Daniel Coats

Mr. COATS

Mr. COATS. Mr. President, I want to, first of all, inform my colleagues that I have no intention of using the 29 minutes. I do, also, though, want to say that I had promised the Senator from Kansas he would be first up. He has commitments. I have commitments. He was in line, and the clock precluded him from getting his statement in. I would be willing to forgo all but about 1 minute of my remarks if we could go forward with this, and we will get to the other Senators as quickly as possible. A lot of people have been waiting all afternoon to speak, but they were not allowed to speak because of the unanimous consent agreement. We had promised them, if they were here right after the votes, they would be first up. Mr. BUMPERS addressed the Chair.

Mr. COATS. Mr. President, parliamentary inquiry. What is the regular order?

Mr. COATS. Mr. President, it was my understanding that we would immediately return, after these votes, under the previous unanimous- consent request, to consideration of the pending amendment and that there was a little bit of time remaining. I only say that, not because I want to use the time--I know Members want to speak on a number of subjects--but because Senator Brownback had been on the list to speak. He was precluded by the clock when we shifted over under the order. I am just inquiring as to whether or not that is the case.

Mr. COATS. Mr. President, I thank the Chair. I again inform my colleagues that we will be brief. I am just trying to fill some commitments we made earlier. I will dispense with my ringing, articulate, persuasive rebuttals to the opponents of this amendment that I have ready to go here, to Senator Boxer and Senator Kennedy and others who spoke against the amendment, and save those until Tuesday. Even though I have the attention of my colleagues who are in the Chamber that I might not have on Tuesday, I will have to trust that yielding the time is probably more persuasive in getting support for my amendment than giving those arguments at this particular point. So, I will defer that. However, I have made a commitment to the Senator from Kansas. I think he is going to be relatively brief. I yield to him such time as he may consume. Then, if no one else wants to speak on this particular amendment, I will be happy to yield back.

Mr. COATS

Mr. COATS. Mr. President, I thank the Senator from Vermont. I have been listening carefully to the words of the Senator from Massachusetts. I have clearly come to the conclusion the only remaining problem with the entire 215-page bill is section 404. We have had considerable debate about that yesterday and today. The Senator said this is the last remaining piece. The Senator correctly pointed out, of the 20 items that he was interested in, 19 have been resolved. That is an awfully good batting average, 19 out of 20. Yet the Senator says the bill cannot go forward until the last one is resolved. We had a debate on this. The Senator passionately presented his case, but it was not persuasive. Mr. President, 65 Members of the Senate did not agree with the Senator from Massachusetts. We had the vote. That issue has been dispensed with. I know the Senator is upset that his view did not prevail, but it did not prevail, despite lengthy and passionate argument to the contrary. But, putting that aside, I hope we can take the Senator at his word, that this is the only part of the bill that remains of concern to him. I have word the FDA lobbyists are currently trying to work the House to undo the negotiations, some of the negotiations on some of those 19 items. I trust the Senator, having acknowledged that those have been negotiated fairly and addressed, would support us in maintaining the language that is in the Senate bill when this bill goes to conference, and not encourage any kind of modification of that or weakening down of that agreed-upon compromise. I assume that means section 406 is satisfactory and there is nothing more we need to do with it, based on the Senator's remarks. I am pleased we can go forward on that basis. I also heard the Senator say that basically everything is fine at FDA, that this revolution that has taken place under Dr. Kessler solved the problem, admitting there were problems before but we really don't need to do anything more. To quote him, he said, ``If it ain't broke, don't fix it.'' FDA is improving as we speak. Everything is going fine at FDA. The reason why we are here is that everything is not going fine at FDA. It has not for 20 years. We have been attempting to reform the process at FDA for the past 20 years and there are some reasons for that. It is not fine because there clearly have been delays that have resulted in impaired health and safety of Americans. You know, there are two edges to this sword. There are two sides to this issue. One side is making sure that we have a Food and Drug Administration that follows careful procedures before approving drugs and devices, because clearly that is in the best interests of the health and safety of Americans. There is no one on this floor, as Senator Dodd said yesterday, who does not want to maintain a vital FDA, with the authority to review drugs and to review devices and to make sure, to the best of their ability, that those drugs and devices promote the health and promote the safety of Americans. They will not always be perfect, as we have learned in this discussion. They make mistakes. Sometimes politicians lean on them to approve things that should not be approved and they approve them only to find out later that they should not have approved them. Maybe they should not be subject to that political pressure. They should not. None of us, whether we are for or against a particular drug or device, should be involved in the scientific process of approving or not approving a drug. But we can involve ourselves in requiring that the FDA do what is necessary to avoid the bureaucratic delays, avoid the inefficiencies, and make itself a more efficient administration. I will talk about that in just a moment. But let me talk about the other side of this issue. Let me talk about the patients and the consumers, the Americans whose health and safety and whose lives have been jeopardized or lost because of inefficient FDA bureaucratic delays. We talk about those who have been impacted by drugs that have been approved, in some people's view, too quickly. What about those whose health and safety has been impaired and who have died because the drugs have not been approved quickly enough? A very prestigious institution, the Hudson Institution, has done a seminal study on that issue and put out a report in November of 1995 titled, ``The Human Cost of Regulation. The Case of Medical Devices and the FDA.'' I hope my colleagues will read this to understand the other side of the issue, the rest of the story. I will just quote briefly from it. When policymakers weigh the costs and benefits of our current policies governing the production of new medical technologies, persons who die from the absence of a device that should have been available should count as much as the victims of a defective device. We have heard a lot here about victims of defective devices, but we have not heard very much about victims of devices that have been unnecessarily delayed that could have saved patients' lives, that could have improved their safety.

Mr. COATS. Let me yield the floor, because I do not think I will speak again, but not before commending the chairman of the committee, who has persisted with the patience here that is remarkable. He has persisted because he believes that this is an important thing to move forward on, that this issue is important to the health and safety and lives of Americans. I appreciate his effort and work and his cooperation and his standing tall with us even though it has not been easy. So I thank the chairman, The Senator from Vermont, and, in view of that, yield the floor. Mr. JEFFORDS addressed the Chair.

Mr. COATS. I will be happy to yield to the Senator for a question.

Mr. COATS. November 1995. I will quote further: Although these improvements are certainly laudable, they are not worth the human costs of the FDA's approval system. Rather than protecting public safety, in some cases the FDA's system for approving medical devices actually endangers lives. Let me cite some examples: Coronary stents. Coronary stents are simply a wire mesh tube that holds the artery open to facilitate the flow of blood to the heart muscle. During angioplasty, which nearly 400,000 Americans a year undergo, before the coronary stent was developed 15 percent of patients undergoing that operation had a blood vessel collapse and had to go into emergency bypass surgery, which placed them at greater risk, and a lot of lives were lost. The coronary stent, however, became an alternative method of treatment for most of these patients and reduced dramatically the amount of collapsed blood vessels and dramatically the lives that were lost. You would think that, given the importance of this technological breakthrough, the FDA would have given expeditious handling to the application for approval of the stent. Sadly, for thousands of Americans who died when they could have benefited from this stent, this was not the case. It took 9 months for the device's developers to obtain permission from the FDA to even begin preliminary phase I clinical trials. These trials took another year. Then the manufacturer conducted phase II trials for 9 months, and based on those results requested immediate permission to begin the final phase III trials. The FDA rejected this request. The manufacturer appealed and then again requested permission to begin phase III trials. Three more months and the FDA came back and said no, you can't start. In the meantime, the manufacturer had repeated a whole series of phase II trials again. Finally, 7 months later, the manufacturer completed the first segment of phase III after the FDA finally granted permission, and on and on it went for another 15 months. Four months later the FDA's advisory panel of medical experts said OK, we will issue the order granting approval--excuse me. They recommended the order to grant approval. It then took the FDA 12 months to comply with their medical experts' request to order the approval of the stent. The Hudson Institute estimated the number of lives lost, and it is an estimate. But, based on a very thorough study, and it is all documented here in this report, they estimated that the lag time attributable to the FDA cost Americans 2,888 lives. That is the other side of the story. We hear about mistakes, and, yes, mistakes are made. We are all humans after all. We hear about mistakes, and the Senator from Massachusetts has detailed and had his charts up about individual patients who have been injured, or had their health jeopardized through FDA approval of a product and then the fact that product was not everything that it was billed to be. But we have not heard anything said about the 2,888 patients who died because of FDA bureaucracy and inefficiency in approving a lifesaving medical device. Let's assume that only 25 percent of that delay was due to FDA. We are still talking about 1,570 lives. That is the other side of the story. I could go on and on. The omnicarbon heart valve, the left ventricular assist device, the heart transplant procedures, all of these, just dealing with the heart--delays because of FDA inefficiency. That is why the committee has been so insistent on moving forward with reform. That is why the committee has said, no, everything is not fine at FDA. Yes, we appreciate the fact that they are doing a little bit better since they taxed the pharmaceutical industry to provide the funds to hire the researchers to expedite the approval of drugs. But they have not done better with devices. The statements that the Senator has made were wrong. We have not had improvement in the way that devices are handled. High-risk and novel device review times in 1995 increased from 348 days to 773 days; if you count the days in FDA hands, 247 to 606. That is on average. I could go over example after example. In fact, in the budget this year, in responding to that, FDA said we are actually going to slow down, we are actually going to have to slow down review times with respect to device submissions. The agency itself predicted that they would complete 6 percent fewer reviews but review them 20 percent slower. Part of that is our fault. We are not giving them the resources that they need to speed up the process. But there is another part of this story that we have not heard from the Senator from Massachusetts. That is the testimony of the then- Commissioner of FDA, Dr. David Kessler. The Senator this morning said that under the revolution that is taking place under the leadership of Dr. Kessler, everything now is just hunky-dory. Well, we had Dr. Kessler before our committee. Dr. Kessler did not say everything was hunky-dory. Dr. Kessler did not say everything was fine. In fact, Dr. Kessler pretty much threw up his hands and said, ``I can't control the agency. I can't administer this agency.'' In an astounding statement to Members of Congress, he said, ``It's only under pressure from the Congress that we have been able to expedite and move things here.'' He said, ``I'm at a loss to do this, but you keep the pressure on.'' Well, if we listen to the Senator from Massachusetts, we would take the pressure off. Then they probably would revert to the same old ways. It is a bureaucracy that has not been administered well under the previous Commissioner. Let us hope the current acting Commissioner or the new Commissioner can do a lot better job than the previous Commissioner. The previous Commissioner seemed more intent on pursuing a political agenda than he did in approving drugs and approving devices that save the lives and improve the health of Americans. To respond to a question from a Member of Congress, to make the statement that, ``The only way we can improve is if you put pressure on us,'' probably explains the sudden rash of approvals that have come out of FDA. Why? Because we have a reform bill in the process. They have gotten the message. They have gotten the message that Congress will no longer tolerate this delay. They heard it not just from Republicans, not just from people who so- called represent the device industry or the pharmaceutical industry or the business side, they have heard it from Republicans and Democrats, liberals and conservatives, people on both sides of the aisle. How did we possibly get out of that Committee on Labor and Human Resources, probably as divided philosophically as any committee in the U.S. Senate, how did we possibly get 14 out of 18 votes? We got it because liberals, Democrats, Republicans, conservatives, all came to the same conclusion. The conclusion was: FDA needs reform, and it needs it now. We have delayed several weeks here, and even months here, simply trying to get this thing through the Congress. We have had two filibusters. We have had untold procedural tricks and gimmicks, all perfectly within the rules but designed to delay the process. We have had one objection after another. It was not that long ago when the Senator from Massachusetts was down on the floor saying, ``If we can just fix this cosmetic''--he had his pictures up with problems with the cosmetic and food industry. ``That doesn't go to the heart of the problem; the FDA's drugs and devices, that part is fine. That part is settled. We just have to fix the cosmetic part.'' And so we said, ``OK. We'll fix it.'' And Senator Gregg negotiated a compromise with the Senator from Massachusetts and the Senators from California, and others, and we eliminated that concern. All of a sudden, when we were told that that is all we needed to do to move this forward, all of a sudden a new issue comes popping up, not one that was offered by amendment in the committee. If it was the primary, the No. 1 priority of the President and the Secretary of Health and Human Services, you would have thought the Senator from Massachusetts or someone would have offered an amendment in committee. But no, it was then the next thing to delay the bill, the next cause celeb, the next throw down the gauntlet, the next draw down the line in the sand, the next ``we can't move forward,'' the next ``this bill is totally worthless without a fix here.'' Fix 19 out of 20. Actually it was 34. The Senator miscounted. Since markup--14-4--since markup, 30 sections of this 60-section bill have been altered. And 34 provisions-- as I hold this here in my hand--of negotiations trying to get the Senator to allow us to move forward with this bill. The Wall Street Journal today in an op-ed piece calls this a timid bill. It has been watered down. It has been watered down substantially. A lot of us would have liked to have gone a lot farther than we have been able to go with this bill. We had provisions which would allow outside help for the agency, third-party accreditation. Only over the strenuous objections and resistance of the Senator from Massachusetts were we able to move forward with that. Yet, the FDA had its own pilot program going on that. This is the medical device equivalent of the PDUFA, of the user fee. Let us get some outside help from accredited agencies that FDA certifies, not that Dan Coats selects, not that some device company selects, but that FDA selects. We gave FDA the authority to go out and find scientific laboratories and testing laboratories that met their standards and, under their standards, would be able to assist them in the process of speeding up the review time of devices. Then we built in all kinds of-- all kinds of--FDA authority to select the companies, to make sure that there was no conflict of interest, to oversee the process, to withdraw it at any time, to have a final veto over the approved product. Those are just some of them. I have five pages in this bill here of accredited party participation, restrictions that go to FDA to make sure that process is valid, to make sure it has integrity, to make sure it is not a loophole. Here we are trying to do something that helps FDA, that helps speed the approval of devices that can save lives and improve health. We give FDA all kinds of authority, and we still have to negotiate as if this was going to destroy FDA. Every latest thing we saw, and then something else comes up. ``This is going to destroy FDA.'' FDA retains plenty of authority here, but it gets some help in the reform business and gets a strong message from Congress to ``get your act together, get a Commissioner that knows how to administer as well as how to politic.'' I am more exercised than I usually get on this legislation. We have all tried to be patient as we have worked through this process. But more than one person on this Senate floor can get indignant and upset when people's safety and health and lives are in jeopardy. And there is more than one way that people's safety, health and lives are in jeopardy. Delay of this bill, obfuscation, resistance also jeopardize people's health and safety and lives. To suggest that those of us who do not agree that the Senator's 20th item that he wants compliance with is something that is going to destroy FDA, undermine the entire device section of FDA, put Americans at risk of their health and safety and maybe even their lives, I do not think that is a responsible charge. I think the obvious answer to that is, delay puts just as many, if not more, people at risk. The Hudson study certainly points that out. What does that mean? It does not mean that we should have no FDA reform. It does not mean we should necessarily have the FDA reform I think we should have. But it means we should have FDA reform. It means we ought to move forward without an ill-conceived attempt to destroy the whole bill. I do not think the opposition here has been designed to make this a better bill. I think the opposition--and I think it has been made clear with the Senator's statement this morning that everything is fine at FDA, hunky-dory, it is not broke, it does not need to be fixed, it is improving as we speak, with revolutionary changes under Dr. Kessler. I do not think anybody believes that. Well, maybe two people. We had a vote yesterday 98 to 2. Sixty-five people voted for the so-called provision that the Senator said would absolutely kill the bill. And then 33 more joined with those 65 in voting for the bill, even though the Senator's point did not prevail. So 98 to 2 is a pretty good indication that there is a solid belief here for reform and the solid need for reform. I just hope now we do not have to go through this same tortuous delay process in the House of Representatives where the hard work that has been accomplished here is undermined by those foes of any change in FDA, the status quo people. ``Everything's fine. Let us just keep it as it is. Let's just keep denying Americans the health and safety improvements. Let's keep denying them an efficient FDA.'' Anybody who can stand up and defend efficiency and the effectiveness of this Government-run monopoly has not had very much experience with the private sector. All we are trying to do here is--not strip FDA's authority; there is a public function for that. We are trying to give them some help in accomplishing what I think, what 98 of us at least believes needs to be accomplished. I am glad I do not have to vent my spleen any more than I already have on this because we are nearing final disposition of this in the Senate. It goes to the House. We will have a contentious conference. I think those who do not want FDA reform will continue to resist this. As I said yesterday, the clock is ticking. If we want funds to provide for the expedited review of drugs, we have to complete this very shortly. September 30 is the date on which it runs out. We are not going to go forward with PDUFA funds, appropriations or reauthorization unless it includes the reforms that are in this bill. I think that has been made clear. And I think 98 people made that clear yesterday. I will tell you what. I am reluctant to put this whole Hudson study in. It is several pages. It would be at considerable cost to the taxpayers. I ask unanimous consent that excerpts, some portions, of the Hudson briefing paper be printed in the Record so it is not so voluminous. But it is available in my office for anybody to review it.

Mr. COATS

Mr. COATS. I move to lay that motion on the table. The motion to lay on the table was agreed to.

Mr. COATS

Mr. COATS. Mr. President, I send an amendment to the desk and ask for its immediate consideration.

Mr. COATS. Mr. President, I ask unanimous consent reading of the amendment be dispensed with.

Mr. COATS. Mr. President, I know the Senator from Oregon is waiting to bring forward an amendment and I will not take but just a few minutes. We have sent the amendment to the desk as the pending business. It will be debated tomorrow. Senator Lieberman and I are joining as cosponsors in offering this amendment. I have a number of Senators, I think on both sides of the aisle, that wish to speak to it. There will be ample time for them to speak tomorrow on the amendments. They do not need to be concerned about rushing over here now. We did, however, want to have the amendment introduced so it is the pending business when we begin tomorrow. In brief summary, the amendment provides opportunity scholarships for children in the District of Columbia in grades K through 12 whose family income is 185 percent or below the poverty level. The scholarships can be used for tuition costs of public or private scholarships in the District of Columbia, and adjacent counties in Virginia and Maryland. Scholarships are available for tutoring of students who attend public schools in the District. The legislation creates a District of Columbia Scholarship Commission, a seven-member private, nonprofit corporation, to administer the scholarship program and certify institutions that will be eligible to participate in the scholarship program. One board member will be appointed by the mayor of Washington, DC, and the remaining six are to be appointed by the President, three from the list of nominees provided by the Speaker of the House of Representatives and three by a list of nominees provided by the majority leader of the Senate, both in consultation with the minority. Members must be residents of the District of Columbia and may not be Federal Government employees. Students whose family incomes are below the poverty line may receive a scholarship of up to $3,200. Students whose family incomes are above the poverty line but below 185 percent of that level may receive the lesser of 75 percent of the cost of tuition, and mandatory fees for and transportation to attend an eligible institution, or $2,400. Students receiving tutoring assistance are eligible for up to $500. Both of these figures are indexed for inflation. If there are not sufficient funds available for all of the eligible applicants, scholarships are to be awarded on a random basis by a lottery selection. The lottery is required to the extent practical to award an equal number of tuition scholarships and scholarships for fees. In other words, there will be no skimming of the green, there will be no biasing of the selection. If there are more scholarships than students, then, of course, every student would receive a scholarship that requested one. It is on a voluntary basis. If there are more students than scholarships, they will be awarded on a random basis. The amendment authorizes $7 million for spending in fiscal 1998 out of the Federal contribution earmarked to repay the cumulative Federal fund deficit for the District of Columbia. This total is $30 million. This $7 million earmark would leave $23 million remaining for that specific purpose of deficit fund reduction. I point out that that is above the amount recommended by the administration. The administration requested a total Federal contribution for the District of Columbia of $160 million, and the bill before us, the D.C. Appropriations bill, contains $190 million. In summary, then, we are not taking a dollar or a penny away from the D.C. public schools. We are not taking any money away from the current operating requirements of the District of Columbia that we are funding. In fact, we are adding $30 million for the purpose of reducing the general fund deficit. Of that additional $30 million, we are earmarking $7 million for these opportunity scholarships. In the interest of time, I will not continue here. I will have much more to say about this tomorrow. I am looking forward to offering this amendment, together with my counterpart, Senator Lieberman. This is a bipartisan effort. We are hopeful that we can begin the process of providing alternatives to students and their parents, who do not feel they are getting an adequate education. Our goal is not to undermine the school system of the District of Columbia; it is to improve it. Our goal is to move from the status quo, which is failing many, many students. We think this is an opportunity to do that. We look forward to debating this issue. I yield the floor. Mr. WYDEN addressed the Chair.

Mr. COATS

Mr. COATS. I thank the Senator for yielding. I want to commend the Senator from Connecticut, Senator Dodd, for his statement. Much of what I was going to say he has articulated probably better than I could articulate, in terms of the purpose of the 510(k) approval process, the nature of the tests that are involved in approving the devices that are substantially equivalent, and the technicalities that are involved in this that I know not a lot of Members have had the opportunity to focus on or really even the necessity of focusing on. The point the Senator makes about the fact that the work of the committee over 2\1/2\ years has been careful and thoroughly undertaken in a way that is designed to provide the very best of protection for the consumer, the very best of safety and effectiveness so that the drugs and devices that are approved by FDA are devices and drugs that we can have confidence in. No one on the committee is attempting to undermine the essential function and the essential purpose of the Food and Drug Administration. We want a dynamic, vibrant, effective agency in this country that tests the safety and effectiveness of devices and drugs before they are brought to the market. Now, no process is ever going to be perfect. There will be mistakes. But we want to ensure that this agency has the very best of what it needs to accomplish that essential purpose. What we don't want, and what we are attempting to do with this reform bill is to have a situation continue where the approval process cannot even begin to meet the requirements that the agency thinks are appropriate and that we have dictated by law, by statute. Numerous examples have been cited here on the floor, whether it is for drugs, or devices, or even other products that the FDA reviews, of unconscionable delays, of unnecessary delays, of letters being lost, of material that has been misplaced, of the inability of FDA to have the personnel, the manpower, the computer power, the administrative procedures in place that provides for effective, efficient approval. It is all of this that has led to a number of suggested reforms of FDA. And one, which has been working very successfully is the PDUFA, Prescription Drug User Fee Act, where the drug companies themselves put money into a fund that allows the FDA to hire individuals and to purchase equipment and speed up the approval of life-saving and health-improving drugs to the market. That has worked. We want that to continue. We are up against a deadline on that. Funding for that runs out on September 30, the end of the fiscal year. We have been pressing hard now for several months--in fact, all year--to try to move this process forward so we don't run up against this deadline. Yet, we have encountered delay after delay after delay because of disputes about very small portions of a 200-plus page bill, carefully undertaken by the committee over a 2\1/2\ year period. This is not a partisan issue, as Members who have been engaged in this understand. The Senator from Connecticut; the Senator from Minnesota, Senator Wellstone; the Senator from Iowa, Senator Harkin; the Senator from Maryland, Senator Mikulski, have joined with the majority, Senator Jeffords and others on the committee, to produce a very, very substantial majority in support of the original bill, a 14 to 4 margin. Since then, some of the concerns of those four have been addressed in ways that the vote margin and support for the bill has even increased. There were 30-some concessions, which I held up a list of on the floor last week--more than 30 such negotiations and concessions with those who had continuing concerns about the bill. So it is not a matter of saying: we won, 14 to 4, and this is the bill, take it or leave it. We are open to producing the very best bill that we can, and we think we have. We have been open to negotiation. But every time we have met an objection, something new pops up. It is ironic that in the committee the amendment we have been talking about here, the amendment that Senator Kennedy has been debating at length, the reason for the filibuster that has gone on, is over language that wasn't even brought up in committee. If this was such an important, egregious omission on the part of the committee, how come an amendment wasn't offered in the committee to debate it or to discuss it or to change it? The language that we are talking about here was proposed by Senator Wellstone--hardly someone who is viewed as being anticonsumer or someone viewed as trying to open a loophole so that the health and safety of Americans is jeopardized. In the negotiations and discussions, postcommittee markup, this wasn't on the list. I have in my hand the memo from the Labor Committee, from David Nexon, suggesting items that need to be covered and need to be discussed. This isn't even on the list. We went over these amendments. All of a sudden, when at one point, the only thing left, to our knowledge, was a resolution of the cosmetic portion of the bill, which was resolved, all of a sudden this then pops up. So you have to question what is going on here. We have a bipartisan coalition, people from liberal, conservative, and in-between perspectives, politically--Democrats, Republicans, people who worked on the committee, delved into the issues and worked to ensure that we have the very best bill possible. Yet, we meet delay after delay after delay and obstruction after obstruction after obstruction. So I think it is important not just to look at the specifics of the amendment, but to ask the question: What else is going on? What is the true intent here? Is it to undo FDA reform? Is it to block any reform? Here we are up against this deadline for PDUFA, and I think it is important that Members keep all that in mind. I was going to go through the technicalities of the 510(k) process, but Senator Dodd did a marvelous job explaining it. As he said, it's the lower risk devices. We are attempting to find a way in which we can efficiently expedite the approval of devices that are designed for the same purpose, which, in the FDA language, are substantially equivalent, and give those devices the opportunity to come to market without having to go through the same lengthy, costly approval process that the original device--the device called the predicate device--is subject to. Sometimes that takes months; often it takes years for that original device to accomplish a specific purpose to be approved. Once that is approved, there are others that can market and make devices that are roughly equivalent--not roughly, substantially equivalent to that. If the FDA determines that it is substantially equivalent under their review procedures, then that device can be approved. As Senator Dodd has said, however, that is only one part of the test. The other part of the test is that if there is a technological difference that raises safety and effectiveness concerns, FDA can say, ``not substantially equivalent.'' You have to go through the process. FDA retains that authority. Nothing in this bill changes that authority. Nothing in this bill alters one iota of that authority. Every example raised by the Senator from Massachusetts ignored totally and failed to acknowledge that the second part of the test gives FDA the authority that they said FDA doesn't have. So that's what is at issue here. It is an issue that doesn't have to be here. It is an issue that we don't need to be talking about. No one raised it in committee. No one raised it in negotiations postcommittee. No one indicated that this was a bill stopper. The last indication of a bill stopper was the cosmetic concern, which was negotiated and an acceptable compromise was reached. Then, all of a sudden, this provision, 404(b), the language offered by the Senator from Minnesota, Senator Wellstone, and accepted by the committee as part of the bill, without objection, all of a sudden this now becomes the bill stopper, the killer language, the language that is going to destroy the FDA and place 260 million Americans in jeopardy of their life and their health. I think Senator Dodd very effectively outlined why the examples used were not relevant examples. They are tragic examples. We all regret that they happened. But they have nothing to do with the language that we are talking about. They have nothing to do with the amendment offered by the Senator from Rhode Island. And so let's keep that in mind as we move forward here in this torturous process of getting a bill passed through the Senate that has been substantially delayed because of procedural practices, which enjoy no support from this body. We have had two votes. I think the opponents of the legislation got five votes on the first try and four votes on the second try. The other 95 of us, or 96, depending on how you count it, are still here attempting to move forward. Now, we have the good fortune of having Dr. Frist--Dr./Senator Frist--on our committee. For those of us who don't have the medical training and expertise to fully understand all of this, we frequently-- in fact, every opportunity we have on medical questions--turn to Dr. Frist for the expert's view. I think it is a phenomenal addition to the Senate that we have this capability available to us. He will be commenting on this and, frankly, I put a great deal of reliance on his judgment. Some of us could be reading this the wrong way, could be not understanding certain aspects of the process. We represent companies that make these devices. We hear their side of the story and it certainly sounds reasonable, and we try to make sure there is a proper balance between the need to bring products to market quickly and a need to make sure they are safe and effective. So we turn to people like Dr. Frist to give us the expert view in terms of what we are doing. I know I have used my time here. I will have more to say about that, as I think we have considerable time left under the cloture procedures here. At this point, I yield the floor.

Mr. COATS. Apparently they convinced your staff, Dr. Nexon, that this was a safe procedure and it should not be withdrawn.

Mr. COATS. I ask unanimous consent the letter be printed in the Record.

Mr. COATS. Will my colleague yield?

Mr. COATS. Will the Senator yield?

Mr. COATS. If the Senator will yield----

Mr. COATS. Just briefly. Senator Dodd asked the question, if this is such an egregious violation of FDA policy, why hasn't FDA acted on it? Why has it not acted?

Mr. COATS. I have a copy of a letter. The Senator was handed a letter. I was handed a letter. The letter was addressed to Senator Kennedy thanking him personally for the assistance that he provided, for the ``assistance provided by your staff'' to U.S. Surgical ``in our efforts to deal with the Food and Drug Administration on the matter of the certification of the Advanced Breast Biopsy Instrumentation.'' That is what we are talking about.

Mr. COATS. It says here the Senator assisted in making sure the FDA did not withdraw it. It specifically cites, ``Please convey my gratitude to Dr. David Nexon and Gerry Kavanaugh,'' who I believe are on the Senator's staff, ``for their willing assistance.'' Maybe they are on the market because the Senator intervened to keep it on the market.

Mr. COATS. Happy to yield for a question.

Mr. COATS. Mr. President, again I want to tell Members I think it is important to keep their eye on the goal here and on the facts. Senator Dodd went through part of the chronology of the approval of the device that Senator Kennedy was talking about. I say to my colleagues, the system is working the way it is supposed to work. FDA has the authority. The company submitted the application, FDA cleared the device, then questions came up about it, and the FDA responded and asked for some additional material, and then they acknowledge that, yes, we had the material, you sent it to us, but we didn't get a chance to review it. We have now reviewed it.

Mr. COATS. I will be happy to in a moment. They made a change in the ``indication'' and ``contraindication'' in accordance with what FDA asked them to do. They resubmitted for a new 510(k). FDA, with the help, apparently of Senator Kennedy and his staff, approved the 510(k) and then the new 510(k) was applicable. So that is exactly how FDA is supposed to work and it did work under the existing procedures. Again, over and over and over, what has not been described and discussed is the authority that the FDA has regarding changes in technology that raised questions of safety and efficacy, effectiveness of the predicate device.

Mr. COATS

Mr. COATS. Mr. President, I am going to repeat points that have already been made, because I think it is essential to the understanding of what we are about here just before we are ready to vote. Section 404, the section under debate, preserves a very key premarket statutory authority to the agency. It is important for Members to understand that the agency can call, still call for a premarket action requiring full data on the safety and effectiveness whenever there is a technological difference arising, and I quote from the statute, ``that raises different questions of safety and effectiveness in the earlier approved device.'' This authority is premarket. In other words, the product is never cleared for marketing. It is never distributed before the agency has an opportunity to act. The authority is extremely broad. As soon as a product raises a question about safety and effectiveness, the agency can require the filing of a premarket authority, PMA. The agency retains full discretion to control the showing of safety and effectiveness. There are no words of limitation on that statutory authority. I point out that that authority has never been challenged successfully by a company in court. It was Senator Kennedy's own committee, as chairman of the committee, his own committee report on safe medical devices in the 1990 Device Act that confirmed the breadth of this authority, and I quote from that report. However, notwithstanding data that may demonstrate comparable performance, the agency will not find the device substantially equivalent to a predicate device where the newer device raises different safety and effectiveness considerations than the predicate device. Under these circumstances, a finding of not substantially equivalent is made, necessitating a class 3 designation and the requirement of an approved PMA before the new device is marketed. This is the language that was--