Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. Mr. President, in typical fashion, Senator Jeffords has given great credit where credit is due, and as I mentioned just before, the chairman of our committee really deserves credit for the passage of this very important bill. I commend him. If I could, I will just take a moment of the Senate's time, but I think it is important to mention on our side David Nexon and Diane Robertson, who worked so closely with us; Jim Manly, Debbie Kochevar, Meg Archdeacon, Burt Cowgill, Susan Hammersten, Jonathan Halperin, and Danielle Drissel, Carrie Coberly and Addy Schmidt; Bonnie Hogue on Senator Reed's staff and Deborah Walker on Senator Bingaman's staff; Sabrina Corlette with Senator Harkin and Anne-Marie Murphy with Senator Durbin. I would like to believe the staffs have been helpful to all of us and don't work so much in a partisan way as in a common spirit, to try to advance the common interests. That has been, certainly, true on this legislation. I thank all of those, and the majority staff as well, for all of their courtesies and for their cooperation. I think the record ought to show the dedication of, really, an outstanding group of men and women who have really served the Senate very, very well. I thank the chairman.

Mr. KENNEDY. We hope that we can be convincing as this legislation goes forward. We have not been convincing here on the floor. We hope provisions can be accepted that will make 404 acceptable in terms of the public health issues. I want to express my sincere appreciation to the chairman of the committee, Senator Jeffords, who has been a chairman's chair. He is strong in his belief. He is a fighter for the things that he champions. He has been willing to accommodate differing views. He protects his strong posture and positions on his own views, and I respect that. I thank the other Members of this body for their courtesy during the course of what I know has been a continuing discussion and debate on a very important measure. I thank all of our Members for their courtesy and consideration as we move toward a vote on this legislation. I thank my chairman. At the time when the Senator from Vermont is prepared to yield back his time, I will be prepared to do so likewise and move to our vote. unanimous-consent request

Mr. KENNEDY. Mr. President, I yield myself 3 minutes. Just a short while ago, we heard some comments on the floor about how this whole process has taken a long period of time. It has taken a period of time. But I think one can see from any fair review of the history of the legislation that very substantial progress has been made in making this a better bill. As I pointed out earlier in the debate, of the 20 major health safety issues identified by the administration, 19 have been addressed, not only in our committee markup, but also in the negotiations that we had prior to the time of the legislation coming to the floor. There is the one remaining item, which deals with safety and medical devices. It is extremely important. We have given focus to this issue because it deserves the focus that we have given it. Mr. President, I have in my hand the statement of the administration policy. It indicates that it has two major concerns with the bill. One is the technical provision with regard to the budget agreement and how they are going to allocate to PDUFA, which is a technical issue. But the other issue mentioned by the administration is this particular provision: First, section 404 of the bill would lower the review standard for marketing approval by precluding the FDA from reviewing medical devices for uses other than those for which the manufacturer says they are intended. The administration indicates, as they did in the letter in September, as they did in June, that this particular provision is dangerous in terms of the consumers in this country. We have reviewed, over the course of the debate, the dangerous situations that have been the result of medical device disasters. We are committed to avoiding that kind of disaster in the future. We have a good safety record at the present time, but we are endangering that record with section 404. We noted that virtually every consumer group supports changing section 404. It is enormously important. It goes to the fundamental question of providing FDA with the power and authority to pursue the protections of the American health in the area of medical devices. Mr. President, I ask unanimous consent that the statement of the administration policy supporting our position regarding 404 be printed in the Record.

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

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

Mr. KENNEDY

Mr. KENNEDY. I thank the distinguished Senator from Arkansas for describing the reasons why this section is so important to patients and to the health professions. I want to especially commend his staff for working with mine to develop this legislation that exempts from Federal law the activities that are appropriately regulated by the States. It is my understanding that some of the conditions are intended to ensure that the volume of compounding does not approach that ordinarily associated with drug manufacturing. Other conditions appear to be intended to ensure that the compounded drugs that qualify for the exemption have appropriate assurances of quality and safety since these compounded drugs would not be subject to the more comprehensive regulatory requirements that apply to manufactured drug products.

Mr. KENNEDY. First, I want to commend my colleagues and their staffs for their efforts in the difficult task of drawing the line between drug manufacturing and pharmacy compounding. Ordinary pharmacy compounding has been traditionally regulated by the States, but drug manufacturing, even when conducted by State-licensed pharmacists, is regulated under Federal law. Under current law, the Federal Food, Drug, and Cosmetic Act specifically exempts from the inspection and registration provisions of the act pharmacies that compound drugs for sale in the regular course of dispensing or selling drugs at retail. However, FDA and the courts that have addressed the matter interpret the act as not providing any general exemption from the new drug, adulteration, and misbranding provisions for drugs compounded by pharmacists. It is my understanding that section 809 of S. 830 would bring the legal status of compounding in line with FDA's longstanding enforcement policy of regulating only drug manufacturing, not ordinary pharmacy compounding. This legislation would, as I understand it, exempt drugs compounded in pharmacies from the new drug, and certain other, provisions of the act, but the exemption would not create a loophole that would allow unregulated drug manufacturing to occur under the guise of pharmacy compounding.

Mr. KENNEDY. Madam President, I would like to engage my colleagues, Senator Jeffords, the distinguished chairman of the Labor and Resources Committee, and Senator Hutchinson, the distinguished Senator from Arkansas, regarding a provision in S. 830 pertaining to the practice of pharmacy compounding.

Mr. KENNEDY. Mr. President, I yield myself 20 minutes. Mr. President, I will just review quickly the work that was done by the committee. As I outlined earlier, there were 20 major proposals that were made by the Secretary in June. We have addressed 19 of those. The one remaining proposal we have not addressed is the one that brought about the Reed-Kennedy amendment which was defeated yesterday, and the one which virtually all of the consumer groups feel ought to be altered and changed before we get to final resolution and passage of this legislation. I reviewed some of the other provisions and the changes that were made as a result of bipartisan efforts, which I think are important and significant improvements, and also provide additional kinds of protection. I mentioned the fast tracking of the various products, and the ability of individuals who do not have expanded access to drugs still under investigation for patients who have no alternatives, the inclusions of the Snowe-Feinstein bill that will help to expand opportunities by using the NIH database, and some of the streamlining of the FDA procedures. I will mention just a final few. One concerned the improved consultation between manufacturers and the FDA. Prior to this provision, if there were any changes being implemented by manufacturers with these medical devices, they had to be cleared. We have changed that so that manufacturers can make adjustments and changes that are not going to affect issues of safety in order to make their production more efficient. But we also have some protections for safety included in there. The environmental issues. The original bill would have eliminated all the environmental impact statements from FDA applications. I didn't think that was what we were doing when we were extending PDUFA. We made adjustments and changes on that to ensure that those environmental impact statements will be preserved. The strengthening of the safety protections of the various medical devices. FDA will still require device manufacturers to file supplemental applications when they are making changes that affect safety and effectiveness of the devices, but we have made efforts to streamline that provision. The tracking of various devices after approval. Under the initial bill, there was a termination of tracking of medical devices. We had a good debate on this. I thought the Senator from Illinois [Mr. Durbin] made a strong case for continuing postmarketing surveillance of medical devices. We have now compromised and said that we permit the FDA to make the judgment. We have found that a principal reason for postmarketing surveillance was a safety factor, a belief that if you track the various medical devices and are able to get information that shows that those medical devices may pose a danger to the people, you should be able to notify others who might have used a similar kind of device to give those individuals protections as well. Initially it was thought that by having that kind of review, you could advance these medical devices because you are going to have a pretty good evaluation of those medical devices as they affect people by having tracking mechanisms rather than just attempting to evaluate safety and effectiveness prior to the time that the medical devices are actually utilized. So it was an attempt to speed up the process that the tracking provisions were put into effect initially. Now they are enormously important because if we find out that people do have adverse impacts from these medical devices--and we have tracking mechanisms--we can protect not only those individuals but also others who might have the same kind of device implanted in them. We worked out a compromise, and I think the public interest is protected. It would not have been if we had not worked it out. The tightening of the process for FDA approval of medical devices. We have 180 days for these devices. What we are saying is at the end of 100 days the FDA indicates the deficiencies in those devices but still has 180 days to be able to make a final judgment. But it does give an earlier indication to the medical device manufacturer about the potential problems that they are going to face. Recordkeeping by distributors of devices. In the initial bill, they wiped out all of that information. So if there was an adverse impact from the medical device, the distributors would not have collected the information and the FDA would not know about it. What we have done is maintained that the distributors have to keep the information which they have with regard to adverse impacts from devices. They do not have to report it to the FDA, but they have to keep it. And then if there is some kind of indication about adverse impact, the FDA will be able to pursue it. It saves a good deal of paperwork. And, it still adequately protects the public. We have made many changes in a bipartisan effort to improve and strengthen the bill. We have safety standards for drugs to ensure that the alternative use of a drug is going to meet high safety standards. That is an improvement. Health care economic information. When pharmaceuticals are given or sold to health care organizations, there is going to be complete information given in terms of alternative treatments for individuals, and this is a very important element. Health claims for food products. In the initial proposal, this legislation which was to extend the PDUFA to ensure faster consideration of pharmaceutical drugs, was effectively going to eliminate any FDA rule on health claims for food products. There was an example where the industry was leaning on us again in order to undermine the kind of information that would be given to consumers on these various food products, the health claims. I was around here in the late 1980's when we passed the legislation with regard to food labeling to make sure that the consumer was going to have the right information as to the health assets a particular food might provide, and our committee wanted to effectively eliminate those advances. We were able to maintain them. I think that was important. Those are some of the items. And in each and every instance, the public health was enhanced, with the exception of one--404. There is the record. I could have taken more time and gone into greater detail. And there can be no review of any of those 19 that would bring one to a different conclusion except for the one that we are talking about here. That is the only one that was brought out in the June 11 letter by the Secretary of HHS that said you have to address it because of the compelling need to protect the public. That is the one that every consumer group has said, why don't you address that the way you did the other 19? You worked out bipartisan agreements on all of the other 19 proposals and enhanced the public protection. Why can't you do it on this one? Well, we have been unable to. But we still hear from some of our colleagues about what a long process this has been, that we could have passed this in June, you would not have passed it without those health protections. I think that we protected the public with the one exception--and that stands out. We have gone over the FDA's impact on the lives of the consumers of this country. How in so many different ways it impacts and affects our lives and how they have taken action in each and every one of those circumstances to protect the public health. I have gone through in detail about how the medical device industry is prospering. They have a more positive attitude than they have ever had. Now what they are going to do is restrict the protection of the public health with this particular provision, and it is wrong. The issue is clear. Will medical devices be approved on the basis of false and misleading labels? All we needed was to add the words ``false and misleading`' to the bill. This bill would have gone through unanimously. But we were defeated on the amendment that would have prohibited false or misleading labels. When our colleagues go back home and they are asked in their town halls, why were you for permitting medical device companies to submit false information? I hope they have a good answer, because I cannot think of one, not when the industry is making the progress it is making and is having record sales, and safety is still being protected. Will dangerous medical devices that have not been tested for safety and effectiveness be foisted on the American people? Will unscrupulous companies like U.S. Surgical Corp. be rewarded for deceiving the FDA? Will there be a higher value placed on the profits of the powerful than the health of the American people? Section 404 of the FDA bill requires the FDA to approve a medical device based on the use identified on the label submitted by the manufacturer, even if that label is false or misleading. It prevents the FDA from requiring the manufacturers show that their product is safe and effective for the purpose for which it will be really 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. Nothing better shows the need for the Reed-Kennedy amendment than the recent history on the Advanced Breast Biopsy Instrumentation system device developed and marketed by the U.S. Surgical Corp. This attempt to mislead the FDA and foist an untested machine on women with breast cancer shows why it is critical that section 404 not be passed in its current form. The U.S. Surgical Corp. submitted their new machine to FDA for approval based on a label claim that it was to be used for biopsy of breast tissue suspected of being malignant. This is a common procedure used in mammograms or other diagnostic techniques to identify suspicious looking areas of the breast that may indicate malignant tumors. If the biopsy of a small piece of the suspicious material indicates a malignancy, surgery would normally follow to remove the cancerous tissue. But U.S. Surgical's label claim was false. One of the models of the machine was designed to excise a piece of tissue 50 times as large as previous biopsy instruments--the size of a piece of hot dog as compared to the size of the tip of a lead pencil. It was clearly designed to be used to excise small tumors, not just to perform a biopsy. But the machine was not tested to see whether it was safe and effective for this purpose. The company was, in effect, proposing to subject women with breast cancer to surgery with a machine that might have been less effective in treating their illness than existing therapies. It placed the company's profits first and the patient's needs last. Because FDA initially relied on U.S. Surgical's false and misleading label, the device was subjected only to an engineering review and was cleared for use on February 1, 1996. Had the product been honestly labeled, FDA would have reviewed it using a multidisciplinary team and required the company to present genuine clinical data in support of the application. On March 29, 1996, the FDA obtained a copy of a promotional videotape that U.S. Surgical was distributing to physicians to try to sell their product. We have a copy of it right here, Mr. President, and the videotape clearly describes the device as appropriate for surgically removing small lumps of cancerous tissues. Let me quote some extracts from this slick production. U.S. Surgical is entering a new millennium in breast surgery by combining advanced stereotactic technology with minimally invasive surgery. Unlike needle biopsies where small samples of the lesion are removed for pathological analysis, the ABBI system removes the entire specimen. If the specimen proves to be cancerous but pathology reports the entire margin is clear, it is up to the clinical judgment of the surgeon to decide to remove additional tissue or if the procedure can be considered complete. The ABBI system-- Which is the needle I referred to-- allows surgeons to provide the benefits of a minimally invasive technique to breast surgery. . .. Benefits to the patient include: Reduced physical and emotional trauma as a woman undergoes only one versus two procedures. Minimally invasive breast surgery. A new standard of patient care offered only by United States Surgical Corp. Here is their advertisement: ``The latest technique is minimally invasive breast biopsy.'' And here is the language included in the videotape that says minimal invasive breast surgery. And we heard out on the floor, well, U.S. Surgical Corp. did not have anything to do with promoting this. ``A new standard of patient care offered by the United States Surgical Corp.'' It is clear that this company has designed this machine for breast surgery, not just biopsy, and is promoting it for this use despite the false and misleading label submitted to the FDA. Here is what a distinguished physician, Dr. Monica Morrow, professor of surgery at Northwestern University, had to say about the company's machine: I am writing to express my feelings regarding the importance of the FDA's mandate to evaluate ``behind the label'' uses of devices and drugs. The need for such evaluation is clearly exemplified by the marketing strategy for the U.S. Surgical breast biopsy device (ABBI). This device was approved for use as a diagnostic instrument. However, the company video clearly depicts the use of the device for definitive breast cancer therapy. No clinical trials using the accepted techniques for comparing cancer treatments have been conducted to validate this claim, and without such trials, the device could potentially pose a significant risk to patients. In addition, other claims regarding improved cosmetic outcome and patient acceptance are similarly unsubstantiated. The indications for the uses of devices and drugs should be determined by appropriate clinical and scientific data, and not by their appeal as marketing gimmicks. This video was dropped off in my office by a company representative as part of an effort to interest me in purchasing this 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 label--tumor removal--without adequate clinical testing. The FDA then acted to require the company to include a strong cautionary label that the device was only to be used for tissue sampling, not tumor excision. And it required it to submit clinical data on its use for the original claimed purpose of biopsy. Based on this revised label and the new clinical data, the FDA recleared the machine for breast biopsy on September 24, 1996. And it further required the company to conduct studies on the safety and effectiveness of the machine for tumor removal, studies which are ongoing. Evidently the company sees its potential now, and now is doing the studies which it didn't do before on the removal of the breast. Now they are doing it, after the FDA caught them promoting this device for that purpose. We have listened out here, ``This is just another machine. This is just another biopsy machine.'' And we find the clearest example of a case where it gets approved for one purpose, it is promoted and used for another purpose. When it is caught by the FDA, they did submit additional clinical information for the removal of breast--and they are doing it now. They didn't say, Tumor removal? We never thought we were going to use it for tumor removal. Why is the FDA suggesting that we had ever intended to use it for that, but, OK, there is an idea, we will go out and conduct the clinical studies. Let's be realistic here, they had intended to use it for an alternative use. They promoted it for an alternative use. And they never supplied the FDA with the safety information on that alternative use. How much time do I have remaining?

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

Mr. KENNEDY. What is the date of that particular study? I did refer to recent studies. I was just interested in the date.

Mr. KENNEDY. Will the Senator yield just for a question?

Mr. KENNEDY. They are listed here. There are 20 items, major concerns about the cumulative aspect of the regulatory burdens, the various kinds of advisory committees, the advisory committees and the regulatory burdens that would have added to the complexity, and even the process of considering new drugs. The basic concerns the administration had on features of the third-party review, the approval standard for some of the drug and biologic devices, limits that were put on the FDA to evaluate some of the clinical outcomes for devices, and the lower approval standards that were included in some radio- pharmaceuticals. They had some concerns about the health claims for foods and expanded access to investigational therapies, which allow drug or devices companies to sell investigational products for any serious disease without FDA approval and without appropriate protections for clinical investigators. The device modification allowed the companies to make manufacturing changes that affected devices' safety and effectiveness without ever notifying the FDA; the health economic claims that would allow industry to discuss health economic claims given to managed care organizations under a low evidentiary standard and without FDA review. There was pediatric labeling, and the whole question on the humanitarian use of devices and collaborative determinations. There were also some concerns about off-label use of drugs, drug compounding. If you look at the improvements in the bill and the compromises worked out here, 19 of the 20 have been worked out to the satisfaction of HHS and the FDA. There may be some groups that do not feel that certain provisions are worked out adequately. But I am prepared to defend those compromises. There is only one that remains. That is the provision that we are addressing here. Whether we are going to permit false and misleading labeling on a particular product and deny the FDA the right to look behind that label in order to protect the safety of the families of America. There were 19 accepted, only one remains--but it is an important one. Why is it, if we are able to work out 19 of the 20, can't work out this one? The Senator from Rhode Island offered an excellent amendment yesterday saying, ``OK, we will go along with the existing language that is in the bill. But we will also add the language that nothing in the label will be false and misleading.'' False and misleading; that was defeated. Those Member who voted against it, I expect, will have to explain to their constituents why they would resist an amendment that said we should not permit the medical manufacturer to submit something false and misleading. Members are saying that this has been a long process that has taken a good deal of time. This measure was considered in the last Congress and now again in this Congress. We could have acted on these measures. We could have acted before June 11 and not dealt with any of the outstanding health and safety issues. But the fact of the matter is, we took the time, we listened to the arguments of the FDA and the Department of Health and Human Services, the people who are charged with protecting the American people. We worked out the 19 of the 20. Everyone gave a little, took a little, but 19 of those 20 have been worked out. Not this particular provision. It took time to work out those compromises. I think the time spent was well worth it. This is a much better bill than would have come out of that committee or on the floor in June or July or August, or even the early part of September. What were those steps that we took? First of all, we preserved the States' oversight of the safety of cosmetics. This compromise assures that the States will be able to continue to regulate the safety of cosmetics. The Gregg proposal in the underlying bill would have barred the States from any regulation whatsoever of cosmetics, even though the FDA has neither the authority nor the staff to regulate these products. The compromise allowed the States to continue their regulation unless a specific inconsistent regulation has been issued by the FDA in a particular area. We went through that debate. We found the examples, particularly with regard to the State of California, how they were able to protect their consumers. In some cases there were carcinogens in the products and the manufacturing company changed the formula and were able to get right back out there and produce the product and have record sales. The toluene that was in lipstick, which is related to another carcinogen that was related to some birth defects with children was altered and changed. We have had important studies that have been done up in Seattle, WA, at the University of Washington and other medical centers, about some of the potential dangers of use of talcum powder on small infants and its relationship to ovarian cancer. These were studies, scientific studies that were done by the States, that are directly related to protecting health and safety. The FDA does not provide for that kind of protection. Nonetheless, there was an effort to preempt States from protecting health and safety. We were able to defeat that. I think that was important. I believe the consumers in those States think so. Second, the safeguard for off-label use of drugs. This important compromise will allow companies to circulate reputable journal articles about off-label use of drugs but will ultimately enhance the public's health and safety because the FDA will be given the opportunity to review, comment on, and approve articles which the companies circulate. The compromise also requires the companies to undertake studies on the safety of their drugs for the specific off-label use and submit applications to the FDA for approval for their drugs for these uses within 3 years. That was not in the legislation prior to this compromise. We saw the steps that were taken to meet the safety standards. Currently, companies are circulating articles without reviewing them for off-label use, without seeking review or approval by the FDA, and without conducting the studies which would lead to an ultimate FDA approval or disapproval of the drug. We wanted to make sure that the companies were going to conduct the safety standards for the use of those particular drugs. We were able to work that out. Again, to protect the American public. Expanding access to drugs for patients and fast track approval. The fast track approval--this is one of the most important new initiatives in the legislation--will provide the same streamlined availability for drug treatments for patients with any life-threatening disease now available to patients with cancer or AIDS. It is a major breakthrough for patients who have life-threatening diseases. We were moving through the measures in the bill and pointing out in June of last year that the Secretary of HHS identified 20 major areas that we ought to review and work through in trying to accommodate some of the health and safety concerns. Effectively, we have resolved 19 of those. The only unresolved matter, according to the letter from the HHS, is the provision on section 404. What I was trying to do is to point out a number of these areas where we have made important progress and to mention the safety provisions that had been worked out and included in a bipartisan way. I was mentioning the expanded access to drugs for patients on the fast-track approval. We have had more than 17 different pharmaceuticals or drugs that have been identified for fast-track procedure. We are taking what has been the practice of the FDA and actually demonstrating by legislation, the importance of this particular procedure. We are trying to make the progress available to all those that have life- threatening diseases by giving authority to those researchers who believe the opportunities for fast-tracking these various pharmaceuticals will benefit the American public. That has been successful for AIDS and cancer, and now we are encouraging its use for other life-threatenting conditions. We have also expanded access for drugs under investigation for patients who have no other alternative. So an individual who might not otherwise qualify for various clinical trial protocols can get access to a drug if they have no other alternative. If this is the last gasp, the last hope that they will be able to have access to some of the modalities that might not have been particularly identified for this particular illness or sickness but their medical professionals believe they should have access, and we are moving in that direction. I think that gives a degree of hope to many of those who really wonder if they have any hope at all in trying to get some of the modern kinds of breakthrough drugs We have accepted the Snowe-Feinstein piece of legislation that will give individuals who have a particular life-threatening illness or sickness the opportunity to tap into the NIH database to find out what clinical trials are taking place. This is a very, very important additional provision, and I commend our Senators who are not on the committee but who have been interested and involved in this. That is very, very important. Mr. President, another area that we reviewed is the streamlining of the FDA procedures. The concern initially was in the areas of contracting out of various functions of the FDA. We talk about not only timeliness but also about the importance of preserving quality. We have to make sure that we are not only interested in timeliness, but we are also concerned about the quality. We have also, in this streamlining of the FDA procedures, worked out how we were going to try to review third-party review. That was worked out in a way which I think has virtual broad support. It permits 70 percent of all the devices that would be eligible to be reviewed. But in the areas that are the very significant higher level of class II--a limited number of class II and class III will remain outside of that particular protocol so that we will have a chance to review the results of the research that will be done. We have accelerated the time for that review, so the information will come back in quicker and we will be able to evaluate the results of that particular process. Mr. FRIST addressed the Chair.

Mr. KENNEDY. If the agency was not doing a good job, if we were seeing these bureaucratic delays denying patients products, at least there would be an arguable position. But what we are talking about here is the industry's own assessment about the effectiveness of the agency. They are pointing out how hopeful and optimistic they are about the recent performance of the agency in quickly approving devices. Not only have they made progress in moving them expeditiously, but now a number of the medical manufacturers want to diminish the existing power of the FDA to assure proper safety. The American people must ask why. We do not have the kind of problems that we had years ago with the Dalkon shield and the Shiley heart valve. We do not have the kinds of problems that we had with earlier medical device tragedies. What we have now is an excellent record of safety and effectiveness with devices, and it is against that background we find some in the medical device industry want to make it even more profitable for themselves, and to do so at the risk of the public. Continuing along with the survey: The overall results of the survey indicate widespread satisfaction with the medical device business climate. A substantial majority of the survey respondents characterized business conditions for the device industry as good to excellent. One important cause of this year's improved outlook is perceived improvement in relationships with the FDA. The declining complaints about the agency mirror the increase in positive business outlooks. Much of this improvement is no doubt due to the dramatic decrease in the last 2 years of 510(k) product approval times which the FDA has made a lead focus of its internal reforms. Ray Larkin, President and CEO, Nelcor, Purett & Bennett, Pleasanton, CA, underlines the extent of the improvement of the FDA: ``As critical as I may have been a year ago, I think they have made significant improvements in the product approval and the compliance side. The whole regulatory environment is improving.'' This is what industry itself is saying about the FDA. This is not just those of us who are opposed to this particular provision. This is the industry itself. How many times have we heard, ``If it is not broke, why fix it.'' And here we have the wide approval by the regulated industry itself. And yet some here in this body want to deride this progress and put the American public at risk by denying the agency the ability to review important information about safety and effectiveness when the information on the label is false and misleading. And here is Medical Economics of this year. The demand for devices has created a worldwide market of $120 billion including $50 billion in the U.S. That's growing by 8 percent annually. A healthy industry, thank goodness, because I think all of us know the importance of these medical devices when they are safe and effective. But we have to make sure they are safe and effective. We do not want to compromise the current superb safety record. An extensive study was conducted by the Medical Device Diagnostic Industry magazine this year that showed that the executive rating of device industry business is at an all-time high--58 percent favorable, 11 percent unfavorable. ``Expectations of the medical device business conditions.'' The best that it has been in any time in recent years. All the measures indicating that the medical device industry is doing well, that the public is being served, safety is being addressed. Even with regulatory protections for safety, the speed with which these devices are being approved has been improved, nonetheless we are being asked to alter those conditions. We are being asked to handcuff the FDA from being able to look at that medical device that may meet the safety standard substantial equivalence but it clearly intended to be used and marketed for another purpose. A purpose for which safety and effectiveness data have not been gathered or evaluated. Let's get back to the fundamentals. The main purpose of the FDA reform bill was to reauthorize the Prescription Drug User Fee Act of 1992 known as PDUFA. PDUFA is one of the most effective regulatory reform programs ever enacted. Under PDUFA, the pharmaceutical industry pays the user fees that cover part of the cost of FDA's drug approval and regulatory functions. And with these additional resources the FDA has been able to hire additional personnel so that drugs can be reviewed more promptly. As important as these additional resources were, equally important were the specific performance targets for speedier drug review negotiated between the industry and the FDA as part of the PDUFA agreement. This is where the industry, working with the agency, said, well, if we give support for this and it becomes law and they get the additional resources to hire the personnel, can we reach these target timeframes for approval, and the agency agreed to that. And we had extraordinary accountability. We found a 90 to 95 percent compliance with those goals. The industry establishing the support for the PDUFA fee resulted in important and dramatic progress made. The combination of performance targets, additional resources, and the leadership of Dr. Kessler, the former FDA Commissioner, has created a regulatory revolution at the FDA. Listening to some of the speeches we have heard during the course of this debate, you would think the FDA was a regulatory dinosaur mired in the past, cumbersome and bureaucratic, imposing unnecessary and costly regulatory burdens on industry and denying patients speedy access to lifesaving drugs. That is a myth that those who want to destroy the FDA in the interest of an extreme ideological agenda or in the interest of higher profits and at the expense of the patients, would love you to believe. It is not true. The FDA's regulatory record is the envy of the world, and it sets the gold standard for protection of patient health and safety. Over the last few years, in partnership with Congress and the administration, the FDA has responded to growing criticisms of delays in approving new products by taking impressive steps to improve its performance. The Prescription Drug User Fee Act of 1992 was one of the most effective regulatory reform programs ever enacted. The bill established a new partnership between the industry and the agency. The industry agreed to provide the additional resources. The agency agreed to a measurable performance standard to speed the review of products, and every goal set by the legislation has not only been met but been exceeded. So today the FDA is unequaled in the world for its record in getting new drugs to market quickly, without sacrificing patient protection. In fact, last year average review times in the United States were twice as fast as in Europe. Fifteen new drugs were approved in both the European Union and the United States. In 80 percent of the cases, the United States approved the new drugs either first or at the same time as the European Union. More companies chose the United States for the introduction of breakthrough drugs than any other country. That is the current record. In addition to speeding the review times, the FDA has taken far-reaching steps to reduce unnecessary burdens on industry and modernize its regulatory processes. More needs to be done, but these steps have added up to a quiet revolution in the way FDA fulfills its critical mission. When the prescription drug user fee was originally passed, the device industry refused to agree to the user fees that would give the FDA additional resources and performance standards that have contributed so much to the agency's outstanding record on drugs and biologics. But even in the device area, the recent FDA achievements have been impressive. I think it is fair to say that following passage of PDUFA, the primary priority of the FDA was to implement that commitment and contract with the pharmaceutical industry. And I do think that the agency gave that a higher priority than it did moving ahead in terms of the medical devices. I think that is probably a fair criticism. But once PDUFA had been effectuated, the priorities shifted to the medical device industry. I remember the debate on PDUFA quite clearly. I welcomed the opportunity to join with my colleague, Senator Hatch, and others in the adoption of PDUFA, and I remember the efforts we made in the area of the medical device industry to do exactly the same thing. But we were unable to get the device industry to agree to that. I think it is unfortunate. Any fair evaluation in terms of the FDA in looking over the period of the time since the passage of the PDUFA, the changes in the way that the agency worked in advancing and accelerating the consideration of pharmaceuticals and biologics would understand that they get the priority. It has been only in recent years that the device industry has received attention, with the results which I mentioned just a few moments ago. The so-called 510(k) application devices, which are approved on the basis of substantial equivalence to a device already on the market, account for 95 percent of the device submissions. The FDA has virtually eliminated its backlog. Last year it reviewed 94 percent of these devices within the statutory timeframe compared to 40 percent just 4 years ago--dramatic improvement. And we haven't compromised safety in the process. Why are we now attempting to undermine the health and the safety of the American public? Why are we risking it? Mr. President, even in the area of class III devices, which is where most problems remain, the FDA has improved its performance substantially. According to a study by the GAO, median review times dropped 60 percent between 1991 and 1996. A recent survey of device industry executives reported that the business climate for the industry is the best in a 5-year history of the survey. The sponsor of the survey attributes the favorable response in large measure to the improvements at FDA and concludes: The agency has not only reduced the product approval delays that slowed new product introductions, but, perhaps more importantly, has also greatly reduced both executives' and investors' uncertainty about the timeliness of future product introductions. That is the conclusion of the General Accounting Office. That is not the conclusion of those of us who are trying to say look, the system is working, the devices that are getting into the FDA are being approved in record time, they are getting out to benefit the people and we have a solid safety record. We are being asked here to walk away from that safety record. We are being asked here, for the first time since we passed serious medical device legislation 25 years ago, to take steps backward in the area of protecting the American public. In a recent FDA report, the agency sets new targets for even quicker review of the class III devices while still giving assurances that we are going to continue to protect the public. The agency is doing a good job now. It will be doing an even better job in the future. There is no justification for weakening the FDA power to protect the public--not based on the myth that it is denying patients prompt access to needed new products. If you listened to this debate for the past days, the other side's description of the FDA may have been accurate 5 years ago or 10 years ago, but does not reflect where the FDA is today. And that is not just my opinion, but it is what we hear from the General Accounting Office, and what we have the industry itself saying. The most important aspect of this bill is the reauthorization of PDUFA. The new PDUFA program was negotiated between the FDA and the industry. It expands existing programs by setting additional performance standards and puts special emphasis on expanding early cooperation between the FDA and industry so the drug development process, not just the regulatory process, can be stepped up. The agency has been creative in anticipating the possibility of major new drug breakthroughs. They have been working with the industry in new ways to help shape and formulate the way the industry effects its application so it can be approved in more expeditious manner. This is because we are not just interested in drug approvals but also development times. We had a long debate about how we were going to reduce the number of days: 180, 360, 120, or 90 days--for the approval on these various issues. That was taking our eye off the ball. What is important is development time. In our own review of FDA, what makes the most difference reducing total approval time is reducing development time. The agency has been doing really excellent work. In addition to PDUFA, there are a number of other provisions changing the way the agency does business, particularly in the area of medical devices. As originally introduced, the bill included many extreme provisions that posed significant threats to public health. It was important that these provisions be modified before the legislation could be allowed to move forward. I compliment Senator Jeffords and the other members of the committee, Republicans and Democrats alike, on their willingness to compromise on these unacceptable proposals over the months we worked on the bill. I would like to review a number of these provisions for the Members of the Senate so they understand the changes this legislation makes and the pitfalls that have been avoided. These compromises must not be undone as the bill moves further through the legislative process. I am proud the progress that has been made. We have reached constructive compromises on more than 20 items. I have here the letter that was sent to the chairman by the Secretary of Health and Human Services in June, June 11, as the committee was considering the FDA reform. In this, the Secretary mentions, ``Unfortunately, the Chairman's substitute to S. 830, also includes a number of provisions which as drafted do not reflect consensus and about which I have very significant concerns.'' I will not take the time of the Senate now to review those. But basically they include some 20 different provisions. I ask unanimous consent to have those printed in the Record.

Mr. KENNEDY. Mr. President, we are moving on in the consideration of FDA reform. I would like to review where we are, where we have come from, and where I believe we ought to go on this important issue that is intimately tied to the public health and safety of the American people. I would just like to remind our colleagues and others about the importance of this agency. We will be debating about section 404 of the FDA legislation that is before us. It might sound like a small, narrow provision in a complicated piece of legislation, but its implications are profound in terms of potential impacts on the health and safety of millions of American people. Senator Reed, myself, and others have attempted to make the case that we are unnecessarily risking the health of the American people. We are doing this because we are effectively permitting false and misleading information to be placed on the labels of medical devices that are submitted to the FDA for review. We are doing this and at the same time, tying the hands of the FDA to look behind those labels and into the real purpose of the medical device. We are creating a loophole that will allow companies to submit their products under a protocol they know will allow for quick approval, but whose clear intention is to market the device for uses that are different from those they listed when they went through the approval process. Over the last few days, we have reviewed the most prominent example of this issue when we talked about the biopsy needle of U.S. Surgical Co. We discussed how they were able to get approval for the device by telling FDA that it was substantially equivalent to a device they already had on the market. But, in reality, the biopsy needle that was on the market excised an amount of tissue that was less than the size of the lead in a pencil, and the new device they submitted to FDA removes a piece of tumor that is 50 times larger than would be removed with the existing needle biopsy device. It is quite clear from the evidence that we are able to advance on the floor of the Senate, both the correspondence we received from doctors about marketing practices and a promotional videotape, that this device was being promoted for an entirely different purpose than the one U.S. Surgical listed on the label it submitted to FDA. Due to this maneuvering, we did not have the proper kind of safety information available to the principal agency of Government that is charged with protecting the safety and health of the American people. I cannot understand why we, by way of this legislation, are denying that Federal agency the opportunity to adequately protect the American people. And it isn't just me, 35 other Members of the Senate, more than a third of the Senate, indicated a similar position with their votes yesterday. Virtually all of the consumer groups are with us as well. I have illustrated on this chart some of the organizations that are working to protect patients, that listen to patients, and that understand the need of patients, and that stand with us on this issue. They are virtually unanimous in their concern about this particular provision. I have in my hand articles about the FDA which have been published over the period of the last 2 days. This is an agency that is on the cutting edge of many health-related issues. It is charged with many different responsibilities that have enormous impacts on the lives and well-being of American people. Here we have on September 22 a major article: ``Doctors want approval to inject themselves with live virus''--HIV. This will be a decision the group will seek approval. From whom? From the FDA. Here is another--``FDA sets rules on supplemental labels.'' The FDA published final rules yesterday aimed at making * * * manufacturers put more information on labels. Why are they doing that? To protect the American public. They have responsibilities for that. FDA acts to get more women in drug studies. That is very appropriate and very important to do. FDA moved [yesterday] to force drug companies to stop excluding young women from studies of promising new medicines out of fear they will get pregnant, curbing the research. And, again: FDA told the drug companies to include women in all stages of drug tests. Then it goes on about the importance of having women represented in drug trials so we can understand how they will affect women. That can't be learned from studying the effects on men because of the metabolic and other differences between men and women. Here is another example of FDA looking out after public health issues, and the impact of pharmaceuticals on our population. On September 23 here is the long story in the New York Times. Thirty-seven years later, a second chance for thalidomide. Officials at the agency announced today they intend to approve thalidomide for use in leprosy patients, as long as the New Jersey . . . company seeking market approval adheres to conditions, including elaborate restrictions intended to keep the drugs away from women who might be pregnant. Here is the FDA looking after what? Looking after a possible cure for leprosy and making sure that women who are expecting are protected from thalidomide. What is the role of the agency? Looking after the women and children--looking at trying to find some cure for leprosy. What is another role of the FDA? Trying to make sure that all members of our population are included in the review of various pharmaceuticals. Here is a story on E. coli bacteria. We remember the stories across the country a little over a year ago and the dangers that were posed in terms of the health of the American people. This has no direct connection with the issue surrounding FDA reform except that it, too, comes against a background of years of determination, --the ``meat industry and anti-regulatory forces to block long overdue improvements in the way the Government monitors the meat safety.'' Here is an example of an editorial advising us to be cautious in our rush to regulatory reform. Let's not override safety. That is what this editorial is about--the same message we are delivering today--in our rush to reach these thoughtful and important reforms, let's not override safety. This editorial involved a different issue--E. coli and meat products. It may be E. coli today, but it may be an unsafe medical device tomorrow. Again, on the 23d, FDA. The approval of thalidomide, lawsuits filed against the fen/phen, and many other articles. The FDA published a rule on the 23d--from the Washington Post: Final rules aimed at making supplemental manufacturers put more information on the labels. The rules restrict the use of the term ``high potency,'' requiring products such as vitamins, minerals, herbs, and amino acids to be labeled as dietary supplements and labeled also to provide information about serving size. What is the agency doing in each of these cases that made the newspapers over the past few days? Protecting the American public. In each and every example that we have cited FDA is trying to protect the American public on a wide variety of issues. We are talking today about doing the same thing with regard to medical devices, protecting the public from false and misleading labels. That is the issue. It is not the only issue, but the Senator from Massachusetts, the Senator from Rhode Island, for the patient advocacy and consumer groups, it's the primary issue. There hasn't been a single patient advocacy group that has been advanced by those that are opposed to our position here during the course of this debate. Not one. Why? Because they cannot find any. Why? Because this provision is a direct threat to the health and safety of the American consumers. And virtually every group that has studied it, that has reviewed it, understands that. That is where we are. We want to let the American people know the importance of the FDA. Let them know how it is out there trying to provide protection for the American people. That is what we believe should be the case on the provisions that we have been discussing here, with section 404. Because of the Senate vote yesterday tabling the Reed amendment, the FDA reform bill still includes the provision that seriously threatens the public health--the provision that must be removed before this legislation becomes law. This provision encourages device manufacturers to lie to the FDA and forces FDA to approve medical devices that have not been adequately tested to assure that they are safe and effective. Weeks ago, the Secretary of HHS identified this provision as one that would lead her to recommend a veto if it were not removed. Despite what some of my colleagues say, this is not a new issue. The Secretary identified it last June, identified it again in July, and identified it again in September as one of the administration's principal concerns. It is virtually the only technological issue that remains to be resolved on this bill. Every major public health and consumer organization that has taken a position on this provision strongly opposes it. While the Reed amendment was defeated yesterday, I anticipate the bill itself will be adopted by the Senate today. This is not the end of the story. There are many procedural steps that must be taken before the bill becomes law, including action by the House, reconciliation of the bills passed by the House and Senate, and the signature of the President. There will be many more opportunities for debate before this bill can even go to conference. I believe that in the end the public interest will prevail. I intend to discuss this provision during the course of today's debate on the bill. I would like to begin by reviewing the reasons we embarked on an FDA reform bill in the first place and how much we have been able to improve the original bill. As I mentioned earlier, there are few more important agencies of the Federal Government than the Food and Drug Administration. The FDA is responsible for assuring that the Nation's food supply is pure and healthy. The FDA provides a guarantee that the drugs and devices we rely on to cure or treat diseases are safe and effective. It wasn't always that way. Medical device legislation was adopted in the mid- 1970's. If it does its job well, the FDA can speed medical miracles from the lab bench to the patient's bedside. And if the agency does its job poorly, it can expose millions of Americans to unsafe or ineffective medical products and jeopardize the safety of our food. The record of the FDA in moving these various medical devices through the process and moving them from the manufacturer onto the market is improving. We have seen significant and dramatic improvement over the period of the last 3 years. In the premarket notification process known as 510(k), which about 95 percent of all the medical devices come through, the median review times have dropped from 199 days to 93 to 85 days, meeting the standard of 95 percent of all of those submitted. That is extraordinary progress. And for the more complicated, newer devices, the breakthrough kinds of devices, which account for only 5 percent of submissions, review times have been reduced to about 40 percent of the time between 1993 and 1996. This is the record. That is why there is within the medical device industry, general support for the steps taken by the agency. Here is the Medical Device and Diagnostic Industry magazine of this year. With improvements in FDA product review performance, despite a more challenging domestic market, device companies are more optimistic than ever. Company executives report a substantial improvement in FDA performance, particularly in 510(k) product approval times. This is the Medical Device and Diagnostic Industry magazine commenting on the performance of the FDA in terms of its approval ratings. This year's survey of medical device manufacturers marks the highest business climate ratings ever. Here we have the industry magazine talking about how effective the FDA is in moving these devices through the process expeditiously. And now, even with this information, we are undermining the ability of that agency to provide adequate protections for public health and safety. (Mr. COATS assumed the chair.)

Mr. KENNEDY. Mr. President, I also join in expressing great appreciation to the Senator from Maryland in terms of the FDA reform. She speaks very eloquently, passionately, and emotionally about the family's personal experience with the breakthroughs of modern medicine and what it can mean to those afflicted by the scourge of so many of these diseases. I must say I join with Senator Jeffords in saying that no one on the committee has been as tireless in pursuit of FDA reform as the Senator from Maryland. As a tireless advocate for FDA, she has brought great knowledge and understanding to achieve the goals that she has outlined here and I think all of us pay tribute to her. I want to thank her, as well, for commenting positively on the work of the people at the agency. There are many individuals at FDA who could, at the drop of a hat, go to the private sector and other areas and be better off financially. But who, because of their commitment to the public, are trying to do a job they believe in and are willing to serve the public.

Mr. KENNEDY. Mr. President, U.S. Surgical's public response to this sorry record of profiteering at public expense is a disgraceful attempt to avoid responsibility for its unacceptable behavior. It claimed it had not produced the video--even though the video carries the company log and it is impossible to watch it without it being clear that the company paid for it, produced it, and wrote the script. It claimed that it had not distributed the video, even though there is no reason to produce a promotional video except to distribute it, and even though Dr. Morrow has written that the video was delivered to her office by a company representative trying to convince her to buy the U.S. Surgical machine. And, according to the Associated press, a company spokesman said that ``the label * * * makes clear that the biopsy divice is `to be used only for diagnostic breast biopsy and is not a therapeutic device.' '' But as the history of this machine makes clear, that clear disclaimer is only on the label because the FDA stepped in and stopped the company from its illegal promotional efforts. If section 404 is passed in its current form, the FDA will be handcuffed in its efforts to protect the public against untested and potentially harmful--even fatal--devices. Under current law, the FDA is able to require that the company develop data to show that the new device was safe and effective for removing tumors--the real use intended by the company, not the false and misleading use submitted on their proposed label. When the FDA made a mistake and inappropriately cleared the device, it had the authority to go back to the company and warn that it would revoke their approval unless adequate warnings were placed on the label and necessary clinical testing was performed. But under section 404 of the FDA reform bill, the FDA would be forced to approve the new device without such evidence. Unscrupulous companies will not only be allowed but encouraged to submit misleading labels, because they will gain a competitive advantage over companies that play by the rules. American women do not want to die from breast cancer because companies are allowed to sell devices that may be unsafe and ineffective. No Senator would want their own wife or mother or daughter to be subjected to such an untested device, solely because a greedy company wanted higher profits. Supporters of this measure claim that FDA will still have the power to require that dangerous devices be shown to be safe and effective before they are sold. They point to the language of the statute that says a device approved as substantially equivalent must meet two tests. First, it must have the same intended use as the predecessor device. Second, ``the information submitted that the device is substantially equivalent to the predicate device contains information, including clinical information if deemed necessary by the Secretary, that demonstrates that the device is safe and effective as a legally marketed device, and does not raise different questions of safety and efficacy that the predicate product.'' What their argument ignores is the first part of the test--the intended use test. Today, the FDA can look at the device and say, from the technical characteristics of the product, that it is obvious that it has been redesigned so that it is primarily for a different use than the older device. But under the amendment, they would be barred from doing this. They would be forced to accept the manufacturer's word as to the intended use of the device--even if that label were false and misleading, even if the manufacturer was lying. That is what happened with U.S. Surgical and the biopsy machine that was really designed to treat breast cancer. Under the current law, FDA could require that U.S. Surgical show their device was safe and effective for treating breast cancer. Under the amendment, they could not. This is not just my opinion. It is the reason that the administration has singled out this provision as possible grounds for a veto. It is the reason it is opposed by a broad coalition of consumer and public health groups. It is obvious that the only reason that the proponents of this provision are not willing to compromise is that they want to hamstring the FDA for the benefit of the industry. How else can they possible justify requiring FDA to evaluate a device based on a false and misleading label. If allowed to stand, this provision will give unscrupulous companies a license to lie to the FDA. It will penalize ethical companies who are truthful and do the necessary testing to prove that their products are safe and effective. Most of all, it will put the health of America people at risk so that a greedy few may profit. The issue goes far beyond products to excise breast cancer. If applies to lasers to treat prostate disease, stents to place in carotid arteries, imaging systems to detect breast cancer, and a host of other treatment for dread diseases. 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 fenphen 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. It can fairly be called the fen-phen device provision. It is shocking that this shameful provision has been so cavalierly included in this bill. It is incomprehensible that reputable device manufactures are not prepared to support a compromise that allows the FDA to look behind labels that are false or misleading. Medical devices can heal, but they can also main and kill. The history of medical devices is full of 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 incomprehensive about the bill before us is that it would take backward--in the direction of less protection of public health rather than more. The whole history of device regulation has been to provide the public greater protections. 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 has 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. Robbins, 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 Co. the Shiley Co. was subsequently sold to Pfizer, which continued marketing the value. 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. Another device disaster is toxic shock syndrome from superabsorbent tampons. Most women would not think that a tampon could kill them or a change as minor as increasing the absorbency of the material used could have life-threatening consequences. About 5 percent of toxic shock syndrome cases are fatal. As a result of this problem FDA began requiring testing of the absorbency of all types of tampons. Women deserve protection. FDA should be strengthened, not crippled. 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. In yet another example, the FDA was able to block a device that involved a plastic lens implanted in the eye to treat nearsightedness. 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 Corp. 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 2-month period, leading to serious cardiac damage, emergency coronary bypass surgery, and even death. Devices as simple as patient restraints used in nursing homes and hospitals have been implicated in 231 injuries, including 128 deaths. The list goes on and on. 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 backward by forcing the FDA to try to protect the public with one hand tied behind its back. This bill actually forces the FDA to approve devices based on false and misleading labels. 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. 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. 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 approved for better diagnostic imaging of a potentially cancerous lump in the breast that has already been detected. 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. Another example involves the large number of patients who have suffered serious fractures and who benefit from orthopedic implants that help the broken bones to heal. In some cases, these implants are designed to be removed after the healing is complete. In other cases, to avoid further surgery or to strengthen the bone, the implants are left in place. Under this legislation, a manufacturer of plates and screws approved for short-term use could modify them in a way that clearly shows they are intended for long-term use. The FDA would be prohibited by this bill from looking behind the false and deceptive label and requiring the manufacturer to show that the device will not degenerate or weaken the bone during long-term use. Pedicle screws are a clear example of just such behavior by manufacturers. Originally designed to hold long bones in place after a fracture, they were modified by the manufacturer so that they could be used to make the spine more rigid, with the goal of reducing painful back problems. But the many manufacturers of these screws did not present safety and effectiveness data to the FDA for this new use. The result: the screws sometimes broke and sometimes caused spinal fractures. Reoperation rates ranged from 14 to 52 percent--and patients suffered permanent pain and disability. This is exactly the kind of unethical behavior by manufacturers that this bill encourages. 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. Still another example involves contact lenses, which can be approved for either short- or long-term wear. Extended wear contact lenses can be left in the eye overnight, and sometimes are worn for weeks. Under this bill, a manufacturer could take contact lenses approved for short- term wear, and modify them in a way clearly intended for long-term wear. The FDA would have to approve the modified lenses based on the false and misleading label for short-term use. Unsuspecting patients could suffer corneal ulcers and even blindness. 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. And there is certainly no justification for giving a competitive advantage to unscrupulous companies who will exploit this gaping loophole in the law. Companies that hope to benefit by weakening the FDA are powerful and profitable. They believe they have the votes to push this disgraceful provision through the U.S. Senate. Today, they probably do have the votes. But 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 labeling. The legislation we are considering has many constructive elements. But it does not deserve to go forward unless this disgraceful provision is removed. False or misleading labels should have no place in approval of medical devices. Unscrupulous manufacturers do not deserve a free ride at the expense of public health. I intend to continue to fight to modify this provision so that public health can be protected, and I believe that we will ultimately be able to reach a compromise that will not sacrifice the public interest to the profits of greedy manufacturers. We have been successful in assuring that every other objectionable provision of this bill has been modified so that the public health is protected. This provision must be changed as well. Here are some significant advances in the FDA bill and compromises worked out on S. 830 since the committee markup on June 18. First, preserving State oversight of safety of cosmetics. This compromise assured that the States will be able to continue to regulate the safety of cosmetic products. The Gregg proposal in the underlying bill would have barred States from any regulation whatsoever of cosmetics, even though the FDA has neither the authority nor the staff to regulate these products. The compromise allows States to continue their regulation unless a specific inconsistent regulation has been issued by the FDA in a particular area. Second, safeguards for off-label use of drugs. This important compromise will allow companies to circulate reputable journal articles about off-label use of drugs but will ultimately enhance the public health and safety because the FDA will be given the opportunity to review, comment on, and approve articles which the companies will circulate. The compromise also requires companies to undertake studies on the safety of their drugs for the specific off-label use and submit applications to the FDA for approval of their drugs for these uses within 3 years. Currently, companies are circulating articles without reviewing them for off-label use without seeking review or approval by the FDA and are also never conducting the studies which would lead to ultimate FDA approval or disapproval of the drug. Third, expanding access to drugs for patients and fast track approval: Fast track approval. This is one of the most important new initiatives in the legislation. Fast track approval will provide the same streamlined availability for drug treatments for patients with any life-threatening disease now available only to patients with cancer or AIDS. Expanded access to drugs still under investigation for patients who have no other alternatives. The compromise combines protections for patients with expanded access to new investigational therapies, without exposing patients to unreasonable risks. Providing access for patients to information about clinical trials for serious or life-threatening diseases. This compromise will assure that patients suffering from serious or life-threatening diseases will have available to them information about ongoing clinical trials relating to these diseases. Fourth, streamlining FDA procedures. In order to expedite some product reviews, the compromise authorizes the Secretary to contract out to third-party reviewers when it will improve timeliness, but not when it will reduce quality. For medical devices, the compromise establishes in law an already existing pilot program for reviewing devices by outside third parties. The compromise limits the review only to low-risk class I devices and specifically excludes higher risk devices that are life-sustaining or if the device was not shown to be appropriate could cause substantial impairment to human health. The FDA will not have to expend resources on unnecessary reports which may be duplicative of other reports already required to be filed by the agency. Fifth, improved consultation between manufacturers and FDA. The compromise increases the requirements on the FDA to consult with device manufacturers and specifically to work toward achieving agreement on what set of data needs to be provided by the device manufacturer before approval can be granted. In addition, the device manufacturers are required to supply progress reports to the FDA, and in particular, report significant deficiencies in the device which have developed during the review period. Sixth, environmental issues. The original bill would have eliminated environmental impact statements from FDA applications. The compromise ensures that the bill does not undermine environmental protections provided by the Environmental Protection Act. Seventh, strengthening safety protections of medical devices: Safety and effectiveness of devices. The FDA will still require device manufacturers to file supplemental applications when they are making changes to their manufacturing procedures which may affect the safety and effectiveness of the devices. Tracking of devices after approval. The compromise ensures that FDA can require surveillance of products after they have been approved for as long as needed to protect the public health. Tightening up the process for FDA approval of medical devices. The FDA will now be required to accept the classification made by the manufacturer unless questions are raised within a specific period of time. The compromise also tightens up timeframes within which the FDA must make a final decision on a device application. Recordkeeping by distributors of devices. The compromise requires limited recordkeeping by device distributors so that patients using devices will be readily identifiable if there is a health problem. Eighth, other issues: Safety standards for drugs. Supplemental applications for drug approvals need to meet the same safety standards as the original application. Health care economic information. Only valid and supportable health economic claims may be made by drug manufacturers. Health claims for food products. This compromise assures that the Nutrition Labeling Act is not undercut or weakened, and that any health claims by food manufacturers have to be substantiated. Mr. President, we want to be able to give the FDA the authority, when it is clearly indicated as a result of the technological changes in that medical device that an alternative use is intended, to look in behind the proposal and examine the safety data that would indicate that device is going to be safe, for the American public to be protected. That is the issue. We have had too many medical device tragedies in this country. It has not been that long ago, whether it is the Dalkon shield or the Shiley heart valve, or even the adjustments in absorption level in tampons that produced toxic shock and resulted in the deaths of women--there have been too many medical device tragedies. We have been able to avoid them in recent times. The industry is doing well. We are having new breakthrough technologies. We have reviewed 19 of the 20 key elements that have been raised by those who have been most concerned about the safety and security of the American people. We have addressed them and advanced the public's interest in protecting the health of the American people with the exception of this provision. It would be wrong and a major mistake to permit this legislation to be passed without making that change. I reserve the remainder of my time.

Mr. KENNEDY

Mr. KENNEDY. I yield 10 minutes to Senator Reed. I will take 9 minutes.

Mr. KENNEDY. Mr. President, I list those who support the Reed amendment: The administration, the President, Patients' Coalition, Consumer Federation of America, National Women's Health Network, American Public Health Association, National Organization for Rare Disorders, the Consumers Union, and the Center for Women's Policy Studies. I believe my time is expired. I ask for the yeas and nays.

Mr. KENNEDY. Mr. President, as I understand I have 30 seconds?

Mr. KENNEDY. How much time, Mr. President?

Mr. KENNEDY. Two minutes.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I am honored to introduce President Clinton's proposal for the reauthorization of title V of the Higher Education Act. The goal of this important legislation is to improve the quality of teacher preparation programs and to bring more qualified teachers into America's classrooms, particularly in the areas of highest need. Investing in teachers is an investment in the Nation's children and its future. The Nation is clearly committed to the highest quality training for our doctors, engineers, and attorneys, both in their initial training and in subsequent professional development opportunities. President Clinton is right to ask us to make that same commitment to the training of teachers who are charged with educating the Nation's most precious resource--our children. Not since the Teacher Corps initiatives of the 1970's has the Federal Government given such high priority to teaching and teachers. Through inaction, the Nation has tacitly condoned low standards in too many schools, particularly in urban and rural areas. Through inaction, we have left too many of these schools understaffed and unsupported. We must recognize the urgency of this situation and act now. In other initiatives, we are already asking teachers to ensure that children meet high standards, but we are not asking whether teachers are ready to meet this challenge. Because of the shortage of teachers, many educators are forced to teach subjects outside their certification area. This shortage is especially serious in communities with high concentrations of students from low-income families. Annually, more than 50,000 underprepared teachers enter the classroom. One in four new teachers do not fully meet State certification requirements, and 12 percent of new hires have had not teacher training at all. Students in inner-city schools have only a 50-percent chance of being taught by a qualified science or math teacher. In Massachusetts, 30 percent of teachers in high-poverty schools do not even have a minor degree in their field. This gap is unacceptable. Teachers must have a strong knowledge base in their subject area, so that they can motivate young learners and teach strong basic skills. Teachers must be comfortable with topics, so that they encourage extended thinking and questioning on issues. Teachers must also have opportunities to improve their own skills, learn how to integrate technology, and employ strategies that encourage all students to achieve. Clearly, we must invest in better teacher preparation, do all we can to ensure that all of our schools are fully staffed with qualified teachers. We must attract the best and the brightest new teachers to adequately prepare students to compete in the global marketplace. During the next decade, because of rising student enrollment and massive teacher retirement, the Nation will need over 2 million new teachers. But teacher preparation programs are currently producing between 100,000 and 150,000 new teachers a year, leaving the system with an annual deficit of at least 50,000 teachers, particularly in underserved, high-poverty schools. The Federal Government, through the Eisenhower Professional Development Program, already invests in upgrading the skills of current teachers, but the investment is far from sufficient. In addition, we must invest in the front end of teacher training, to ensure that the Nation's children are taught by highly qualified, well informed teachers. The President's proposal will help improve teacher preparation and bring well-qualified teachers into more classrooms. The legislation addresses these issues by encouraging strong partnerships among institutions of higher education with exemplary teacher preparation programs, other institutions that want to improve their programs, and the school districts that they serve. The program would be authorized at $67 million for fiscal year 1999. A Lighthouse Partnership Program will identify lead institutions from the variety of successful teacher preparation programs that now exist. These programs provide aspiring teachers with the newest information about the best classroom practices, and give them the concrete clinical experiences they need to develop the skills to help students achieve high standards. State and local education agencies, community colleges, and other professional groups will participate as partner institutions. The lead institutions will demonstrate their strength in cutting-edge, clinically based teacher preparation and course content. They must also demonstrate that they are committed to strong ongoing cooperation with school districts that serve needy families in rural and urban America. A second major part of the President's proposal focuses on recruiting the best and the brightest teachers to serve in needy school districts. It supports partnerships between teacher preparation institutions and local education agencies that provide scholarships and other assistance to students who complete teacher preparation programs and agree to teach in targeted underserved areas for at least 3 years. President Clinton's proposal is far-reaching, and it discusses broad bipartisan support. The United States is in urgent need of creating and maintaining a stronger supply of world-class teachers. These wise investments will provide high-quality opportunities today to the teachers who will be teaching the Nation's children tomorrow. I look forward to working with my colleagues on both sides of the aisle to enact this major teacher recruitment and training proposal. Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. KENNEDY

Mr. KENNEDY. Will the Senator yield?

Mr. KENNEDY. Will the Senator yield?