when only 3 months into General Petraeus's leadership in Iraq they are suggesting that the rug should be pulled out from underneath his efforts. General Petraeus was sent there with an overwhelming vote of this body in support of his efforts to try to bring stability, specifically to Baghdad, and to give the Government of Iraq, which was freely elected--something which the other side of the aisle manages to ignore with a fair amount of energy--to give them the breathing space they need in order to be able to get going and to be able to create stability. A stable Iraq is critical to our national defense, and it is critical to our ability to fight terrorism. A unilateral withdrawal forced upon us by the Democratic leadership of this Congress within the next 3 months--which is the proposal they put into the language of this bill-- will guarantee that Iraq goes into chaos. It will probably guarantee that thousands, tens of thousands of Iraqis will die as a result of genocidal activity or activity that will border on genocide, and that will make the Balkans look like it was minor in comparison to Iraq as far as chaos. It will establish without doubt a client state for Iran, probably partitioned within Iraq. It will clearly create functioning safe havens for al-Qaida, which has sworn, of course, to attack America on American soil, and has already done so and has proven its ability to do this. The fact that after only 3 months of General Petraeus being in the field we would pull from beneath him the ability to support the troops he needs there is really, in my opinion, an act of cynicism. The plan is set up in a manner--the language which was put into this plan is set up in a manner so that the Iraqi Government must meet 16 major goals in restructuring its Government within 2\1/2\ months. My goodness, the Congress of the United States, the Senate of the United States can't pass anything in 2\1/2\ months. Yet we expect the Iraqi Government and Legislature to reorganize its entire structure within 2\1/2\ months? That is the condition put in this bill in order to maintain funds for our troops who are in the field. If the Iraqi Government is unable to meet those conditions, then within 3 months the money is withdrawn from the troops in the field, General Petraeus's flexibility is removed, and he is essentially handcuffed. The commanders in the field are no longer the generals in the field. It is no longer General Petraeus and his colonels and lieutenant colonels, his captains and his lieutenants. The commanders become the leadership of the other side of the aisle. They make the decisions on military action within Baghdad. General Petraeus's hands will be tied behind him, or at least one hand will be tied behind him. Even if the Iraqi Government did the amazing thing of putting in place all these, significant conditions--and there should be conditions, no question, benchmarks for Iraq--these fairly significant conditions in a compressed timeframe, which guarantees they will not be accomplished, but let's say even if that Government were able to succeed in those conditions, then what is the reward for putting in place that type of stability and that type of restructuring? The language in the bill requires that the troops begin to be withdrawn and the money start to be cut off 3 months later. They are giving them a 3- month breathing space of having the support they need and General Petraeus having the support he needs in order to accomplish his goals. The other side of the aisle comes to the floor of the Senate and acts as if these are not significant; that we are not putting in place things which can't be accomplished; that we want to support the troops in the field. Well, read the conditions. The conditions cannot be met, and they are intentionally structured not to be met. Listen to the real language from the other side of the aisle. The majority leader says the war is lost. He wasn't talking just about Iraq. It appears he was talking about the entire war against terrorism, which happens to be a fairly significant statement. It is also obvious that when you make a statement like that, as the leader of the Democratic Party, the most senior Democratic Member of the Senate, one of the most senior Members of the Democratic leadership of the Government of this country, when you say the war is lost, you put your credibility on the line. Quite honestly, if we institute the language as proposed in this bill, which dramatically limits the capacity of General Petraeus and the American troops to succeed in their mission, well, I guess that will probably guarantee the war is lost, so they will have a self- fulfilling prophecy as relates to Iraq. The consequences of that will be catastrophic in the area of death and destruction within Iraq. For us, as a nation and for our national security, should a client state be created for Iran within Iraq, should al-Qaida have free haven in Iraq, the consequences for us could be equally dramatic. In addition, a little point should be made here. The language in this bill, as it is being brought forward, is blatantly unconstitutional. It essentially cedes responsibility for the management of the troops in the field to the legislative branch. Nowhere in the Constitution did the Founding Fathers believe there should be 435 people running military decisions in the field. They had just been through a war. They had been through the revolution, where they had one person running the army in the field, George Washington. They understood that you either put one person in charge or you have chaos in any sort of military action. That is why the Constitution says the Commander in Chief shall be the President, and that the military shall report to the Commander in Chief. The language of this bill, on its face, is clearly unconstitutional because it essentially cedes responsibility for field command over our troops to the leadership of the Senate, the Democratic leadership of the Senate, ironically, which guarantees chaos in the area of order relative to defining and executing the mission as assigned to the troops in the field. You can't say to the American soldier, who is on the ground in Iraq, who is in Baghdad, who is doing their mission, and doing their mission well, very, very well--and General Petraeus has said there is progress occurring there--you can't say to that soldier: A, we are going to take the money away from you to support your mission; B, we are going to give your enemies a defined date when we are going to leave so that your enemies, our enemies, can wait you out and can basically harass you knowing that you are going to withdraw; and, C, that your new commander is the majority leader and the assistant leader of the Senate and the Speaker of the House. We can't say: When General Petraeus gives you a command, you don't necessarily have to listen to him because the people who are going to make the decision as to how you execute your mission aren't in the line of authority of the military or the Commander in Chief; they have suddenly become the legislative branch of the Government. The language in this bill is structured to accomplish one thing, and that is to assure defeat in our efforts to try to bring about a stable and responsible Government in Iraq. All you have to do to confirm the logic of that view and the accuracy of that view is to return to the words of the majority leader. The war is lost, he said. In order to assure that happens, they have brought forth the language in this bill which guarantees that our enemy will know when we are going to leave; that the freely elected Government of Iraq will not get the support it needs to survive as a stable and responsible Government; and that our soldiers will not know who is commanding them, but they will know they are not going to get the necessary support to accomplish their mission. That is defeat. Mr. President, I yield the floor.

Mr. GREGG

Mr. GREGG. Madam President, let me step over to the chair from which the junior Senator has been speaking. I wanted to speak about a couple of issues. The first issue I want to talk about is the recent report which came out yesterday from the Medicare trustees which said that the Medicare trust fund is in dire straits. The Medicare trustees are required under law to report to the Senate and to the Congress and to the American people what the economic status is of the trust fund as it looks out into the future. A lot of us have been talking for a long time about the problems with the entitlement programs we have--specifically Medicare, Medicaid, and Social Security--and the fact that these three funds are headed toward a meltdown, which is going to take with them the economy of this country. The practical effect of these three funds in their present spend-out situation is that they have approximately $70 trillion of unfunded liability--$70 trillion over their actuarial life. Now, $1 trillion is a number that a lot of us have a problem comprehending. To try to put that number into perspective, if you took all the taxes paid in the United States since we became a country, I think we have paid about $46 trillion in taxes. If you take the entire net worth of America--all our assets, including all our cars, all our homes, all our stocks--that, again, is in the $45 trillion to $50 trillion net worth. So what we have on the books as a result of the projected costs of the Medicare, Medicaid, and Social Security system is a cost that exceeds all the taxes paid in the history of this country and exceeds the net worth of this country. Why is that? Why are we confronting this problem? Well, it is basically a function of demographics. The postwar baby boomer generation, of which I am a member, the largest generation in American history, is beginning to retire. By the year 2020, 2025, the number of retired citizens in this country will double from the present number who are retired today. It will go from about 35 million retired citizens up to about 70 million retired citizens. The number of people working to support those retired citizens will drop commensurately. So both Social Security and Medicare, and to some extent Medicaid, were programs designed with the concept that there would be a lot of people working for every person retired. They were essentially pyramids. In fact, in 1950, there were about 12.5 people working for every person retired. So 12 people were paying into Social Security for every 1 person taking out. Today, there are about 3.5 people paying into Social Security and Medicare for every one person taking out. Social Security is running into surplus. But as this baby boom generation retires, that number changes radically. We go from those large numbers paying in and a small number taking out to a large number taking out and a small number paying in. There will be about two paying in for every one person taking out by about 2025. We go from a pyramid to a rectangle and the system cannot support itself. This chart reflects the severity of the problem. These three programs--Social Security, Medicare, and Medicaid--as a percentage of spending of the GDP, by the year 2025, or 2028, will absorb almost 20 percent of GDP. Why is that a problem? Today, and historically, the Federal Government has only spent 20 percent of gross national product. So the practical implications are that by 2025, or 2028, the total spending of these three programs alone will absorb all of the money that has historically been spent by the Federal Government, which means that nothing else could be spent--no other money--on things such as national defense, the environment, and education. It would all be going to these three programs, assuming you maintain the Federal share of the GDP at its present level. Things get worse, unfortunately, as the baby boom generation accelerates into the 2030 period, when paying for those programs alone reaches 27, 28 percent of GDP by about 2040. Obviously, it is not a sustainable situation. Obviously, it is a situation where if we continue on this path, we would essentially be saying to our children that we are going to subject you to a cost that far exceeds anything you could afford and basically hit you with a tax burden that would essentially mean that you--our children and grandchildren--in order to support this retired generation, would be unable to send your children to college, buy your home, purchase your cars, live your lifestyle in the manner our generation has been able to live. The money is going to have to be spent by taking taxes out of your pocket. A lot of us have been talking about and some people have even tried to address this issue--specifically, the administration. The biggest part of this problem is not Social Security, ironically; it is Medicare. Now, the Medicare trustees yesterday made the point once again that if we don't do something and start to do it fairly soon in addressing the Medicare problem, we will bankrupt our children and our children's children's future with the cost of this program. This was their obligation as trustees. They are supposed to look at it objectively, and they have. They said this program is headed toward about $35 trillion of unfunded liability, that that is a huge number and we need to correct that. Ironically, and fortunately, a couple of years ago we put into place a law that requires that when the Medicare Program starts to go in the direction of insolvency at a rate that means it is going to take a significant amount of money from the general taxpayers' pockets versus money from the wage earner, as they pay their hospital insurance, that at that point the Federal Government is supposed to act. The way it works is this: If more than 45 percent of the Medicare trust fund is being supported by general fund dollars, what does that mean? Well, the Medicare trust fund theoretically was supposed to be the Parts A and B, the hospital and doctor part; that was supposed to be supported primarily by insurance premiums being paid on your hospital insurance tax taken out of your salary every week. But, of course, under the Part B program, we have never done that. We have ended up subsidizing that program with general funds instead of having it come out of the payroll tax. What this law says is when those general fund subsidies exceed 45 percent of the total cost of the Medicare system, it is an excessively dangerous situation and it has to be addressed. If this happens 2 years in a row, where the cost of Medicare is exceeding 45 percent of the general funds coming from the Federal Treasury, that means people's income taxes, the taxes people pay every day--then at that point the administration is supposed to send up--whatever administration is in power--a proposal to correct the problem. That is what the Medicare trustees concluded. Last year, they concluded the trust funds were in severe strain and we are going to hit the 45- percent level. This year, they have concluded the trust funds are under severe strain, and it is going to hit the 45-percent level. The practical effect of that is now the administration is required, prior to the next budget, to send up a proposal to correct the problem. Unfortunately, under the law, even though the administration is required to send up such a proposal, the Congress is not required to act on it. Ironically, the administration, in an act of true fiscal responsibility to our children and our children's children, this year sent up a proposal to try to correct this problem, or at least begin to correct the problem, although not fully. They suggested this year that there should be two adjustments in the Medicare trust fund, neither of which would have a significant impact on beneficiaries. In fact, for the most part, it would have absolutely no impact on the beneficiaries, and unless you were a beneficiary in a very high-income situation, with more than $85,000 of personal income, or if you are married and have more than $160,000 of joint income, it would not affect you at all. There are two proposals that insulate beneficiaries. The first proposal was that we do an accurate reimbursement to providers. Under the present law, the health care professionals have estimated that provider groups are getting about a 1.2 percent extra payment over what they should be getting as a result of the fact that there have been new efficiencies introduced into the provider repayment systems, through technology primarily, that have reduced costs, but that reduction in cost has not been reflected in the reimbursement. So we are actually paying more than we should be paying in these accounts. The administration didn't suggest that they capture all that money. They suggested let's take half of that--leave the provider groups with half of that money--I don't want to use the word windfall, but as a bonus to them. Let's take the other half and use it to try to bring the Medicare trust fund into some sort of solvency. That was the first proposal of the administration. It was a reasoned proposal in light of the fact that all of the professional groups have concluded that this overpayment is occurring. The second proposal they made was that people getting Part D, the drug benefit--if they are very high-income individuals--should pay part of the premium for that drug benefit. Under the Part D premium, there was no contribution required, unlike Part B, which has a means test-- very limited, but it has one. Part D did not. The administration said, listen, if you are a retired Senator, you should not be subsidized by somebody who is working in a restaurant, or in a gas station, or on a manufacturing line, which is what happens today. The way the law works today, a person who is out there working for a living, maybe trying to raise their children, is actually having to pay to subsidize retired Senators who are getting Medicare or, for that matter--I don't want to pick on Bill Gates' father as an example, but Bill Gates' father, or Warren Buffet--millionaires and billionaires--are being subsidized by people who are making an everyday wage and trying to make ends meet for their families. So the administration suggested if you have more than $80,000 of personal income as an individual, or $160,000 of joint income as a family, then you should be required to pay a portion--just a portion--of your Part D premium. That is a very reasonable approach. Those two proposals together would have reduced the outyear insolvency of the Medicare trust fund by almost a third. It would have taken tremendous pressure off of the trust funds, especially the Medicare trust fund. They were both rejected out of hand by the other side of the aisle. They were demagoged. People came to the floor and said this would savage Medicare, would destroy Medicare, that it was going to undermine the rights of senior citizens to get Medicare. Outrageous statements were made on the other side of the aisle, and they continue to be made relative to these proposals that were reasonably benign, that didn't affect beneficiaries, and would have actually put Medicare on a solvency footing instead of insolvency, which is where it is headed now. Now the trustees have done their job and said, the administration is absolutely right. If we don't correct this problem, we are going to have a Medicare system that cannot be afforded by our children and grandchildren. As a result, we will have a major contraction in the system. Yet even though the Medicare trustees have said that--and they are a pretty objective group and they are required under the law to be so--we have the leading Senator on the other side, Senator Schumer, taking the position that that is just politics, that Medicare is fine, and instead of peddling an ill-conceived Social Security privatization plan that has already been overwhelmingly rejected by the American people, the administration should turn its attention to strengthening Medicare. Where was Senator Schumer when this amendment was offered on the floor? He voted against it. When the administration suggested something that was responsible, such as making high-income individuals pay a part of their premium on Part D, Senator Schumer rejected it. When this administration came forward and suggested we should reimburse providers honestly and directly and fairly but not overly reimburse them--not too much overly reimburse them--and take the savings and use it to make the Medicare system more solvent, where were Senator Schumer and his colleagues? They rejected that. Now they have the audacity to come forward and attack the Medicare trustees, whose job it is to present the facts as they are, and the facts are the Medicare system is going into bankruptcy, and him saying that is politics and trying to hyperbolize it into privatization, which has nothing to do with Medicare--how outrageous and irresponsible for one generation not to face up to the problems it is giving the other generation. Senator Schumer is a baby boomer, as I am. It is our problem we are passing on to our kids. We are the problem. We exist and we are going to retire in massive numbers, and then we are going to turn the bill over to our children. We have a responsibility as a generation but, more importantly, we have a responsibility as policymakers in the Senate to act, especially when the Medicare trustees have told us the problem is there, it is legitimate, and it is pretty obvious to anybody because we are all alive. We have a bill, a law on the books, that says specifically this problem must be addressed when the Medicare trustees, 2 years in a row, have determined there is a problem, that 45 percent of the General Treasury or more is being used to support Medicare, and we need to adjust the system to effectively address that issue and to make the system solvent and affordable for our children. And especially we should act when reasonable proposals are brought to the floor, proposals that have no maliciousness to them, have no political agenda to them, have no purpose other than putting in place policies which are going to make the system more solvent and more affordable. Yet they are rejected--rejected with partisan rhetoric of the worst order because it has nothing to do with the Medicare plan; privatization is thrown at the suggestion that we correct the Medicare system by making rich people pay more of their costs by getting the reimbursement formula correct. That is subject to pejorative privatization by the Senator from New York, with no proposals at all--none--from the other side of the aisle to correct this problem which is looming. Other than fighting terrorism and the threat of an Islamic fundamentalist detonating a weapon of mass destruction in one of our cities or somewhere in America, there is probably no problem which is more significant to the future of this Nation than the pending fiscal meltdown which we are going to confront as a result of the cost of these programs which we put on the books and which, in their present process, cannot be afforded. If we just wait until we arrive at the cliff--and we will be going pretty fast when we reach that cliff; we are not going to be able to stop--and only try to deal with it then, what will be our options? They will be so few and they will be so painful that they will have a dramatic and dislocating effect not only on the generation that has to pay the costs but on the generation that receives these benefits. We can, today, put in place changes which are gradual, which are reasoned, and which will accomplish the type of adjustments that are necessary to make this program work--work well for the beneficiaries so we have a strong, solvent Medicare system and work well for those who pay the taxes to support them. But if every time the issue is raised that there has to be legitimate action in this area, especially when it is being raised by the Medicare trustees, who do not have a political agenda but are simply reporting a factual assessment of an actuarially existing fact pattern--which is there are so many people alive today who are baby boomers that when they retire, they are just going to basically overwhelm the system--if every time those red flags are raised, they are going to be responded to by the leadership on the other side with pejoratives and partisanship and the use of phrases such as ``privatization,'' then we are not going to accomplish anything around here. All we are going to see is that we can deal with the next election but we can't deal with the next generation. You might win the next election, which I guess is the purpose of Senator Schumer, but it is going to leave our kids one heck of a mess, and seniors who retire in the 2020 period are going to also be in a pretty horrific way. Total irresponsibility in the remarks of the Senator from New York in response to the very responsible warnings brought forth by the Medicare trustees. On a second issue to which I wish to speak briefly--actually, not so briefly--which is the issue before us, the competitiveness bill, this competitiveness bill is well-intentioned. We all know that we as a nation are confronting some very severe issues relative to our capacity as a culture to compete in this world and be successful. We also know that the essence of our capacity to compete is tied directly to our capacity to produce an intelligent, thoughtful, knowledge-based society. We are, without question, a country where success in the global competition is not going to be built off of excessive manpower or a dramatic amount of resources. It is going to be built off of having brighter and smarter people who add value to products and produce items that people around the world need and want, and they are inventive and creative. The great genius of America is our creativeness and our inventiveness. So the goal of this proposal is appropriate, genuine, and well-intentioned, but the question becomes whether the execution of that goal, on balance, accomplishes its purpose. The Congress has this tendency--and I have seen it innumerable times--when it sees a problem, to create a plethora of different little programs, most of them not too big, all across the spectrum, which are basically the ideas of a bunch of different people who came to the table, but because there wasn't one cohesive idea that was dominant, everybody's idea got into play. I guess that is the problem when you have the committee designing the horse. That famous story--if a committee designs a horse, you end up with something that doesn't look like a horse. That is what happens when you have a proposal which puts a large chunk of money on the table and then says: Here, let's spend it. That, unfortunately, is where this proposal ends up to a large degree. Ironically, this proposal has a lot of specific initiatives in it which we already tried before or which are duplicative programs we have tried before, the irony being pretty apparent in items such as the Manufacturing Extension Program, which, during the first few years of this administration, it sent up proposals to basically zero it out. That is a program the purpose of which was to create these manufacturing extension centers around the country, which we did--they are called the Hollings centers--but we also understood they would be self-sustaining centers once the Federal Government got them up and running. We now find they are not, so this bill essentially continues them. Also, it basically restarts something called the ATP program. It gives it a new name and title. It creates a brandnew series of education initiatives in the Department of Energy which are pretty much duplicative of initiatives in the Department of Education, and some education initiatives in the National Science Foundation. It creates new directives to the NOAA which are almost identical to what NOAA already does but in addition are completely duplicative of what the Oceans Commission concluded should be done and which was put into action about 2 or 3 years ago as a result of the Oceans Commission. As well-intentioned as this bill may be, in the end what it does is it increases spending by $16 billion. That is the proposal: $16 billion over 4 years. What it buys is a whole lot of little initiatives all over the country which are the interests of this Senator or that Senator but which in their totality have very little cohesion to them, direction to them, or purpose to them and, as a practical matter, are not paid for. Here is the situation we confront. It is not as acute as the issue I was talking about before in the Social Security entitlement accounts, but the situation is this: We are spending a lot of money we don't have. In the nondefense discretionary accounts, we have been fairly disciplined over the last few years, but we are still spending a lot of money we don't have. What this proposal says is, even though we are spending a lot of money we don't have, we are going to spend more money we don't have because these are feel-good initiatives, and if we just sprinkle a little crumbs all over the place, we can put out good press releases and feel content that we have addressed the competitiveness question in this country. The competitiveness question in this country is not going to be dramatically improved by spending $16 billion we don't have and then sending the bill to our kids. If we want to improve competitiveness in this country, we should be doing fairly substantive things that will impact a lot of different areas and won't necessarily cost us too much money. We might start, for example, with tort reform, where we see a massive amount of money spent inefficiently in this culture because we have to fear lawsuits that are, quite honestly, in many instances frivolous and that end up causing people to do defensive activities. Correct the tort system, and that would create a fair amount of efficiency and productivity in this economy. Correct the regulatory morass we have. The fact is that to can get an efficient powerplant on line--which we need a lot of in this country if we are going to have an efficient economy--it literally takes years and years of regulatory hoops to jump through, many of which are duplicative, before you can get a decent powerplant up and running. When was the last time a nuclear powerplant was brought on line in this country? Well, I think it was 1988. Nuclear power is by far the most efficient way and the most environmentally sound way to bring large amounts of power online. Yet we can't license nuclear powerplants. Senator Domenici, in a recent bill he produced in this Senate, which didn't pass the Congress, has tried to streamline the effort. Hopefully, it will result in more powerplants coming on line. The simple fact is that we regulate ourselves into noncompetitiveness. So if we want to correct the issue of competitiveness, let's address some of these regulatory issues. They don't have to be broad. It doesn't have to be a broad exercise. It can be reasonably narrow. In the area of immigration policy, we know there are very bright, capable people around this world who want to come to America and be productive. As Bill Gates described them in testimony before the HELP Committee, he looks at them as job-setters. When he brings one of these really bright people from someplace else in the world and puts them to work at Microsoft, the way he sees that is that person is generating jobs. It is the opposite of outsourcing; it is insourcing. If you bring somebody in with special talents and abilities, especially in the science and mathematics areas, that person becomes a job center around which other jobs are created because of their creativity and their abilities. And what do we do to those folks? We tell them they can't come to the United States even though they want to, even though they have jobs here. We say: I am sorry, we can only have 65,000 people with that talent in this country. That is it--even though there may be 150,000 or 200,000 who would like to come to this country and all of whom could come into this country from the standpoint of being safe, sound, good contributing citizens and all of whom, if they were here, would probably be giving us economic added ability which would create jobs. It doesn't cost us any money to bring these people in. In fact, it gives us more economic activity, which gives us more jobs, probably more tax dollars from these people, generating more taxes to the Federal Treasury. That is something we can address if you want to improve the productivity of this Nation. The idea that the Federal Government is going to sprinkle $16 billion around to various programs--and it is sprinkled all over, a lot of programs here, many of which either existed before or are being recreated--and it is going to result in significantly more competitiveness--well, it might work, but the only way you could justify it is if you paid for it by reducing $16 billion somewhere else in inefficiencies before you move down this road. The irony of this is we have done it so many times before, and it hasn't worked because the Federal Government can't command and control the economy. That is why it doesn't work. I was Governor when President Bush 1, who was very concerned about education and wanted to be known as the education President, called a conference of Governors together--the first time it happened since Lincoln--I believe in Charlottesville, VA. The purpose of the conference was to figure out how we as a nation were going to capture and reform the education agenda. This was in 1989. I was Governor at the time. Do you know what the first conclusion of that Governors conference was? I think we came up with 10 directives. The first conclusion was that we would lead the world in math-science education in the elementary and secondary school systems by the year 2000 because at that time we were 14 out of 16 countries of the industrialized world. I heard Senator Kennedy a while ago doing his presentation on this issue on the Senate floor, and he put up a chart. I think he said we were 24th out of 24 industrialized countries. We actually lost ground if that is true. I don't know what the number is, but we are certainly not at the top. Yet throughout this period we have created program after program after program. There is an initiative in here for the National Science Foundation to reenergize its directorate on education. I was here the last time we did that. I was in the House. It is a good idea, especially if you have the funds to pay for it. But the fact is, it is a sprinkling effort. The marketplace, in creating an atmosphere where there is competition, is the way you make yourself more competitive. Spreading money over a whole plethora of new programs might produce some results, but unless you pay for it, in the end it is going to end up costing us significantly. It is going to end up costing the next generation significantly. So as well-intentioned as this proposal may be, I have serious reservations about its effectiveness. I would probably be willing to support it if it were paid for, but it isn't paid for, and it is just going to add $16 billion to the debt. Now, we will hear from others that this is just an authorized number, but I can assure everyone that all we will hear about once this authorized number is passed is that we need to appropriate the money to meet those needs. So that is a straw dog argument. If you put on the table that you are going to spend $16 billion more, that you don't have, the odds are the Congress is going to spend $16 billion once it gets authorized to do so. At this time I understand we are not taking amendments, but if we were in the process of taking amendments, I would offer an amendment to do something substantive in the area of competition and making our country more viable, and that would be to lift the cap on the H1B visa program from 65,000 to 150,000. A very simple action. It would bring in a large group of people who would be constructive citizens with science and technology backgrounds that we need. We would not be replacing people who are in jobs, but we would actually be creating more jobs--probably a lot more jobs in the arenas in which they work--and that would actually have an immediate impact on competitiveness in this country. We wouldn't have to wait another 10 years to have another conference by another Presidency or another Congress that says we are not caught up in the competitiveness area and therefore we have to address math and science education. We would actually have the people here next year who would have the math and science skills and who would be able to contribute constructively. So that would be the amendment I would offer, and I certainly hope to have the opportunity to offer that amendment before this bill leaves the floor. Mr. President, I yield the floor.

Mr. GREGG

Mr. GREGG. Mr. President, I rise today along with Senator Lautenberg to introduce the Coastal and Estuarine Land Protection Act. We are introducing this much needed coastal protection act along with Senators Cochran, Warner, Wyden, Kennedy, Lieberman, Snowe, Boxer, Kerry, Menendez, Cantwell, Feinstein, Reed, Murray, Collins, and Sununu. In addition, this legislation is supported by the Trust for Public Land, The Nature Conservancy, Association of Fish and Wildlife Agencies, the Land Trust Alliance, The Conservation Fund, Restore America's Estuaries, The Ocean Conservancy, American Fly Fishing Trade Association, Society for the Protection of New Hampshire Forests, National Estuarine Research Reserve Association, Association of National Estuary Programs, Coastal States Organization, New Jersey Audubon Society, and the NY/NJ Baykeeper. The Coastal and Estuarine Land Protection Act promotes coordinated land acquisition and protection efforts in coastal and estuarine areas by fostering partnerships between non-governmental organizations and Federal, State, and local governments. As clearly outlined by the U.S. Commission of Ocean Policy, these efforts are urgently needed. With Americans rapidly moving to the coast, pressures to develop critical coastal ecosystems are increasing. There are fewer and fewer undeveloped and pristine areas left in the Nation's coastal and estuarine watersheds. These areas provide important nursery habitat for two-thirds of the Nation's commercial fish and shellfish, provide nesting and foraging habitat for coastal birds, harbor significant natural plant communities, and serve to facilitate coastal flood control and pollutant filtration. The Coastal and Estuarine Land Protection Act pairs willing sellers through community-based initiatives with sources of federal funds to enhance environmental protection. Lands can be acquired in full or through easements, and none of the lands purchased through this program would be held by the Federal Government. This bill puts land conservation initiatives in the hands of State and local communities. This new program, administered by the National Oceanic and Atmospheric Administration, would provide Federal matching funds to states with approved coastal management programs or to National Estuarine Research Reserves through a competitive grant process. Federal matching funds may not exceed 75 percent of the cost of a project under this program, and non-Federal sources may count in-kind support toward their portion of the cost share. This coastal land protection program provides much needed support for local coastal conservation initiatives throughout the country. In New Hampshire, we have worked collaborative1y with local communities, environmental groups, willing sellers, and the State to conserve lands around Great Bay, Sagamore Creek, Massacre Marsh, Hurd Farm, Moose Mountain, Winnicut Headwaters, Marden Woods, Sleeper Wetlands, and the Piscassic River Greenway. These lands are home to a wide variety of plants and animal species that are particularly threatened by encroaching development and environmental pollutants. By working with local communities to purchase lands or easements on these valuable parcels of land, New Hampshire has been able to successfully conserve the natural and scenic heritage of this vital estuary. Programs like the Coastal and Estuarine Land Protection program will further enable other states to participate in these community-based conservation efforts in coastal areas. This program was modeled after the U.S. Department of Agriculture's successful Forest Legacy Program, which has conserved millions of acres of productive and ecologically significant forest land around the country. I welcome the opportunity to offer this important legislation, with my good friend from New Jersey, Senator Lautenberg. I am thankful for his leadership on this issue, and look forward to working with him to make the vision for this legislation a reality, and to successfully conserve our coastal lands for their ecological, historical, recreational, and aesthetic values.

Mr. GREGG

Mr. GREGG. Mr. President, I rise today along with Senator Lautenberg to introduce the Coastal and Estuarine Land Protection Act. We are introducing this much needed coastal protection act along with Senators Cochran, Warner, Wyden, Kennedy, Lieberman, Snowe, Boxer, Kerry, Menendez, Cantwell, Feinstein, Reed, Murray, Collins, and Sununu. In addition, this legislation is supported by the Trust for Public Land, The Nature Conservancy, Association of Fish and Wildlife Agencies, the Land Trust Alliance, The Conservation Fund, Restore America's Estuaries, The Ocean Conservancy, American Fly Fishing Trade Association, Society for the Protection of New Hampshire Forests, National Estuarine Research Reserve Association, Association of National Estuary Programs, Coastal States Organization, New Jersey Audubon Society, and the NY/NJ Baykeeper. The Coastal and Estuarine Land Protection Act promotes coordinated land acquisition and protection efforts in coastal and estuarine areas by fostering partnerships between non-governmental organizations and Federal, State, and local governments. As clearly outlined by the U.S. Commission of Ocean Policy, these efforts are urgently needed. With Americans rapidly moving to the coast, pressures to develop critical coastal ecosystems are increasing. There are fewer and fewer undeveloped and pristine areas left in the Nation's coastal and estuarine watersheds. These areas provide important nursery habitat for two-thirds of the Nation's commercial fish and shellfish, provide nesting and foraging habitat for coastal birds, harbor significant natural plant communities, and serve to facilitate coastal flood control and pollutant filtration. The Coastal and Estuarine Land Protection Act pairs willing sellers through community-based initiatives with sources of federal funds to enhance environmental protection. Lands can be acquired in full or through easements, and none of the lands purchased through this program would be held by the Federal Government. This bill puts land conservation initiatives in the hands of State and local communities. This new program, administered by the National Oceanic and Atmospheric Administration, would provide Federal matching funds to states with approved coastal management programs or to National Estuarine Research Reserves through a competitive grant process. Federal matching funds may not exceed 75 percent of the cost of a project under this program, and non-Federal sources may count in-kind support toward their portion of the cost share. This coastal land protection program provides much needed support for local coastal conservation initiatives throughout the country. In New Hampshire, we have worked collaborative1y with local communities, environmental groups, willing sellers, and the State to conserve lands around Great Bay, Sagamore Creek, Massacre Marsh, Hurd Farm, Moose Mountain, Winnicut Headwaters, Marden Woods, Sleeper Wetlands, and the Piscassic River Greenway. These lands are home to a wide variety of plants and animal species that are particularly threatened by encroaching development and environmental pollutants. By working with local communities to purchase lands or easements on these valuable parcels of land, New Hampshire has been able to successfully conserve the natural and scenic heritage of this vital estuary. Programs like the Coastal and Estuarine Land Protection program will further enable other states to participate in these community-based conservation efforts in coastal areas. This program was modeled after the U.S. Department of Agriculture's successful Forest Legacy Program, which has conserved millions of acres of productive and ecologically significant forest land around the country. I welcome the opportunity to offer this important legislation, with my good friend from New Jersey, Senator Lautenberg. I am thankful for his leadership on this issue, and look forward to working with him to make the vision for this legislation a reality, and to successfully conserve our coastal lands for their ecological, historical, recreational, and aesthetic values.

Mr. GREGG

Mr. GREGG. Mr. President, I want to join my colleagues in recognizing Senator Ted Stevens upon this milestone of his serving longer in this body than any other Republican Senator. This is a significant moment and our former President pro tempore of the Senate has set an impressive, historic accomplishment. I think this is most significant not because we are recognizing Ted Stevens for his length of service in this body, but rather because we are recognizing what Ted Stevens has accomplished in this institution as a U.S. Senator. There are few individuals who can equal his service and accomplishments as a true leader. As Alaska's Senior Senator, his steadfast and tenacious advocacy of his State and constituents is widely known. His career transcends Alaska's transition from a frontier and U.S. territory to an important and vibrant State. After earning his law degree at Harvard University, Ted Stevens moved to the heart of Alaska, the Chena River and Fairbanks, where he became a prosecutor and a U.S. attorney in the early 1950s. Ted quickly became a leader in the statehood movement and in 1956 he served his first assignment in Washington as the Department of Interior's legislative counsel and later Solicitor General. He later returned to Alaska and was elected to the Alaska House of Representatives where he became the majority leader and speaker pro tempore. In 1968 he was appointed to fill Senator Bartlett's seat in the U.S. Senate. He was elected to retain that seat in 1970 and has been a part of this institution ever since. Ted is a forceful and dedicated advocate for the people of Alaska. He has brought about significant economic development, be it clearing the way for North Slope petroleum development and the construction of the Alaska pipeline, the upcoming natural gas pipeline, countless small airports and aviation improvements, or overall basic infrastructure. He has been a tenacious advocate for the Alaskan fishing industry, including creation of the Exclusive Economic Zone to allow the sustainable harvest of the largest and most valuable fishery in the United States. It is not by chance that the basic law governing fisheries in this Nation is called the Magnuson-Stevens Act. Like most Alaskans, Ted is a true sportsman with a rich appreciation for the unique and special environmental resources of his State. Men and women fishing on the Kenai River or trolling off Cape Chacon or other waters need just look next to them, through sunshine or inclement weather, to see the Senior Senator from Alaska fishing for kings, or reds or silvers or halibut. Ted Stevens is an American Senator who has made tremendous contributions to U.S. security policy and defense posture since the 1960s. Ted Stevens left college to fight in the Second World War. Senator Stevens served in the Army Air Corps and flew support missions over the Himalayas to General Stillwell and our forces in the China/Burma theater. Since 1980, Senator Stevens has served as either chairman or ranking member of the Senate's Department of Defense Appropriations Subcommittee. The aircraft, the ships, the missiles, the tanks and combat vehicles, and the weapons systems that are manned by our dedicated men and women in the U.S. Armed Forces have been developed, procured and supported under Ted Stevens's steady and pragmatic leadership. The training, pay and support of our personnel have been carried out by programs that he championed and shepherded through the Congress. The ``operating tempos'' and readiness levels are items of personal interest for him. He is a champion of research and development to ensure our Nation's leadership is not diminished, and that America remains prepared to take on threats to its national security. As an appropriator, Ted Stevens has often focused on the business of national defense. Like others, he has been a champion of the ``top line'' for the Defense Budget, seeking to ensure that national security is remains a priority and receives appropriate funding. He has also dedicated long hours to ensuring that funds are not wasted and that priorities are addressed. Finally, Ted Stevens should be recognized for his work as a legislator in this body. Ted Stevens has authored and championed legislation far too numerous to list. He has left his mark on so many laws, policies and programs that benefit Americans across this Nation. For example, Ted Stevens has played a leadership role in our national space programs, and it was his personal effort that allowed NASA to recover from the Challenger disaster in 1986. He helped create the National Oceanic and Atmospheric Administration and has been the sponsor or cosponsor of countless significant pieces of environmental legislation. He has championed remote sensing satellites that protect our Nation from severe weather and is the author and foremost supporter of our Nation's ocean exploration program. Ted Stevens has also left his mark on every piece of telecommunications legislation over the past 20 years. He has put forward legislation that provides for our airports and air transportation systems, and terrorism countermeasures. He is a strong advocate for the Coast Guard and has overseen fleet, aircraft, and system modernization during the 1980s and 1990s. Ted Stevens has been a leader on issues as diverse as reform of U.S. civil service retirement programs, to the rules governing the operation of the U.S. Senate. So often it is Senator Stevens's style to be the workhorse and moving force behind legislation, but to let others receive the credit. He is a Senator who pulls up his sleeves and works and he is a man of his word. Ted is a dedicated family man--to his wife Catherine and his daughter Lily, and his children from his first marriage to Ann Stevens. Ted Stevens is a Senator who lives every day to the fullest. He is tireless. So Mr. President, it is very appropriate that the Senate convene here today to recognize and congratulate our Republican President pro tempore, the vice chairman of the Commerce Committee and the former chairman of the Senate Appropriations Committee. We are here today to recognize the length of his service and the accomplishments of his Senate service.

Mr. GREGG

Mr. GREGG. Yes. The term ``safe importation'' means importation only from countries with strong safety laws. The additional language ``with strong safety laws,'' which was included in last year's budget, was redundant, but the absence of those words does not alter the meaning, in my opinion. ``Safe importation'' refers to the importation of prescription drugs from countries that require the review of drugs for safety and effectiveness by an entity of the government of the country; that require the methods used in and the facilities and controls used for the manufacture, processing, and packing of drugs in the country to be adequate to preserve their identity, quality, purity, strength, and efficacy; that require the labeling and promotion of drugs to be in accordance with the approval of the drug and whose valid marketing authorization system is equivalent to the systems in the United States.

Mr. GREGG

Mr. GREGG. Mr. President, I begin by returning the courtesies of the chairman and doing it with sincerity. The chairman and his staff have been gracious and fair with us and, obviously, they are always professional. It is a pleasure to work with him and his staff. We do, obviously, have philosophical differences, but hopefully it is a reflection of how this place should work, which is we do it professionally, we don't game each other, we don't yell at each other-- sometimes we yell at each other--we basically air our views, make our points, go to our votes, and allow everybody to get their 2 cents in. That is the way this place should work, and it works because the chairman is courteous enough to allow us to accomplish that. I thank him for that and his staff. They have done a great job here, as well as mine. I do agree the country needs a budget. That is critical. But regrettably, the budget he has brought forward is not a good budget for this country. It is a budget that is inconsistent in many areas, but at its essence is the fact that it spends a lot more money, grows the size of the Government, increases taxes a great deal, increases the debt a great deal and, regrettably, does not address the most essential issue we face today, which is the fiscal meltdown this country is going to face when we put on our children the cost of the Government as we head into the retirement of the baby boom generation. This chart reflects that situation. It is a little outdated because it was done earlier, and we don't have a chart machine like the chairman, but it essentially captures the concept that this budget has $700 billion in tax increases. That is the one number which is wrong on this chart because of the Baucus amendment being adopted--$700 billion of tax increases. That is the largest tax increase in the history of the country. There is $144 billion minimum in nondefense discretionary spending, $2 trillion of new debt, and it does nothing in the entitlement area. The inconsistencies in this budget are palpable. In the tax area, for example, this budget, as I mentioned, will be the largest tax increase in the history of the country and will take us down the road toward what is essentially a European tax system where essentially we are going to be looking at a total tax burden on the American people that will head toward the tax burden of the nation of France. When this budget reaches its end, it will be about a 19-percent to 19.5-percent tax burden on the American people. Historically, the Federal Government tax burden has been about 18.2 percent. That is a huge increase. The chairman holds up these charts which show the lines are very close between the President's tax increases and his tax increases. But his tax increases, as he says, recalculated now are about 2 percent higher than the President. Two percent is real money when you are talking a base of $3 trillion. In fact, 2 percent represents approximately a little more than a quarter of a trillion dollars in new taxes above what the President would have suggested. Those are huge tax increases which the American people are going to have to bear. The concept that keeps being put out here, that these are not going to be tax increases, that they are going to be found behind a curtain somewhere, is simply not defensible. It doesn't pass what I call the duck test. It is ducking the issue, basically. But it doesn't pass the duck test; that is, if it looks like a duck, walks like a duck, and talks like a duck, it must be a duck. When you put $700 billion of new taxes into a budget, you are talking about raising taxes dramatically, you are talking about increasing taxes on working Americans dramatically, and that is what this budget does. In the pay-go area, this budget is also totally inconsistent. It says we are for pay-go. In fact, pay-go has become a solemn oath of the other side of the aisle. I read a New York Times editorial the other day that says pay-go is wonderful. Somebody tell the New York Times that the Democratic leadership, under this budget, has exempted most of their favorite programs from pay-go. They have pay-go for programs that maybe the Republican side of the aisle would support, such as not allowing taxes to increase--yes, they apply pay-go to that issue. But when they have their programs they think are important, they don't apply pay-go to it. In fact, they specifically exempt it. For example, the agriculture language is exempted from pay-go. It looks as if SCHIP may be exempted from pay-go. The Baucus tax proposal which came to the floor was exempted from pay-go. The AMT amount in this bill is exempted from pay-go. The simple fact is, pay-go has become Swiss cheese-go under this bill. There is no relevance at all because it is an arbitrary effort to keep one side from doing what they philosophically agree with while the other side ignores it or basically overrules it for what they like to do. The argument is that they haven't increased spending that much. Well, $144 billion in nondefense discretionary spending is a lot of money when you put it on top of the base. That is a big number. At least in New Hampshire it is a big number. I mean, $144 billion would run the State of New Hampshire for probably 20 years. Yet they claim it is not a big number. Then there is no talk again of the inconsistency in this, there is no talk about the fact that there are over 27 reserve funds representing a $200 billion cost in new programs should they be instituted. That is a growth of the Government--which, I am sure, not all of those will be instituted, but the game plan is there to institute them--$200 billion of potential expansion in the size of the Government. They take the position that they have added other programs by using the 920 account. There was an interesting debate yesterday where the chairman of the committee said to the Senator from Minnesota: We can't use 920 to address the extension of renewable tax credits relative to wind energy and issues such as that because that would cut veterans and it would cut health care and education. But he failed to mention to the Senator from Minnesota that there was already about $38 billion of the 920 account in here. Mr. President, 920 is a euphemism for, well, we really don't know how we are going to pay for this, so we are going to use the 920 account, and that is allegedly a cut across the board. So there is another $40 billion of spending in this bill that probably, in the end, is going to occur and not get paid for. There are huge expenditures, huge expansion in the size of the Government, tremendous growth in the size of the Government in this bill. Then we have entitlement accounts. The chairman of the committee continues to allege he has $15 billion in entitlement savings in this bill. That is an impossible statement to make unless you are only willing to look at one part of the bill because in the other section of the bill, they spend $50 billion in new entitlement programs. So you can't claim you are saving money when you are expanding entitlement programs and not net the two out. It is totally inconsistent. This bill expands entitlement spending. It does not restrict entitlement growth. Ironically, it does it in a way that makes those programs probably not subject to pay-go when they are expanded. This is the biggest failure of this bill. The spending is pretty bad and the taxes have improved a little, but basically this is the biggest failure of this bill, the failure to address what the chairman has talked about--I agree with his discussions, I agree with his hearings-- has talked about the most severe problem we face as a nation; that is, the fact that when this baby boom generation retires, this Government becomes unaffordable for our children. The cost of three major entitlement programs--Social Security, Medicare, and Medicaid--will actually exceed the total Federal Government cost as a percentage of gross national product by 2025, and we will have nothing available to do anything else or, alternatively, will have to tax our children into oblivion so they cannot enjoy a quality lifestyle. Yet this bill does nothing on that. We offered a reasonable amendment on this subject. We suggested that people earning more than $80,000 as individuals and $160,000 jointly should not be subsidized in their drug benefit by people working in restaurants across this country or working at gas stations or working on assembly lines, and it was rejected by the other side of the aisle. We suggested that hospitals and provider groups that are getting an inflated payment under the COLA by about 1.2 percent should have that inflated COLA payment reduced by about half. They will still be getting an extra half a percent, six-tenths of a percent in benefits, and that was rejected. If either of those had been accepted, we would have moved toward some semblance of getting under control this outyear instability in our Medicare fund. Those two amendments would have done more to make Medicare solvent than anything else we could do around here and thus make it available to seniors when they retire and have our children able to afford it. But that was rejected. There was no action at all in that area. The tax issue--have to come back to this issue. The idea that there is not a tax increase in this bill is so patently absurd on its face that the first amendment out of the box offered by the Democratic leadership was to extend the tax cuts for certain tax cuts they felt they didn't want to have go up, and the reverse of that, of course, is they are willing to let the other tax cuts go up. That is obvious. That is just A follows B or 1 and 1 makes 2. So there is no question they are taxing. This idea that there is a comparison between the President's numbers and their numbers in tax increases, again is a total inconsistency. They use OMB to score the President's numbers and they use CBO to score their numbers. But if we score it apples to apples and oranges to oranges, we see the difference is significant. This was calculated before the Baucus amendment was adjusted, so these would be adjusted down somewhat, but the differences are still significant, somewhere in the range of $250 billion of difference if we compare apples to apples and oranges to oranges. When we peel everything away from this bill--I understand we are going to start voting at 9:30--all these inconsistencies, the fact that they don't use pay-go for programs they like but they do apply to positions which the Republicans might take, the fact that the tax increase in this budget is the largest in history and yet they claim there is no tax increase, the fact that the spending goes up dramatically and they claim spending doesn't go up, the fact that there is virtually--there are no savings in entitlements on a net basis and there is actually significant aggravation of the cost of entitlements for our children in this bill as a result of new programs which they anticipate, this bill is going to do significant damage to our economy, and it is going to grow the Government and make us larger. It comes down to a very simple fact, really, when we take everything away: This bill essentially is a classic Democratic tax-and-spend bill. That is all it is. Bigger taxes, bigger spending, bigger debt, larger Government, and as a practical matter, it is not going to be a constructive event for us as a nation. So I hope my colleagues, when we get to final passage, will vote against it. We are going to have a lot of votes here, but in the end, what is going to pass, if this bill passes, is your classic tax-and-spend bill. Mr. President, I believe we are supposed to start voting at this time.

Mr. GREGG. I think this is actually the likeness of somebody from Nevada.

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

Mr. GREGG. Mr. President, I send an amendment to the desk, and I ask that it be reported.

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

Mr. GREGG. Mr. President, I ask unanimous consent that the amendment be accepted.

Mr. GREGG. Mr. President, I say to the Senator from North Dakota the purpose of this amendment is to make it absolutely clear we do not make reconciliation a stalking-horse to spend money. You have to use it to reduce the deficit.

Mr. GREGG. Mr. President, I suggest we do this amendment on a voice vote, and I ask unanimous consent that be the case.

Mr. GREGG. I ask unanimous consent the amendment be adopted.

Mr. GREGG. Mr. President, I agree with the Senator from North Dakota. I would note, in our batting order, we have Senator Bunning on Social Security, Senator Dole on IRAs for soldiers, Senator Allard on mandatory spending, Senator Smith on SCHIP, Senator Thomas has one on extraneous items in the supplemental. Then we will have, potentially, Senator Grassley and--Senator Sessions on AMT first. Then Senator Hatch is going to get in here. We are going to get Senator Hatch taken care of. That is the lineup on our side so people have some type of idea.

Mr. GREGG. Mr. President, in my statement earlier, I failed to mention we have an agreement that Senator Kyl's vote will come before 11 o'clock.

Mr. GREGG. Unfortunately, it is not whom we have left, but it is what the order is. I wish it was what we had left. Anyway, we go to Senator Nelson and Senator Kyl, which are under a prior agreement to have both those votes before 11 o'clock; then Senator Hatch, Senator Allard, Senator Smith, Senator Thomas, Senator Specter, and Senator Graham on our side. We are picking up other people as they come along and ask for time. That is the order now. All those will require votes potentially.

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

Mr. GREGG. Mr. President, I wish to make a point. I have talked to the chairman and this will be a 10-minute vote, not a 15-minute vote. From here on out, they will all be. Anybody who is not here, you are going to miss it.

Mr. GREGG. Mr. President, for the information of Members on our side, the amendments, as they are presently lined up, are Senator Hatch, Senator Allard, Senator Smith, Senator Thomas, Senator Specter, Senator Graham, Senator Grassley, Senator Lott, myself, Senator DeMint, and Senator Thune. Amendment No. 508