Daniel Coats

Mr. COATS

Mr. COATS. I would be happy to.

Mr. COATS. Mr. President, I thank the chairman and I thank the ranking members who are ahead of me for allowing me this time. I have a schedule conflict and I appreciate the opportunity to say a few words. I will have more to say as we move forward with this legislation. I wanted to make some opening remarks. I am very pleased that we are actually here at this time with the legislation on the floor. It has been a long and arduous road that we have traveled over this past 2\1/ 2\ years to address the need for FDA reform. We have, as the chairman and Senator Kennedy said, had numerous hearings. We have listened to the Commissioner of the FDA and his representatives and employees and colleagues. We have listened to outside experts. We have heard from the various industry groups. But the real reason that we are here is not just the fact that a few Senators got an idea that perhaps we ought to address some issues at FDA. The real reason we are here is that all of us have been besieged by consumers, by patients, by, yes, manufacturers of drugs and devices and others who have outlined to us the nightmare that exists at FDA in terms of approving products for beneficial use by patients. What I will primarily do this morning is briefly state the ``why'' of the need for FDA reform and save my remarks on what we have done--which I am sure will be outlined by many others--save my remarks on what we have done for debate on Monday, Tuesday, or following that, depending on how long this discussion goes on. First of all, let me state that the precipitating reason for moving forward was the need to reauthorize PDUFA. That is the user fee that is paid for by the drug prescription industry to allow FDA to hire additional personnel and to employ additional technology to speed up the approval of drugs. I am not sure who bears the responsibility for lack of personnel or lack of updating technology. I have worked with Senator Mikulski on a more comprehensive modernization of FDA, consolidating their campus, giving them the new technology that they need, and giving them the personnel that they need. Because SBA was in such desperate shape in terms of its ability to use drugs we enacted sometime ago a user fee whereby the industry itself would be taxed with the money designated specifically to hire the personnel and improve the process and procedures for approval of prescription drugs. That is what finally moved us from debate and delay to the NIOSH action. I am particularly pleased that Senator Jeffords, the chairman, responded to my concerns that if we move only with a limited PDUFA reauthorization we will have addressed only a small part of the problem that exists at FDA, that what we needed was a comprehensive bill, broad in scope, that would allow us to address a number of problems that exist at FDA, including substantive reform for medical devices and other products regulated by the agency. I commend the chairman for agreeing to do that. We held extensive hearings and broadened the scope of the bill. The bill we have put forward is one that does address a number of issues and that is why it receives such widespread support from the Congress. Clearly, the vote in committee, a strong bipartisan vote for moving this process forward in support of the comprehensive bill and the vote that was just taken this morning--overwhelming, almost historic in proportion--vote on cloture I think indicates the depth and the breadth not only of the bill but of the support for the bill with Democrats, Republicans, liberals, conservatives, moderates, everybody in between. Only a handful, literally a handful of Senators voted against cloture. So I think that shows the need for moving forward on this bill. FDA bureaucracy and delay, inconsistent rules, lack of willingness to use outside expertise--all of this has jeopardized the health of American patients. FDA opponents of reform like to state, ``Oh, we cannot jeopardize the health and safety of Americans,'' and yet in their insistence on maintaining virtually status quo in total FDA control on their assistance on that, they have denied Americans lifesaving and health-improving benefits both through prescription drugs and devices and other forms of medical assistance. They have denied people the opportunity to beneficially affect their health and have forced them to go outside the United States, forced manufacturing companies to go outside the United States, forced drug device companies to go outside the United States in order to market their product whereby they would be subject to the rules and regulations of foreign countries rather than this country. To imply that only the United States FDA has the wisdom to be able to determine what is in the best interests of the health and safety of its citizens is, I think, a slap in the face to countries like Germany, Britain, France, and others who have similar approval processes that benefit the citizens of their own country. FDA average review time, just taking medical devices, average review time for low- to moderate-risk medical devices, the so-called 510(k)'s in 1995 increased over the previous 6 years by over 200 percent, from 82 days to 178 days, for total review days from 66 days to 137 days for time actually in the FDA's hands. The law says they need to do this in 90 days--the law. We passed the law, a statute here that says that the FDA on low- and moderate-medical devices you have 90 days. The FDA said, OK, 90 days. In that period of time since we passed the law it has doubled in terms of the amount of time they take to review those. Those are average review times. Specific examples show how ridiculous and how scandalous the process is or has been at FDA. Fortunately, we are in the process of looking for a new Commissioner, and hopefully that Commissioner will bring some business sense instead of simply an ideological bent to the agency and provide for some expediting of some of the devices that do not pose serious health risk to Americans at all. We all hear about this whole idea that FDA is standing at the bridge, keeping Americans from being subjected to the most egregious of violations, drugs and devices perpetrated by a greedy industry that is concerned only about the bottom line. I have a device manufacturer in my State that makes hospital beds. That device manufacturer, which is well respected on a national basis, that device manufacturer designed a new bed cover. This is the cover you put over a mattress, on a bed. The bed had been approved, the mattress has been approved, the old device cover has been approved. It is a piece of cloth. But they designed a new one that prevents bodily fluids from leaking into the mattress. Obviously, that could be a potential health risk to not only that patient but perhaps a subsequent patient. So they had come up with a new mattress pad which achieved significant improvement in promoting the health of patients who would use that mattress. Of course they had to submit it to FDA for approval. This is a class I device, the lowest risk to the patient. So they submitted it to FDA, and the FDA took 476 days to review that mattress pad before it would grant approval. So we talk about the average review times and protection of the party but when you bring it down to specific examples of the ineptness and the bureaucracy that exists at FDA, there are examples on both sides. The other side likes to use relatively rare anecdotes and of course many of these go back 20, 30, and 40 years, and no one--no one in support of FDA reform--is stating we ought to compromise on health and safety. What we are trying to do is say we think we can expedite and utilize new technology that improves health and safety if FDA could get its act together. Now, if you takes 476 days to approve a mattress pad which clearly is in the benefit of the health and safety of hospital patients because it prevents bodily fluids from seeping through the currents mattress pad, then if it takes 476 days to do that, something is wrong at FDA. Meanwhile, new 510(k) notifications have dropped dramatically, from 7,000 annually in 1989 to a projected 4,800 in 1998. So high-risk, if you look at that, and novel device review times increased from 348 days to 773 days, on average. Many are far longer than that. Some have been languishing in the system for 4 and 5 years. Now, the statute says that FDA has 90 days on low to moderate risk, 180 days on high risk, and yet, FDA's average review time in 1995 is 773 days on high-risk and novel devices. So, clearly, something needs to be done. What the committee has tried to do is simply say, let's take an agency that we need, an agency that is important to the health and the safety of Americans and let's see if we can improve it, let's see if we can reform it. The best step and the first step was the resignation of the Commissioner, who admitted to the committee in what was one of the most astounding statements I have ever heard any agency head ever deliver, which was basically saying, ``I am incapable of doing this. You in Congress are going to have to force me to do it. I need the pressure from Congress to do it.'' Can you imagine a CEO of a corporation coming before the board of directors and saying, ``I am not capable of running this company efficiently like you want me to, but if you will put pressure on me and force me to do it, then I can go to my vice presidents and say the board is insisting that I do this''? Is that an example of the weakest form of management and oversight that you can possibly imagine? I could not conceive that the then Administrator, Dr. Kessler, of the FDA would make such a statement. ``I am incapable of doing it, but you force me to do it and then maybe I can convince the people that work for me that we ought to do something.'' Well, let me talk about another example of intolerable delays. This isn't a mattress pad. This goes to life and death. The product was a stent, a small, mesh, spring-like device used to keep coronary arteries from closing. A new stent product that was developed by a manufacturer was submitted to the FDA in November 1986. In August 1987, FDA said, ``We need more paperwork.'' It took them that long to figure out they needed more paperwork. In April 1988 and in August 1989 and in June 1991 were additional requests for more paperwork. An FDA panel meeting was held in May 1992, and they gave unanimous approval to the product. Four years after it was first submitted, an FDA panel gave unanimous approval to the product. It then took the agency an additional year to issue a letter allowing the device to go to market. Now, have you ever heard of such bureaucratic ineptness? After 4 years of reviewing paperwork on a life-saving device, on which the statute said the FDA had 180 days--after 4 years, the FDA panel met and gave unanimous approval. From that time, it took 1 year for the FDA to issue the letter saying, ``Congratulations, you have been approved.'' Now, critics of reform talk about the potential threat to American health and safety for approval of devices. But they never talk about the demonstrated not only threat but consequence to the safety and health and even life of Americans for ineptness and delay in the approval of drugs. How many people died or suffered serious incapacity because a life-saving stent on which we could not get a letter of approval from FDA, which approved it, until 1 year later? How many people, over a 5-year period of time, lost their lives because a life-saving device didn't receive FDA approval for 5 years? Let's say it took 4 years; let's grant them that it took 4 years of reviewing paperwork to make sure that this life-saving stent device was worthy of FDA approval. There is no excuse. What possible excuse could there be for a delay of 1 year in submitting the letter so the company could go ahead and market the product? Dr. Frist, who is a member of our panel, said, ``I would have loved to have had that stent. I known what that stent does. I've used that stent. Had I known that stent was available before approval * * *''--to think that it was languishing in FDA 1 year after FDA approved it unanimously--it took them a year to get the letter out so that they could market the device. So there are people lying in their graves. This Senator is tired of hearing about FDA being the guardian of the health of Americans and we should not move forward with any kind of reform at all. When you touch the words ``reform of FDA'' and try to move up their approval process or expedite the process at all, why, then you are jeopardizing the health and safety of Americans. The burden of that lies on the shoulders of those who won't move forward with responsible reform. Fortunately, today, this Senate, in an overwhelming bipartisan vote-- only five people opposed--said it is time to move forward with reform and it is past the time to move forward with reform. We owe apologies to the families of the Americans who have been denied life-saving treatments and devices because people have blocked reform and efforts to move forward. A Hoosier who attended one of our FDA hearings recently had a life- saving vascular graft implanted in his body. Mr. Friar testified before our committee. He was one of the fortunate patients to receive the graft because he needed the product only after it was approved. Other patients who were denied that before FDA got around to approving it, were not so fortunate. I could go on and on with examples, but I won't. I do get exercised over it because it is unfair to characterize those that try to seek meaningful reform as those who somehow don't care about the health and safety of American people. We care so much we want to get something done. We want to get some reform underway. The Hudson Institute, in late 1995, surveyed this question and came up with an estimate. It is difficult to talk about an estimate when we are talking about human life. The Hudson Institute is a respected institution. Let me cite an example from their study. Delay in approving the coronary stent, they say, reached 27 months. The FDA gave access to this product to American patients 27 months after European patients had access to the product. Depending on how one attributes responsibility to the agency, partial or total, the regulatory delay is estimated to have resulted in 1,600 to 2,900 lives lost, patients whose lives were lost because of bureaucratic excess. So we stand on this floor and talk about it being irresponsible to move forward with FDA reform and we delay FDA reform. We won't even allow a disputed issue to come to a debate on FDA reform, when we are talking about a potential loss of lives of Americans who are denied products because of FDA ineptness. That is the human side of the question. I am not even going to get into the business side of the question because the two don't even begin to compare. We have lost manufacturing and jobs to overseas facilities in record numbers because manufacturers are throwing up their hands and saying they will go broke waiting for FDA to approve their products. It means a significant number of jobs. Sixty-one percent of U.S. device companies plan to market offshore first. We lead the world in drug and device product development. But they are being pushed out of the country by the FDA. They are being aggressively lured by foreign governments who know that our bureaucratically bloated system provides them the competitive advantage they need to draw those American companies and employees and the brain power away from the United States. A Netherlands foreign investment company has a publication out highlighting the oppressive climate in the United States. They say, ``Come over here and we will provide a much more favorable climate.'' Now, we will hear in rebuttal about some product that was approved and later turned out to be a mistake. Well, there are exceptions and there will be exceptions, whether they are in the Netherlands or in the United States. We are talking about human beings. We can't guarantee 100 percent perfection. But that is no excuse for not reforming FDA and trying to give it the tools and give it the wherewithal to do a better job. It has been estimated that the delay in U.S. availability of products threatens a loss of 50,000 jobs in the next 5 years. This is one of the greatest industries we have ever had in this country, in terms of promoting job growth, but beyond that, providing health-improving and life-saving benefits for the American people. Why do we make it so difficult for them? I don't want to go any further with that because, as I said, you can't compare economic benefit with health benefit. We ought to be focusing on the denial of benefits, the loss of life for failure of the FDA to meet its statutory requirements. We are not asking the FDA to compromise; we are not asking them to compromise on health and safety. We are saying: Do what you said you could do, or at least let's look at alternatives. I proposed an alternative to try to help the FDA. You would have thought I was proposing an amendment to disband the FDA and let the free market sort it out. It was nothing of the sort. That is not what we are after here. I thought we would try to give them some assistance with a third-party review, the FDA certified agencies or organizations outside of the FDA. But FDA looked at it and said: You have the testing wherewithal and the scientific wherewithal to help us expedite approval of these products, and as long as we certify you and as long as we approve the process, and as long as we have a veto power, even if you approve it, if we have a veto power and say, no, we have changed our mind, or we are not sure about that--not even that was acceptable to the opponents of this bill. But it is acceptable, fortunately, to the majority of the committee. It is acceptable to a majority of the American people. It is acceptable to a majority--not a majority but a supermajority--of this Congress. But yet with all of that debate, there is delay and withholding of moving forward, and procedural delays, all in an effort to oppose an honest effort at trying to help the FDA do its job. The irony is the FDA was already doing some of this. We are trying to provide a way that they can do more of it. So the FDA couldn't come forward and say, ``Well, we think everything ought to be done within the FDA.'' They admitted they needed help from the outside, and we structured the statute in such a way that you even wonder if it is going to work because the FDA has so much preapproval, during the process approval, postapproval, veto, and everything else on the thing. But at least it is a start. At least it is a movement in the right direction. FDA has made all kinds of promises about internal approval, approval, improvement, reinventing itself, and so forth and so on. The record speaks for itself. Prescription drug user fee types have improved, and we are grateful for that. And they have improved because we taxed the industry. The industry said, ``We are so anxious to try to get some of these drugs to market we will pay for it. Not only the development of the drugs, which is enormously expensive, not only the approval of the drug but we will tax us some more and we will give the money to FDA, and you can hire more people so you can look at it. If you turn it down, you turn it down. But at least get an answer one way or another so we can move on to something else, if you don't approve it.'' People say, Why don't you do the same thing with devices? Let's tax the device industry. We are not talking about American-owned products, or Merck, or Pfizer, Glaxo, major international companies with the funds able to do this. The device companies are often small organizations-- startup venture capital organizations. To tax them at this stage is going to just accelerate driving them offshore, and in many cases they in no way have the wherewithal to provide a tax for that. It is not their responsibility. It is a governmental responsibility. The President's budget hasn't helped much either. The President's budget proposal for fiscal year 1998 reflects something other than an effort to strengthen the agency. In fact, it proposed a cut of funding for the agency. They wanted to cut the Device Center budget by 27 percent. Clearly that calls for congressional action to address the issue, to ensure that the bureaucracy, and the old ways of doing business give way to some efficiencies and accountability in this era of tight budgets. So that alone is reason for us to move forward. Here we are now in September on PDUFA and a jeopardy of laying off--expiring and laying off--a whole bunch of people. And we are way behind the timetable that we ought to be on in terms of moving this forward. Just on another point about the size of device companies. Of roughly 8,000 device companies that exist in United States, 88 percent have fewer than 100 employees and 72 percent have fewer than 50 employees. User fees are clearly not workable in a situation like this. And I am pleased that the bill doesn't impose those. I have all kinds of statistics here, and all kinds of anecdotes and all kinds of stories. The bottom line is we are attempting to bring the FDA into this century. This century is almost over. We are attempting to try to take a tired, inefficient bureaucratic ideologically driven agency and introduce it to the modern era. We are trying to take advantage of these marvelous technological breakthroughs in drugs and devices and products that are occurring at an ever increasing rate around the world, but particularly in the United States, and make them available to American consumers to improve their health, to ensure their safety, to prolong their lives, to save their lives. That is why we have formed an extraordinary coalition between Republicans and Democrats. This has nothing to do with party lines, liberals, conservatives, and everybody in between. There was an almost unprecedented vote in committee of 14 to 4, and we would have had even a better vote than that if we went back and did it now because we have resolved some of the concerns that those four had. We wouldn't get all four. But we would have even a better vote--probably more like 16 to 2 because we have addressed those concerns that were raised in committee. Those Members thought that they had better reserve their vote and negotiating ability. And we resolved that. We have done an extraordinary amount of negotiating from the time the committee passed the bill out until this point. We were that far away in July from resolving this. In the negotiations with Senator Kennedy, we made 30-some concessions on a bill that passed 13 to 4 in order to get the approval of one person because one person could tie this thing up procedurally. We made 30-some concessions--concession after concession after concession by the chairman, this Senator, and other Senators. What is the problem? How can we fix it? Can you work it out? Can you go along with the bill, if we did that? Can you do that? We finally threw our hands up in total exasperation because every time we thought we were at the goal line, no, move the ball back another 15 yards to another position. Take that up. Will that do it? Yes. Solve that. Then they thought of another one. There was always a reason to delay and delay. And then we went through the August recess. If we were talking about making a widget, if we were talking about something that didn't affect the health and the safety of the American people--I suppose that is just part of the process here--but we are talking about people waiting for steps that would save their lives; waiting for approval from FDA of drugs that can potentially keep them from dying, waiting for products that can make their life a little more tolerable while we play games in the U.S. Senate because one person doesn't think it is a perfect bill in front of him, even though there is a widespread majority in support of it. That is wrong. So I am glad we are moving forward. I am sorry that we had to invoke a procedure to cut off a filibuster to do it. I understand people may have some concerns about this bill. It is not a perfect bill. It passed through months of arduous negotiation. There has been give and take. Every Senator is free to come down here and make his point and raise his objection and offer an amendment and take a vote. If it passes, the bill will be modified. If it fails, instead of taking the ball and going home and saying we are not going to play anymore, let's just say apparently I wasn't persuasive enough, or maybe I got my facts wrong, or maybe that is not what the majority wants to do. But let's not deny health improvements and safety improvements for the American people and the American consumer just because we don't get our way. Let's move forward. We will now. We have invoked cloture. I regret that we had to do that. I regret we had to go through the month of August waiting to reconvene, because there are people out at FDA that are going to be laid off if we do not get this thing moving. All the efforts that we have done to try to hire additional people out there will be undermined in terms of drug approval because we can't get this bill moving. So let's move forward. Let's raise our objections. Let's have a debate. Let's have a vote and accept the result, and let's move forward with FDA reform. Mr. President, I will have more to say about this at a later time. I have not gotten into the ``what.'' I was talking about the ``why'' here--why do we need reform. I have not gotten into what the bill includes. It is a broad bill with a lot of depth. It covers a lot of areas. It is significant reform. It is not as much as this Senator would like. It is more than some other Senators would like. But it is a big step in the right direction. I just note for the Record that I don't know what is going on, Mr. President, at the White House. We have been without a commissioner now at FDA for some time. They nominated someone this week, and then withdrew the nomination 24 hours later. I don't know why. But I urge the administration to continue its search. I am going to suggest a couple of names to them of people, if they need people to look at. I don't do it with any hope that they think anybody I would suggest ought to head up FDA--not this administration. But we ought to get somebody in there who is willing to exercise the oversight and the administrative ability to work with the Congress in bringing this agency into the modern era and improving the way things are done there. There are a lot of dedicated, competent, hard-working scientists and researchers and medical personnel at FDA who deserve to have competent leadership, competent management, and deserve to have the support of this Congress in providing the funds and providing the technology and providing the assistance in expediting in an appropriate manner the bringing to market of drugs and devices that can make a difference in people's lives. Mr. President, there is more to come later. I yield the floor. Mr. DURBIN addressed the Chair.

Mr. COATS

Mr. COATS. Fourteen to four.

Mr. COATS. Or the Republicans have somehow conspired to deny the Senator from Massachusetts the right to make his point or to argue his point, my goodness, we have been hearing that over and over and over and over. We know what the Senator's position is. He has the right to argue it, and he has the right to delay it. Let's make sure it is not implied somehow there is some devious effort on the part of the Republicans to deny the Senator his opportunities.

Mr. COATS. I felt compelled to give the other side of the story. Yesterday, when I offered the fetal tissue amendment to the Parkinson's legislation, I had discussed the matter with Senator Wellstone. I had indicated I was willing to take a 20-minute time agreement on the amendment, 10 minutes on each side. I didn't want to do anything that unnecessarily delayed the bill. I was informed that it was not--it was acceptable to Senator Wellstone but it was not acceptable to Democratic Members who wanted to speak on the bill but didn't want to do it yesterday. That is within their rights. We could have proceeded. We didn't. This Senator agreed to allow to be pulled over until this morning. I once again offered a time limit, and the time limit was not acceptable. So we essentially sat here for 2\1/2\ hours this morning listening to Members of the party of the Senator from Massachusetts oppose the amendment, which they have a right to do. But there was no delay initiated on the part of the Senator who offered the amendment, nor was there any delay on the part of the majority leader. In regards to the FDA legislation, we were ready to go with that legislation before the recess, and it was the Senator from Massachusetts who prevented us from doing that. The Senator has every right to do that. If he has an objection to a part of the bill, he has a right to utilize the rules of the Senate to stop the bill from moving forward. But the facts are that the Senator doesn't have the votes. I didn't have the votes on some of my amendments. I didn't have the votes on fetal tissue, but I didn't stand here and insist the Senate stay in on a day when Members from both sides made plans and made travel plans just because I didn't have the votes or I couldn't get my way. The Senator does not have the votes for the bill. He did not have them in the committee, and he does not have them on the floor. There is widespread support for the FDA reform bill, including the cosmetics provision which was voted on in committee. We had debate, and we voted on it in committee. The Senator didn't have the votes from the opposition party, didn't have the votes from his own party. He doesn't have the votes on this floor. If he wants us to go through this exercise on a motion to proceed-- this is just the procedure to start debate on the bill--why doesn't the Senator do what the rest of the Senators are doing, and that is, move forward on the bill, make your argument, have a vote, count the votes? If you win, you win; if you lose, you lose. But you can use the rules of the Senate. It is a right to the minority. We have used it. If the Senator wants to do that, he has the opportunity to do that, but it inconveniences everybody else, and if you think it is going to change the result, maybe it is worth it, but if it is just to be obstinate or intransigent because you didn't win or your point of view isn't accepted by your fellow colleagues, it puts everybody else at a disadvantage. To imply the majority leader----

Mr. COATS. Will the majority leader yield?

Mr. COATS

Mr. COATS. Mr. President, I yield to the Senator from Missouri such time as he requires.

Mr. COATS. Mr. President, let me make two points. One is that I don't need to be reminded by the Senator from California about the ravaging effects of Parkinson's disease, having watched my grandfather suffer and die from Parkinson's, and having watched my father suffer and die from complications from Parkinson's. I am well aware of the debilitating nature of Parkinson's disease. I think many of us have had personal experiences with that. I have not mentioned that before. But I think the implication is that if one truly understood Parkinson's, you couldn't begin to support the Coats amendment. I think I truly understand Parkinson's and what it does and how it affects an individual, how it affects family and loved ones. There is the very real possibility that it is genetically induced and that I may go through the same experience. Second, let me just state for those who suggest that there is no hope for the millions of Parkinson's sufferers, there is great hope for the millions of Parkinson's sufferers. There is hope because, No. 1, fetal tissue research can continue if the Coats amendment is adopted. I do not deny research utilizing human fetal tissue through this amendment. I simply say that that fetal tissue cannot be obtained through induced abortions. It can be obtained through spontaneous abortions, miscarriages, or ectopic pregnancies. But, second, there is hope because there are so many viable, wonderful alternatives that are now being researched which offer far more promise than the fetal tissue research. If you want to continue fetal research--and it probably should be continued--that fetal tissue can be obtained through sources other than human fetal tissue. In fact, it is much more promising now using animal tissue. There are a number of alternatives being explored, both through the use of cell engineering techniques, genetic engineering, and other developing cell lines. There are also alternatives outside tissue research that hold some promise. Perhaps the recent discovery of a gene that has an effect on Parkinson's, which perhaps is the cause of Parkinson's, albeit for a percentage of people and not for all the people, offer hope. So there is great hope. There is great promise in Parkinson's research. And nothing in this amendment denies that hope, denies that promise. So I think Members need to understand when they are voting for the Coats amendment that it is a way to preserve and continue Parkinson's research. But it is done so in a way that avoids what I think is a potential significant, ethical, and moral dilemma in terms of utilizing human fetal issue without the consent of the person giving the tissue. The very person who makes the decision to terminate that life is not the person who gives the consent to utilization of the tissue. That is a moral and ethical dilemma that I think is important for us to explore. So for those two reasons, I think the Coats amendment is more than a reasonable amendment. I hope my colleagues will support it. With that, I yield the floor. Mr. CRAIG addressed the Chair.

Mr. COATS. Mr. President, we will be resuming discussion of the amendment I offered last evening. I don't intend to repeat all that I said last evening. I do know there are a few other Senators who wish to speak on this amendment, and, hopefully, we can accomplish that in a reasonable time and then move to a vote. It is not my intention to utilize this amendment as a means of delaying a vote on the larger appropriations bill or specifically on the amendment that we adopted last evening, increasing funding for Parkinson's research, an amendment I supported and worked together with Senator Wellstone and others on this effort. I was pleased the Senate adopted my amendment related to the whole area of medical research so that we can commission a study which would give us, before the next appropriations and authorization cycle, a better idea of how we can direct research funds to achieve the greatest good for the greatest number. There are allocations currently made on the basis of who has the best lobbying effort and perhaps who has the best champion in the Congress. While I don't in any way mean to impugn the motives of anyone here who is putting their heart and soul into providing support for research on a disease that affects them or that they believe is important and critical, I do think that in the interest of the widespread number of diseases that are currently under research at NIH and other places and the Federal funds that are used for that research, having a better understanding of where we can best apply those dollars to achieve the breakthroughs that can prevent the suffering and, hopefully, provide the cures for a number of these diseases is the direction we ought to go. We adopted that amendment last evening, and I am pleased the Senate supported that. This particular amendment is designed to address a specific issue that relates to the utilization of human fetal tissue in research in a number of neurological disease areas. There is a broader question of whether we ought to utilize human fetal tissue and put restrictions on how that is sustained as applies to neurological research in a whole number of areas-- Parkinson's, diabetes, and there are a number of other neurological traumas that this could apply to. However, this specific amendment applies only to research in Parkinson's. I offer it because this is really the issue in terms of where we are applying specific research and increase in research dollars, and we will leave the discussion as it applies to other neurological disease research areas to the NIH reauthorization bill or a more appropriate time. But I believe it is relevant to this particular issue because we are addressing the question of Parkinson's research. I will summarize the two arguments that I made last evening. One is that we really don't have a pressing need to utilize human fetal tissue obtained through abortions other than human fetal tissue that is obtained through spontaneous miscarriages and through ectopic pregnancies. Because we have available to us some information that indicates that there is a diminishing viability of the utilization of human fetal tissue for Parkinson's research--it hasn't proved to be the promising breakthrough that we once thought it would be--there are alternatives to the utilization of human fetal tissue, specifically cell engineering, specifically utilization of animal fetal tissue, genetic engineering, and some other alternatives. Second, there are more promising areas of research that don't involve human fetal tissue at all, that involve brain implants, that involve a number of other research areas which I could detail, but I did last evening and I won't do that again. More importantly, however, than the question of whether or not this is even necessary to continue significant and important human fetal tissue in Parkinson's research, more importantly and most importantly, there are ethical considerations that I believe ought to give us significant pause before we just simply allow the utilization of human fetal tissue research. A number of moral and ethical questions have been raised, and I raised those last evening. I think Members ought to consider those, particularly those who perhaps don't have a personal concern about the utilization of fetal tissue research. It ought to be considered by them particularly since we have alternatives that allow us to address this problem without utilization of human fetal tissue for this research. If medical research becomes dependent on widespread abortion--and this is a concern because if human fetal tissue is determined to be effective in treatment, when we look at the whole widespread area of neurological research, we are talking of potentially utilization of fetal tissue of up to 20 million fetuses. That presents a wrenching dilemma for those of us, and I think that is most of us in this body, who believe that abortion ought to be rare, if not banned. For those who say it ought to be legal, safe and rare, we certainly would not be moving down a path that would allow us to limit abortions to only those that are most medically necessary. Second, let me just say that the dilemma that is posed is that the person who is responsible for the termination of the life of the child is the very person who gives the consent for the use of fetal brain tissue from that particular child. It is not consent of the child for utilization of the tissue. The very person who volunteers to have an induced abortion gives consent for the utilization of fetal brain tissue for one who has no voice in that consent. I think that presents a real ethical and moral dilemma that each of us ought to contemplate before we cast our vote in favor of the use of human fetal tissue. Third, I think there is a concern that we might be encouraging abortion by covering it with a veneer of compassion. ``After all, there is a benefit,'' the thinking goes. ``There is a benefit to this abortion because the product of the abortion can be used in alleviating human suffering.'' We all want to alleviate human suffering. We all want to do everything that we possibly can to find a cure for these diseases. And yet we have to be confronted with the moral and ethical dilemma of the possibility of the abortionist, the person encouraging the abortion, covering the fundamental underlying question about the life of a child by saying, ``Well, after all, we can mitigate your concerns because look at the good that it will do, the side benefit of the good that it will do.'' Ultimately that is a question that is a great question that ought to be pondered by each of us before we just simply say there is a great benefit to this fetal tissue research. So on the narrow question of whether or not fetal tissue is necessary for significant Parkinson's research, I think we have answered the question in saying it isn't. There are alternatives available and there are many more promising areas of research that can lead us to breakthroughs in Parkinson's research. And on the question of the moral, ethical dilemma, we can address that dilemma, particularly in this specific narrow area, by not allowing the use of human fetal tissue research with the exception that the research can go forward with fetal tissue obtained from spontaneous abortions or fetal tissue obtained from ectopic pregnancies. So it seems to me that we have addressed this issue in a way that allows the research to go forward, utilization of alternatives other than induced abortions, on a voluntary consent basis, and in ways that will not present us with this horrible ethical and moral dilemma that I think deserves great consideration before Members vote. That is the crux of the dilemma that I have presented. I hope Members consider that carefully before they cast their votes and not simply be caught up in ``this is anti-Parkinson's, this impedes Parkinson's research, this has nothing to do with abortion, this has nothing to do with the fundamental moral questions here.'' We can address this and then save and reserve the greater debate in terms of utilization of human fetal tissue for other neurological research at a time when we are addressing that specific bill. So that is the crux of the argument, Mr. President. I yield the floor at this particular point in hopes that we can move forward to a successful resolution of this particular issue. Mr. President, I yield the floor. Mr. KENNEDY addressed the Chair.

Mr. COATS. Mr. President, just in summarizing before we vote at 12 o'clock on the Coats amendment, let me just, for Members' information, clarify things here. This amendment does not prohibit all Federal funding for fetal tissue research. Fetal tissue research can go forward. It allows fetal tissue research to go forward with tissue obtained from ectopic pregnancies and spontaneous abortions. It does prohibit Federal funds from being used for research on fetal tissue obtained by induced abortions only. We encourage research in the most promising areas of Parkinson's disease with animal tissue transplants, gene-based therapy, deep-brain stimulation. So this applies not to diabetes research, not to other neurological research--just to this. Other alternatives exist. Even fetal tissue could go forward. I hope our colleagues will understand the practical nature of this and the ethical and moral considerations of doing this, and I urge a vote in support of my amendment.

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

Mr. COATS

Mr. COATS. I understand that shortly the Senator from Alaska will make a proposal that is certainly acceptable to Senator Lieberman and I, and I will be very brief in my comments. I am pleased to join my colleague from Connecticut in coauthoring and cosponsoring this amendment to increase funding for charter schools. Clearly, we are in a situation where I think there is a growing recognition that the status quo in our public schools is unacceptable, particularly our public schools located in low-income and urban areas. That status quo has existed for quite some time. It has been nearly 13 years since the President's commission reported about mediocrity in public education. We have seen numerous attempts both through public policy and through local initiatives to try to address the mediocrity and improve educational opportunities for our young people. We have met considerable resistance from the Federal Government, from the Department of Education, because they do not want to upset the status quo. Yet parents are voting with their feet and with considerable sacrifice and demanding at local and State levels that change be made. They are demanding alternatives. Senator Lieberman and I have explored a possibility of vouchers for low income, providing parents who do not have a choice, a choice that most of the rest of us have, that if their failing public school is not educating their young people they would have some means and wherewithal to utilize a voucher to achieve a better education. This is not that amendment. This is an amendment that addresses another alternative, a viable alternative called charter schools that Senator Lieberman has said is being more and more accepted throughout America. Even the Department of Education, in releasing its first formal report on the study of charter schools, has some findings indicating that charter schools have racial compositions similar to statewide averages, and in many cases have a higher proportion of minority students. So the charge that they are just for a certain race or just for the elite is not a well-founded charge. Sixty percent of public charter schools are new startups rather than conversions of public and private schools to charter status. They enroll roughly the same percent of low-income students on the average of other public schools. So a lot of red herrings about charter schools undermining the effectiveness of public schools is not proven. The Hudson Institute, located in Indianapolis, has undertaken a very significant and comprehensive study of charter schools called Charter Schools in Action. Their research has involved visiting 14 States, 60 schools, and visiting thousands of teachers and students. The key findings are that three-fifths of charter school students rate their charter school teachers as better. Over two-thirds of parents say the charter school is better than the child's previous school with respect to class size and school size. Over 90 percent of the teachers are satisfied with their charter school educational philosophy, their size, colleagues and students. And among students who said they were failing at their previous school, more than half are now doing excellent or good work. The gains were dramatic, most dramatic for minority and low-income youngsters, and were confirmed by their parents. In summary, the Hudson Institute study found charter schools point to important ways to improve and reinvent public education as a whole. The implications from the success of charter schools indicate that successful public schools should be consumer-oriented, diverse results oriented and professional places that also function as media institutions in their area. Because of the tremendous success of charter schools in the past 6 years, I joined Senator Lieberman in an attempt to double the funding. As Senator Lieberman pointed out, they offer great accountability, broader flexibility for classroom innovation, and ultimately more choice in public education. Senator Lieberman and I have addressed what we think are some offsets to provide for this doubling of funding to encourage charter schools. There has been some concern about where that funding comes from. I think there are some creative, innovative, and useful offsets, but it would engender considerable debate and discussion and might undermine this effort. Senator Stevens has found, I think, a very acceptable way to address this, and I appreciate his involvement and his efforts and his support for this. With that, I thank my colleague, Senator Lieberman from Connecticut, for his initiatives, and I am pleased to join him in this. I yield the floor.

Mr. COATS

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

Mr. COATS. So with that, Madam President, I send my amendment to the desk and ask for its consideration with the understanding that it may be possible to enter into an agreement that would limit the time.

Mr. COATS. Let me return to the question of the ethical dilemma that is posed with utilization of fetal tissue in research. There is a broad ethical question that affects all neurological research or any research that utilizes human fetal tissue. I have tried to raise some of the questions that I think ought to give all of us pause before we sign off on the use of human fetal tissue in medical research. Does it create an irreversible economic and institutional bond been abortion centers and biomedical science? That is a legitimate question. Because if the cure or alleviation of symptoms for neurological diseases, diseases including Alzheimer's and Parkinson's and diabetes and other neurological trauma, is dependent on utilization of human fetal tissue, then we are talking about the need to supply fetal tissue patches or pieces from up to 20 million abortions, induced abortions a year. That poses a profound ethical question. Second, the question is, by what right will we obtain this fetal tissue? We obtain it with the consent of the very person who has made the decision to end the life of the fetus from which the fetal tissue will be derived. So there is no such thing as consent of the human species, the human being, the human person whose life is ended to provide the fetal tissue in the name of medical science. And is it really possible to separate the practice of abortion from its use in biomedical research? Are researchers merely using the results of abortion, or are they dictating its practice? There are real concerns about how fetal tissue is derived, how it is procured. A report issued by the University of Minnesota Center for Bioethics has stated that in Sweden, ``Doctors say they have obtained brain tissues with a forceps before the fetus was suctioned out of the mother. That raises the question of whether the fetus was killed by the harvesting of brain tissue or by abortion.'' Janice Raymond, professor of women's studies and medical ethics at the University of Massachusetts, has testified that doctors are already altering the methods of abortion in order to get the tissue that they desire, and I quote from her. Doctors who are eager to get good tissue samples must put women at additional risk of complication by altering the methods of performing abortions and by extending the time it takes to perform the conventional abortion procedure. Dorie Vawter of the Center for Bioethics at the University of Minnesota has reaffirmed this observation, noting that some clinics currently alter abortion methods for tissue harvesting--slowing down the abortion procedure, reducing the pressure of the suction machine, and increasing the size of dilation instruments, all practices which place women at additional risk. And so in the harvesting of human tissue, the human tissue has to be at a certain condition. I talked a few moments ago about how much of this tissue is unfit for effective use in Parkinson's research or other neurological research. And now we have testimony of people who are altering the procedures of obtaining the human fetal tissue so that the human fetal tissue is in a better condition for this research. But in doing so they place the health of the woman who is carrying the child, from whom the fetal tissue is derived, at greater health risk. And then I think we have to ask probably the most difficult of questions, and that is, are we encouraging abortion by covering it with a veneer of compassion? Dr. Kathleen Nolan, formerly of the Hastings Center, writes, Lifesaving cures resulting from the use of cadaveric material might make abortion, and fetal death, seem less tragic. Enhancing abortion's image could thus be expected to undermine efforts to make it as little needed and little done procedure as possible. This is a very real concern because often people come up to me and say: Why do you offer amendments? Why do you think that utilization of fetal tissue should be restricted to noninduced abortions, because it does so much good, it holds so much potential. Look at the ethical question involved. Is taking a life, is killing a fetus in order to obtain material that is useful in providing research which offers promising health benefits to individuals, is that not one of the most profound ethical and moral questions that we have to face? And so I think when we look at a question like this, we clearly have to understand, as Stephen Post said, Ultimately, it is the specter of a society whose medical institutions are inextricably bound up with elective abortion and whose people come to believe that for their own health they have every right to feed off the unborn, that gives pause. Arthur Caplan of the University of Minnesota expresses these concerns in another way. This is the ultimate issue of generational justice. You're not just asking for the pocketbooks of the young--you're asking for their body parts. Now, fortunately, Madam President, we have alternatives available to us. I have listed those alternatives. In the case of Parkinson's, and that is the issue we are facing here--we will address the other issue at another time--but in the case of Parkinson's research, we are learning that fetal tissue research is of diminishing importance and of diminishing effectiveness. We are learning that there are more viable alternatives that hold far greater benefit and hope for breakthroughs in treating Parkinson's than fetal tissue. And so while I think it is appropriate that we are focusing on increasing funds for research in Parkinson's, I believe it is also appropriate that we place this most limited of restrictions on this research, both for practical reasons because it offers very little hope of any research breakthroughs and because this tissue can be obtained by other alternatives without taking human life, without inducing abortions. Fetal tissue cells from human fetuses can be obtained through miscarriages, spontaneous abortions, ectopic pregnancies, but the other forms of research, the xenografts from animal tissue, which are now being found to be more useful than human tissue, human cell lines, genetically engineered cells, and then all the other more promising means of research in Parkinson's, I think allow us to say that at least in this area we will not pursue and we do not need to pursue the utilization of human fetal tissue. Amendment No. 1077 (Purpose: To prohibit the use of funds for research that utilizes human fetal tissue, cells, or organs that are obtained from a living or dead embryo or fetus during or after an induced abortion)

Mr. COATS. Madam President, I regret that we were not able to obtain an agreement. I will finish my statement very shortly here and then offer the amendment. I certainly would agree to set it aside so that the Senator from Pennsylvania can continue with what other business he has. We obviously will have to address this issue in greater detail at another time, either later this evening or tomorrow.

Mr. COATS. Yes.

Mr. COATS. I would be happy to yield to the Senator.

Mr. COATS. The amendment I will offer, and I will hold offering it until such time as an agreement can be at least reached on the other side, this amendment is something that we have debated before. I think it is an important debate. I think it does not require that we make a lengthy debate because it has been discussed and debated. I want to make sure that each Senator is aware of a certain practice and the implications of that practice before they cast their final vote on the Parkinson's research or any other research that might involve the use of fetal tissue. The amendment says, briefly, notwithstanding any other provision of law, none of the amounts subject to the provisions of subsection (e) of the Morris K. Udall Parkinson's Research Act of 1997 may be expended for any research which utilizes human fetal tissues, cells, or organs obtained from a living or dead embryo or dead fetus during or after an induced abortion. The subsection does not apply to human fetal tissues, cells, or organs obtained from a spontaneous abortion or an ectopic pregnancy. We just debated, and I believe will vote tonight or tomorrow, and certainly it will pass and I will vote for it, the provision offered by the Senator from Minnesota to increase funding for Parkinson's research. I was pleased the Senate accepted the amendment I just offered to provide a study which will give us guidance in terms of how we can direct research funds in the future. But on the question of Parkinson's research, it is important that we address an issue that a lot of people do not like to talk about but it is an issue that I think is relevant and one that is important, and that is that in certain research--and I believe it is very limited research, and fortunately it is research that is much more limited than it was in the past because it has not shown that much promise--the implantation of human fetal tissue has been one of the means by which researchers have attempted to address the symptoms of Parkinson's disease. Now, from a practical standpoint it is important to understand that the amendment here only affects use of fetal tissue, the use of funds to provide fetal tissue research for Parkinson's disease. There are a number of other diseases, diabetes and others, that use fetal tissue research, and that is a subject for a separate time. This only applies to that particular section of the Udall bill and it simply says that funds that we will appropriate cannot be used for fetal tissue research. It does not affect research in other areas. It does not affect indirect research that affects Parkinson's. Frankly, I do not know that this should even be an issue in Parkinson's, and I cannot speak with scientific authority, but to the best of my knowledge fetal tissue research has held very little and is diminishing in importance in terms of Parkinson's research. The Parkinson's Action Network has issued a statement, and I will quote from that statement that says: Even those involved with fetal tissue research readily acknowledge that the result of their research will not use human fetal tissues. Current work is intended only to demonstrate the capability. Ultimately, another source of fetal material must be found. That is the statement from the Parkinson's Action Network. So we are not even talking about direct use here as a potential cure or alleviation of circumstances of Parkinson's. One of the reasons for that is that human tissue has consistently been found to be unsanitary or not fit for clinical use. Now, the good news is that there are other sources of tissue that have shown some promise that are not from induced abortions. There are xenografts, fetal pig tissue, that at this time and to my understanding are believed to be more useful than human tissue. There are human cell lines that are more promising sources of tissue than tissue derived from abortions. Genetically engineered cell research has shown significant promise. And tissue that is derived from miscarried pregnancies is now being utilized as a substitute for utilizing fetal tissue from induced abortions. So I want my colleagues to understand, we are not trying to impede significant research on Parkinson's from the limited amount of research that does come from fetal tissue. There are alternative means of obtaining tissue, whether it is animal tissue, whether it is human cell lines, whether genetically engineered, or whether it is actual fetal tissue, but fetal tissue obtained from miscarriages, from spontaneous abortions, which are miscarriages, but also from ectopic pregnancies. So there are alternatives to obtain the material necessary for this research. In addition, the research seems to be moving away from fetal tissue and even new tissue toward more promising areas of research in Parkinson's disease. Implanted brain stimulators work for some but obviously do not work for all. Surgical pallidotomies, proton therapy, genetic-based therapy--these are all alternatives to the fetal tissue research. So, therefore, just from a practical standpoint, regardless of how you feel about the ethical question, I think there is a real basis to avoid the controversy and to avoid the profound ethical questions and concerns that arise from the utilization of human fetal tissue through induced abortions. What are those ethical questions that we ought to be asking ourselves? Many of us in the Senate--I am included in this--either have parents, children, spouses, relatives, friends, or colleagues who have, unfortunately, incurred a neurological disease in which fetal tissue transplantation has offered some hope of treatment. So it is not a subject that we ought to lightly dismiss. I just outlined why I think in the area of Parkinson's research that it is really not even a major issue any more. But I think we have to address the question of the wrenching dilemma that it ought to pose-- that is posed--by the issue of human tissue research. Therefore, I think we ought to be searching for a path that serves both public health needs and concerns and the questions of moral principle, a path that offers hope for breakthroughs in research, for cures, for alleviating symptoms, but a path which also shows ethical insight. Scientific research does not occur in a moral vacuum. I think it has to be guided by something that is more than just practically possible or feasible research. It has to be guided by some ethical considerations that I think each of us need to ask ourselves. In this regard, the ethical questions, I believe, are the following: Question No. 1: Will the use of tissue from elective abortions create an irreversible economic and an institutional bond between abortion centers and biomedical science? Just think for a minute. If medical research becomes dependent on widespread abortion, a vested interest would clearly be created in a substantial uninterrupted flow of human fetal tissue. Medical science would be dependent on continued legal abortion on demand. Does that create an ethical dilemma? I would argue that it does. The reason that it does is that there is no way that we could provide sufficient tissue from spontaneous abortions, miscarriages, or ectopic pregnancies because we know that if tissue transplants are the cure for diabetes, Parkinson's, Alzheimer's, and other neurological trauma, then we are talking about between 34 million and 20 million fetuses a year necessary to supply the need for the fetal tissue to address the problem. So just on this basis alone, it seems that we need to look at alternative ways to generate fetal tissue without elective abortions-- to look at cell cultures, use of animal tissue, and other research that I have just mentioned. We have an ethical nightmare, a potential ethical nightmare that we will face if we can't address ourselves to alternatives. Another question is: By what right is this fetal tissue obtained? Certainly the remains of the fetus in elective abortions are not donated in the traditional sense of the word. The fetus can't give consent. It is instead provided by the very people who have made the decision to end the life of the fetus. Can the person who ends the life be morally permitted to determine the use of the organs in the life that that person just ended?

Mr. COATS. If I could state to the Senator, before we have an agreement, why do I not just, while we are working on the agreement, why do I not begin? I could probably pretty much make my statement, and I might not need the full 10 minutes in the agreement. I will be glad to yield back. There are a certain amount of things I want to say. Until we hear from the other side----

Mr. COATS. Mr. President, I appreciate the support and the efforts that Senator Wellstone has provided. We have discussed this matter on a number of occasions. He is, I believe, willing to accept the amendment and supports what we are trying to do. I know Senator Frist and maybe others would like to speak on the Coats amendment. I yield the floor.

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

Mr. COATS. Mr. President, I now offer this amendment by sending it to the desk, and ask unanimous consent that Senator Frist be added as an original cosponsor.

Mr. COATS

Mr. COATS. Madam President, I yield the floor.

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