Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. Reserving the right, I apologize to the manager. Could I hear that request again?

Mr. KENNEDY

Mr. KENNEDY. I had yielded----

Mr. KENNEDY. If you would be willing just to maintain the current law, we could move very quickly toward final passage. The Senator has just given an excellent explanation about how the FDA works at the present time. That procedure is being halted dramatically in this law. So if the Senator would support----

Mr. KENNEDY. I will yield in a second. We have just seen what the medical companies were doing with fen/phen. They weren't promoting it. All they were doing was paying the doctors thousands and thousands of dollars to go out and promote it. When we look at this promotion, it has ``U.S. Surgical'' on it, and it is a U.S. Surgical medical device-- and we have the doctors' letters on this that say, ``The indications for the use of devices. . . it should be determined by appropriate-- This video was dropped off in my office by a company representative-- Company representative-- as part of an effort to interest me in purchasing this equipment. Now, there may be other information. I am glad to have it included in the Record but I find this convincing.

Mr. KENNEDY. I suggest the Senator take the time to see it because when you turn it on, the first thing that you are going to see is the U.S. Surgical logo on it. I don't see how you can say that it is not being promoted or advanced or whatever if that is exactly what you will see. I would suggest to the Senator, if you are saying that those of us who have represented that it is being promoted for other uses--and we have the doctors' letters and we have this video, which you haven't seen--I would think that perhaps you ought to check again with U.S. Surgical and find out what they are doing. We have just seen it.

Mr. KENNEDY. Has the Senator seen this video?

Mr. KENNEDY. I yield, sure.

Mr. KENNEDY. Mr. President, I would like to just respond briefly to some of the points that have been made and then to get into the substance of the argument. I want to reiterate the importance of this particular provision. There are those who are trying to dismiss it as a relatively unimportant part of this legislation, and saying that we really didn't bring this issue to the attention of the committee until the final hours, therefore, we could not have been serious about it. Of course, this is completely untrue. I won't take the time to put in the Record the agenda for June 17 where this was listed in ``items under discussion'' on section 4 of the labeling claims. This was exactly the matter that was brought up in the markup in June. It was identified by the Secretary of HHS in the June 11 letter to the committee. It was repeated on September 5. Secretary Shalala identified the very few items that she would recommend that the President veto this legislation about. She listed the environmental issue, the elimination of the environmental impact statement. Another one was a technical amendment dealing with PDUFA. A third item was the cosmetic provisions. But this is the provision that was identified by the principal protector of the American people's health as the most important provision in terms of adverse effects to public health, this provision. Let's understand that right from the beginning. I know that my colleagues say, well, there are only a couple of Members of this body that are really concerned about this particular provision. Well, it is interesting that, time in and time out, the No. 1 person in the administration that has the principal responsibilities for protecting the American health has said this is it, this is the provision. With all due respect to those who say this is a low-risk issue that doesn't matter, that this is a technical question and we should just get through this business and get on with the vote, these arguments should be disregarded, because this is an enormously important issue. It was raised during the course of the markup back in June, and identified by the Secretary of HHS during the course of the summer. Many people were briefed by the Secretary indicating her priorities and this was right out there. It is in the papers submitted by her in September as being the primary technical concern in regard to safety for the American people. That might not make a difference to some Senators but it ought to make a difference to the American people. And it is not just the Secretary who is concerned about this provision. We have virtually every single group of health professionals charged with protecting the consumers' interests have expressed concern about this issue--the President of the United States, the Secretary of HHS, the Consumer Federation, the National Women's Health Network, the National Order for Rare Disorders. Who are these groups and individuals? They are the very people that benefit from innovations in medical devices. They are the people whose lives are enhanced. They are ones who are saying, ``No, don't do this. Support the Reed amendment.'' I am glad to listen to my colleagues. I am interested in the number of people employed by these companies. I am interested in what a great job a company does. I am interested in the opinion of some of our colleagues who say, ``Well, this really isn't such an important measure because there are only a few people out there who oppose it.'' Go down the list of the organizations that are out there protecting the people that will benefit most from progress in these areas, and they say, ``Don't do this. Support the Reed amendment.'' Do they make the judgment that this is not important just because it deals only with class II devices--the relatively low risk devices. There has been the suggestion here on the floor of the Senate that these are virtually low-risk devices. These are some of the devices: Ventilators. Low-risk? Who has not been in the hospital with a member of their family and hasn't understood the importance of making sure that ventilators are going to perform as they are labeled? You have digital mammography with possibilities of missing tumors in women with breast cancer. We want to make sure that these devices are going to be safe and do what they are represented and designed to do-- not just what is listed on the label. You have the fetal cardiac monitors that monitor infants. I saw them working yesterday in Springfield at the Bay State Fetal Center in one of the greatest neonatal centers in this country. Do you want to take a chance on fetal cardiac monitors? Or on surgical lasers? The list goes on--these are class II devices, low risk. We are not talking about tongue depressors. We are not talking about bedpans. We are talking about the kinds of items where we need to make sure they are going to be safe and effective. That is why these organizations whose job it is to protect the public are concerned. With all respect to my colleague and friend from Connecticut, who I heard state three times that these products, which have not been approved for safety and effectiveness for the uses for which they are being advertised, are not being mislabeled. And that we shouldn't dispute or cast aspersions on the good, legitimate name of the U.S. Surgical Corp. Mr. President, I have right here the letter from Dr. Monica Morrow, professor of surgery at Northwestern University School of Law, dated September 22. Dear Senator Kennedy: I am writing you to express my feelings regarding the importance of the FDA's mandate to evaluate behind the scene use of devices and drugs. The need for such evaluation is clearly exemplified by the marketing strategy of U.S. Surgical's breast biopsy device. This device was approved as a diagnostic instrument. However, the company video clearly depicts the use of the device for definitive breast cancer therapy with no clinical trial using the accepted technology for comparing cancer treatments that have been conducted to evaluate this claim, and without such trials the device could potentially pose a significant risk to patients. In addition, other claims regarding approved cosmetic outcome and patient acceptance are similarly unsubstantiated. The indication for use of the devices and drugs should be determined by appropriate clinical and scientific data, and not by their appeal as a marketing gimmick. This video was dropped off at my office by a company representative as part of an effort to interest me in purchasing the company equipment. I have it right here. For people who doubt it, take a minute and watch the video. Read the letter. Call Dr. Morrow. It is being marketed out there today. This is what we are talking about. That is the issue. When colleagues get up and say, ``Well, it has not been, and it won't be, and that is wrong if it is?'' I say, ``It is being done.'' And that is exactly the problem that we are attempting to address. Mr. President, this is an enormously significant and important health issue. This body has taken many actions on medical devices since the mid-1970's to enhance public health the protections since the mid- 1970's that enhanced protections for public health. This provision which will create a loophole through which unscrupulous manufacturers of a medical device will be able to drive a truck is the exception to that commendable history. This provision will make a mockery of the substantial equivalence requirement, and will allow irresponsible companies to go out, as this company has, and advertise and represent a particular product for a purpose and use that differs from the one they put on the label. Mr. President, it was interesting that some of our colleagues addressing the Reed amendment pointed out that there are two ways of approving the medical device. Only about 5 percent medical devices use this particular provision, the premarket approval. That provision says, ``In making the determination whether to approve or deny * * * the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all the material facts pertinent to the proposed labeling.'' Mr. President, I daresay that there is probably a less compelling reason to use the proposed labeling as ``neither false nor misleading'' in this provision because you are going to have such a survey in an oversight for new materials as it is in the other provision. What the proposal that is before us now, the one that is for 95 percent of all devices, says is, ``* * * the determination of the Secretary under this subsection * * * with respect to the intended use shall be based on the intended use included in the proposed labeling.'' I would like to point out to those that have suggested here on the floor that the intended use is a subjective decision to be made by the FDA, that isn't what the legislation says. It says, ``* * * the determination of the Secretary under this * * * section with respect to the'' * * * device ``* * * shall be based on the intended use included in the * * * labeling.'' Who makes up the labeling? The manufacturer has the labeling ``submitted a report under this section.'' The only thing the amendment of Senator Reed is proposing is that the FDA be restricted to looking solely at the labeled use only in instances where ``* * * the proposed labeling is neither false nor misleading.'' How can anyone be opposed to that? We have just seen the example of the approval of a biopsy needle for one particular purpose--taking the biopsy. Then we find that this similar machine is represented as being for the purpose of biopsies, here it is in their advertisement--the latest technique in minimally evasive breast biopsy. This device takes 50 times the amount of material as the other one. Here it is being advertised in Canada. Here it is being advertised in the United States--not for use in biopsies but to remove the tumor itself. And there is no information available to the Food and Drug Administration about how good or safe the device is for that use. Maybe it does work. We are not here to say it doesn't work. We just want the company to have to provide the information that says it does work. If that is what you are going to use it for, why should the Food and Drug Administration, which has the responsibility of protecting Americans, be limited by the language of this particular legislation that says you can only look at what is on the label? When, at the same time, they have letters from doctors and they have videotapes that show it is being used for an entirely different purpose. That is the issue. The Reed amendment says, OK, we are willing to only look at the use on the label, but let's just make sure that we are not going to encourage false and misleading labeling. Is the Senate of the United States going to say to the FDA that if even if they know that the labeling is false and misleading that they should be prevented from protecting the American public? That is what you are going to do if you do not accept the Reed amendment. That is what this debate is about. It is as simple as that. Here we have this extraordinary example, where you have a biopsy machine that is supposed to take a biopsy about the size of the lead in that pencil versus something that takes 50 times the amount and the purposes for it is intended to be used are quite different, as mentioned here in the letter which says, ``I am expressing my feelings * * * the importance of the FDA mandate.'' ``The video was dropped off at my office'' with the interest of purchasing the equipment. When the FDA became aware that the company was promoting the device for this unauthorized purpose, it also became aware that it had made a mistake in clearing a device that was clearly designed for a purpose not stated on the labeling--tumor removal for clinical testing. The FDA then acted to require the company to include a strong label that the device was only to be used for tissue sampling; not tumor excision. I cannot imagine why the company failed to give the full information on that. But, nonetheless, that is what is happening. Mr. President, I listened with interest to many of our colleagues talking about how there really are no dangers in terms of medical devices, that my examples are not really what this issue is all about. They are mistaken. We are committed to ensuring that these kinds of circumstances will not occur in the future. That is why we are out here. We don't have to go through another incidence similar to the Dalkon shield where 18 women died from a perforated uterus and 2,700 women suffered miscarriages. We don't want to go through another episode like the Shiley heart valve one where a change in the angle of the valve would have changed the way the device interacted with the heart raised questions as to its safety. The FDA discovered this and refused to let it go to market in the United States. But the modified device was marketed in Europe and 15 times the number of people died using the new device over the earlier one. With all respect to those who say how much better the system is in other countries--15 times the deaths. And the whole toxic shock issue that we raised and its impact on American women. What we are pointing out is that there are dangers that can take place in our country, that affect our people, when you start fiddling around with safety and effectiveness and medical devices. That is the issue. There are those who say, ``Look. We have a little loophole. But it really isn't quite the same as it is with some of these other terrible kinds of situations.'' We have given the illustration of the kinds of challenges that are out there today. There are the laser technologies, cutting tissue laser technologies, where you have submitted to the FDA a laser that, everyone who has really looked at it agrees, is going to be used for prostate surgery. But there is virtually no information as to the safety and effectiveness of that particular medical device for that use--none. That is what happens. There are the various digital mammography devices that may be very good for obtaining diagnostic information and evaluating a particular tumor but may be questionable for screening purposes. Questionable as to there effectiveness in allowing women to know whether they are going to have the first indications of a small tumor. Don't we want to be sure that this isn't what it is going to be used for? Don't we know what they are out there marketing this for and how well it performs? We have just seen in the period of the last 5 days, the example of the terrible events concerning the off-label use of the drug fen/phen-- and the health hazards and challenges faced by the people who have used it. Are we here today saying we don't want to include language in this bill that will allow the FDA to be able to look at safety of medical devices if they find the labeling is false and misleading? We have offered five different compromises to work this out. It is the No. 1 concern of the Secretary of Health and Human Services, the No. 1 concern by the FDA. I have listened here in the Chamber, to those who oppose this amendment who say the FDA has all the authority in the world to protect the public. I have quotes here from Senators who have said, in effect, that we should not be bothered by this because the FDA has all the power it needs and that this is really not a problem. I was tempted to take the language of their quotes and offer it as an amendment because their description of the FDA is not what the law is and will be if this legislation is passed. We would have taken the kinds of protections that were implied by their quotes. Where they say, look, they have the real right to go behind if they think there is some kind of question in terms of safety. The FDA would not have that authority under this bill as written. But if it is your understanding and that is what you want, let's take an amendment and ensure that they do. But we do not have that opportunity. We are faced with the real possibility for a situation where the FDA does not believe it has the power and the authority to protect the American consumer. The FDA does not believe it has authority. If they know that the predominant use is going to be other than that which is listed on the label and which could provide a substantial threat to the American people, the FDA will not have the power or the authority to protect the American public. Members of Congress can come out here and say, ``Oh, yes, they do.'' I have listened to that argument. ``Oh, I don't know why everyone is getting so worked up about it. You know, they really do have the authority.'' They do not have it. The FDA itself states they do not. They have testified they do not. The President does not believe it. The Secretary of HHS does not believe it. The consumer groups do not believe it. National Women's Health Network does not believe it, the Consumer Federation, the Patients Coalition. We have had this discussion and debate for a number of days. We believe we are finally getting through. But where are all the consumer calls saying, ``Look, let's go with what is proposed in the legislation. We have read the record. We have looked at the law. We believe the FDA is out there and can protect the American public. I don't know what everybody is getting worked up about.'' But we aren't getting those calls because virtually every consumer group that has looked at this issue, has discovered that the language in the bill will not provide adequate protection for consumers. National Women's Health Network: ``Women need the FDA to act as a safety sieve screening out drugs and devices that are hazardous and defective. If 404 is enacted, a device manufacturer could label its product for a very simple use. The FDA would be limited to ask for safety and effectiveness for that use only.'' The groups understand this issue, and they are concerned. ``Even if it were clear from the device's technical characteristics that it might be used for other more riskier purposes.'' That is the biopsy needle. You have a needle that is 50 times larger than is necessary for a biopsy and you have the clear evidence from doctors, both in this country and abroad, who have seen the videotape that the company is out there marketing it for a different use. We have it right here--a slick promotion for this particular issue. All we are saying is if the FDA is able to show that the labeling is false and misleading, they can look at safety.

Mr. KENNEDY

Mr. KENNEDY. Under this legislation, the FDA, even though they know this might provide an important safety question for the American people, are handcuffed from doing anything about it. Why are we doing this to the American people? For what purpose? Are we that far behind in terms of online medical devices? We are not. I can put in the Record the various publications of the medical device industry that show they have been making important progress over the past several years, and the profits have gone up, and a different atmosphere is out there to bring the various products on the market. A GAO report has shown that medical device review times are down. So if that is the case, why, now, are we going to rush these devices on through when their purposes are clearly different from the labeled use and for which we do not have adequate safety data? This is a major step back, and puts the public at risk. Madam President, we can go through what some of the dangers are when we find various devices are used for one purpose and then changed and altered for another purpose. In this diagram we have the long bone screws that are used effectively to mend bones. I have a member of my family that has had those implanted and they have been enormously effective. A member of the family had a broken shoulder, and I went back to see her 5 days later and she was able to move her arm, move her shoulder. It was unbelievable when you think of what most of us understood would be a recovery time of several months. We have seen how, when used properly, how they can help mend a bone, give stability to bone, and be effective in helping and assisting those people with that kind of a break to long bones. Then what happened? We found out the screws were being sold to back surgeons for another purpose. They were marketed for use in the spinal column to give stability to the spine. What happened? Madam President, the screws broke, and they were disasters for many Americans who had the operation. Those screws were not adequately tested for use in the back and should not have been used in that manner. These examples are what is happening every day. We have the biopsy needle, the contact lenses, we have the long bone screws, and the list goes on. We ought to be very careful about denying the Food and Drug Administration needed information in terms of their safety and effectiveness. Now, Madam President, we cannot prohibit off-label use of medical devices. We are not doing that in the proposed amendment. What we are saying is that when you have on the face of it a clear intention that the new proposal that is being submitted to the FDA is going to be used clearly as a dominant use for another purpose, such as the breast biopsy instrumentation, that the FDA ought to be able to look at the safety and efficacy of the device. Why are we going through this, Madam President? Why are we tying the hands of the agency that has the skill and the knowledgeable people to try to protect the public? All we are saying is when there is a clear record on the use of a device, make sure the American public's interest is going to be protected and not denied. All our amendment says is when the label is false and misleading, the FDA is going to be able to look behind it. That does not seem to me to be a very dramatic or radical kind of resolution to this particular issue. We have indicated four or five different types of compromises to this particular measure to try to protect the public's interest. We are ready to look at different language to protect the public's interest. But the guiding light is, when we know a medical device is being submitted with false or misleading information and that the device is clearly designed for another purpose, the FDA should be able to look at the safety and the efficacy of the device. We have seen in recent years the dangers of simple changes like the absorbency of tampon material. It looked like it was just a very modest kind of alteration or change. But women were injured, and subject to infections that caused toxic shock syndrome sometimes leading to death. Why are we doing less for the protection of our consumers? Why are we restricting the protections of the American consumers? We are going to have a difficult enough time trying to make sure that when medical devices go through vigorous requirements for safety and effectiveness that they are indeed safe and efficacious. Some mistakes may very well be made. At least we will know we have given it our best shot. At least we will know we have given to the American people the best we have, in terms of scientists and researchers, to try to make sure those products are safe. On this particular provision, for the first time in 23 years, we will be effectively rolling back public health protections at FDA. We will be effectively handcuffing the FDA on a major matter that affects the health and the safety of the American people. It is unwise. It is unjust. There is absolutely no rationale or justification for this provision other than the profits of the medical device industry. Madam President, I cannot help but believe as the American people understand this issue, understand the health implications, understand on the one hand we are risking the public health of the American people in favor of the profits of the medical device industry, that they will be heard on this issue. This provision puts at serious risk the health of the American people--that is what the HHS says, that is what the Women's Health Network says, that is what the principal consumers groups that are out there to protect the American people say. What is the benefit on the other side? The profits of unscrupulous medical device manufacturers. It is not only going to be the profit of those individual companies like U.S. Surgical, but it will be an invitation to other medical device companies to go through a loophole, because otherwise they will be put at a competitive disadvantage. It makes absolutely no sense. I hope very much, that when the Senate addresses this issue in the next week, we can have the support of our colleagues and we will have the support of the House of Representatives and we can move forward with an otherwise reasonable bill. I see my friend and colleague, Senator Durbin, here on the floor. I yield the floor.

Mr. KENNEDY. Mr. President, I yield myself 50 minutes. Mr. President, this morning we continue the discussion of one of the most important and one of the most controversial and I believe one of the most dangerous provisions of S. 830. We are hopeful that we will be able to garner the attention of the Members of the Senate to support an amendment that will be offered and voted on Tuesday next that will address this dangerous provision that puts the American consumer at risk. At the outset, I want to mention that those of us who are concerned about this particular provision are many. The Department of Health and Human Services, which is the principal agency of our National Government responsible for the health and safety of the American people, is strongly opposed to section 404, and supports the position that I have taken here today. Other groups opposed to section 404. Those groups that are opposed to the provision also include the Patients' Coalition, which represents patients from all over this country, a real grassroots organization that understands, at the grassroots level, or the Main Street level, the dangers that this particular provision will mean unless we address it; the Consumer Federation of America; the National Women's Health Network; the National Organization for Rare Disorders; the American Public Health Association, which is charged with protecting the public health of Americans; the Consumers Union, another grassroots organization that looks after the interests of the consumer for a range of different issues and has targeted this particular provision; the Center for Women's Policy Studies; the National Parent Network on Disabilities; the National Association of Social Workers; the Policy Center for Children, Youth and Families; the American Council on Consumer Awareness; and the TMJ Association, they are the victims of the artificial jaw joint group. All of these organizations, and there are many more, are reflecting the anxiety and very deep concern and legitimate concern that consumers have about a particular provision that is included in this legislation, which will effectively handcuff the FDA from looking beyond just the manufacturer's label to get to the bottom line, whether a particular device which has a manufacturer's label is really going to be both marketed and utilized in such a way as to pose a serious and grievous health hazard to the American consumer. I think the National Women's Health Network states the situation very well. I will just take a moment, before getting into the principal reasons for hoping that we will be able to alter and change this provision on Tuesday next, to read it, because it really summarizes the concerns of, in this case, the National Women's Health Network representing the millions of women across this country. On behalf of the 13,000 individual and 300 organized members of the National Women's Health Network, I am writing to express our continued opposition to S. 830 because of the serious implications this legislation has for our Nation's women. The network is extremely concerned that section 404 prevents the FDA from requiring medical device companies to perform complete reviews of the safety and effectiveness of a medical device. This provision must be amended to give the FDA the authority to verify that the label used is not false or misleading. That is what we are talking about this morning, labeling, by the manufacturing company, of a medical device, that is false and misleading. The amendment which we will offer next Tuesday will say that when FDA finds that the medical device company is filing a false and misleading label, that the FDA will be able to look at the safety considerations of that device in order to protect the American consumer. The Food and Drug Administration has a staff of scientists and researchers, individuals who have expert knowledge of different medical devices, whose only purpose is to protect the public. It is that group of individuals that we entrust--we recognize that they are human and are capable of making mistakes, nonetheless, they are the principal agent to trust to protect the American public's health and safety. When we have false and misleading labels by medical device industries, we need to make sure that the FDA scientists and researchers, who are charged with protecting the American public, are going to be able to make a thorough determination as to the safety and the efficacy of the devices. This is the issue. That is what the National Women's Health Network illustrates. The letter continues: Women need the FDA to act as a safety sieve, screening out drugs and devices which are hazardous or ineffective. If section 404 were enacted, a device manufacturer could label its product for a very simple use and the FDA would be limited to asking for proof in safety and effectiveness about that use only. Even if it were clear from the device's technical characteristics that it might be used for other, riskier purposes, the FDA would be prevented from looking beyond the conditions of use on the label. If we are concerned about protecting the American consumer, this makes no sense. We should not be tying the hands of the FDA when we should be protecting the health of the American consumer. Look at recent history and the medical device disasters that this country has faced. This bill opens the potential for those diasters to be replicated. We all hope they will not be. But one of the principal safeguards for preventing this is the FDA being able to examine the safety of devices. The letter goes on: Section 404 is a serious danger to women's health. I repeat, this particular section, section 404-- is a serious danger to women's health, which must be fixed before S. 830 is acted upon by the Senate. In light of today's front page coverage of the fen/phen catastrophe, in which women were the victims of off-label drug use, we find it inconceivable that the Senate would pass a bill with this provision. There it is. They have it right. We just had the fen/phen disaster, in which scores of individuals have suffered--have perhaps lost their lives--as a result of off-label use. And here we have on the U.S. Senate floor a particular provision that will invite unscrupulous medical device companies not to clearly and accurately state what their medical device is going to be used for. This is the issue. We have scores of other letters, similar to the one I just read, expressing concern about section 404. The issues are clear. Will the Senate vote in favor of approving a medical device based on false and misleading labels? Will the Senate allow dangerous medical devices that have not been tested for safety and effectiveness to be foisted on the American people? Will companies like U.S. Surgical Corp. be rewarded for deceiving the FDA? Will the Senate put a higher value on the profits of the powerful than the health of the American people? Mr. President, let me point out, that if U.S. Surgical Corp. is able to have their way--if they are allowed to misleadingly label their medical device as being substantially equivalent--they will be virtually guaranteed approval under the language of this bill. Because this bill says that if the medical device is substantially equivalent to one that has been approved and meets those safety requirements, it must be approved. Despite the fact that this corporation, U.S. Surgical Corp., has a device that is being advertised and will be used for an entirely different purpose. A purpose for which it has not been tested for safety. What happens to the ethical companies? What happens to the other medical device companies that are trying to provide safe medical devices? They are going to be at a competitive disadvantage because they will come up and say to the FDA, ``Look, our device is for this purpose and we have conducted these expensive safety tests.'' That is going to cost that company, and it means that their medical device is going to be more expensive. What happens to these other companies when a company like the U.S. Surgical Corp. is able to get in the door without providing safety information, without doing that kind of testing? This is also an issue. It is not the most important argument. The most important one is health and safety. If this language is not altered or changed, it will be an invitation for medical device companies all over America to jump through this loophole in order to get their products on line. Will the Senate put a higher value on the profits of the powerful than the health of the American people? Section 404 of the bill requires FDA to approve a medical device based on the use claimed on the label submitted by the manufacturer-- even if that label is false and misleading. Think of it. The FDA will be required to give approval even though the label is false and misleading. Whose interests are we protecting? Are we protecting the American consumers' interests, or are we protecting the profits of the medical device company? The way this law is currently constructed, it will help protect the profits of companies like U.S. Surgical Corp. It prevents the FDA from requiring manufacturers to demonstrate that their product is safe and effective for the purposes for which it will be used as opposed to the purpose falsely claimed on the label. It stands 20 years of progress toward safer and more effective medical devices on its head. For 20 years, since 1974, we have tried, through the FDA, to make sure that medical devices are safe and efficacious. This is the first time in over 20 years that we are taking a step backward. We take modest steps forward on the basis of experience, at both the FDA and across the country, to provide additional protections for the American consumer. Now we are faced with the first significant and major step backward. Mr. President, to illustrate that, the U.S. Surgical Corp., a large and successful manufacturer of medical devices, submitted a new machine to the FDA for approval. This machine was called the Advanced Breast Biopsy Instrumentation System. The company claimed that the machine was to be used only for taking biopsies of breast tumors suspected of being cancerous. Cancer is a word that any family in America hates to hear. Many Members of this body, many Members of the House of Representatives and so many American families have been touched by cancer. There are few people listening today whose family has not been touched by cancer in some way. With the increasing number of breast cancers, this particular medical device is the most offensive, because the principal disaster is not only contracting cancer, but it is in the failure of being able to diagnose it and treat it effectively. What has the U.S. Surgical Corp. done? The company claimed that the machine was to be used only for taking biopsies of breast tumors suspected of being cancerous, but the machine was designed to excise a piece of tissue 50 times as large as other biopsy devices already on the market. It was obvious from the machine's design that it was intended to remove breast cancer tumors, not simply take samples for biopsy. Maybe it works. Maybe it is a major breakthrough. Maybe it can do all the things that the U.S. Surgical Corp. says can be done. Wouldn't that be wonderful? But we don't know. Maybe it doesn't. Maybe it doesn't work. Maybe when the doctor says we have excised the tumor, it doesn't do it completely. We don't know. Maybe when that woman walks out of the doctor's office or leaves the hospital, she is still in danger. She believes she has been treated effectively, but maybe this device isn't effective at removing tumors. Then there is the possiblity that in 4 weeks, 5 weeks, 6 months, 1 year, 1\1/2\ years, the cancer is still present and life and health are still at risk. Why are we taking a chance, Mr. President? Because the medical device companies want this provision. It was obvious from the machine's design that it was intended to remove breast cancer tumors. In fact, we have obtained a videotape, made in Canada, that demonstrates that the company knew it would be used for that purpose, despite their false claims to the FDA. Here you have the U.S. Surgical Corp. saying to the FDA that we have a small biopsy needle the size of the lead in a pencil, that will be used to check a tumor, returning to the FDA for approval of what they label as a substantially equivalent medical device. Under this legislation--even though the company is out advertising that medical device for an entirely different purpose, for which they have not provided any health or safety information to the FDA and under this legislation--FDA would have to approve it. Despite the fact the FDA knows the device will be used for another purpose. Under this bill, the FDA could not say, ``Provide the information to show that this is safe and effective.'' This is the example, Mr. President. We are talking about cancer-- breast cancer. We are talking about 1 out of 7 women who are going to be affected at some time in their lives. We know the enormous legitimate concerns that women have, that mothers have, that daughters have. And we are going to say we are prepared to allow them to have less than the best protections we can offer? Mr. President, under this section of the FDA bill, the FDA would be forced to approve the new device without any evidence on the safety and effectiveness for new uses. American women do not want to die from breast cancer because the companies are allowed to sell devices whose safety and effectiveness have not been demonstrated. No Senator would want their wife or mother or daughter to be subjected to such an untested device solely because a greedy company wants higher profits. The issue goes far beyond the products to excise breast cancer. It applies to lasers to treat prostate disease, stems to be placed in carotid arteries, imaging systems to detect breast cancer, and a host of other treatments for dreaded diseases. Public health professionals will tell you as we continue to develop new technological advances this problem will only grow along with the threats to public health and safety. We will be rolling the dice. How many people are willing to roll the dice for a member of their family and use a medical device that has not been adequately tested? The companies are out there, Mr. President, and they won't mind if we roll the dice. Are we going to permit that? This provision will give unscrupulous companies incentives to lie to the FDA. It will penalize ethical companies who are truthful and doing the necessary testing to demonstrate that their products are safe and effective. Most of all, it will put the health of the American people at risk so that a greedy few can increase profits. Companies that hope to benefit by weakening the FDA are already powerful and profitable. They believe they have the votes to push this disgraceful provision through the Senate--and this morning they probably would have. It is absolutely untenable and outrageous and unnecessary that we would, except to provide additional profits for a company that will use this loophole to get their devices on market earlier. If the American people truly understand what is at stake, I do not believe they will permit this dangerous provision to become law. When the vote comes on Tuesday, we will see how many Senators are willing to stand with the American people and how many are willing to vote in favor of false and misleading labels. Let me make it very clear that the Tuesday vote will not be the end of the story. We will continue to fight to keep this provision from becoming law, and I believe we will succeed in the end. The FDA bill has many constructive elements, but this disgraceful provision should be eliminated. The false or misleading label should have no place in the approval of medical devices. Unscrupulous manufacturers do not deserve a free ride at the expense of the public. Mr. President, what we are talking about is S. 830, and section 404, which prohibits the FDA from reviewing the safety of a device for uses not listed by the manufacturer. This provision handicaps the principal agency of Government that is charged with safety, and we are writing into the law language that will prohibit FDA--which is the agency charged with protecting the American people from unsafe pharmaceutical drugs and medical devices--from doing its job. The FDA would be prohibited from reviewing the safety of a device for uses not listed by the manufacturer. What our amendment says is, OK, we'll prohibit the FDA from reviewing the safety of a device for uses not listed by the manufacturer--unless the label is false or misleading. How can Members of this body say that they will refuse to stand with those of us who support the Reed amendment that says ``unless the label is false and misleading''? We have the example of U.S. Surgical Corp.'s biopsy needle. A needle designed to extract a small amount of cancerous tissue, maybe the size of a pen or the lead of a pencil. Now what has the company done? It has developed a much larger device that may be able to take a biopsy, but which, in fact, is primarily designed for tumor removal. But all they will have to be able to do is show that they are substantially equivalent. Under this proposal, the FDA will not be able to look at what the real purpose of this medical device is. We know what the U.S. Surgical Corp.'s real purpose for this medical device is. We know because we have seen the advertisement they have already prepared. This device which can take out 50 times more material than its predecessor--50 times more material--is not intended to be used for a biopsy, but is designed to excise the tumor. Maybe it can do it well, Mr. President. Maybe it is an important and major step forward. But any woman who has a procedure done with this device, will not be able to judge from the safety information that is provided to the FDA because there has been none provided. They won't know the results of testing conducted on this device because there have been no tests submitted to the FDA. They won't know whether this is a successful device because there is no information to indicate its success. We are talking about women and breast cancer. We are talking about a medical device that is put forward with virtually no intention for use for biopsies. Where an earlier smaller, less intrusive device already exists for biopsies. A device that is going to be used to remove tumors, and is advertised to doctors as such. What are the American doctors supposed to believe? They say, ``Well, we have FDA approval.'' ``Well, isn't that fine. Then it must be all right, it must be safe.'' But no doctor is able to give that kind of assurance to a woman who is going to have this particular medical device utilized to excise a tumor, because it has not been done. How would our amendment change that? Our amendment would say that if the advertising is false or misleading, that anyone would be able to see that this particular device is going to be used to excise a tumor--U.S. Surgical, show us your studies, show us your information that would indicate that this is safe for American women. Show us where you have tested it to show that it does the job. Show us that it will do what you are advertising will be done. Let us examine that. And if that is the case, we approve it for that particular purpose. This provision is unconscionable, Mr. President, when you look at the tragedies that have resulted from device disasters. We are not talking about Band-Aids and tongue depressors. We have seen medical device disasters which have cost the lives of hundreds and thousands of American consumers. I was here and chaired the hearings on the Dalkon shield IUDs, which injured tens of thousands of women. Their injuries included pelvic inflammatory disease, sterility and perforated uteruses. That is because, Mr. President, with the Dalkon shield we found out that bacteria crept through the string of the device and caused infections in American women. As a result of this disaster in the mid-1970's we set up protections for the American consumer with regard to medical devices to ensure that they would be safe and efficacious. Prior to the mid-1970's we did not test for safety and efficacy. We want to be able to make sure that the FDA is going to be able to test for safety and efficacy on a product that is going to be the predominant use of a particular medical device. In another example of a human and public health tragedy involving a medical device, the firm Telectronics marketed a pacemaker wire for use in the heart. Twenty-five thousand of these pacemakers were marketed, beginning in 1994, before it was discovered that the wire could break, cause damage to the wall of the heart, or even destroy the aorta. Why are we being asked in the U.S. Senate to deny the FDA adequate authority to protect the American people? Safe and effective medical devices is what the American public deserve and it is what Senator Reed's amendment to section 404 would ensure. Mr. President, another example is patients with defective Shiley heart valves who died, underwent painful and dangerous surgeries to remove the valves. The company increased the degree of a particular vent from 60 degrees to 70 degrees. But because FDA had the power to examine whether this presented any additional health hazards to the American people, the modified valve was not marketed in the U.S. The company sold them in Europe. And the modified valve had six times the amount of disasters in the hearts as a result of that 10-percent increase. Hundreds of deaths resulted in Europe and thousands and thousands of people put at risk. Then we have the angioplasty catheters that failed causing dozens to suffer emergency coronary bypass surgery, cardiac damage and death. Mr. President, this is what we are talking about. We are talking about S. 830 which allows false and misleading labels for medical devices. S. 830 could result in the surgical needles that do not safely remove the breast cancer tumors. FDA has been asked to clear surgical lasers for marketing despite the lack of safety data submitted to support the clear intent of the manufacturer--to cut prostate tissue. What we have are laser manufacturers that say, ``Well, all right, we want to use lasers in the operations on the prostate. And a certain amount of cutting is going to be necessary.'' They effectively say, ``Our laser is substantially equivalent to lasers that are already approved for general cutting,'' when the intention of the company is to use the newer designed laser not just in the ordinary cutting of tissues but for use in a prostate operation. Therefore, through this loophole, a device may be used for a purpose for which it was clearly designed but not adequately tested. We have also, Mr. President, the example of contact lenses that may cause blindness. FDA can tell by the materials and design of a contact lens that it will be used for extended wear. But a company could submit data only on a labeled use of daily wear and FDA would be prohibited from asking for additional information on extended wear. Extended wear lenses that are not adequately tested may cause ulcers on the cornea and can be sight-threatening. Mr. President, we may see in the future digital mammography screening machines that may misdiagnose breast cancer. We have seen enormous progress being made in terms of mammography with all the benefits of early detection of breast cancer which permits early treatment and saves lives. These advanced technologies, Mr. President, may be able to perform diagnostic mammography but not mammography screening. There is an important difference. The screening is used to find out whether there are tumors as compared to examining a tumor for diagnostic purposes to make a determination of the appropriate kinds of medical treatment. A mammography instrument labeled for use as a diagnostic machine could have features specific to mammography screening and the safety data should be submitted to support that use. Why do we have to take a chance on it? What is the compelling need to take a chance on women's health? Why shouldn't we say to FDA that if they have reason to believe that the primary purpose of this new machine is going to be for screening and the label is false and misleading that they can ask for safety data for the intended use. Why should we hamstring the FDA when we know that the purpose for these new kinds of medical devices are not consistent with what is being labeled by the manufacturing company? (Ms. COLLINS assumed the chair.)

Mr. KENNEDY

Mr. KENNEDY. Mr. President, the underlying piece of legislation that we have before the Senate is S. 830, which is the drug reform legislation. Earlier in the course of the debate and discussion, I pointed out one of the most serious proposals in that particular piece of legislation that puts the future health care of all at serious. I also pointed out the bewilderment the President of the United States and I share, which every consumer group shares: Why in the world are we providing the kind of change in protections for the American consumer that are included in this legislation? I am reminded, Mr. President, that 30 years ago this Nation was faced with a thalidomide tragedy, and all the implications that that terrible situation had for hundreds of mothers and children. Twenty years ago, we had the Dalkon Shield tragedy, where 18 women died from perforated uteruses, 2,700 women had miscarrages, and millions of women were adversely affected with great illness and sickness and, in many instances, were unable to have children in the future. Why? Because we had a medical device that wasn't safe for American women. Ten years ago, we had the Shiley heart valve. A certain part of that heart valve that was found to be unsafe here in the United States, but it was advertised and used overseas and resulted in hundreds of deaths. We know that some medical devices can be dangerous. We have to ask ourselves, as we are coming into the final consideration of this legislation, why in the world we are retreating from protecting the American public in this area? That is what we are doing. We are putting the interests of the medical device industry ahead of the public health of the American people. For what reason? For the profits of those medical device industries. The provisions of the legislation are clear and simple. S. 830 says: . . . prohibits FDA from reviewing the safety of a device for uses not listed by the manufacturer. If the manufacturer labels a device as substantially the same as another device that has already been approved, the Food and Drug Administration cannot look at that medical device, beyond the use listed on the lablel, in terms of its safety and effectiveness in protecting the American consumer. We are effectively handcuffing the Food and Drug Administration with this language. The amendment, which will be offered by Senator Reed--on which I will join him, says: . . . prohibits FDA from reviewing the safety of a device for uses not listed by the manufacturer unless the label is false and misleading. Who could defend a medical device manufacturer that knowingly submits false and misleading information? Anybody who is listening to this would say, we can't believe that, Senator. We can't believe that is really happening. Well they should believe it because that is what is happening. The clearest illustration of this development is the use of a certain biopsy needle that has been manufacture by U.S. Surgical Co. A biopsy needle used to excise tumor tissue to see whether it is cancerous or not. The biopsy needle is maybe the size of the lead in a pencil. It is used to remove sufficient amount of material to be analyzed. Now, along comes U.S. Surgical Corp., which develops medical devices, with a new medical device that can take 50 times more material than the earlier biopsy needle. U.S. Surgical says: Look, this new device is the same purpose as the other medical device. It is substantially the same. It is for taking material that can be a biopsied. We have been approved previously in terms of safety and effectiveness. According to our label, this new device is a biopsy needle and, according to the law, under S. 830, FDA cannot look beyond that use and into the real purpose of this new device to determine whether or not the device is safe and effective for that new use. Well, Mr. President, unfortunately for U.S. Surgical Corp., a number of us have seen their ads and promotions for this particular medical device. What is U.S. Surgical Corp. promoting? It is promoting this new device as a device that is going to remove the tumor, not just take the biopsy, but remove the tumor from a woman's breast. Now, it may be very good in removing that tumor. It may be able to get all the cancerous material. It may do the job better than any other medical device we have had before. But we don't know that. The patient won't know it. The doctor won't know it. The family of the patient won't know it. Why? Because U.S. Surgical Corp. would not have to provide one paragraph of information demonstrating that this medical device is safe and effective for removing tumors. The doctors will see it and say, well, this has been approved by the FDA, it must be safe. I think I will use it, especially after reading about, hearing, or watching the promotion film used in Canada to promote this device. The FDA would be prohibited from looking behind the labeling of the device to determine whether it is safe and effective. The FDA can say, look, we know the manufacturer is out there day in and day out promoting this device for tumor removal. They can hardly wait to get approval to go out and sell that medical device for the purposes of removing the tumor. According to the proposal under S. 830, if the label says that it is substantially equivalent to the biopsy needle, the Food and Drug Administration cannot require U.S. Surgical Corp. to provide information demonstrating that the device is safe and effective for its marketed purpose. That is wrong. We are taking an important step backward in protecting the American people. And it is not just this particular medical device. The real concern is all the other medical devices that are out there now being considered. It is the mammography screening machines that are being used for breast cancer screening. The mammography screening machines may be very good in terms of the diagnostic evaluation of tumors, once the tumor is detected. They may be even better as screening tools to look for such a tumor. But we don't know because the FDA wouldn't be able to ask for safety and effectiveness data for its use in breast cancer screening. So we have examples of mammography machines coming into the FDA that will be approved because they are effective in terms of evaluating and diagnosing tumors, but have not been studied in terms of their effectiveness in screening. Yet we find the machine is being used for screening purposes. American women will say that they have been screened with mammography machines, and they have been found to be free of any kind of cancer. They will be very happy about that. Since we have no data on how effective this device is for screening, they may find later, maybe too late, that they have some kind of a tumor. They may find out that this machine didn't do what it was represented to do because it had not been tested in terms of effectiveness. That should not be the case. That is true with regard to the surgical lasers that haven't been tested for safety and effectiveness in cutting cancerous prostate tissue. It has been demonstrated that the lasers are safe and effective in cutting general tissue. But, the manufacturer changes the design and puts another laser in that also cuts tissue. But the purpose of that new laser is to cut through tissue in the prostate area, whether it is a cancerous tissue or noncancerous tissue. The laser has not been approved for that purpose. We do not have safety information to know that it is effective in dealing with this particular kind of operation. The manufacturer doesn't have to provide it. All they have to do is say it is a laser that cuts tissue and they get approved. The FDA can be fully aware that they are going to promote it for prostate cutting, but they will not be able to ask the manufacturer to provide safety information for that use. The same is true with contact lenses that get approved though this loophole channel--saying that the lenses are substantially equivalent to equipment that has already been approved. But those lens manufacturers are intend to promote these new lenses for long-term use rather than short-term use like the ones that have been approved. The FDA can know about the advertising--and can even tell from the change in materials used to make the new lenses that they are designed for long-term use. But they cannot evaluate the new lenses for safety and long-term use. We can see the dangers that could result--maybe even blindness. Mr. President, we shouldn't be taking a risk with the health of the American people in this way. It is fundamentally wrong. The only reason to do so is to give a competitive advantage to unethical medical manufacturing companies. Those are the ones that will use this loophole. And when they do, they will gain a competitive advantage over the ethical manufacturers that take the time and spend the money to conduct the safety and effectiveness studies to show that thier devices are safe. They will be at a financial and competitive disadvantage because less ethical companies will use this loophole for approval. That is why each and every one of these consumer groups are opposed to this provision--why we have recommended five different alternatives to address this issue over the past weeks. The medical device industry has turned those down because they say they have the votes. They can roll over the public health concerns of the American people. That has happened in the past. But I hope it will not happen next Tuesday. This issue is too important. It is important for our wives, our daughters, our sons, our fathers, our grandparents--to be sure that when they have to use medical devices, those devices are going to be safe and effective. We have the ability to ensure safety in so many new ways-- ways that were unimaginable years ago. But with this provision, we are effectively tying the hands of the FDA. If there is an appropriate title for the provision, it is the false-claims provision of the medical device and pharmacy legislation, S. 830. And it is the wrong way to go. We look forward to debating this issue next week. I am hopeful that we can address it in a way that will provide the real protection the American people deserve. Mr. President, I suggest the absence of a quorum.

Mr. KENNEDY

Mr. KENNEDY. I thank the Chair. I yield myself such time as I might use.

Mr. KENNEDY. Mr. President, as I understand the situation we are now under a time control of the minority leader?

Mr. KENNEDY

Mr. KENNEDY. I thank the Chair. I will say this evening what I have said before, and that is to commend the chairman of our committee, Senator Jeffords, and the other members of our committee for working out, by and large, a commendable piece of legislation to bring pharmaceuticals onto the market safely and rapidly, and to assure that Americans would be able to have the benefits of advances in the areas of medical devices. There is a very important provision which has been included in the bill and which I think poses a very significant threat to the health and safety of the American people. I want to take some time this evening to discuss the reasons why this particular provision should be eliminated from the bill or modified to retain existing protections available under the Food and Drug Act. I will use the time that I have this evening to try to spell out for the Senate and for those who are watching these proceedings the dangers of this provision so that, hopefully, when the Senate has the opportunity to change this particular provision on Tuesday next it will do so. It is time to make the changes that will protect the American people, and it is important that we do so. Mr. President, this is not just a provision that I have reservations about. We have put in the Record, and I will mention at this time once again, that the President of the United States has indicated that this is one of four major concerns that he has in this legislation because of its potential to adversely effect the public health. It isn't only the President of the United States who has identified this particular provision as being a danger to the health of the American people, but it is the Patients' Coalition, which is made up of patients from all over this country, who review various pieces of legislation to ensure that the patients of this country are adequately protected: the Consumer Federation of America, the National Women's Health Network, the National Organization of Rare Disorders, the American Public Health Association, Consumers Union, Center for Women's Policy Studies, the National Parent Network on Disabilities, the National Association of Social Workers, and the list goes on and on and on. That is why, Mr. President, this particular provision should be revised to protect the health of the American people. It does not do so now, and it has not since it has been reported out of the committee. If this provision becomes law, it would force the Food and Drug Administration to approve unsafe or ineffective medical devices in cases where a manufacturer submits false or misleading information about the product. This issue goes to the heart of the role of the FDA, and it is an unconscionable provision. The result is that patients who rely on medical devices may well be exposed to dangerous products that could maim or kill. Ninety-five percent of all devices approved by the FDA involve upgrades of existing devices. The upgrades are reviewed in what is called the 510(k) procedure under the statute. Under this procedure, the manufacturer of the device asks for an FDA approval based on the fact that the new device is substantially equivalent to an existing device that is already on the market and that has already been approved as safe and effective. On this basis, the FDA usually quickly approves the new device. If the new device has significant technological changes, the manufacturer must submit the data to the FDA to show that the new device is as safe and as effective as the older device to which it is being compared. That is the current law. In making these determinations under the current law, the FDA looks at the use of the earlier device and the claims that the manufacturer of the new device makes on the label for the new product. Sometimes, however, the new device has technological characteristics that make it clear that the device is intended to be used for a new purpose, a different purpose than the one the manufacturer claims on the proposed label. All we are asking is that the FDA be able to act in these circumstances to assure that the device is safe. We want to prohibit false and misleading labels. Mr. President, this is not a hypothetical case. A recent case demonstrates the basic problem. A new biopsy needle for diagnosing breast cancer in women was submitted for approval to the FDA by the U.S. Surgical Corporation, a well-known manufacturer of medical devices. Compared to the existing biopsy needle, the new needle was huge, far larger than would normally be used in a biopsy. In fact, the tissue removed by the device was 50 times as large as the standard instrument would remove. It was obvious to the FDA that the new needle would be used to remove small tumors, not just to perform a biopsy. In fact, the company marketed the device for that purpose in Canada. Yet, the corporation proposed to market the device with the old biopsy label, which gave no hint of the obvious new use of removing cancer cells. Under current law, the FDA has the authority in such cases to require the manufacturer to submit data on the safety and effectiveness of the needle for the new use, to be sure that it is capable of removing tumors without leaving some cancer cells in place. Under this legislation, if the FDA said, ``Well, let us examine whether this particular medical device provides safety and protection for American women when that device is used to remove tumors,'' the FDA would not be permitted to do so. Under the old law, it would. Under the new law, it would not. In this particular case the tissue removed by the device was 50 times as large as the standard instrument would remove. It was obvious to the FDA the new needle would be used to remove small tumors, not just to perform biopsies. In fact, videos were distributed in Canada demonstrating how to use the device to remove breast tumors. Yet, the corporation proposed to market the device with the old biopsy label which gave no hint of the obvious new use for removing tumors. Under the current law, the FDA has the authority in such cases to require the manufacturer to submit the data on safety and effectiveness of the needle for the new use to be sure that it is capable of removing tumors without leaving some cancer cells in place. But not under the law that is before the U.S. Senate. No woman would want to have a breast cancer removed by a medical device that cannot do the job safely and effectively. No Member of the Senate would want their wife or mother or sister or daughter put at risk by such a device. That is precisely what this bill does in changing the existing law that would permit the FDA to look behind the label to examine the safety and efficacy of a use clearly intended by the technological characteristics of the device. The proponents of this legislation say no to an amendment when we have tried to ask that the FDA be able to look at the primary use of medical devices to make sure that when a company, such as the U.S. Surgical Corporation, is going to say that this is really just the old small needle, to permit the FDA to look behind it. They say, ``No. We've got the votes. Public be dammed.'' Unless the American people are going to pay attention to this issue, they will have the votes when we vote on this next Tuesday. But they should not have the votes on it. They should not have the votes on it if we are interested in protecting the American consumer, not only on this particular measure, this particular device, but on others as well. The justification offered by the proponents of this provision is that the FDA, in its zeal to protect the public, has sometimes required manufacturers to offer data on safety and effectiveness on purely hypothetical, possible uses of the new device, uses never intended by the manufacturer. If that is the goal of the provision, it goes too far because it puts public health at risk. No American should die or suffer serious injury because the FDA is forced to ignore false or misleading claims. That is what Senator Reed's amendment next week will be, just prohibiting false and misleading claims. People will have a chance to vote on that up or down. No American should die or suffer serious injury because the FDA is forced to ignore false or misleading claims. That is what this is about. As I mentioned, the administration has singled out this proposal as one of the four in this legislation that merit a veto. It is strenuously opposed by a broad coalition of health and consumer groups. An obvious compromise can correct this defect so it achieves what the sponsors say is its legitimate purpose, without undermining health and safety. Under the compromise, the FDA will have the authority to look behind the label only in cases where the label is false or misleading. This is a bare minimum requirement to protect public health. What possible justification can there be for the FDA to approve a device based on false or misleading labels? No ethical manufacturer would submit a device with a false or misleading label. No unethical manufacturer should get away with submitting one. And no Senator should vote to protect a false and misleading label. The protection is already in the bill for the 5 percent of the devices that go through the traditional approval process. But for the 95 percent of the devices that go through the 510(k) procedures, the bill gives a license to lie to the FDA and harm the public. Mr. President, a few days ago the public was made aware of the tragedy that resulted from the use of diet drugs in ways that had not been approved by the FDA as safe and effective. This so-called ``off-label'' use of fen/phen may well have caused serious and irreversible heart damage in tens of thousands of women who thought the drugs were safe. The legislation before us would actually encourage the use of off-label, unapproved uses of medical devices. We have seen in every newspaper in the country, we have heard on every radio station, every television, the dangers that the off-label use of fen/phen has posed for the American people. Now, just at the time that the country is looking at that, we are inviting the same kind of disaster for off- label use of medical devices. It is shocking that this shameful provision has been so cavalierly included in the bill. It is incomprehensible that reputable device manufacturers are not prepared to support a compromise that allows the FDA to look behind the labels that are false and misleading. Medical devices can heal, but they can also maim and kill. The history of medical devices is full of medical stories of unnecessary death and suffering. But thanks to the authority the FDA now has, there are also many stories of lives saved by the vigilance of the FDA. What is incomprehensible about the bill before us is that it would take us backward in the direction of less protection of public health rather than more. That isn't just Senator Kennedy saying that, Mr. President. Those are the findings of our Secretary of HHS, the Patients' Coalition, Consumer Federation of America, National Women's Health Network, National Organization for Rare Disorders, the American Public Health Association, Consumers Union--the list goes on and on. They have reached the same kind of conclusion, Mr. President, that we are going backwards instead of advancing the interests of the public health. The whole story of device regulation has been to provide the public greater protections since the mid-1970s. Mr. President, let me just take a few moments and talk about what has happened previously in terms of medical devices that posed very important health threats, injury and death to American people when we were not attentive to the public health interests of the people of this country. Two decades ago, the Dalkon Shield disaster led to the passage of a law giving the FDA greater authority over medical devices. At the time, this birth control device went on the market, the FDA had no authority to require manufacturers to show that devices are safe and effective before they are sold. In 1974, an FDA advisory committee recommended that the Dalkon Shield be taken off the market--after almost 3 million women had used it. The device was found to cause septic abortions and pelvic inflammatory disease. Hundreds of women had become sterile, and many required hysterectomies. According to the manufacturer's own estimates, 90,000 women in the United States alone were injured. The manufacturer, A.H. Robins, refused to halt distribution of the device, even though the FDA requested it, while the issue was reviewed by the advisory committee. The Shiley heart valve disaster was so serious that it led to the enactment of further legislation. This mechanical heart valve was approved in 1979. It was developed by the Shiley Company. The Shiley Company was subsequently sold to Pfizer, which continued marketing the valve. It was taken off the market in 1986 because of its high breakage rate. By that time, as many as 30,000 of these devices had been implanted in heart patients in the United States. One hundred and ninety-five valves broke and 130 patients died. Thousands of other patients who had the defective valves in their hearts had to make an impossible choice--between undergoing a new operation to remove the device, or living with the knowledge that they had a dangerous device in their heart that could rupture and kill them at any moment. Depositions taken from company employees indicated that cracks in defective valves may have been concealed from customers. Before the defective valve was withdrawn, the manufacturer had tried to introduce a new version with a 70 degree tilt instead of the 60 degree tilt approved by the FDA. The increased tilt was intended to improve blood flow and reduce the risk of clotting. The FDA's review found that the greater tilt increased the likelihood of metal fatigue and valve breakage, and the new version was not approved for use in the United States. Four thousand of the new devices were implanted in Europe. The failure rate was six times higher than for the earlier valve--causing at least 150 deaths. In another example of a human and public health tragedy involving a medical device, the firm Telectronics marketed a pacemaker wire for use in the heart. Twenty-five thousand of these pacemakers were marketed, beginning in 1994, before it was discovered that the wire could break, cause damage to the wall of the heart, or even destroy the aorta. The case of artificial jaw joints--referred to as TMJ devices--are another tragedy that devastated tens of thousands of patients, mostly women. These devices were implanted to assist patients with arthritic degeneration of the jaw joint, most with relatively mild discomfort. But the impact of the new joints, sold by a company called Vitek, was catastrophic. The new joints often disintegrated, leaving the victims disfigured and in constant, severe pain. To make matters worse, Vitek refused to notify surgeons of the problems with the joints, and FDA had to get a court order to stop distribution of the product. Similar problems were experienced with Dow Corning silicone jaw implants. You see with this chart these dramatic, tragic, human disasters caused by unsafe, inadequately tested medical devices. Do we want less safety? Do we want less protection when we have seen these kinds of human tragedies take place, when there have been these instances? Mr. President, another device disaster is the toxic shock syndrome from super absorbent materials in tampons. Most women would not think that a tampon could kill them, but they would be wrong. About 5 percent of toxic shock syndrome cases are fatal. What seemed like minor design changes, the absorbency of the material, resulted in enormous human tragedy. Women and their families deserve protections from unsafe medical devices. FDA should be strengthened, not crippled. In yet another example, the FDA was able to block a device that involved a plastic lens implanted in the eye to treat near-sightedness. The device was widely marketed in France, but the FDA refused to approve it for use in the United States. Long-term use of the device was later shown to cause damage to the cornea, with possible blindness. The angioplasty catheter marketed by the Bard Corporation turned out to be a dangerous device that the company sold with a reckless disregard for both the law and public health. The device was modified several times by the corporation without telling the FDA in advance, as required by the law. The company was prosecuted and pleaded guilty to 391 counts in the indictment, including mail fraud and lying to the government. Thirty-three cases of breakage occurred in a two-month period, leading to serious cardiac damage, emergency coronary bypass surgery, and even death. Now, Mr. President, these tragedies resulted in expanded powers for the FDA to protect the public against dangerous devices and greater vigilance on the part of the agency. But this bill steps back by forcing the FDA to protect the public with one hand tied behind its back. This bill actually forces FDA to approve devices based on false and misleading labels. I have already discussed the dangers of a breast cancer biopsy needle that would have been used to treat breast cancer without adequate evidence that it was effective. There are many other examples of the kind of dangerous devices that could be foisted on the American public, if the provision of the bill allowing false and misleading labels is allowed to stand. Under the provision, the FDA cannot look behind the manufacturer's proposed use to demand appropriate safety and effectiveness data, even if it is obvious that the device has been designed for an altogether different use than the manufacturer claims. Surgical lasers are increasingly used for general cutting, in place of traditional instruments such as scalpels. In a recent case, a manufacturer called Trimedyne adapted the laser in a way that indicated it was clearly intended for prostate surgery. But it submitted an application to the FDA saying that the laser was only intended for general cutting. The label was clearly false, and the FDA was able to require adequate safety data before the product was allowed on the market. But under this bill, the FDA would be forced to approve the product, without requiring evidence that the device is safe and effective for prostate surgery. Prostate surgery is a very common procedure affecting tens of thousands, if not hundreds of thousands of older men. Failed surgery can result in permanent incontinence and other devastating side effects. Do we really want surgical tools to be used to treat this common illness that may not be safe and effective? If this legislation passes unchanged, that is exactly the risk that large numbers of patients needing prostate surgery could face. A further example involves digital mammography, an imaging technology that is becoming an alternative to conventional film mammography. The new device is being tested for better diagnostic imaging of a potentially cancerous lump in the breast that has already been detected and shows great promise. But it is not known whether the new machine can be used effectively in screening for breast cancer when there are no symptoms. Under this bill, if a manufacturer seeks approval for a digital mammography machine that is clearly designed for breast cancer screening, not just for diagnosis, the FDA would be prohibited from requiring data to show that the machine is effective for screening. Does the Senate really want to support legislation that could result in women dying needlessly from undetected breast cancer? That is what this device provision could cause. We know that there is more money that is going to be made by those particular companies that can get on the market faster than their competitor through this loophole. Is that what we are about in terms of trying to protect the public? The FDA is the principal agency of the government to protect the health and safety. The various professionals in consumer organizations and patient organizations that spend every day trying to protect the public health understand the dangers that are involved in this provision. They are all saying why doesn't the Senate build in these protections? But no. There is that majority in the United States Senate that would go ahead and accept this, and pass this legislation as it is without the adequate protections. And, unless the public is going to understand that this is something which is important and let their representatives understand that by Tuesday next, that is what will happen. The President of the United States has had the courage to say no to this particular provision, because he understands, as the Secretary of Health and Education understands, and as the public health community understands the dangers to the American consumer if we let this provision continue. Mr. President, I want to review as clearly as I can exactly what the bill that is before us, S. 830, does. It prohibits the FDA from reviewing the safety of a device for uses not listed by the manufacturer. Senator Reed's amendment will prohibit the FDA from reviewing the safety of a device for uses not listed by the manufacturer unless the label is ``false or misleading.'' You would think we would get 100 votes on that. Is the Senate going to say, ``OK, it is going to be all right for device manufacturers to have false and misleading labels?'' Other examples in the way that this provision could allow unsafe and ineffective devices abound. A stent designed to open the bile duct for gallstones could be modified in a way that clearly was designed to make it a treatment for blockages of the carotid artery. Without adequate testing, it could put patients at risk of stroke or death. But under this bill, the FDA would be prohibited from looking behind the label to the actual intended use of the device. Mr. President, the vast majority of medical device manufacturers meet high ethical standards. Most devices are fully tested and evaluated by the FDA before they are marketed. But as many examples make clear, if the FDA does not have adequate authority to protect innocent patients, the result can be unnecessary death and injury to patients across the country. There is no justification--none whatever--for Congress to force the FDA to approve devices with false or misleading labels. Each and every time amendments to medical device and pharmaceutical provisions have been approved by the Congress, Republican and Democrat, the public health and safety of the American people has been enhanced. There are provisions in this legislation that will do so. But not this provision. This provision, if left to stand, poses significant health risks to American consumers. We ought to be making sure that when the FDA gives their stamp of approval, that devices are going to be safe and efficacious, and that every doctor in this country and every patient knows they are going to meet the highest safety standards. That ought to be our commitment to the American people. But this particular provision does not do it. Rather than being a step forward, it is a significant and dangerous step backward. Unscrupulous manufacturers do not deserve a free ride at the expense of public health. We have good legislation that is going to extend the PDUFA which is going to mean that we will have many excellent additional professional people to help to move various pharmaceutical products onto the market sooner. The public health organizations know what is happening out there, and they have pleaded with all of us in the Senate and said, My God, for once put the profits of this handful of industries that is trying to circumvent the health and safety protections of the American people, put that aside and make sure, when you act next week, the roll will be called, act to protect the public here in the United States. That is what this debate is about. That is what we will have a chance to vote on next week. Mr. President, I believe my time is just about up. I thank the Chair. We will have an opportunity to go back to this tomorrow morning at 9:30 to add additional information. We hope we will hear from the American people if they care about assuring that their children are going to have safe medical devices, that their parents are going to have safe medical devices, that their daughters and their husbands, their grandparents are going to have safe medical devices. There is only one way to do it, and that is on next Tuesday when the rollcall comes, Senators will support the Reed amendment, which I welcome the opportunity to cosponsor, which will be the most important action we can take in the Senate on this legislation to protect the health and safety of the American people. Mr. President, I yield the floor.

Mr. KENNEDY. Mr. President, as I understand the agreement, we have an hour for the discussion of S. 830, which is the FDA reauthorization bill. Is that correct?

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I am pleased to join with Senator Hatch in sponsoring legislation requested by Mother Teresa to waive visa application fees for religious workers coming to the United States to perform charitable work for temporary periods. During her visits to the United States, Mother Teresa asked President Clinton to take this step to waive visa fees for her missionaries coming to work in this country. Her Missionaries of Charity come to America to help the poor in our communities and to minister to the sick and the elderly. Each time they travel here, they are required to pay a $120 visa fee to the United States Government. It makes no sense to require these religious workers to pay a fee to the federal government in order to come here to help our communities. The legislation we introduce today would waive the fee in these instances. This past weekend, while attending Mother Teresa's funeral in India, the First Lady met with Sister Nirmala, Mother Teresa's successor at the Missionaries of Charity Order in Calcutta. Sister Nirmala asked once again for a waiver of the visa fee and was delighted to learn that the United States Senate would be considering legislation this week to accomplish this goal as Mother Teresa had requested. This is an important step that Congress can take to honor the memory of Mother Theresa and the compassionate work that her Order brings to America. I urge my colleagues to support this legislation.

Mr. KENNEDY. Mr. President, I am honored to join with Senator Abraham, Senator Hatch, Senator Leahy and my other colleagues in sponsoring legislation to reauthorize provisions of our laws permitting immigrants to come to this country to serve communities in churches and other religious institutions across the United States. One of the most significant achievements of the Immigration Act of 1990, which I sponsored in the Senate, was the creation of this important visa category. Religious institutions perform extraordinary services for families and communities. In doing so, they often find it worthwhile to bring in religious workers from other lands as immigrants, to help them carry out their activities in the United States. One of the best known supporters of this practice was Mother Teresa. Missionaries in her Order come to the United States frequently to work with the poor in our country. She and the members of her Order have directly touched the lives of millions of Americans. Much of the recent work by her Missionaries of Charity in this country would not have been possible without this important provision in our immigration laws. Unfortunately, this visa category expires on September 30, just two weeks from today. We cannot allow this to happen. As His Eminence Cardinal Maida of Detroit testified before the Immigration Subcommittee last week, ``Should the program be permitted to expire, the impact would be far reaching. Not only would religious organizations and denominations lose access to the much needed contributions of these religious workers, but so, too, would the many communities in which these individuals work.'' The legislation we are sponsoring would make this visa a permanent part of our immigration laws. Renewal of this visa would be a small, but enduring memorial to Mother Teresa and her work in America. It will enable the members of her Order to continue their charitable and compassionate work in this country long into the future. I have been honored to see her good work in America and around the world. I recall meeting her when I visited India in 1971 and viewed firsthand the extraordinary compassion of this remarkable woman. And I was impressed also by the tremendous difference that she and her Missionaries of Charity made in the lives of hundreds of thousands of starving families during the famine in Ethiopia and Sudan in 1984 and 1985. My family and I visited the area during the Christmas season in 1984, and was deeply moved by Mother Teresa's extraordinary healing presence amid that great tragedy. Since this visa category was established in 1990, over 20,000 religious workers have entered the United States to serve in our communities. These men and women have brought their skills and compassion to churches, synagogues, mosques, and other places of worship across America. They teach in our parochial schools. They serve as health care workers, cantors, and catechists. They provide religious training to youths and after-school programs that keep young people off the streets and give them hope for a better future. I have been deeply moved by the ways in which this special visa has benefitted Massachusetts. Maria Alvarez came to Boston at the invitation of the African Mission Fathers, and has devoted her life to helping city youth deal with gang violence, depression, and other problems that plague inner cities. She has also extended her helping hand to refugees in the Boston area, helping them build new lives in our state. Sister Vitolia came to Lawrence, Massachusetts on a religious worker visa through the Society of Mary. She works with unemployed and homeless Spanish speakers there. She helps them find jobs and helps keep their families together. Once again, I commend Senator Abraham for his leadership on this issue, and I urge my colleagues to support this important legislation. Amendment No. 1247 (Purpose: To provide for waiver of fees for nonimmigrants engaged in certain charitable activities)

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I join my colleagues in strong opposition to this amendment, which would severely undermine the American heritage rivers initiative proposed by President Clinton in his State of the Union Address this year. Since the President's announcement, many communities across the Nation, including impressive coalitions along the Connecticut River, Blackstone River, and Merrimack River in Massachusetts and New England, have expressed their strong support for this new program. They recognize it as an excellent opportunity to work in partnership with the Federal Government to protect the environment and cultural resources that make each of these rivers a unique part of our history and heritage. The initiative is designed to join the National Park Service's technical expertise with local decisionmaking, so that cities and towns across the country can decide how best to revitalize their rivers and communities. This amendment would impose a host of unnecessary Federal mandates that would make it difficult for communities to nominate their rivers for designation as American heritage rivers. It would be impossible to carry out the program as President Clinton intended. The amendment would dictate the size of each river corridor--requiring uniform boundaries with a 20-mile-wide span along each river--rather than allowing flexibility for local circumstances. It would require mandatory participation of each and every property owner within the 20- mile-wide boundary of the corridor, and upset the ongoing application process that many communities are pursuing in good faith to meet a December 10 deadline. It would also require congressional approval of the President's selection of rivers, injecting politics into a nomination process that is currently based on merit. This amendment is a frontal assault on the American heritage rivers initiative. It would strip citizens of their ability to protect and revitalize their rivers on their own terms, and give Congress the authority to micromanage these important local efforts. The American heritage rivers initiative has great potential, and has won high praise from communities across the country. It makes no sense to change the ground rules of the game at this late stage, and I urge the Senate to reject this amendment.

Mr. KENNEDY

Mr. KENNEDY. I am pleased to join with Senator Hatch in sponsoring legislation requested by Mother Teresa to waive visa application fees for religious workers coming to the United States to perform charitable work for temporary periods. During her visits to the United States, Mother Teresa asked President Clinton to take this step to waive visa fees for her missionaries coming to work in this country. Her Missionaries of Charity come to America to help the poor in our communities and to minister to the sick and the elderly. Each time they travel here, they are required to pay a $120 visa fee to the U.S. Government. It makes no sense to require these religious workers to pay a fee to the Federal Government in order to come here to help our communities. The legislation we introduce today would waive the fee in these instances. This past weekend, while attending Mother Teresa's funeral in India, the First Lady met with Sister Nirmala, Mother Teresa's successor at the Missionaries of Charity Order in Calcutta. Sister Nirmala asked once again for a waiver of the visa fee and was delighted to learn that the U.S. Senate would be considering legislation this week to accomplish this goal as Mother Teresa had requested. This is an important step that Congress can take to honor the memory of Mother Theresa and the compassionate work that her order brings to America. I urge my colleagues to support this legislation.

Mr. KENNEDY

Mr. KENNEDY. I am pleased to join with Senator Hatch in sponsoring legislation requested by Mother Teresa to waive visa application fees for religious workers coming to the United States to perform charitable work for temporary periods. During her visits to the United States, Mother Teresa asked President Clinton to take this step to waive visa fees for her missionaries coming to work in this country. Her Missionaries of Charity come to America to help the poor in our communities and to minister to the sick and the elderly. Each time they travel here, they are required to pay a $120 visa fee to the U.S. Government. It makes no sense to require these religious workers to pay a fee to the Federal Government in order to come here to help our communities. The legislation we introduce today would waive the fee in these instances. This past weekend, while attending Mother Teresa's funeral in India, the First Lady met with Sister Nirmala, Mother Teresa's successor at the Missionaries of Charity Order in Calcutta. Sister Nirmala asked once again for a waiver of the visa fee and was delighted to learn that the U.S. Senate would be considering legislation this week to accomplish this goal as Mother Teresa had requested. This is an important step that Congress can take to honor the memory of Mother Theresa and the compassionate work that her order brings to America. I urge my colleagues to support this legislation.

Mr. KENNEDY. Madam President, an educated work force has become the most valuable resource in the modern economy. Our Nation's long term economic vitality depends on the creation of an effective, accessible, and accountable system of job training and career development which is open to all our citizens. Schools must assume more responsibility for preparing their students to meet the challenges of the 21st century workplace. Disadvantaged adults and out of school youth need the opportunity to develop job skills which will make them productive members of the community. Dislocated workers who have been displaced by the rapid pace of technological change deserve the chance to pursue new careers. The way in which we respond to these challenges today will determine how prosperous a nation we are in the next century. The importance of highly developed employment skills has never been greater. The gap in earnings between skilled and unskilled workers is steadily widening. For those who enter the work force with good academic training and well developed career skills, this new economy offers almost unlimited potential. However, for those who lack basic proficiency in language, math and science and who have no career skills, the new economy presents an increasingly hostile environment. The Workforce Investment Partnership Act which I am introducing with Senators Jeffords, DeWine, and Wellstone will provide employment training opportunities for millions of Americans. It responds to the challenge of the changing workplace by enabling men and women to both acquire the skills necessary to enter the work force and upgrade their skills throughout their careers. It will provide access to the educational tools that will enable them not only to keep up, but to get ahead. The legislation which we will be introducing represents a true collaboration of our four offices. I want to publicly commend Senators Jeffords and DeWine for the genuine spirit of bipartisanship which has made this collaborative effort possible. Senator Wellstone and I appreciate it. Over the last 6 months, each of us has devoted an enormous amount of time and effort to fashioning a legislative consensus which will truly expand career options, encourage greater program innovation, and facilitate cooperative efforts amongst business, labor, education, and State and local government. While each of us can cite provisions in this bill which we would like to change, we all believe that the Workforce Investment Partnership Act will accomplish our principal goals. I also want to recognize the important role President Clinton has played in bringing about this dramatic reform of our current job training system. He has consistently emphasized the need for greater individual choice in the selection of career paths and training providers. The philosophy behind the skill grant proposal is reflected in our legislation. The Workforce Investment Partnership Act is designed to provide easy access to state of the art employment training programs which are geared to real job opportunities in the community. The cornerstones of this new system are individual choice and quality labor market information. In the past, men and women seeking new careers often did not know what job skills were most in demand and which training programs had the best performance record. All to often, they were forced to make one of the most important decisions in their lives based on anecdotes and late-night advertisements. No training system can function effectively without accurate and timely information. The frequent unavailability of quality labor market information is one of the most serious flaws in the current system. In order to make sound career choices, prospective trainees need both detailed information on local career opportunities and performance based information on training providers. That information will now be available at easily accessible one stop employment centers, along with career counseling and other employment services. The legislation places a strong emphasis on providing information about what area industries are growing, what skills those jobs require, and what earning potential they have. Extensive business community participation is encouraged in developing this information. Once a career choice is made, the individual must still select a training provider. At present, many applicants make that choice with a little or no reliable information. Under our bill, each training provider will have to publicly report graduation rates, job placement and retention rates, and average earnings of graduates. Because of the extensive information which will be available to each applicant, real consumer choice in the selection of a career and of a training provider will be possible. The legislation establishes individual training accounts for eligible participants, which they can use to access career education and skill training programs. Men and women seeking training assistance will no longer be limited to a few predetermined options. As long as there are real job opportunities in the field selected and the training provider meets established performance standards, the individual will be free to choose which option best suits his or her needs. This legislation will organize the delivery of services more effectively and utilize resources more creatively. There will be a significant consolidation of the dozens of narrowly focused programs which currently exist into several broad funding streams for the distinct populations needing assistance. Consolidation makes sense in those areas in which multiple programs are currently serving the same population. However, it is equally important to preserve separate streams of funding for distinct populations. The programmatic needs of middle age dislocated workers with extensive employment histories are quite different from the services required by young adults with limited skills and no work histories. Similarly the problems faced by out of school youth require very different solutions than those confronting the adult population. Ensuring that services which are designed to meet the needs of each of these populations are available is a Federal responsibility. For that reason, this legislation maintains distinct programs with separate appropriations for dislocated workers, disadvantaged adults, and at risk youth. The WIPA gives State and local government significantly enhanced discretion in designing their training systems. If this reform is to be truly responsive to those at the community level who are in need of services, it is essential that the authority which the Federal Government delegates to the States be exercised through a broad based decisionmaking process. Governors, State legislatures, mayors, and other county and local officials should all have a meaningful voice in the design of a State's new job training system and they will under this legislation. Local boards of business, labor, education and community leaders are--in my opinion--essential to insuring that programs meet the real world needs of participants, and that the training programs correspond to labor market demands. The success we have had a Massachusetts has been due to large measure to active participation by local business leaders on the regional employment boards. WIPA strengthens the role of such boards, giving them major new policy making responsibilities. These boards will play the primary role in assuring that training programs address the actual employment needs of area businesses. An essential element of the new system we have designed in accountability. As I noted earlier, each training provider will have to monitor and report the job placement and retention achieved by its graduates and their average earnings. Only those training programs that meet an acceptable performance standard will remain eligible for receipt of public funds. The same principle of accountability is applied to those agencies administering State and local programs. They are being given wide latitude to innovate under this legislation. But they too will be held accountable if they programs fail to meet challenging performance targets. There is no challenge facing America today which is tougher or more important than providing at risk, often out of school, youth with meaningful education and employment opportunities. Far too many of our teenagers are being left behind without the skills needed to survive in the 21st century economy. I am particularly proud of the commitment which the Workforce Investment Partnership Act makes to these young men and women. This legislation authorizes a new initiative focused on teenagers living in the most impoverished communities in America. These areas range from the poorest neighborhoods of our largest cities to impoverished rural counties. Each year, the Secretary of Labor will award grants from a $250 million fund to innovative programs designed to provide opportunities to youth living in these areas. The programs will emphasize mentoring, strong links between academic and worksite learning, and job placement and retention. It will encourage broad based community participation from local service agencies and area employers. These model programs will, we believe, identify the techniques which are most effective in reaching those youth at greatest risk. The Workforce Investment Partnership Act includes titles reauthorizing major vocational education and adult literacy programs. Both programs will continue to be separately funded and independently administered. We have incorporated them in the Workplace Act because they must be integral components of any comprehensive strategy to prepare to meet the demands of the 21st century workplace. Students who participate in vocational education must be provided with broad based career preparation courses which meet both high academic standards and teach state of the art technological skills. Adult literacy programs are essential for the 27 percent of the adult population who have not earned a high school diploma or its equivalent. Learning to read and communicate effectively are the first steps to career advancement. In vocational education and adult literacy, we are placing the same emphasis on program accountability which we did in job training. The Workforce Investment Partnership Act we are introducing today will make it possible for millions of Americans to gain the skills needed to compete in a global economy. In doing so, we are also enabling them to realize their personal American dreams. In closing, I want to recognize the important contribution which Stephen Springer, a key member of my staff during the 104th Congress, played in the evolution of job training reform. Tragically, he died at a young age after a courageous battle with cancer. He believed that the type of innovative work force development system which this legislation would create had the potential to open doors of opportunity for millions of Americans. His commitment was extraordinary. He continued to work on this issue even as his health was failing. He is no longer with us, but he continues to inspire us. Stephen Springer's creative vision of a work force development system equal to the challenges of the 21st century economy is reflected in the Workforce Investment Partnership Act. When enacted, it will be a wonderful legacy for this extraordinary individual.

Mr. KENNEDY

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

Mr. KENNEDY. Mr. President, here we go again. Every year since 1989, Congress has held a highly charged debate about the future of the National Endowment for the Arts. This year is no different. Ironically, extremists opposing NEA have recently been claiming that there has been inadequate oversight of the agency. Dollar for dollar, it is likely that no agency has been more heavily scrutinized than the Arts Endowment. The arts and humanities have, and deserve to have, a central role in the life of America. The Arts Endowment has contributed immensely to that role. It has encouraged the growth and development of the arts in communities across the Nation, giving new emphasis and vitality to American creativity and scholarship, and to the cultural achievement that are among America's greatest strengths. Americans have a great deal to celebrate and learn about our extraordinary cultural traditions. The arts are an important part of our complex and modern society, and will play a key role in fulfilling our country's many possibilities for the future. Critics used to claim that the Endowment spent money unwisely-- awarding grants to unqualified artists or to artists that clearly did not merit Federal aid. But the critics quickly ran out of examples. Over the period of its entire 32-year history, a grand total of about 25 of the tens of thousands of grants awarded by the Endowment have raised genuine concerns. Yet, the budget for the Arts Endowment has been cut to penalize the agency for these so-called inappropriate grants. Other restrictions have also been imposed--on content, on seasonal support grants, on grants to individuals, and on subgrants. Nothing will ever satisfy the critics, because their real intent is to eliminate any Federal role in the arts. Their goal is to abolish the agency--either directly by denying it any funds at all, or, indirectly by block-granting all the funds to the States. In fact, the Arts Endowment has an extraordinary record of successful achievement. As a result of the its leadership over the past three decades, there are now double the number of orchestras in America, 11 times the number of dance companies, and 50 times the number of local arts agencies. The NEA reaches out to thousands of America's communities and neighborhoods. It is functioning as it should, encouraging the arts in all parts of the country, providing the seed money that enables local arts to grow and thrive. Let us be honest. In recent years, since the rightwing's misguided ideological assault on the agency first began, Congress has gone the extra mile. We have taken every reasonable action to ensure that the Arts Endowment only supports grants and programs that are responsible, that fulfill the agency's widely accepted mission, and that reach the widest possible audience. Every year the agency has to run the appropriations gauntlet and every year it convinces a majority of Congress that it deserves support. This year should be no different, because there is no new evidence to justify the critics' shameful attack. The Labor and Human Resources Committee recently approved a 5-year reauthorization of the Arts Endowment. The bill includes appropriate restrictions and set-asides, so that the arts will reach as many communities across the country as possible. The bill also establishes arts education as a primary focus of the agency. The bill was approved by a solid bipartisan committee vote of 14 to 4. I commend Senator Jeffords of the Labor Committee for his excellent job in guiding that authorization through the committee. He is a strong supporter of the arts and has been thorough and conscientious in his oversight of the Endowment. The Appropriations Committee has also demonstrated its support for the Endowment, by recommending just over $100 million for the Arts Endowment in this bill. I commend the committee for its support. The agency has made a significant contribution to the quality of life in thousands of communities in our country. The arts have broad appeal, and the Endowment's mission is to encourage artists and institutions across the country to create, produce, and present programs to tap and encourage that appeal. In 1996, for example, the NEA supported significant programs such as the Delaware Theater Co., the Atlanta Ballet, the Tulsa Philharmonic Society, the University of Southern Mississippi's Folk and Traditional Arts Program, and the International Association of Jazz Educators. Countless other examples can be cited. Federal support for the arts has clearly made a large difference in communities across the country. The current Federal role is significant, and it has overwhelming support in every State. Families want their children to visit symphonies and museums. They want to enjoy theater and dance. The arts are more than a diversion or entertainment. They are educational and enriching, and their central place in the Nation's life and experiences should be supported and increased. The Conference of Mayors has strongly endorsed the Arts Endowment. These local officials, who know their communities best, clearly understand the positive role of the arts. They know that the arts contribute to the vitality of their locality, and increase its economic base as well. In Massachusetts, the arts community is thriving and dynamic. A wealth of cultural and educational activities is available to every citizen. These activities also attract tourists to our State. Recently, the Museum of Science presented its hugely successful Leonardo da Vinci exhibition. A major retrospective on Picasso's early years is about to open at the Museum of Fine Arts. Many of my colleagues, I am sure, had the opportunity to see this extraordinary exhibition at the National Gallery of Art in Washington. The Endowment's support helped to make this dramatic exhibition possible. People in every State treasure their own arts institutions and arts programs in the same way. Whatever the size of the State or community, the impact of the arts is significant and indisputable, from the youngest child to the oldest senior citizen. Leaders in State and local institutions across the country are convinced that support by the Arts Endowment has been a significant part of their success. Federal aid is seed money. It has never been intended to replace State or local or private support for the arts. But it has often been a critical component in the overall development and success of countless local institutions. In many communities, the Federal role has been indispensable, especially in disseminating innovative programs to institutions that might not have the resources to develop and produce their own programs. Arts education is an excellent example of this impact. Music is an especially effective tool in developing the discipline and the learning potential of students. Recent studies by the college board show that students who have studied 4 years of music or more do significantly better in both their math and verbal scores on standard SAT tests. Let me just repeat that. The studies by the college board show that students who have studied 4 years of music or more do significantly better in both their math and verbal scores on standard SAT tests--up to about 50 points more. You would find it extremely difficult to point to any single particular educational program that results in that kind of a bump in terms of educational achievement and accomplishment. But there it is. There are the statistics. And it should not be any mystery. We know, for example, for 300 years the Greeks had the greatest mathematicians in the world. It is interesting to note that the reason that they had the greatest mathematicians in the world is that they taught their youngest children mathematics through the arts and through music--for 300 years. I have 10 schools in my own city of Boston where the Conservatory of Music is working with those schools to try and provide the same kinds of initiative in terms of the music and the math that was used many hundreds of years ago with phenomenal success. I remember being in the Trotter School in Boston with Larry Lesser, who is probably one of the world's great cellists, and the time he was working in an inner-city school and working with those inner-city children in terms of enhancing their academic achievement and accomplishment. You would, as I say, rarely find a particular educational program that would have that kind of result. We are all looking to what is going to be magical in terms of education, that is going to enhance academic achievement. We have the results in with regard to those students who study music for 4 or more years and how that has enhanced children who have that 4 or 5 years of study in their academic achievement. And it is out there for all of us to see. So it is not only an issue that we are talking about in terms of the value of the arts, in terms of the culture, and the values which we value in our society, but it is very, very tangible and a very important component in terms of education. We have some important alterations and changes in the authorization to try and enhance and build on that in the reauthorization which Senator Jeffords and I have been strongly supportive of. We should be doing more, not less, for the arts. The heavy-handed attempt by the House Republican leadership to eliminate the Arts Endowment should be categorically rejected, and it is gratifying that President Clinton has pledged to veto any bill that reaches his desk that attempts to do so. In fact, many of the agency's strongest and most effective supporters are on the Republican side of the aisle. Congress should start listening to the people and stop bashing this small agency. When we listen to the exaggerated protests of the critics, it is hard to remember that we are talking about a program that costs each taxpayer 37 cents a year. We have already taken a full range of steps to see that the agency operates as effectively and responsibly as possible. It is time to support fair funding for this important agency, and give it the solid vote of confidence it deserves. Mr. President, I remember last year--maybe others do--when we had the Vermeer exhibition at the National Gallery. It was in the wintertime. I remember over a weekend going down to try and visit that exhibit on a cold and blustery day and getting there on a Sunday morning at 8 or 9 o'clock in the morning, and seeing the lines there four blocks long, people outside waiting 4 hours. Finally, when I was able to get in there a number of people came up and spoke to me just quietly saying to me, ``Senator, we hope you will tell Members in the Congress and the Senate that we value the arts. We are prepared to wait for the 3 or 4 hours outside to see this extraordinary exhibit of the arts.'' Whether the National Endowment supported that particular exhibit or not, it is doing otherwise, primarily in exhibits that might not have as high a visibility as the Vermeer exhibit but certainly still bringing the value of those programs to the American people. Mr. President, in his 1960 campaign for President, President Kennedy discussed the close historical relationship between great achievement in public life and great achievement in the arts. He said, ``There is a connection, hard to explain logically but easy to feel, between achievement in public life and progress in the arts. The age of Pericles was also the age of Phidias. The age of Lorenzo de Medici was also the age of Leonardo da Vinci. The age of Elizabeth also the age of Shakespeare. And the New Frontier for which I campaign in public life, can also be a new frontier for American arts.'' Three years later, as President, in a major address at Amherst College in October 1963, he said this: I look forward to an America which will reward achievement in the arts as we reward achievement in business or statecraft. I look forward to an America which will steadily raise the standard of artistic accomplishment and which will steadily enlarge cultural opportunities for all our citizens. And I look forward to an America which commands respect throughout the world not only for its strength but for its civilization as well. Those are timeless goals. They apply to our own day and generation as well. I urge the Senate to heed them, to give the arts in America the strong support they so eminently deserve. Mr. President, I have one further observation. Yesterday one of the critics of the Endowment raised the issue of elitism and cited a grant to my State as an example of the elitist focus of the National Endowment for the Arts. Well, I agree. This grant--to the Phillips Academy--is a perfect example. It is an example of a worthwhile program--and an example of the distortion that critics of the agency rely on to make their specious arguments. The Addison Gallery of American Art, which is affiliated with Phillips, applied for a NEA grant as the lead members of a consortium. The grant seeks support for a project entitled ``To Conserve a Legacy: American Art From Historically Black Colleges.'' The other consortia organizations are Clark Atlanta University, Fisk University, Hampton University, Howard University, North Carolina Central University, the Studio Museum of Harlem, and the Williamstown Art Conservation Center. Art work from each of the five participating black colleges and universities will be selected for conservation and inclusion in the exhibit which will travel to Clark, Hampton, Howard, and the Studio Museum of Harlem, in addition to the Addison. The works in the exhibition will represent artists such as Romare Beardon, Sam Gilliam, Jacob Lawrence, and others. And one component of the project is a year-long training program in which minority students will be selected by the participating universities to work on-site for one school year during the selection and conservation of the art work. This is one of those grants that is going to Massachusetts--yes, it is, but its scope and audience and impact is national. And the funds were matched on a 3-to-1 basis. I believe that this grant is not only defensive but also commendable. And I think those that have criticized this grant as an elitist grant will take a second look.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, the National Endowment for the Arts has been accused of elistism. But the true record of the Endowment is far different. It is a record of diversity, excellence, and outreach. The Endowment has been supportive of national efforts of the Country Music Foundation. The Endowment supported their commission of the Thomas Hart Benton famous last painting ``Sources of Country Music'' through its Art in Public Places Program. The painting is on display, it has traveled the Southeast, and has been exhibited in a vast array of venues from the Hirshhorn Museum to the cafeteria of the Nissan Plant in Nashville, TN. Another grant in the late 1970's catalyzed fundraising for a major country music discography of the early 78 rpm recordings from 1922 through the 1940's. The project is just being completed today. Again, in the 1980's, the NEA supported an educational kit entitled ``Tennessee Traditions'' distributed to every public school in Tennessee. One of the components of the kit was a folk music tape. Each year the Arts Endowment honors National Heritage Fellows. The fellows are from a wide variety of disciplines of the folk and traditional arts. Among the honorees this year are bluegrass musicians Jim and Jesse McReynolds of Tennessee; Gladys LeBlanc Clark who is a Cajun weaver from Louisiana; blacksmith Francis Whitaker from Carbondale, CO; Hystercine Rankin, a quilter from Lorman, MS; and Ramon Jose Lopex, a metalsmith from Santa Fe, NM. These honorees will be honored next week at a White House ceremony and will perform and celebrate their work. The National Heritage Fellowships are the Nation's most prestigious recognition of accomplishment in the folk and traditional arts. And it is an NEA program. Another traditional program that owes early and critical support to the NEA is the Cowboy Poets Festival. In the early 1980's Elko, NV, was chosen as the site for the Western Folklife Center. It was established in the center of the ranching community to celebrate its culture and folk traditions. They approached the NEA for support when corporate sponsors and other funders were hard to come by. With NEA support in 1985, the first cowboys festival got underway, with about 60 poets and approximately 1,000 audience members. Today, corporate supporters join the NEA to support the festival and the center and this year's festival welcomed 8,000 attendees. Support for the folk and traditional arts continues at the Arts Endowment. This year the Endowment has funded the Southern Arts Federation's ``Southern Connections,'' which is a 2-year training and touring program to support indigenous southern artists. The Endowment also supported the West Virginia Folk Arts Apprenticeship program; the Creative Arts Guild of Dalton, GA; and the Alabama Folklife Association. The grant to Alabama will support the publication of documentation of primitive Baptist hymn singing through a publication, cassette recordings, and compact discs. The Endowment also funded Appalshop, Inc., Roadside Theater in Whitesburg, KY. This grant will work with the theater and a consortium of the Performing Arts League/Prairie Mountain Players of Choteau, MT, and Community Connection of Austin, TX, to develop, test, and document a nationally applicable model for the creation of rural drama. I hope that, as we debate the appropriate funding level for the National Endowment for the Arts, we can be fair about its record, and responsive to the overwhelming need across America for the programs that the Endowment supports. In many ways, in so many communities, the NEA is a lifeline of financial stability. I urge my colleagues to oppose the seemingly relentless attacks of the critics and support the record of the Endowment. Let's support full funding for this small, but worthy, Federal program.

Mr. KENNEDY

Mr. KENNEDY. Madam President, an educated work force has become the most valuable resource in the modern economy. Our Nation's long term economic vitality depends on the creation of an effective, accessible, and accountable system of job training and career development which is open to all our citizens. Schools must assume more responsibility for preparing their students to meet the challenges of the 21st century workplace. Disadvantaged adults and out of school youth need the opportunity to develop job skills which will make them productive members of the community. Dislocated workers who have been displaced by the rapid pace of technological change deserve the chance to pursue new careers. The way in which we respond to these challenges today will determine how prosperous a nation we are in the next century. The importance of highly developed employment skills has never been greater. The gap in earnings between skilled and unskilled workers is steadily widening. For those who enter the work force with good academic training and well developed career skills, this new economy offers almost unlimited potential. However, for those who lack basic proficiency in language, math and science and who have no career skills, the new economy presents an increasingly hostile environment. The Workforce Investment Partnership Act which I am introducing with Senators Jeffords, DeWine, and Wellstone will provide employment training opportunities for millions of Americans. It responds to the challenge of the changing workplace by enabling men and women to both acquire the skills necessary to enter the work force and upgrade their skills throughout their careers. It will provide access to the educational tools that will enable them not only to keep up, but to get ahead. The legislation which we will be introducing represents a true collaboration of our four offices. I want to publicly commend Senators Jeffords and DeWine for the genuine spirit of bipartisanship which has made this collaborative effort possible. Senator Wellstone and I appreciate it. Over the last 6 months, each of us has devoted an enormous amount of time and effort to fashioning a legislative consensus which will truly expand career options, encourage greater program innovation, and facilitate cooperative efforts amongst business, labor, education, and State and local government. While each of us can cite provisions in this bill which we would like to change, we all believe that the Workforce Investment Partnership Act will accomplish our principal goals. I also want to recognize the important role President Clinton has played in bringing about this dramatic reform of our current job training system. He has consistently emphasized the need for greater individual choice in the selection of career paths and training providers. The philosophy behind the skill grant proposal is reflected in our legislation. The Workforce Investment Partnership Act is designed to provide easy access to state of the art employment training programs which are geared to real job opportunities in the community. The cornerstones of this new system are individual choice and quality labor market information. In the past, men and women seeking new careers often did not know what job skills were most in demand and which training programs had the best performance record. All to often, they were forced to make one of the most important decisions in their lives based on anecdotes and late-night advertisements. No training system can function effectively without accurate and timely information. The frequent unavailability of quality labor market information is one of the most serious flaws in the current system. In order to make sound career choices, prospective trainees need both detailed information on local career opportunities and performance based information on training providers. That information will now be available at easily accessible one stop employment centers, along with career counseling and other employment services. The legislation places a strong emphasis on providing information about what area industries are growing, what skills those jobs require, and what earning potential they have. Extensive business community participation is encouraged in developing this information. Once a career choice is made, the individual must still select a training provider. At present, many applicants make that choice with a little or no reliable information. Under our bill, each training provider will have to publicly report graduation rates, job placement and retention rates, and average earnings of graduates. Because of the extensive information which will be available to each applicant, real consumer choice in the selection of a career and of a training provider will be possible. The legislation establishes individual training accounts for eligible participants, which they can use to access career education and skill training programs. Men and women seeking training assistance will no longer be limited to a few predetermined options. As long as there are real job opportunities in the field selected and the training provider meets established performance standards, the individual will be free to choose which option best suits his or her needs. This legislation will organize the delivery of services more effectively and utilize resources more creatively. There will be a significant consolidation of the dozens of narrowly focused programs which currently exist into several broad funding streams for the distinct populations needing assistance. Consolidation makes sense in those areas in which multiple programs are currently serving the same population. However, it is equally important to preserve separate streams of funding for distinct populations. The programmatic needs of middle age dislocated workers with extensive employment histories are quite different from the services required by young adults with limited skills and no work histories. Similarly the problems faced by out of school youth require very different solutions than those confronting the adult population. Ensuring that services which are designed to meet the needs of each of these populations are available is a Federal responsibility. For that reason, this legislation maintains distinct programs with separate appropriations for dislocated workers, disadvantaged adults, and at risk youth. The WIPA gives State and local government significantly enhanced discretion in designing their training systems. If this reform is to be truly responsive to those at the community level who are in need of services, it is essential that the authority which the Federal Government delegates to the States be exercised through a broad based decisionmaking process. Governors, State legislatures, mayors, and other county and local officials should all have a meaningful voice in the design of a State's new job training system and they will under this legislation. Local boards of business, labor, education and community leaders are--in my opinion--essential to insuring that programs meet the real world needs of participants, and that the training programs correspond to labor market demands. The success we have had a Massachusetts has been due to large measure to active participation by local business leaders on the regional employment boards. WIPA strengthens the role of such boards, giving them major new policy making responsibilities. These boards will play the primary role in assuring that training programs address the actual employment needs of area businesses. An essential element of the new system we have designed in accountability. As I noted earlier, each training provider will have to monitor and report the job placement and retention achieved by its graduates and their average earnings. Only those training programs that meet an acceptable performance standard will remain eligible for receipt of public funds. The same principle of accountability is applied to those agencies administering State and local programs. They are being given wide latitude to innovate under this legislation. But they too will be held accountable if they programs fail to meet challenging performance targets. There is no challenge facing America today which is tougher or more important than providing at risk, often out of school, youth with meaningful education and employment opportunities. Far too many of our teenagers are being left behind without the skills needed to survive in the 21st century economy. I am particularly proud of the commitment which the Workforce Investment Partnership Act makes to these young men and women. This legislation authorizes a new initiative focused on teenagers living in the most impoverished communities in America. These areas range from the poorest neighborhoods of our largest cities to impoverished rural counties. Each year, the Secretary of Labor will award grants from a $250 million fund to innovative programs designed to provide opportunities to youth living in these areas. The programs will emphasize mentoring, strong links between academic and worksite learning, and job placement and retention. It will encourage broad based community participation from local service agencies and area employers. These model programs will, we believe, identify the techniques which are most effective in reaching those youth at greatest risk. The Workforce Investment Partnership Act includes titles reauthorizing major vocational education and adult literacy programs. Both programs will continue to be separately funded and independently administered. We have incorporated them in the Workplace Act because they must be integral components of any comprehensive strategy to prepare to meet the demands of the 21st century workplace. Students who participate in vocational education must be provided with broad based career preparation courses which meet both high academic standards and teach state of the art technological skills. Adult literacy programs are essential for the 27 percent of the adult population who have not earned a high school diploma or its equivalent. Learning to read and communicate effectively are the first steps to career advancement. In vocational education and adult literacy, we are placing the same emphasis on program accountability which we did in job training. The Workforce Investment Partnership Act we are introducing today will make it possible for millions of Americans to gain the skills needed to compete in a global economy. In doing so, we are also enabling them to realize their personal American dreams. In closing, I want to recognize the important contribution which Stephen Springer, a key member of my staff during the 104th Congress, played in the evolution of job training reform. Tragically, he died at a young age after a courageous battle with cancer. He believed that the type of innovative work force development system which this legislation would create had the potential to open doors of opportunity for millions of Americans. His commitment was extraordinary. He continued to work on this issue even as his health was failing. He is no longer with us, but he continues to inspire us. Stephen Springer's creative vision of a work force development system equal to the challenges of the 21st century economy is reflected in the Workforce Investment Partnership Act. When enacted, it will be a wonderful legacy for this extraordinary individual.