Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. I yield the remaining time to the Senator from Iowa. I think we will have more time later.

Mr. KENNEDY. Mr. President, under those circumstances and to accommodate the Member, I will not press this, although I do think we will have an opportunity to address these issues later in the morning.

Mr. KENNEDY. The Senator from Iowa wanted to be heard on a matter. I wanted to speak just briefly to clarify the record. I was wondering if we can divide that time between now and 10:30--we took up some of the time between 9:30 and 10 for debate and discussion--and then go to Interior.

Mr. KENNEDY. Mr. President, with all due respect to my friend and colleague, the majority leader, the fact of the matter is by the votes that we had last week requiring that we have some opportunity to examine a very important provision--and that is the preemption of various States' ability to protect their public--we have seen a rather dramatic change in the language of the provision that will continue to permit the States to protect their public. That was very important for the protection of the American public. I know that there are some people around here who want to see the trains run on time. But some of us--not only those of us here but the National Governors' Conference, the public health organizations, the women's network organizations that deal with women's health issues--a wide range of consumers believe, quite deeply, that we are absolutely within our rights to make sure that this provision was offered and changed, and we did so. And, by doing so, the public health interest is preserved. Now here we are on the floor of the U.S. Senate the morning after having seen the headlines from two national journals--yesterday in the Wall Street Journal, talking about a particular prescription drug called fen/phen, that had been moved through, rushed through the FDA. It has been linked to everything from brain damage in animals to primary pulmonary hypertension; a rare but fatal lung disease; millions of Americans tried the drugs to slim down; some 60 million people worldwide were estimated to have taken the drug; the straw that broke the camel's back was a heart valve problem which now has been widely recognized. Here is an item in the Washington Post. Two diet drugs are pulled off the market. Why? Because the products were used for purposes for which the drug was not approved. We are talking about an identical provision in this body with regard to medical devices--the use of the medical device for purposes for which it has not been approved. We have seen the whole world being awakened to this particular health problem. Some of us are trying to making sure that we don't have headlines like this in 3 months, 4 months, or 6 months with regard to the medical device issue. That is what we are talking about. Mr. President, I would just point out that there are about six little words that, if the majority would be willing to accept, would move us right ahead, and get us very short time agreements on the other elements. Let me just point out. Mr. President, there are the two provisions with regard to medical devices--one they call class II--devices which represent about 5 percent of the devices. Those are the new devices. In the language of this bill, it says, whether or not there is reasonable assurance of safety effectiveness, if the proposed labeling is neither false nor misleading. ``Neither false nor misleading,'' that is in regard to class III devices. But, if you look at class I and II devices with regard to the representations that are made involving the FDA, there is no such language. If the majority will take the language that we propose for class III and apply that to class I and II, we will call this cloture vote off. What person in the United States of America wants to permit medical devices to be approved if we cannot have agreement by the manufacturers that their statements to the FDA reflect the true uses for the devices? My goodness, are we in that big of a hurry? That is why this issue is important. Now, the majority leader says we have just one more item. We are glad to deal with this issue, and we have offered compromise language to deal with it. It is of vital importance and we will have a chance later to discuss the health hazards associated with it. The medical device industry, which has been enormously cooperative in working out other provisions on this, had refused to go along with our proposed language. Medical device labeling has important health implications. You can rush this through and say the rest of the bill is fine. It is fine. Senator Jeffords and his Republican colleagues deserve great credit. My Democratic colleagues deserve great credit. But do we have to be reminded again that the FDA has the responsibility for the protection of the public health. If we do, we don't need to look any father than reading this mornings newspapers. All we are saying is let's not do with medical devices what was done with regard to these diet medicines. I think that is an important health matter. So do the overwhelming majority of patient coalitions and public health coalitions. If the industry wants to debate that, we are going to take the time to debate it. If there are Members on the floor of the U.S. Senate who want to take the position that we don't need this change in the bill language on medical device regulation, let them make that case on the floor of the U.S. Senate. Because that is the case they are going to have to make, because the amendment has been filed. If the majority indicates they will accept that, that's all fine and well. Our amendment will ensure that FDA is able to comprehensively examine the safety of medical devices. We will move through this legislation very rapidly indeed. But this is one Senator who is not prepared to roll over on that issue. We will have the opportunity during the course of this morning or this afternoon or tonight or tomorrow, or however long it takes, to go through the various instances where medical device labeling could pose an important and significant public health threat, a threat to the American people. There may be those who do not think this is an important issue. I believe the overwhelming majority of the American public will think so. As they are reading their papers this morning and listening to those who say, let's rush this bill on through, I would think some Americans would say, let's take another look at what we have in this legislation, particularly with regard to the medical device provisions. Mr. President, with all respect to my friend and colleague, we have talked about this. Senator Durbin has talked about sections 404 and 406. This particular issue is the key issue. If we can get the language in the bill ensuring that we will not permit the medical device industry to restrict the FDA's ability to make a full study of medical device safety, I think we would move ahead with the legislation. I withhold the remainder of my time.

Mr. KENNEDY. Mr. President, reserving the right to object, I do not object to moving the vote to 12:15 today. I understand the leader wants to get to the Interior appropriations bill. I do not want to unduly delay that provision. However, it says under the proposal, ``I ask consent that following the debate this morning regarding the FDA reform bill, that the Senate resume * * *.'' We would like to have at least a limited period of time. I know the Senator from Iowa wanted to speak. I was wondering if we can at least get a half hour debate on the FDA reform bill before finishing. It says here, ``I further ask consent that following the debate this morning,'' I was wondering whether ``following the debate'' could go until 10:30? Mr. LOTT addressed the Chair.

Mr. KENNEDY. Mr. President, how much time do we have?

Mr. KENNEDY

Mr. KENNEDY. Mr. President, how much time remains?

Mr. KENNEDY. I yield 1 minute to the Senator from Rhode Island.

Mr. KENNEDY. Mr. President, I yield 7 minutes to the Senator from Illinois.

Mr. KENNEDY. Mr. President, how much time do I have?

Mr. KENNEDY. I yield myself 20 minutes, Mr. President.

Mr. KENNEDY. Mr. President, I thank my colleague and friend from Illinois for reminding us how important this debate is here on the floor of the U.S. Senate. We are talking about the agency of Government that has the prime responsibility for protecting the health of the American consumer. We all have an interest in making sure that medical products are available earlier. Every one of our families have benefited from the innovation and resourcefulness of the medical device industry and from the advances of pharmaceuticals. I doubt there is any Member of the body that has not. So all of us want to be able to make sure that medical advances will be available to the American public. We are in a situation today where the United States through the FDA is leading the world, in terms of approving new drugs as well as medical devices. That has changed from recent years. I think all of us have seen some very dramatic and important progress made in recent years. As I have said many times before, I want to give a tribute to the chairman of our committee who has worked tirelessly on this issue. He has brought together those individuals on our committee and outside that have differing views, all struggling to try and advance the interest of the public health. I think he has made remarkable progress in moving us forward to where we are today. But there are important remaining items that I hope we can dispose of in the Senate within a reasonable time period so that the process could move forward. I take exception from the understanding of the language that has been included in this bill with regard to ensuring that the consumers of medical devices and users of medical devices have the kind of protection that has been referred to here by my friend and colleague, the Senator from Connecticut, and others. I have here, Mr. President, a letter from the Secretary of Health and Human Services, which indicates that they have four major concerns with this particular legislation. One of them was the area of cosmetics. Another area is environmental considerations, and another area is device manufacturing procedures. But the other important area is the one that I am going to address here today, and that is what I call the safety issue, the fen/phen issue as it applies to medical devices. The Secretary, speaking for the President of the United States, has identified this as being a major issue. So when others gather around and say, ``Look, we have debated this and discussed it, why are we bringing these matters up in this debate at this time?'' The reason that we are bringing it up is, as the Secretary of Health and Human Services has recognized, there are very powerful health consequences we ought to take note of and deal with and that we ought to alter and change. It isn't only the Secretary of HEW. Here is the National Women's Health Network, who points out: The network is extremely concerned with the section 404, which prevents FDA from requiring medical device companies to perform complete reviews on the safety and effectiveness of a medical device. This must be amended to give FDA the authority to verify that the label is not false or misleading. Section 404 is a serious danger to women's health, which must be fixed before S. 830 is acted upon by the Senate. Then the Patients' Coalition indicates a similar concern. It outlines probably eight or nine major issues and section 404 is one of them. The Consumer Federation of America wrote: We are writing in support of your amendment to change section 404 to prevent serious injuries to patients and consumers from medical devices with false or misleading labels. This isn't just the Senator from Massachusetts that is saying this. Here is the Secretary of HEW saying it. Here are the primary groups defending women's health and consumers' health, all who have joined in recognizing the dangers that this particular provision provides, and why it is so important that we are going to change it and alter it. The Consumer Federation says: Section 404 has been crafted to permit medical device manufacturers of class II devices to limit FDA's review of the safety and effectiveness of a device based upon conditions of use listed on the label. Even if it were clear from the device's technical characteristics that its real use would be for risky purposes, FDA would be prevented from looking beyond the conditions of use on the label. There it is. That is what the issue is. The Consumer Federation understands it. They are pointing out that 404 was crafted to permit the device manufacturers of class 2 devices to limit FDA's review of the safety and effectiveness of a device based upon conditions of use listed on the label. Even if it were clear from the device's technical characteristics that its real use would be for risky purposes, FDA would be prevented from looking beyond the conditions of use of the labels. That is what we are addressing, Mr. President, and why this is important. Mr. President, all we have to do is look at today's newspapers. Look at this morning's newspapers, the Washington Post, Wall Street Journal, all across the Nation, talking about the off-label use of pharmaceuticals, those pharmaceuticals that were used on an off- label basis. That is similar to the issue we are talking about here today with regard to medical devices, the off-label use of medical devices. But the issue that we have before the Senate this afternoon is more insidious. Why? Because it says that if a medical device company is submitting an application for a certain use, FDA can't look at any other uses even if there is a clear intention--and we are glad to spell out what that criteria would be--for example predominant use--to use the device or market the device for another use. That is what we are interested in--having FDA look at the safety and efficacy of a use clearly intended by the design of the medical device. I am going to illustrate this in just a few moments. The issue is whether the FDA has the authority to look at whether that medical device has been tested for the off-label use, which is the clear intention of the medical device company. And the answer is, no, they cannot. This isn't off-label use of two products that are being put together and then prescribed by various medical professions. This is the guardian of the American public, the FDA, that is being denied the ability to look beyond the label at the technological differences of a device in terms of safety and effectiveness. That is the issue. Now, there are those that say--and we heard the argument by my friend from Connecticut--that FDA inherently retains that power. If they do, let's spell it out. If we spell it out, we haven't got a problem. But the Secretary of HEW does not believe they have the inherent power. The Consumer Federation doesn't believe they have the inherent power. The various patient groups don't believe they have the inherent power. The various groups that are out there protecting the public, virtually none of them believe they have the inherent power. If they have it, let's spell it out. We can work that language out. We have been attempting to do that for a considerable period of time, but we have not been able to do so. The answer on the other side is, well, we can't anticipate every possible use that a medical device might have and we are not going to submit safety data for every possible use and that FDA shouldn't get in the minds of various doctors using that medical device, for whatever purpose. That is not the argument. That will be the argument you will hear out here on the floor of the Senate. That isn't what we are talking about. We are talking about a limited number of medical device companies that will go to FDA and abuse this process because they are able to get through the process with a label that in so many respects matches a previously approved one, but the medical device has an entirely different technology that clearly indicates a different intended use. That is what we are talking about. For example, the new lasers that are being approved by the FDA labeled as general lasers that are for cutting various tissue, but clearly designed to treat prostate cancer. We want the FDA to be able to say, if you are going to use that for prostate cancer, we want to make sure that it is safe and efficacious. We don't want to permit the medical device industry to submit false and misleading statements. That is a powerful statement. But I daresay if they are going to submit a statement that says they are going to use a particular medical device for one purpose and FDA can demonstrate that the company has intended the device for another purpose, and they are already involved in, advertising and promoting that particular medical device in countries all over Europe for an entirely different purpose, I say that is false and misleading. The Members of the U.S. Senate are going to have a chance to decide whether or not they are going to stand and say we will not permit the medical device industry to submit false and misleading information on labeling. We will see how that vote will go. We include false and misleading under what they call the PMA's, which means the various medical devices that have to go through a more elaborate procedure. We have protections against false and misleading advertising on that. But we are going to say that the American public shouldn't be assured that when the medical device industry submits a particular product, that they do not submit information that is false and misleading. And what we mean by that is that they have an intention to use that various medical device for an entirely different purpose for which there have not been adequate safety standards established or safety records advanced. That is the issue, Mr. President. That is a very, very important health issue. It is a very important one. You can say it is only one section out of a whole piece of legislation, but it is very important. First of all, let me review very quickly about how medical devices are approved in the FDA, so that we understand and put this into some criteria. I want to go through examples of some of the problems that we are facing today. I'd like to let the American people make judgments and decisions about whether they think adequate safety information should be available for digital mammography and digital diagnostic x rays. Let the American people judge whether these devices should be used in surveying women who may have cancer when they haven't been approved for that. Mr. President, let's get back to where we are today. In the light of today's revelations about fen/phen should we be thinking about a provision in this bill that would allow device manufacturers to get their products approved for off-label use on the basis of a false and misleading label. There are two stories in the Wall Street Journal--one yesterday and one today--as well as one in the Post today, which tell us why the Senate should give a resounding ``no'' to this fen/phen device division. The first article explains in detail how an unscrupulous drug company engaged in a broad conspiracy to illegally promote the use of a product for treatments that have not been shown to be safe and effective. This conspiracy involved the laundering of money, deceptive deals, and hospital physicians' coercion of honest employees who objected to these corrupt practices. Fortunately, companies which engage in these kind of fraudulent practices are the exception rather than the rule. But it is precisely the exceptions that make a strong FDA so critical. The second story outlines the tragic results of off-label use of two approved drugs, dexfenfluramine and fenfluramine. These two drugs, used in unapproved combination for weight reduction, were found to have caused irreversible heart damage in thousands of women. In addition, there are early revelations that fenfluramine phentermine, known as fen/phen, had also caused severe heart damage. This is truly appalling--women receiving medical assistance for weight reduction, assistance they have been led to believe was entirely safe but which has not been tested adequately for that use--ended up suffering severe heart damage. The provision that is before us, rather than increasing protection for American consumers against products that have not been safe and effective, would actually reduce those protections. It would permit a device manufacturer to design a product for one use and falsely claim on the label submitted to the FDA that the device was for a different use. The FDA would be barred from protecting consumers. It would require the FDA to accept the manufacturer's label at face value. The FDA under this legislation has to accept the labeling that the manufacturer has put forward, even if it were false or misleading. Fen/ phen should teach us that the American consumers deserve to be protected against unsafe product uses. But the provision before us goes in exactly the opposite direction. That is why the President has threatened to veto it. That is why a broad coalition of consumer health groups oppose it. And that is why the Senate should reject it. Mr. President, as we know, there are two categories of medical devices. Let me give a brief explanation of how the FDA regulates and clears medical devices for marketing. It will help clarify the need for this amendment. Under the current law, the manufacturers of new class I and class II devices get their products onto the market by showing that they are substantially equivalent to devices already on the market. For example, the manufacturer of a new laser can get that laser onto the market if it can show the FDA that the laser is substantially equivalent to a laser that is already on the market. Similarly, the manufacturer of a new biopsy needle can get that biopsy needle onto the market by showing that it is substantially equivalent to a needle already on the market. These manufacturers are obligated to demonstrate substantial equivalence to the FDA by showing that the new product has the same intended use as the old product, and that the new product has the same technological characteristics as the old product. If the new product has different technological characteristics, these characteristics must not raise new types of safety and effectiveness questions in order for the product to still be substantially equivalent to the older product. So, if the product is substantially equivalent and doesn't raise new safety effectiveness questions, it moves on through. The logic of the process for bringing medical devices onto the market is simple. If the product is very much like an existing product, it can get to market quickly, but if it raises new safety or effectiveness questions, those questions should be answered before it gets on the market. This process for getting new medical devices on the market, commonly known as the 510(k) process, is considered by most to be the easier route to the market. That process accounts for how 95 percent of all devices get to the market. Devices that are not substantially equivalent class I or class II devices already on market must go through a full premarket review. Thus, device manufacturers have an incentive to get new products on the market through the 510(k) process. In fact, well over 90 percent of the new devices get on the market through the submission of a 510(k) application. Section 404 of the bill prohibits the FDA from requiring safety and effectiveness data on any device following the 510(k) route except for uses the manufacturer chooses to put on the label, even if the label is false and misleading--even if the manufacturer says, ``We are just going to use it for cutting tissue, we are not going to use it for prostate cancer,'' knowing full well that they intend to use it for prostate cancer. All the world knows that they are going to use that device for prostate cancer. The FDA is prohibited from saying, ``Let us see where the safety is.'' Where is the safety information on that? That, Mr. President, is the issue. Let me give you a few more examples. On the biopsy needle for breast tumors, the needle is labeled for performing a biopsy. But the design clearly indicates that it is designed to remove tumors. Here you have a case where you have a small needle with a very narrow opening at the one end which is used for testing a biopsy of a particular tumor. Now the manufacturer comes in with a much broader needle, a much wider needle, and says, ``Look, our needle is for the same thing, just to biopsy the tumor.'' The design clearly indicates that it is built to remove tumors. Under the bill language, FDA could not ask for safety and efficacy data for the needle's use for tumor removal, even though that is clearly indicated by the designer of the device. The company comes in, and says, ``Look, we have a biopsy needle right here. Sure, ours is a little larger. But this biopsy needle is really absolutely intended to do the same thing as the others out there and, therefore, we are substantially equivalent,'' even though they are out there advertising that this needle can be used for removing a tumor. They don't have to provide any safety information about how safe or effective that device is for the removal procedure. There is also the ``laser for cutting'' issue. The labeled use is for general cutting. But the laser has been adapted specifically and clearly to cut prostate tissue. Under the bill language, FDA could not ask for safety and efficacy data for cutting prostate tissue. Digital mammography is currently approved and labeled for diagnostic x rays--which are used to confirm the suspicion of a breast tumor. If digital mammography is clearly going to be used for screening, based on the design of the instrument, which requires a higher degree of accuracy, FDA should be able to look at the effectiveness of that technology for that use. Without this assurance, too many women may undergo biopsies or be misdiagnosed. But this bill would prevent FDA from asking for the data needed to protect women. Orthopedic implants--plates and screws for long bones--some implants are made to be removed after the bone has healed and, therefore, labeled for short-term use. But if the FDA determines from the design of the device, or from the particular materials that the implant will clearly be left in the patient on a long-term basis, FDA should be able to ask for safety and efficacy data. For example, how does the bone react to having the implant there over a long period of time? Is the bone weaker? But this bill would prevent the FDA from asking these questions. Mr. President, I can go on, and will go on when we have the more general debate. But these stories exemplify the issue. The issue is safety. The issue is protecting the safety of the American consumer in regards to the use of medical devices which clearly demonstrate that the dominant use of those medical devices differs from what is put on the label. It would surely seem to me that men and women of reason would be able to work this out in a spirit of order to provide those protections. But we have been unable to do so. Being unable to do so we should understand the real implications. As when you have the off-label use of fen/phen, and the concern of the American people and all of the newspapers all over the country. You would think that here in the U.S. Senate we would be thinking about how we are going to provide further protections for the American people instead of fewer protections. Here in this particular medical device provision, we are hamstringing the FDA and its ability to gather data on safety and efficacy when it is so clear that the devices are going to be used for in a manner that differs from the one claimed. That is why many of us--not only the administration, but many public health groups and organizations that represent women--have been so concerned about this issue. I withhold the remainder of my time.

Mr. KENNEDY. Mr. President, I just say to my good friend from Indiana, as well as the Senator from Vermont, I think if we could work this particular provision out we would probably be able to end this legislation today--tonight. I think this is really the last remaining major issue. I know the Senator mentions the cosmetic issue and then this new issue was raised. This was one of the four items that were identified in the President's letter. I have identified this issue previously. We had a brief discussion on section 404 during the cosmetic debate. But this, I believe, is really the last issue. There are other issues that other colleagues have spoken about, but I urge early time considerations if we are able to resolve this legislation. I shall try to do the best I can to continue to work on these issues. If I can ask consent to have 1 more minute and then 1 more minute on his side, too? I ask unanimous consent to have 1 more minute on either side.

Mr. KENNEDY. We will try to work with the Senator hoping that we might now be able to work something out that will meet both the legitimate objectives that the Senator has and the concerns that I have discussed and share with the administration. I am not suggesting that FDA read the minds of all the device companies and determine every conceivable way that a device might be used. Instead that they be limited to the very narrow case where there is a predominant or dominant use or clearly defined use that would be intended that was not on the label. Perhaps an advisory group could make these decisions. I am not interested in trying to anticipate every possible use, just in those very narrow areas which I think pose a threat. I will try to explore a compromise with both the Chair and the Senator. We are going to the Interior bill and then come back to the FDA reform bill, but as I indicated to Senator Jeffords earlier I thought there could be a very timely disposition of all of the remaining amendments.

Mr. KENNEDY. I thank the Chair.

Mr. KENNEDY

Mr. KENNEDY. I suggest the absence of a quorum.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I am honored to join Senator Abraham, the chairman of the Immigration Subcommittee, in introducing legislation to extend the Visa Waiver Program for 5 additional years. The programs serves the Nation well, and deserves to be extended. I am particularly pleased that the bill we introduce today would create a pilot program to expand the number of countries able to participate in the Visa Waiver Program. I am optimistic that Portugal, for example, will qualify for the waiver program under the legislation which Senator Abraham and I propose today. I have advocated Portugal's inclusion in this program for several years because of the close ties between the people of Massachusetts and that country. Its inclusion in this program will allow Portuguese citizens to come to the United States to visit relatives or conduct trade and business without facing the often time-consuming task of obtaining a visa. This Visa Waiver Program started as a pilot program in 1988 with only one country, the United Kingdom. Today, it has grown into an important part of overall U.S. immigration policy. Twenty-five countries now qualify for the program, and it brings significant benefits to the United States as well as to visitors from those nations. Almost half of those who visit the United States for business or tourism now enter under this program. Billions of dollars in international transactions are facilitated by the ease of travel that it makes available. According to the Travel Industry Association of America, tourists coming to this country under the program contribute $84 billion to the economy and help support 947,000 American jobs in the tourist industry. The Visa Waiver Program also strengthens immigration enforcement. Rather than spending tax dollars to conduct needless visa interviews, the program enables us to concentrate scarce resources on the serious immigration problems of keeping criminals and terrorists out and dealing more effectively with visa fraud. As a result of the program, millions of dollars and hundreds of consular personnel have been reallocated to target the most serious immigration threats. Countries must meet strict criteria before they are eligible to participate in the waiver program, in order to prevent illegal immigration to the United States. The Attorney General may cancel a country's participation at any time if she believes a waiver compromises law enforcement or national security. Travelers from participating countries may come to the United States without visas, but they still must be interviewed by U.S. immigration officials at the airport or other points of entry before they are admitted to this country. According to INS statistics, few travelers abuse the program to enter the United States illegally. INS has turned away less than 1 percent of those seeking entry under the Visa Waiver Program. The bill we introduce today makes a good waiver program even better. It builds on the success of the current waivers by establishing a small pilot program to enable certain countries that do not currently qualify to participate if they meet certain strict requirements. A precondition for the pilot program is for INS to develop and implement an automated entry-exit control system. Today, we know who comes to America, but we do not always know who leaves. We need this information in order to track down visitors who remain in this country illegally after their visas expire, and to ensure that countries are abiding by the requirements of the program, and are not contributing to illegal immigration. In order to participate in the new pilot program, a country must have a low visa refusal rate at our consulates abroad. Under the normal Visa Waiver Program, qualifying countries must have a refusal rate of less than 2 percent over the past 2 years. The Abraham-Kennedy pilot program would set the requirement at 3 percent for countries to enter the program on a pilot basis. In recent times, Portugal's refusal rate has been below the 3-percent threshold, so unless Portugal's refusal rate rises, I would look forward at long last to welcoming Portugal into this program. Mr. President, the Visa Waiver Program works, and I urge Congress to extend it. I commend Senator Abraham for offering this timely legislation, and I am proud to be a sponsor.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I am honored to join Senator Abraham, the chairman of the Immigration Subcommittee, in introducing legislation to extend the Visa Waiver Program for 5 additional years. The programs serves the Nation well, and deserves to be extended. I am particularly pleased that the bill we introduce today would create a pilot program to expand the number of countries able to participate in the Visa Waiver Program. I am optimistic that Portugal, for example, will qualify for the waiver program under the legislation which Senator Abraham and I propose today. I have advocated Portugal's inclusion in this program for several years because of the close ties between the people of Massachusetts and that country. Its inclusion in this program will allow Portuguese citizens to come to the United States to visit relatives or conduct trade and business without facing the often time-consuming task of obtaining a visa. This Visa Waiver Program started as a pilot program in 1988 with only one country, the United Kingdom. Today, it has grown into an important part of overall U.S. immigration policy. Twenty-five countries now qualify for the program, and it brings significant benefits to the United States as well as to visitors from those nations. Almost half of those who visit the United States for business or tourism now enter under this program. Billions of dollars in international transactions are facilitated by the ease of travel that it makes available. According to the Travel Industry Association of America, tourists coming to this country under the program contribute $84 billion to the economy and help support 947,000 American jobs in the tourist industry. The Visa Waiver Program also strengthens immigration enforcement. Rather than spending tax dollars to conduct needless visa interviews, the program enables us to concentrate scarce resources on the serious immigration problems of keeping criminals and terrorists out and dealing more effectively with visa fraud. As a result of the program, millions of dollars and hundreds of consular personnel have been reallocated to target the most serious immigration threats. Countries must meet strict criteria before they are eligible to participate in the waiver program, in order to prevent illegal immigration to the United States. The Attorney General may cancel a country's participation at any time if she believes a waiver compromises law enforcement or national security. Travelers from participating countries may come to the United States without visas, but they still must be interviewed by U.S. immigration officials at the airport or other points of entry before they are admitted to this country. According to INS statistics, few travelers abuse the program to enter the United States illegally. INS has turned away less than 1 percent of those seeking entry under the Visa Waiver Program. The bill we introduce today makes a good waiver program even better. It builds on the success of the current waivers by establishing a small pilot program to enable certain countries that do not currently qualify to participate if they meet certain strict requirements. A precondition for the pilot program is for INS to develop and implement an automated entry-exit control system. Today, we know who comes to America, but we do not always know who leaves. We need this information in order to track down visitors who remain in this country illegally after their visas expire, and to ensure that countries are abiding by the requirements of the program, and are not contributing to illegal immigration. In order to participate in the new pilot program, a country must have a low visa refusal rate at our consulates abroad. Under the normal Visa Waiver Program, qualifying countries must have a refusal rate of less than 2 percent over the past 2 years. The Abraham-Kennedy pilot program would set the requirement at 3 percent for countries to enter the program on a pilot basis. In recent times, Portugal's refusal rate has been below the 3-percent threshold, so unless Portugal's refusal rate rises, I would look forward at long last to welcoming Portugal into this program. Mr. President, the Visa Waiver Program works, and I urge Congress to extend it. I commend Senator Abraham for offering this timely legislation, and I am proud to be a sponsor.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I commend President Clinton for his announcement today of his nomination of Dr. David Satcher to be Surgeon General and Assistant Secretary for Health. David Satcher is an excellent choice for these important positions. As Director of the Centers for Disease Control and Prevention for the last 4 years, he has ably led that agency which is responsible for protecting health and preventing disease, injury, and premature death. He is uniquely qualified to become the Nation's foremost spokesman on health issues. In 1992, under Dr. Satcher's leadership, the CDC launched and implemented a successful childhood immunization initiative. Before the initiative, only a little more than half of the Nation's children--55 percent--were immunized. Now, 78 percent are immunized. As a result, vaccine-preventable childhood diseases are at record lows. Dr. Satcher has also led CDC efforts to strengthen the Nation's defenses against infectious diseases and food-borne illnesses. We rely on the CDC to provide a rapid response to outbreaks of disease and protect public safety. Under Dr. Satcher, CDC has begun to implement a comprehensive strategy on infectious diseases and plays a key role in a new early warning system on food-borne illnesses. Dr. Satcher was previously a member of the faculty of the UCLA School of Medicine and the King/Drew Medical Center in Los Angeles. For 2 years, he served as interim dean of the Drew Postgraduate Medical School. He also served as professor and chairman of the department of community medicine and family practice at the Morehouse School of Medicine in Atlanta. For over a decade, from 1982 to 1993, Dr. Satcher served as president of Meharry Medical College in Nashville, the Nation's largest private historically black institution for educating health care professionals and biomedical researchers. At the CDC, he has combined a proven track record of leadership and effectiveness that make him an excellent choice to be Surgeon General and Assistant Secretary for Health, and I urge the Senate to move expeditiously to confirm him.

Mr. KENNEDY

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

Mr. KENNEDY

Mr. KENNEDY. Mr. President, 30 years ago this week, Senator Robert Kennedy addressed the World Conference on Smoking and Health in New York City on ways to address the mounting death rate attributed to cigarette smoking. He spoke to the conference about the difficulty of convincing people, particularly the Nation's youth, that smoking can kill them. He emphasized the grim statistics of premature death and illness caused by smoking. Today, 30 years later, little has changed. Over 400,000 Americans die from smoking-related diseases each year. In fact, in 1993, smoking was attributed to one in every five deaths--more than alcohol, car accidents, fires, homicides, suicides, drugs, and AIDS combined. This chart, Mr. President, shows very accurately what the impact of cigarettes is in terms of the mortality of Americans--the red line being 418,000. These are all statistics from the Centers for Disease Control--from alcohol, 105,000; car accidents, 46,000; suicides, 30,000, and so on. This is a very clear graph about the magnitude of the impact of the use of cigarettes, of which 90 percent of smokers start when they are children of 14 or 15 years of age. It is an issue that must be addressed in any kind of agreement that this body is going to sanction or support. One million young people between the ages of 12 and 17 take up the deadly habit every year, 3,000 new smokers a day, and 90 percent of the current adult smokers began to smoke before they reached the age of 18. If nothing is done to reverse this trend in adolescent smoking, the Centers for Disease Control and Prevention estimate that 5 million of today's children will die prematurely from smoking-caused illnesses. Congress and President Clinton have a historic opportunity to protect current and future generations from the scourge of nicotine addiction and tobacco-induced illnesses. Study after study has shown that the most powerful weapon in reducing smoking, particularly by the Nation's youth, is to raise the price of cigarettes. A $1.50 price increase, as Dr. Koop and Dr. Kessler have advocated, would have a double benefit. It would reduce youth smoking by more than half over the next decade and provide some compensation to the Federal Government for the damage that smoking has done. Most health economists agree that in addition to Medicaid, tobacco imposes a heavy toll, exceeding $20 billion a year, on numerous other Federal health programs, including Medicare, the Department of Defense health programs for military personnel, veterans health programs, and the Federal employees health benefit programs. To compensate the Federal Government fairly for these high costs, the total settlement would have to be more than doubled from its current figure. The State attorneys general have done a very impressive job in working out the tobacco settlement, but their primary focus was on reimbursing the States for the States' participation in the Medicaid Program. They did not have the responsibility to try to ensure the protection for the Federal Treasury in terms of these other health- related programs--Medicare, the veterans programs and others. If you evaluate those programs and the costs, as Professor Harris has done in his testimony before the Senate Judiciary Committee and also before the Labor and Human Resources Committee, you would see that the cost of treating tobacco-related illnesses to Medicare alone are approximately $9.3 billion, and others have calculated the Medicare costs to be substantially higher. Yet the proposed settlement provides not a single penny to the Federal Government for the recovery of these expenses. As I mentioned, the State attorneys general have obtained a fair reimbursement under the pending settlement for the costs imposed on Medicaid. It would be unreasonable and irresponsible for Congress and the Clinton administration to let Joe Camel and the Marlboro man off the hook for the high costs imposed on Federal health programs. Already this year the tobacco industry had the audacity to write a special-interest loophole in the budget legislation requiring the Federal Government to deduct the $50 billion amount generated by the increased cigarette tax devoted to children's health from the amount the industry would pay under the tobacco settlement. I am pleased that the Senate voted to repeal this flagrant provision earlier this week, and I commend Senator Durbin and Senator Collins for their outstanding effort. But its surreptitious inclusion in the budget legislation demonstrates that nothing has changed in big tobacco's continuing efforts to subvert reasonable legislation. The Federal Government has the same claim for recovering health costs as the States that are suing the tobacco industry for billions of dollars in Medicaid expenses. You could have a situation where one person was in a hospital bed under the Medicaid Program, in the next bed a person might be under the Medicare Program, and in another bed somebody might be there under the Veterans' Administration health care program. All of the patients may have the same kind of illness as a result of their addiction to nicotine. The attorneys general looked out for the individuals who receive Medicaid. But certainly the taxpayers and the Medicare trust fund ought to be able to receive compensation for the costs to the Medicare system. If the tobacco industry understood and agreed to compensation under Medicaid, it is difficult for me to see why they should not also agree to the compensation under Medicare, the veterans health care programs, or other health programs which are supported by the American taxpayers. The tobacco companies admitted that cigarettes are deadly. They have accepted the necessity for broad new restrictions on cigarette marketing and advertising. They have admitted their liability for billions of dollars in compensation for tobacco-induced illnesses. Having made these admissions and concessions, the industry can no longer put up a smokescreen and maintain its past position of total denial. Clearly, the tobacco industry should pay more and can pay more. Given Joe Camel's deep pockets and the substantial toll that tobacco imposes on the Federal Government, doubling the final settlement is reasonable, justifiable, and affordable. A doubling of the settlement would have a number of important public health benefits. I believe that the test ought to be what the impact of the settlement will have on the public health of this nation, primarily in terms of youth smoking. Mr. President, the doubling of the settlement would require that the tobacco industry increase the price of their products by about $1.50 to compensate the Federal Government and the States for the costs of smoking. Professor Harris estimates that under the current settlement, cigarette prices would only rise by 62 cents a pack. Since teenage smokers are very sensitive to price increases because of their lack of income, a 62-cent price hike would reduce tobacco use by the Nation's youth by only 18 percent over the next decade, which is significantly less than the settlement's requirement that teenage smoking drop by 58 percent in 10 years. There have been extensive studies and extensive review of what has happened when the price of cigarettes has gone up and what the impact has been upon youth smoking. We have also seen that, where the price has gone up and the tobacco industry has redoubled their efforts in advertising, still young people will go out and purchase cigarettes. There are studies that make the clear case that when you have a significant increase in the price of tobacco products and have effective advertising restrictions, you have a dramatic impact in reducing teenage smoking. That ought to be our objective, and it ought to be our objective at the beginning of the process, not at the end of the process. The best estimates by those who have reviewed what the price increase ought to be in order to discourage young people from purchasing cigarettes is at least $1.50 a pack. Such an increase would move us much closer to the objective which has been agreed to in the settlement of a reduction of 58 percent in youth smoking over the next several years. With a $1.50 increase, the tobacco industry will be able to meet these youth smoking reduction targets, and will at least partially compensate Federal health care programs for their expenditures due to tobacco-induced illnesses. Doubling of the settlement would also bring cigarette prices in the United States in line with other industrial nations. With a 62-cent increase, cigarette prices in Europe will still be far higher than in America. With the 62-cent increase, we are talking about the price in the United States being $2.56 a pack. In Canada, it is $3.06 a pack. In Germany, it is $3.18 a pack. If we have a $1.50 increase, the United States will be at $3.44. This figure is, in effect, doubling the amount of resources that would be paid by the cigarette companies. This is the price increase recommended by Dr. Kessler and Dr. Koop, which would have a dramatic result in reducing teenage smoking. When you look at that increase, even though it appears to be quite significant, it still puts a pack of cigarettes cheaper in the United States than it would be in France, where it is $3.47 a pack, or in Denmark, where it is $4.75, or Ireland, at $4.94, or the United Kingdom, at $5.27. We would still be in the lower range of the industrialized nations of the world. The best estimate and review by those who understand the workings of the tobacco companies believe that they can afford that. So, doubling the settlement amount would raise an additional $10 to $15 billion a year over the next quarter century to improve the health of the Nation's citizens or other important purposes. For example, we could extend the recently enacted children's health insurance program for low- and moderate-income working adults. We are talking about the sons and daughters of working families who are starting off as teachers or as police officers or social service workers--all starting out at $28,000 or $29,000 a year. We could also act on the new knowledge about the important role of the first 3 years in a child's life by launching an initiative to transform the lives of millions of children. We have learned dramatically in the last several years that early intervention has a significant impact in building skills and confidence in young people. With all of the research that has been done on the brain and early development, we are finding out that children in those first years have immense capacity for learning. We know the vacuum that is out there in so many different parts of America. There are children who are not being encouraged to expand their horizons. Even at the very earliest age, we ought to be about trying to find the ways that we can stimulate that early learning experience for children. This is a matter of national importance. President Clinton has made a strong commitment to improving the early years of children. We would have an opportunity to really respond to that very, very important human need--the need that families are facing. The tobacco industry can easily afford the $1.50 increase in prices. There is broad support within the public health community for a price increase as high as $2 a pack. Dr. Koop and Dr. Kessler and the members of the commission have endorsed such an increase, and so has the American Cancer Society. Doubling the settlement payment is the right thing to do. It will provide a fair measure of compensation to the Federal Government and the American taxpayer for the hundreds of billions of dollars that smoking-induced illnesses have cost us. Robert Kennedy closed his speech 30 years ago with these words which are equally true today: We must be equal to the task, for the stakes involved are nothing less than the lives and the health of millions. . . . But this is a battle which can be won. Congress and President Clinton should accept nothing less than a doubling of the tobacco settlement, and I urge my colleagues' support. Mr. President, I think most of us would agree this Congress is going to be hard pressed this year to get about the business of resolving this issue. But the tobacco settlement will be a matter of enormous importance and consequence at the beginning of the next Congress. It is important that we begin to establish some parameters in which to consider these various agreements. It is important to provide some criteria by which we can judge whether the proposal is beneficial to the country or whether it is a proposal that needs to be enhanced, as I believe this one does need to be. So, this is a matter of enormous importance for the public health of the American people for the future. We must make sure we are not going to involve the nation's children in the nicotine addiction which has brought such tragedy and loss of life into so many families of this country. We can do something about it. It is a challenge for all of us, and I hope we are going to be up to the task. I yield the floor.

Mr. KENNEDY

Mr. KENNEDY. How much time then on each side?

Mr. KENNEDY. Mr. President, first of all, I congratulate Senator Coats, Senator Gregg, and our Republican friends for working with the administration and working with concerned Members in fashioning this compromise. I think there are basically two fundamental approaches that we ought to be doing for our children. One is we ought to have support systems and, secondly, we ought to have accountability. What we are trying to do with this testing program is empower parents, empower parents so that they know how their children are doing, and then to ensure that we are going to have support systems to help those parents. We are seeing an expansion, hopefully, of our literacy program. We have an expansion of our basic skills program with the math and science, with the title I programs. We have seen the support for our technology program. Under Senator Jeffords, we are going to see an expansion of teacher training. Under our Goals 2000 program, 90 percent of the money goes locally to help the local schools meet these standards. So what we are trying to do is have the support systems for our children, but on the other end we want to have accountability for parents and for children so they know how they are doing. If children do not know how to read, as 40 percent of them do not at the fourth grade level, they are going to be in trouble in terms of continuing their education, the problems of dropping out and all the other challenges which they are going to face. This is really an enormously important effort to try and address that very considerable concern for every family in this country. We welcome the strong bipartisan effort we are seeing reflected on the floor at this time. I thank the Senator from New Mexico. Mr. COATS addressed the Chair.

Mr. KENNEDY. Mr. President, I yield the remaining time to the Senator from Maryland.

Mr. KENNEDY. Mr. President, I yield 5 minutes to the Senator from Minnesota.