Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. In a second. Because there will be those in those corporate boardrooms who will say, look, our competitor is getting in through this particular labeling device loophole. All you have to do is change the label a little bit. We will be able to do it as well. We can avoid the time it will take to do it right, we will save a good deal of our resources. We will get on the market sooner, we will beat the competitor, we will be on the shelves sooner. We can use what U.S. Surgical did, where they denied--denied--that they were promoting it, and yet they had some other group that was putting promoting it with their logo, talking about using it for an entirely different purpose. That is the issue. This is not a very complex issue. We heard earlier about sifting out the chaff and moving to the substance on this. This is it. What woman in this country who is facing having a tumor removed from her breast by a medical device believes that device is a low risk device? What mother that looks over a sick child in the hospital and sees a ventilator, thinks that ventilator is low risk? That is the reason that the Secretary of HHS, the President of the United States, virtually every consumer group, every patients' group, every group that will benefit the most by this kind of innovative progress in terms of medical devices, are saying don't do this. Don't play with our future health, don't pass that provision without this language. That is what they are telling us here on the floor of the U.S. Senate. We have been out here with five different sets of language ready to compromise. But, they won't compromise, they have the votes. They say, ``We have the votes. We have the profits that are going to come from it.'' They will profit over their competition. Other hard-working, decent, ethical medical device companies that are trying to play by the rules, trying to get their product in--are going to think, ``Why not? Why not go ahead and do it the other way? Our competitors are doing it and beating the pants off of us.'' I have just a few moments and I will be glad to yield the floor. The question is, will the Senate vote in favor of approving medical devices based on false or misleading labels? Will the Senate allow dangerous medical devices that have not been tested for safety and effectiveness to be foisted on the American people? Will companies like U.S. Surgical Corp. be rewarded for deceiving the FDA? Will the Senate put a higher value on the profits of the powerful than the health of the American people? Section 404 of the FDA bill requires the FDA to approve a medical device based on the user claim on the label submitted by the manufacturer, even if that label is false or misleading. It prevents the FDA from requiring the manufacturers to show their product is safe and effective for the purposes for which it will really be used--as opposed to the purpose falsely claimed on the label. It stands 20 years of progress toward safer and more effective medical devices on its head. Nothing better shows the need for the Reed-Kennedy amendment than the recent history of the advanced breast biopsy instrumentation system, a 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 the FDA for approval based on a labeled claim that it was to be used for biopsying breast tissue suspected of being malignant. This is a common procedure used when mammograms or other diagnostic techniques 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 labeled 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 a 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 curing their illness than existing therapies. Women ought to have a choice on existing therapies whether they want to take a chance on this. It placed the company's profits first--and the patient's needs last. In fact, the only clinical testing the company submitted to the FDA in support of their application had been performed on seven cow's udders and two pieces of beef. 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. The videotape clearly describes the device as appropriate for surgically removing small lumps of cancerous tissue. 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 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 1 versus 2 procedures. * * * Minimally invasive breast surgery. A new standard of patient care offered only by United States Surgical Corporation. They have the audacity to suggest they are not promoting it. It is clear that this company has designed this machine for breast surgery, not just biopsy. And it is promoting it for this purpose-- 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 referenced that-- 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 re-cleared the machine for breast biopsy on September 24, 1996. That is what the FDA has been doing, effectively denying them the opportunity to use it for these other purposes, and permitting them to use it only for biopsy. 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, when asked to provide the additional studies, they agreed. That is interesting, isn't it? Now, once they have gotten caught they say, ``OK, we'll supply the data.'' 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. I hope our colleagues will listen to this. 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. The issue goes far beyond products to excise breast cancer. If applies to lasers to treat prostate disease, stents to be placed in carotid arteries, imaging systems to detect breast cancer, and a host of other treatments for dread diseases. The FDA believes those numbers will increase dramatically as the new technologies come into play. 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 American people at risk so that a greedy few may profit. 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. Later today, we will see if they are correct. 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, 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. And let me make very clear that this vote will not be the end of the story, whichever way it ends up. We will continue to fight to keep this provision from becoming law, and I believe we will ultimately succeed. The FDA reform bill has many constructive elements. But this disgraceful provision should be eliminated. 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. The Reed-Kennedy amendment will protect Americans against dangerous machines and unethical practices. It is a simple amendment. It says that the FDA should not be bound by the company's label if the label is false or misleading. Every Member of the Senate should support this simple, common-sense change. I know that the American public supports it. And I know that every patient and every physician deserve to know that the FDA has had a fair opportunity to assure that the devices on which lives and health depend are safe and effective. I yield the floor. Mr. JEFFORDS addressed the Chair.

Mr. KENNEDY. The Senator is not correct. The FDA is out there looking into this, and it doesn't do much good to try to cloud up the issue as to what the purported purpose of this particular medical device is. Here is what is in the ad. I say again, I wish the Senator would look at the ad, rather than just reading the U.S. Surgical statements on it. This is what their ad says: Minimal invasive breast surgery. A new standard of patient care offered only by United States Surgical Corporation. That is what the ad says. It doesn't say minimal invasive biopsy; it says breast surgery. Maybe that is a new way of doing it. Maybe that is the best way that has ever been devised for protecting American women in terms of breast tumors. But the FDA does not have one sentence of proof or evidence from U.S. Surgical that provides data on the safety and effectiveness on this method of removing a tumor that other medical devices should provide. They have the biopsy needle. It is effectively the size of this pencil. They want one that is 50 times larger. You don't have to have a lot of sense to know what this is all about. Maybe U.S. Surgical convinced the Senator from Connecticut. But the documents and their promotional materials indicate what they are about, and that is to provide for removal of tumors from American women, one out of seven, who have breast cancer. And doctors who see, ``Approved by the FDA,'' then tell their patient this has been approved by the FDA, that it must be safe, and so they undergo tumor removal with this device. These women are entitled to adequate protection, to know whether that device was safe in removing that tumor. They do not know that today. And that is just the tip of the iceberg. You know about all the other kinds of medical devices that can fall within this category. We have mentioned some, like the mammography screening machines that may misdiagnose breast cancer. All this amendment says is, you cannot, if you are a medical device company, submit false and misleading information. I can say it another way, ``Do you want false and misleading information on the labeling?'' If you vote against our amendment, that is what you are going to be pegged with. We are going to be characterized as not caring if labels are false and misleading. Why can't we say we will support the labeling as long as it is not false and misleading? That doesn't sound like an extraordinary or revolutionary concept. This is basically what we are arguing about. Those who are opposed to us say, ``All right, let them provide false and misleading information.'' That is the other side of this argument. If they are not going to go through this kind of loophole, to promote it for some other reason, what do they have to fear? Mr. President, there are all kinds of technologies out there that are just on the cusp, ready to go on ahead through this particular kind of loophole. You have the mammography screening machines that have not been certified for use in screening. The manufacturers have not been provided information on that use. We know the difficulty we have faced in terms of mammography machinery and false negatives and false positives. Are we going to come out on the side of protecting American women on breast cancer, or are we going to say we are going support whatever any medical device company wants to do, no matter how false and misleading that information may be? The vast majority of manufacturers won't use this loophole. But you don't hear the arguments here about what the financial benefit will be to those companies that will not have to conduct the exhaustive tests for safety and efficacy. They will be at a competitive advantage over the other medical device companies that are trying to do it right.

Mr. KENNEDY. If my colleague----

Mr. KENNEDY. If I can reclaim my time, I cannot let that go by, that the FDA has said they are not promoting it. That is not the information on it. I cannot let the statement go by. It is your opinion that it is not promoting. I don't see how you can have that opinion in the face of the fact that this videotape has stated what it has, with this U.S. Surgical's logo right on it.

Mr. KENNEDY. On the needle? All right.

Mr. KENNEDY. I will yield in just a moment now.

Mr. KENNEDY. Obviously, if it is a biopsy needle and it was intended to do that, I had no idea they were out there promoting, as they have been, and representing it for an entirely different purpose. That is the issue we are talking about here, and that is what we want to do. We want to make certain that the FDA is going to be able to look beyond false and misleading information on devices labels.

Mr. KENNEDY. The Senator from Indiana introduced a copy of a letter from a Massachusetts constituent of mine dated October 8, 1996, which purports to thank me for the guidance and assistance my staff provided to U.S. Surgical Corp. in connection with the FDA certification of the advanced breast biopsy instrumentation [ABBI]. The Senator suggested that this letter was proof that I had intervened with the FDA to urge them to approve an off-label use for this device. The letter does not substantiate any such allegation, and it is untrue. I ask that the full text of the letter be printed in the Record.

Mr. KENNEDY. Well, Senator, I will be glad, first of all, to have it included in the Record so the record is clear. But I will say to you that, if U.S. Surgical was distorting and misrepresenting to the American public, then I think they ought to be pursued to every extent of the law. That is my response on it. I had no idea of that unfair kind of consideration at that time, but clearly they have misrepresented themselves in this instance. They practiced that kind of misrepresentation on me as they are doing it with the American public.

Mr. KENNEDY. Sure.

Mr. KENNEDY. They have. As I understand, they have requested the additional information on safety and efficacy. They are demanding that kind of information now. I will be glad to provide that. But that has as much relevancy as yesterday's score of the Green Bay Packers. They are out there now promoting this for unintended uses. I do not think they should be. FDA says they are looking into this. I will find out and give the Senator a more detailed description.

Mr. KENNEDY. I yield at this point now. I would like to go on to just some other remarks.

Mr. KENNEDY. That is just the part I am going to mention. Let me quote some extracts because that is the issue that is before us--the extracts of the promotion. This is the promotion that some do not think is being promoted by U.S. Surgical, even though its logo is on it, even though doctors have said it is being distributed by company representatives. This is the quote: U.S. Surgical is entering a new millennium in breast surgery by combining advanced stereotactic technology with minimal invasive surgery. Not biopsy, surgery. Unlike needle biopsies where small samples of the lesion are removed for pathological analysis, U.S. Surgical removes the entire specimen. That sounds like an operation to me. If the specimen proves to be cancerous but pathology reports the entire margin is clear, its up to the clinical judgment of the surgeon to decide to remove the additional tissue, or if the procedure can be considered complete. Translated, if you use this device and you take out the tumor, then it is the doctor who removes the tumor who makes the judgment whether he has to do any other surgery. That is not a biopsy needle. It continues. The U.S. Surgical system allows the surgeon to provide the benefits of the minimally invasive technique to breast surgery. Benefits to the patients include reduced physical and emotional trauma as a woman undergoes only one versus two procedures. Minimal invasive breast surgery, a new standard of patient care offered only by United States Surgical Corporation. I rest my case on that, Mr. President, about advertising and promotion. I rest my case on exactly the words of that promotion. ``Minimal invasive breast surgery, a new standard of patient care offered only by United States Surgical Corporation.'' If there are Members in this body who want to say U.S. Surgical is not promoting it, that they are not associated with it, that they don't know anything about it, I suggest that they watch this videotape. Now, Mr. President, I want to just come back to--how much time remains because I know there are others who wish to speak.

Mr. KENNEDY. No. I would like to just finish my presentation on this part here, and then I will be glad to yield.

Mr. KENNEDY. Mr. President, I would like to regain my time. I say that that is a promotional document. I would suggest the Senator watch it before he represents that it is not. It has the U.S. Surgical logo on it. We have the doctors who claim this is the case. The FDA has been going after U.S. Surgical. That is another issue. It is an important issue. FDA ought to be concerned about it, and they are. But that doesn't get away from what the FDA may not be able to do sometime in the future. They won't be able to do it in the future, because all the FDA will have the power to do is look at what is on the label.

Mr. KENNEDY. I will be glad to take a look at the letter.

Mr. KENNEDY. Here is their--I will yield briefly on this point. But I want to get back to my theme.

Mr. KENNEDY

Mr. KENNEDY. How much time do we have?

Mr. KENNEDY. I yield myself 8 minutes. Mr. President, my good friend from Rhode Island has put his finger on exactly the problem and the issue. Now, I listened to our friend, Senator Frist, who believes that the FDA doesn't really have a problem if the information is going to be false and misleading, that the FDA has the authority to look behind the label itself and find out if that information is false and misleading. If that is the case, we do not have a problem. We can accept an amendment that would restate what he has just said, or we can drop this whole provision. It is interesting to listen to those who are opposed to the Reed amendment say, well, look, the FDA can do this and that and protect the public, while at the same time they are emasculating the very safety valve with this new provision--restricting the FDA in its ability to judge on the issues of substantial equivalence. Now, Mr. President, before we move to the vote, I want to reiterate where we are so that those who have been listening to the debate for these last few minutes understand where we are. We are talking about the preeminent issue identified by the administration's principal spokesperson charged with protecting American health. This has been identified as the one provision in the whole legislation that is of central concern to the public health of the American people. They mentioned the issues of cosmetics; they mentioned the fact that this eliminates environmental impact statements; they mentioned technical issues dealing with PDUFA; but there was only one public health issue that the Secretary of HHS has recognized, and it is this particular provision which Senator Reed has tried to address. It is of such importance that the Secretary of HHS indicated that if that provision remains unchanged, she would recommend that the President not sign the legislation. And it is not just the Senators from Rhode Island and Massachusetts who are concerned about this provision. Every single consumer group is concerned about it as well. All of the groups that speak for patient rights, all of the groups that are concerned about women's health issues, all of the various consumer groups--I have listed them before--all of them say that we ought to support the Reed amendment, if we are truly interested in protecting the American consumer. We have, over the last few days, talked about why this is so important. Those who are opposed to this amendment keep repeating their assertions that the FDA has the authority to protect the public. That is hogwash. They may believe it. I have yet to see a Member of the Senate who is opposed to our amendment take out this legislation and thumb through it and point to the specific language that states the FDA will have authority to protect the public if this amendment is not carried by the Senate of the United States. They have not done it because they cannot do it. They cannot point to a provision in here that says, ``OK, if we defeat the Reed amendment, FDA will still have the authority.'' They have these assertions on the floor of the U.S. Senate. But they have not pointed to specific language in this legislation, and that is what counts. They cannot point to it because it is not there. We are talking, as the Senator from Rhode Island has pointed out, about medical devices submitted to the FDA for approval, which a company would say is ``substantially equivalent'' to an existing device. But which, in reality, is a device which has significant technological changes in its design and in fact, is designed for another use. However, when the new device is submitted for approval, the label will still maintain that the device will be used for the same purposes as the original device. That is what is happening. That is the danger and that is what the Reed amendment is attempting to prevent. We have discussed the example of this that is currently unfolding. The biopsy needle that was supposed to be substantially equivalent to a biopsy needle the size of your pencil lead but which actually removes an amount of material the size of a hot dog. This device is used to take the place of surgery for women, but it is untested and untried for that purpose. We don't know if it's safe. The company hasn't submitted evidence as to whether it is safe. But we know that this device developed by U.S. Surgical was not designed for the narrow biopsy; it was designed for another purpose. It takes out 50 times the amount of material necessary for a biopsy. We know what it was designed for, we have the promotion tape. We have the statements from doctors saying they were being solicited to use it for surgery, not biopsy. You can claim that these are low-risk devices. You can claim that is really just a technical issue, that its not important. But we know that is not the case. We are talking about anesthesia machines which are used for major surgeries. We want those to be able to perform the way they should and to meet safety and efficacy standards. We are talking about fetal cardiac monitors. We want to make sure that children who need that kind of monitoring have a device that will be safe and do the job. What mother wants to discover that her child is using a fetal cardiac monitoring system that has been approved for some other use and here the hospital or clinic is using it for a different purpose without knowing that it is safe and effective for that use? The list goes on. We have had the situation where surgical lasers are being submitted as general cutting tools when it is clear that the intention is to use them for surgeries for prostate cancer and no information about how safe or effective they are for that purpose has been submitted to the FDA. Why are we risking the health of the American people over this issue? What is the benefit? I have cited examples where we have been called on in this body to make decisions about whether we are going to use a limited amount of money to feed the elderly people--how much will we use in congregate sites? How much will we use for home delivery? If you use more in home delivery, you will be able to feed fewer people. It's a painful issue, and whatever we do some are going to benefit, some are going to lose. We can understand men and women of good judgment differing on that issue. But not on this issue. What is the balance? The balance is that the protections of American consumers are weakened in the area of medical devices--significantly weakened for the first time in 25 years. And the profits of the medical device industry go up. And they have a competitive advantage over the other companies who do the right thing and conduct the tests to provide health and safety information on their devices. Why are we doing that? What is the rush? Why aren't we hearing from the other side that, ``We have 10 consumers' groups that believe we can get the information much more rapidly and their health needs will be advanced and we don't need the Reed amendment.'' Where are those statements, why haven't we heard them. Because they are not there. We have to decide whether we are going to retain, for the Food and Drug Administration, the ability to deal with labeling. The ability to look beyond the label when they find it to be false and misleading. That is a pretty high standard. FDA has to find it false and misleading. Only then can they look to safety. Some of us wish it was a lower standard, but that is the standard we have here, false and misleading. We have given examples, ads have been used to promote medical devices for other purposes. That is happening now. We have also spelled out the human tragedies that occurred when medical devices malfunctioned, when we did not have all the necessary information to assess safety. Are we going to deny the principal health agency charged with protecting the American public, the authority to ask for more data if they find that the label on a medical device is false and misleading. Are we going to say your hands are cuffed?

Mr. KENNEDY. I yield that to myself. Are we going to tie their hands, tell them that they cannot do a thing? Are we going to tell them that we understand that they have done the scientific review? We understand that the label is false and misleading, but you are not allowed to protect the consumers or the American public from it.'' I think that is the wrong position for this body to take, and I hope the amendment is accepted for the reasons I have outlined and for the splendid reasons outlined by the Senator from Rhode Island. I withhold the remainder of my time.

Mr. KENNEDY. Mr. President, I understand we have 20 minutes to each side.

Mr. KENNEDY

Mr. KENNEDY. Madam President, I am prepared to yield the remainder of our time this evening.

Mr. KENNEDY. Madam President, we are making substantial progress on the FDA bill, and I applaud that progress. We have worked out a number of key issues on a bipartisan basis since the committee markup in June. We have worked out the issues on fast tracking some innovative opportunities for dealing with the special challenges we are facing. We built on the fast tracking that we have done on AIDS drugs, and we are trying to do more in the areas of cancer and Alzheimer's, following what has been an important initiative at FDA for getting drugs out faster. We have even worked out differences on the off-label uses of various pharmaceuticals and devices and what information and studies will be required in terms of safety and efficacy. We have worked out the early consultation between device manufacturers and the FDA. We have been working toward reducing the total development time. A key element in our negotiations has been going upstream and working with the pharmaceutical companies, as well as the manufacturers, in shaping and formulating their applications so that they will move more rapidly through the approval process. Many of these initiatives were worked out by Dr. Kessler. We have put them into legislation under the leadership of Senator Jeffords and others on the committee. We have settled the issues of cosmetics, after good debate and discussion. We have also worked our third-party review pilot programs and timeframes for some of the drug approvals. Each one of these issues was worked out in a way that protects the public health. This process continues now with further debate today and tomorrow on what I, and others with me, consider to be the most significant threat to the public health remaining in the bill. These other areas that are complex and difficult, where a wide variety of different positions had divided the committee in a significant way. We have been able to make important and significant progress in ways that advance public health. I believe that we have advanced the interest in the public health. This final issue remains and has been identified by the President of the United States and the Secretary of HHS as being the No. 1 public health risk within this legislation. We had a good debate on that issue earlier today and a real engagement of the differing ideas. I find that we were able to make important progress. The Members realize and recognize what is really at stake. We were unable to win the majority of the Members, but we have a substantial group of Members who are likewise concerned about the public health issues. We have heard from the various consumer groups and they are the ones that will benefit the most from breakthrough devices. If you read through their concern and opposition to the provision in the legislation and their strong support for the Reed amendment, you understand why we are so concerned about this particular provision. The House is in the process of taking up legislation dealing with the same subject matter, although they have reached a stalemate with regard to the extension on PDUFA. PDUFA, which I certainly support, provides the additional resources for the FDA to get the kind of trained disciplined personnel that represents the top of our research technology to work very effectively in the evaluation of these various products. As the prime sponsor of that proposal here in the Senate, with my friend and colleague, Orrin Hatch, we are clearly strongly in support of PDUFA. We tried to take similar action with regard to the medical device industry, but we were unable to do that. But we were able to accomplish it with the pharmaceutical industry, and it is necessary to have this extension. The House will take up the FDA. We will continue to work with the administration, and with the leaders of the Energy and Commerce Committees in the House to make sure the compromises reached in the Senate are retained or improved. We will work to make sure that the medical device issue that we have been debating on the Senate floor is fixed. We believe that the Food and Drug Administration should not be faced with a situation where a device is submitted with a label that contains false and misleading information that would effectively deny FDA an opportunity to review the device on its real uses. And deny them the authority to require the medical device company to provide information relevant to the safety of that medical device. There is nothing that we have heard that changes my very view that the interests of the American consumer and the American public are best protected by strengthening the lead agency for safety--the Food and Drug Administration. The agency to which all Americans turn when they find that there is tampering with pharmaceuticals, or they are concerned about the importation of pesticides on grapes from Chile, or they are concerned about drugs and medical devices. We saw that across the country this last week with the fen/phen tragedy. Now we are being asked to reduce the protections for the American people by prohibiting this lead agency, with all its expertise, from protecting the public when it comes to medical devices. We are handcuffing them from being able to reach out and protect the American public when a medical device is falsely labeled. That is a serious error on our part. A great deal of discussion has taken place in the committee and out here on the floor of the U.S. Senate as to the FDA's ability to approve medical devices in a timely manner. We heard it expressed this morning. We heard. ``Just look how bad the FDA really is.'' We have to accept this provision because it is going to make such a difference to the patients that need these medical devices. Let us look at what the record has been with regard to the FDA. If you go through the GAO study on the FDA and its approval record, the progress that has been made in the recent time is truly remarkable. I have it here. This shows the review times that have been decreasing, starting in 1994, continuing 1995, and 1996. This is the General Accounting Office. The premarket notification 501, the median FDA review time for notification as judged to be equivalent devices already on the market has dropped consistently from 199 days to 95 days in 1996. Look at that difference between 1993 and 1996. The time reduced from 199 days to more than half for the medical devices that are the substantial equivalent. Here is the premarket approvals. Those take longer than the premarket notifications because the FDA reviews the substantial amount of evidence to determine if the devices are safe and effective. The median time for PMA has dropped from 766 days in 1993 to 280 days in 1996. Again, a 40 percent reduction of the time--a dramatic improvement in the most complicated medical devices that are new; to convince the FDA with the range of different new technologies that are coming and that are being implanted in people. We have reduced that time for clearance on the newest devices that have to be tested carefully and evaluated in terms of their safety. We have dropped the time by about 35 or 40 percent. Approval times have been reduced and we still have the best safety record. We are seeing dramatic improvement in approval time for the most complicated medical devices, and we are seeing dramatic improvement in approval times for the kinds of medical devices that are substantially equivalent. And we still have a strong safety record. But that isn't enough for the medical device industry. They are refusing to support an amendment which would permit the FDA to look at the safety features of medical devices that ought to be looked at. It would be an entirely different matter if these improvements had not been made. At least you would have an argument to say you needed dramatic changes in the approval process. But the time it takes for the newest kinds of medical devices are improving dramatically. We heard on the floor of the Senate, ``Well, we have to be able to get these devices out there because all of us are aware of how fast those devices are being approved in Europe. If we do not accept this provision, all our medical device companies are going to go abroad. We are going to lose jobs. This is an issue of jobs. We will take a chance with the health of the American people on this so we can keep our industry here and protect our public.'' Well, let's look at the facts on this one. We have just had the GAO report of June 1997 showing the remarkable progress that is being made in terms of approving these devices while still doing comprehensive examinations of the complex safety issues. They can evaluate the new kinds of safety information provided by the medical device industry, and do it in a timely way, and protect the public. That is what Senator Reed and myself believe should be done with regard to this provision. Madam President, this is a May 12, 1997 document by the World Medical Device Diagnostic News. This is April 21, 1997. I will include the relevant parts in the Record. But I am reading now: France calls on EU to tighten device controls. In a letter to the European Council of Ministers, the French government has called for tighter controls over high-risk medical devices. The government is particularly concerned about implantable devices and other products that fall into the high-risk categories, class 3, class 2. The letter which was sent to other EU member states has not been released publicly. It forms part of the French campaign of ever- increasing intensity for more stringent relations on medical devices. France is also questioning the validity of the European approach to the regulation of products that pose a high risk to health. Then in another section talking again about the European Union, industry experts speculate the French might argue on the basis of the results and the question of medical device directors being unable to cope with the high-risk products. These are storm warnings with regard to the use of high-risk products--storm warnings from our European friends about what is happening over there with their medical device industry. Then we heard here, ``Well, those may be high risk but we are only looking at low risk devices.'' Low risk? The list of the products that are being suggested as low risk: Ventilators, fetal cardiac monitors, imaging devices, MRI ultrasound, x-ray. Who wants to take chances about whether the ultrasound that an expectant mother is having is going to do the job or not? We think that is a low risk? We don't think that mother ought to be able to get satisfactory information about the adequacy of the protection and the soundness of x rays and CAT scans and ultrasound and MRI's, imaging devices. Low risk? Anesthesia machines. Low risk? We have the storm warnings about what is happening in our own country. Here is the February Business Outlook for the Medical Device Link. Here is their cover story February 1997: With the improvements in FDA product review performance, despite an ever more challenging domestic market, device company executives are more optimistic than ever. They talk about the FDA being cited by many as the leading source of their pessimism. While nearly as many blamed the disconcerting restructuring of health care providers, two years later--that is now. This is going back to 1994 and 1995. ``* * * two years later device company executives report a substantial improvement in FDA's performance, particularly in the 510(k) product approval times. This is the medical device industry document. It continues. In fact, this year's survey conducted last October marks the highest business climate ratings ever in the 5-year history of the survey. The highest degree of approval rating ever in the 5-year history. It is going well, my friends. We do not have a Shiley Heart Valve tragedy today. We don't have a Dalkon Shield tragedy today. It is working in terms of protecting the public. But the industry is demanding changes in providing the protection. Why? This is what the industry is saying about the FDA. ``The impact of FDA's internal reforms and review time is more significant than might appear. The agency has not only reduced the approval delays that slowed newer products but, perhaps more importantly, has greatly reduced uncertainty as to the timeliness of future product introductions.'' I will include the appropriate amount of this. I will not take up the whole record, although it is a fairly short document. It continues along: Respondents' rating of the current business climate for the medical device. Here are the results. A substantial majority of medical device executives said, medical device industry, good or excellent. Then it has executive ratings of device industry business climate, 1993 to 1997: 58 percent good or excellent. Last year it was 58 to 11. Find me an agency of Government where those who are being covered by the regulators are saying 58 percent approval, 11 percent disapproval. An examination of this review shows that it was down just in 1995, 37 to 23--37 percent approval, 23 percent disapproval. Now that disapproval has gone from 23 to 12 to 11 in 1997 and the 37 is up to 58 in 2 years. This is the reflection of those who are involved in medical device businesses. ``Expectation of respondents for business conditions in the medical device and diagnostic industry,'' again, going up, enormously favorable. ``One important cause of this year's improved outlook is the clearly perceived improvement in relations with the FDA. As shown in figure 5''--that will be in the Record--``the decline in complaints about the agency mirrors the increase in positive business outlooks.'' You could not get a greater endorsement. You could not find better support for an agency that is being regulated. You could not see a more dramatic improvement in how that agency has been dealing with those that it is required to police. And all while still protecting the public health, all being done to protect the public health. As the Secretary of HHS and the President of the United States said, of all the different provisions, this is the one that puts the public health at risk. All against a background of a device industry that is saying things have never been better. Several committee members have expressed concerns that the FDA will try to think of every possible off-label use for a device and harass the industry to death. There is no justification for that attitude. It is good rhetoric, but it just defies any kind of understanding about what is happening in the medical device industry today. The medical device manufacturers and personnel find that their relationship with the FDA is improving significantly in terms of how they are being treated, the times that are involved, the way that the agency has been considering various applications like the ones we have been talking about. The public health is being protected, but we are being asked to change it. How many times around here do you hear, ``If it is not broke, why fix it?'' Well, this is the attempt to try to fix something that is not broke. And we are not talking about widgets here. We are talking about real health implications to the American public. Why should we take a chance on people's health when those medical devices are being carefully tailored and designed technologically to do something that is different than is on the label? It just defies me. That is the issue. So, as we go on through this survey report, talking about international markets: ``Just as outlooks on business are influenced by market segments, so, too, they are affected by geographical markets. In fact, large companies have a clear advantage over small ones in entering foreign markets. Of the companies surveyed, 91 percent were selling to the United States, just over half were doing business in Europe and Canada, while 36 to 40 percent were in Latin America. Of the largest companies surveyed within the various''--$50 million in annual revenues, 90 percent or more were involved in the survey and they show here when asked what markets offered them the best prospects in 1997, more respondents, 80 percent, named the United States than any other market. This are the medical device companies from Central and South America talking about what they believe the greatest opportunity for market expansion is in the United States, and they are going to have to meet the strict requirements that are being put out by the FDA. They think, even going through those requirements for safety and ensuring the public is going to be protected, that there is this dramatic opportunity for growth. And it just continues. If we go through the Medical Economics magazine of this year, January, it talks about the enormous explosion of the various devices, talking of the demand for devices to treat arteriosclerosis, enlarged prostates, infertility and many others creates a worldwide market of $120 billion, including about $50 billion in the United States. That's growing by 8 percent annually. Feeding this demand are technologies that offer new ways to treat disease, allow doctors to treat illness more quickly, effectively and safely. The coronary stint, for example, created a submarket that exploded from $220 million globally to more than $1 billion in 1996. Sales of this device are growing 30 to 40 percent. I used that as one of the examples here the other day. This is a $1 billion industry. We are talking about the power of this industry to put pressure on Congress, with this kind of economic power, that pressure is dramatic. To resist that kind of pressure when it is contrary to the protection of the public health I think is enormously important. What we are saying is simple and fundamental. That is, the proposal that is being advanced here will permit the medical device industry to submit various medical devices to the FDA and the FDA will be limited to examining only the uses listed on the label of the medical devices. If it is substantially equivalent to a medical device that's been approved, all the company has to be able to show is that it has the same kind of safety protections that the earlier device had, even though--even though--it is the intention of the medical device manufacturer to use that medical device for an entirely different purpose and market it for an entirely different purpose, the FDA is prohibited from examining the safety features. Maybe those safety features are such that they will significantly improve the health and well-being of the person that is using the medical device, but we ought to make sure at least that the agency has the information that would justify that utilization. All this is happening against a background which demonstrates that the medical device industry is happier with the FDA than at any time in the history of the 20 years, 23 years, of medical device legislation. Happier that there has been a dramatic improvement in approval timeframes, important improvement in terms of safety. We are taking that excellent record and risking it with this particular provision. It does not make sense. This makes absolutely no sense at all. We strongly believe that this provision has to be altered or changed. We have missed the opportunity to do that on this particular legislation, but we will have further opportunities to do so in the near future. It is amazing to me, as we went through consideration and as we were able to make progress on so many other items while advancing public health, but the medical device industry does not want to deal with this one. They felt they had the votes. They had them this afternoon. But this is a long road. It is a long road, the completion of this whole process, and we are going to fight every step of the way. We have seen a variety of different options that would attend the kind of concerns that the medical device industry has put expressed, which we and the FDA and the administration were prepared to deal with, but the device industry is unprepared and unwilling to do so. So if they are unwilling, we are unwilling at least to roll over. There are a variety of different procedures which we will have to resort to in order to make sure that this threat to the public health of the American people does not go forward over the objections of those who are in the best position and do represent the patients and the consumers. By accepting this change in the protections available to the American public at this time, we are not saying that the health of the American people is going to be advanced. If this particular provision remains unchanged, a provision which effectively handcuffs the FDA, it is the bottom line of the medical device companies that will be enhanced. And ethical companies and the protection of the American people will suffer. That makes absolutely no sense. It is basically and fundamentally wrong, and we will continue the battle ahead. appropriations ``trigger''

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I yield such time as the Senator from Rhode Island might use.

Mr. KENNEDY

Mr. KENNEDY. I have no objection.