Daniel Coats

Mr. COATS

Mr. COATS. Incorporated in the 1990 Medical Device Act, demonstrating in the Senator's own committee report the breadth and scope of this particular authority.

Mr. COATS. My time has expired.

Mr. COATS. Mr. President, I ask unanimous consent to speak for 2 minutes prior to the scheduled vote on the committee substitute.

Mr. COATS. Mr. President, in 2 minutes we will be voting on the FDA reform bill. This committee substitute has been legislated for a 2\1/2\ year period thoroughly and carefully and responsibly. It is a piece of work that has received a 14-to-4 vote in committee by Democrats and Republicans. People of different philosophical backgrounds have supported it. It is legislation that has survived two filibusters, and the cloture votes have been overwhelming to move forward. It is legislation that has been changed and modified 34 times to meet the objections of the Senator from Massachusetts and some others about its deficiencies; 34 modifications since that 14-to-4 committee vote. There are 8 days left in this month before PDUFA--the tax on the drug companies that funds up to 600 employees at FDA to review and to expedite the review of drugs--8 days left before that authorization expires. The clock is ticking. FDA will be laying off more than 600 people in just 8 days unless we can move this legislation forward. We don't need more filibusters. We don't need more debate. It is time to move forward. If we do not, drug and device reviews will be delayed substantially, and reform will be stopped. Responsible people have legislated responsibly, and I urge my colleagues to support us on this vote coming up.

Mr. COATS

Mr. COATS. I think the Senator from Massachusetts knows exactly what it is we are attempting to do and why we are doing it. It is part of the two-part test. The second part, which the Senator admits on every example he uses and every example he uses does not apply to the situation as it exists. Dalkon shield has nothing to do with this; fen/ phen, as the Senator knows, has nothing to do with this language. This whole thing was supposedly prompted by the fen/phen scare, and the Senator failed to admit that fen/phen is a drug and not a device. Most of us are trying to keep some level of patience and some level of perspective on this whole process and procedure. I don't know of anybody at U.S. Surgical--they may have visited my staff. I have never talked to anybody that I know of from U.S. Surgical. I didn't even know they made that device. All I know is when they got in trouble they went to Senator Kennedy, and the very device he is talking about that is so dangerous to women's health, he intervened, or at least participated in the process of clearing U.S. Surgical. I had printed in the Record the letter citing specifically Senator Kennedy's help and the help of Dr. David Nexon, Senator Kennedy's staffer and Gerry Kavanaugh. There was no explanation of that minor omission in the Senator's presentation. I would be interested to hear what that might be. So, the Senator criticizes the Senator from Connecticut for supporting this company and not being objective with the facts, when the Senator, who is raising the issue in the first place, has been the person to provide that support. What we are attempting to do is to return to past law which sets in place a reasonable procedure whereby devices that are substantially equivalent under FDA's determination to devices that have already gone through lengthy premarket approval processes, where those devices can be expedited into the system because there is no difference and the question is on the label what the intended use is, not on what somebody tries to make the intended use to be. It would be impossible for anybody, any company, anybody to possibly speculate and list all the ways in which people might think up of using devices. The company produces it for a specific purpose, it provides an indicator for a specific purpose, and a contraindicator for how it is not to be used, and if there is in any way a technological change in that device, then FDA has full and complete authority to deny the substantial equivalency label. Let's keep our eyes focused on what we are attempting to do here and not be confused by egregious examples that don't even fit the issue, that don't even go to the core of what we are debating. It makes for good theater. It makes for lousy legislation.

Mr. COATS. Reclaiming my time.

Mr. COATS

Mr. COATS. I thank the Senator from Vermont. Mr. President, it is going to be extraordinarily difficult for us to finish our business on this bill, unify the different positions between the House and the Senate, and get the legislation to the President of the United States before September 30 so we do not have to lay off people at FDA, so we do not have to further delay review of devices and drugs and health-saving and health-improving and lifesaving products for the American people. That is what all this is about, is expediting the process; not to short-circuit the process but just to bring some efficiencies to the process. The United States lags dramatically behind our foreign competitors. But more important than that, we have American citizens who are being denied access to health-improving and lifesaving drugs and devices because of this huge backlog at FDA. So, we can continue to go through these debates, as the Senator from Vermont said, 2 pages out of 150 pages--an important part but a small part of the entire, overall reform bill. I hope we can come to some reasonable agreement in terms of bringing forward amendments; where there are disagreements, agreeing to a time limit on debate of those amendments, let each side present their case and then let the Senate vote on the matter and then move forward. Delay, delay, delay simply postpones what is, or at least what I believe is, inevitably going to happen and what should happen. That is that a majority of the Members of the U.S. Senate, on a bipartisan basis, and a majority of the Members of the U.S. House of Representatives, on a bipartisan basis, and the vast majority of the American people, want to see changes in the current FDA so they can bring lifesaving devices and drugs and health-improving devices and drugs safely but efficiently to the marketplace so that people can utilize those without having to get on a plane and go to Mexico or a foreign country, so we do not have to keep shifting manufacturing facilities and jobs out of the United States into areas which have a more reasonable and effective review process. Many of us thought the device section was resolved and closed and that--at least last week it was presented that the only remaining item left on the agenda was the cosmetics. We went through great drama here over the problem with cosmetics. Now cosmetics has been agreed to. All of a sudden we are back onto devices. Many of us are concerned that even if this issue is resolved, we will suddenly have a new issue appear that will further delay the steps that we need to take here in the Senate to move this legislation forward. So, I ask our colleague from Massachusetts if we could at least set some schedule here to ensure that we do not go another week, that at least this week we complete debate on the amendments, move to final passage, and then allow the House of Representatives to begin their process. I am not asking him to respond. It's just a plea here that we have spent 2\1/2\ years, and each day we delay we run into problems with reauthorization of PDUFA and we run into serious, considerable delay in terms of bringing in the processes which will allow us to more efficiently do the work, the legitimate work, of the Food and Drug Administration. How much time is left? I will be happy to yield whatever time is remaining back to the Senator from Vermont.

Mr. COATS. Mr. President, the Senator from Massachusetts offers expediting of this process. No one wants to keep delaying it. We have been in negotiation for months, if not years. This particular item has been discussed, debated, turned upside down, dissected. I think we are at the point where the best way we can expedite this is simply to have the amendment offered, have the debate, let the Senate work its will. There are Members on both sides who are willing and able to present the case, and then let the Senate work its will. Having said that, this Senator has on two occasions now responded to the Secretary of Health and Human Services, who personally called and asked that I look at new language. I said I will be happy to look at new language, but it just seems every time we look at new language and make a concession, there is another issue that pops up. We made 30 some concessions. We don't want to have 31 and then 32. I appreciate the offer of the Senator from Massachusetts, and we will continue to operate in that spirit.

Mr. COATS. Mr. President, I ask unanimous consent for 1 additional minute to respond to the remarks of the Senator from Massachusetts.

Mr. COATS. Mr. President, I am not sure what unanimous consent is required.

Mr. COATS. Mr. President, I don't intend at this particular point to get in a specific discussion over section 404. I just urge--clearly, there is a differing point of view. We heard from Senator Dodd from Connecticut, who was involved in the drafting of the bill; and Senator Jeffords from Vermont, the committee chairman, explained this. This was someone who was directly involved in the 404 question and has been drafting the language and negotiating the language. This is clearly an issue we are going to have to address. The committee debated it. There has been negotiation subsequent to that. We are now in a position where we are going to have to agree to disagree. I just urge the Senator from Massachusetts, at the earliest possible time--I know it can't be done today given the problems we have with scheduling the Interior appropriations bill--to bring the amendment to the floor and then let us have the debate and then let the Senate work its will by vote and then go forward. Hopefully, this is not something that is going to further delay passage and then implementation of FDA reform. Every day we delay, many things happen, most of them bad. No. 1, we move ever closer to September 30, at which time the PDUFA, the drug prescription user fee which is used to provide the individuals with the resources necessary to expedite drug approval, expires. That expires on September 30. The House has yet to act on this. They are waiting for the Senate to act. We are trying to wrap up appropriations bills. The clock is ticking and we need to move forward with this so we can allow the House to go forward, get into conference, get the bills back here. I wonder if I can ask additional time from the Senator from Vermont? Maybe an additional minute or two. I don't know how much time is left.

Mr. COATS

Mr. COATS. Mr. President, I don't need all the 5 minutes. I would be happy to yield back to the Senator from Vermont to wrap up before the cloture vote. It is unfortunate that we are in this position again. We had a substantially bipartisan, overwhelming vote to invoke cloture on the motion to proceed. I believe the vote was 89 to 5. I think that indicates a very broad level of support for the need to move forward with this legislation that was 2\1/2\ years in the making. There is obviously a widespread, general consensus that FDA reform is necessary to provide better protection for the health and safety of Americans and to provide access to drugs and devices that Americans have been denied due to delays at FDA. We are trying to expedite that process. We are trying to bring in expertise from outside to help FDA, whether it is through the tax that is levied on prescription drug companies that goes to hire additional workers and provide additional resources for FDA, or whether it is for outside agencies, certified by FDA, to help them in the process of reviewing this tremendous backlog of applications for health-improving, and in many cases lifesaving, devices and drugs. What we are trying to do here is give FDA the kind of support and resources it needs, along with a pretty good shove in the right direction, to bring our agency up to world class standards and up to the task of effectively dealing with this exciting explosion of technology through which the American people can reap great benefits. I regret once again we have to go to a cloture vote. We just ran into a problem here, procedurally, with the amendment, the Senator from Iowa fearing that cloture would cut off his ability to offer a relevant amendment under cloture. I would say to the Senator from Iowa, none of us really wants to go to cloture. But in order to move this bill forward, it appears that we have to invoke cloture once again. I know under the rules of cloture, it limits the amendments as to relevancy. No one in favor of FDA reform wants to keep going through this process of invoking cloture, but unfortunately we have to do it in order to move the bill forward. Again, 2\1/2\ years in the making, there were extensive hearings in the Labor Committee, efforts on a bipartisan basis to resolve problems and disputes, votes in committee, negotiations post-committee action, 30-some concessions or modifications in response to concerns that were raised postcommittee on this. So, none of us here supporting and promoting the movement forward of this legislation is trying to delay anything. We are just trying to expedite it. Nor are we trying to say, ``Our way or no way.'' There has been extensive negotiation, extensive accommodation, extensive work to move this bill forward in any way that we possibly can. So I urge my colleagues, as we did a week or so ago, I urge my colleagues to vote with us on cloture. We have no other choice, other than lengthy debate over items and issues that have been discussed over and over and over and voted on and negotiated. Clearly, we know where the Members of the U.S. Senate stand, both Republicans and Democrats, liberals and conservatives. There is about as widespread support for this reform bill as any major legislation that has come before the Senate as long as I have been in here, for 9 years. It is time to move forward. Regretfully, we have to do it once again with a cloture motion. I urge my colleagues to help us move this very needed and very important legislation the next step forward. I yield back any remaining time I have to the Senator from Vermont.

Mr. COATS

Mr. COATS. Mr. President, on behalf of Senator Gregg and myself, I send a modification to the desk. I ask for its modification.

Mr. COATS. Mr. President, can I inquire how much time is available on each side?

Mr. COATS. I yield 2 minutes to the Senator from Missouri.

Mr. COATS. Mr. President, I yield 1 minute to the Senator from Vermont. Before I do, let me just say that I recognize the legitimate concerns that the Senator from Missouri has raised, and that is why we negotiated a totally voluntary process and exemption for any school, any individual, any school district that does not want to participate does not have to participate without any jeopardy of losing any funds. So whether it is a home school, private school, parochial school, individual school district, whatever, if they agree with the Senator from Missouri--and I believe he raises some legitimate concerns--they don't have to participate in this at all. I now yield to the Senator from Vermont.

Mr. COATS. Do I need to ask unanimous consent that the amendment be modified?

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

Mr. COATS. Mr. President, we are debating, here, under this limited time agreement, an issue that has received considerable discussion. There is considerable controversy over the issue of national testing. It has received enormous attention. When the issue was first raised in the context of this appropriations bill, Senator Gregg and I offered an amendment expressing our concern that we were going forward, here, with an issue of considerable controversy, without it being authorized and without hearings and without discussion as to the implications of this. We felt it deserved a full public discussion because there was great controversy over the idea of national testing. Unfortunately, the decision that was made on the part of the administration was to go forward with this initiative without congressional authorization. We attempted to address that issue with our amendment. But last August, without congressional approval or statutory authority, the Department of Education announced that it would develop a national test to be implemented in the spring of 1999, and went forward and awarded a $13 million contract to a consortium of testing companies. Instead of turning the proposed test program over to the National Assessment Governing Board, an entity with 10 years of experience in this area, the administration intended to bypass this procedure. Senator Dorgan spoke on the floor. We raised the issue. Senator Dorgan responded by saying he agrees with us that we would be far better off getting this out of the hands of the Department of Education and into the hands of an independent assessment agency to address some of this controversy about the Federal direction of how the test is derived and how it is administered and so forth. The President, in his radio address a week ago, stated that he would concede to the argument that many were posing, that this would be better if not designed and directed by the Federal Government. That, then, opened the door to our trying to find a way to constitute an outside independent agency to write the test and administer the test. Many of us, even with that, expressed real concerns about the whole concept of a national testing program versus allowing these decisions to be made at State and local levels. But it was clear that the issue was going forward. So, in response to that, what we attempted to do was negotiate with the administration, with our Democrat colleagues and others, to comply, essentially, with what Senator Dorgan was suggesting we do and what the President was suggesting we do. The initial proposal that the President had outlined maintained what we thought was a link with the Harvard education administration, which simply fueled the controversy. So, over the last several days we have had considerable discussion and negotiation with the administration on this, attempting to improve this process and really to reserve further debate, on whether there ought to be national testing or not be national testing, for the conference committee and for this body. There is a division of opinion on that, a division all along the ideological spectrum. Former Secretary of Education Bill Bennett said national testing can be beneficial if done the right way, if not manipulated to achieve a certain result or to drive a curriculum, but as an assessment tool. I quote from an article written by his former assistant, Chester Finn, Jr., who says: Properly done, standards-based national tests would provide useful information to students and their parents and put pressure on schools to improve. Congress, which created the National Assessment Group, NAGB, could easily design a program which would achieve the goals of national testing, being a useful tool in improving public education. The crucial questions [he says] about any test are who decides what's on [the test] and who sets the standards by which student performance is judged. We have set out to do that. I am pleased to announce that late last evening we were able to achieve agreement with the administration on the conditions upon which this would go forward. Under the agreement, and I will briefly explain it, no school or school district will be forced to use the national test if they don't want to. It is strictly voluntary. We also have provided that no school not using the test will in any way be denied the Federal funds that come to that school for various purposes. So, receipt of Federal funds is not conditioned on their using or not using the test. Further, we have provided that no private or parochial school or home-schooled individuals are forced to take a test without their consent. That was a legitimate response to some questions raised by home-schoolers and private and parochial schools. This is a key provision. Currently, States are using a variety of testing instruments to determine how their students are performing. Yet, according to many experts, this patchwork of tests does not provide a common yardstick by which parents and educators can compare results. And while it is true that testing won't help children learn more, it is equally true that testing can give us valuable information about how we are doing, and will ultimately be useful in providing tools for parents to use in holding schools accountable for their results. Second, the changes that we have made allow the National Assessment Governing Board the exclusive authority over all policies, directions, and guidelines for establishing voluntary national tests for fourth- grade English reading and eighth-grade mathematics. To assure NAGB's independence, the amendment provides that NAGB shall have the sole authority to award grants and contracts and otherwise operate independently of the Department of Education. The compromise which we reached gives NAGB 90 days to review and make substantial changes, if needed, in the contract negotiated by the Department of Education. Third, we have directed NAGB to ensure that the content and the standards for the national test are the same as those for the National Assessment of Educational Progress test, the NAEP tests. The President has stated on numerous occasions his intention to have voluntary national tests based on the well-respected, high standard of the NAEP test, and this amendment accomplishes that. Fourth, we have made numerous changes to the composition of the 25- member board, NAGB, to ensure bipartisanship and a new focus on locally elected officials rather than the so-called Washington experts. These changes include the addition of a current or former Governor, bringing the total number of Governors on the board to three; the addition of a new category, allowing participation of two mayors; two additional representatives of business or industry, bringing the total of that to three; and the elimination of five curriculum or testing experts who were employed by the board but should not have had voting privileges, a potential conflict of interest there. We have also increased the length of the terms on the board from 3 to 4 years in order to provide for more continuity. Fifth, the amendment returns to NAGB the authority it had prior to 1994 to nominate individuals to fill vacancies which occur on the board. Under this process, the Secretary must select from candidates nominated by NAGB. The amendment provides a 30-day transition, so that current vacancies and newly created positions are filled by the Secretary after consultation with the House and the Senate. These changes are critical to ensuring that national testing is under the supervision of an independent, bipartisan agency and not the Federal Department of Education. There is no doubt that standardized tests assess performance, but they do not generate it. Yet I am increasingly convinced that giving parents a better and possibly more accurate picture of their child's academic performance will help them obtain the best education for their child. These tests are simply another tool for parents to use in holding local schools and local systems accountable for providing the kind of opportunities for educational achievement that all children in America deserve. Mr. President, I have other Members who wish to speak on this. I reserve my time at this particular point.

Mr. COATS. Mr. President, I appreciate the remarks by the Senator from North Dakota. He raised the issue, and in a sense extended the offer to make the adjustments necessary to make this truly an independent effort and a constructive effort. His support in all of this is much appreciated, along with the Senator from New Mexico. Amendment No. 1070, As Modified

Mr. COATS

Mr. COATS. Mr. President, if the Senator will yield, I am just discussing that with Senator Dorgan and others. I just had a discussion with the majority leader on that. We are in the process of discussing that concept, and we are talking to numerous people on both sides of the aisle. We will not be ready to go with that this evening, I do not believe, but I believe we will be by tomorrow.

Mr. COATS. I am not 100 percent sure it is going to need a lot of debate if we are able to work out a procedure and agreement on proper language, and so forth, in terms of how we will dispose of this. It may be that we don't need an agreement, but I can't give the Senator an answer.

Mr. COATS

Mr. COATS. Mr. President, I know this debate today doesn't have the fireworks that the debate on Friday had about FDA reform. I know we are today detailing some of the specifics of the reform legislation that is before us, but I think it is important for us to lay out this record as to why it is important to go forward with FDA reform and what the FDA reform bill that is before this Congress actually proposes. On Friday, I laid out the why of the need for reform, but I didn't lay out the what it is that we are actually doing to bring about this reform and what is included in this bill. I think it is important for our colleagues and Members to focus on the constructive things that we have done through our exhaustive process in the Labor and Human Resources Committee to conduct an FDA reform bill that can truly bring greater efficiency to this agency. On Friday, I indicated how much many of us resent the charge that we are somehow gutting the FDA. FDA is an important agency. It is an agency that does protect the health and safety of Americans, and we want to do all that we can to give that agency the kind of resources and the necessary support that it needs to continue that effort. Yet, clearly, I think the case that was laid out Friday indicates the need for substantial reform of the agency on how it does its business, how it is going to proceed in the future. Senator Kennedy from Massachusetts has stated the agency has improved so much in the last few years--and others have said the same thing, including a former commissioner--that it doesn't need congressional reform. I think the facts indicate otherwise. As I outlined on Friday, the agency can't come close to meeting its statutory deadlines for approval of either drugs or devices. There have been egregious examples of delays that have affected people's safety and health, and we want to do everything we can to minimize those delays and to make the agency a more constructive force in terms of dealing with these questions. The President's latest budget is outlined in this publication I have entitled ``Department of Health and Human Services Food and Drug Administration, Justification of Estimates for Appropriations Committee.'' This is a backup document, material facts in terms of the President's budget decision, as to how much we should fund FDA for the next fiscal year. Having outlined all of these problems that exist at FDA in approving drugs, in approving devices and expediting the process and even beginning to attempt to meet their statutory requirements, it is astounding that the President's budget for next year does not only not strengthen the agency, it diminishes its effectiveness. The proposal here plans to cut the agency's total appropriated budget by 8 percent and cut the device center budget--that is the center that reviews and approves medical devices--by 27 percent. This is at a time when, if we need to do anything, we need to increase the funding for the agency or at least find ways to help the agency with outside sources to try to do its job more effectively and more efficiently. So that alone--I guess this was designed to meet some budget numbers, but it certainly doesn't square with the assertions that the agency is well on the way to solving its problems and, given a little more time and few more resources, those problems will be solved. It also flies in the face, I think, of the facts that have been presented on this floor in terms of the agency's inability to meet its statutory requirements for review and approval of devices. In just a couple of areas, with respect to the 510(k) submissions, the agency itself predicts that it will complete 6 percent fewer applications in fiscal year 1998 over fiscal year 1997 because it has fewer resources. It also predicts that it will review them 20 percent slower than it did in fiscal year 1996. In fiscal year 1996, it took them an average of 110 agency days for review; in fiscal year 1997, 120 days; for fiscal year 1998 it is predicted to be 130 days and will only complete 40 percent of the submissions in the statutory 90-day period compared with 60 percent last year. So it makes no sense whatsoever to assert that the agency is well on the way to reforming itself and this legislation isn't needed when the agency's own predictions, own plan for what it is able to do with the resources it has for next year, indicates that it is going in the other direction, not toward reform, not toward more efficiency, not toward meeting their statutory requirements, but in the opposite direction. With respect to PMA applications, the agency has said, while it expects to receive slightly more PMA applications than in recent years, it will complete 27 percent fewer applications. In fiscal year 1997, they completed 75. But for fiscal year 1998, they predict they will only complete 55, and that they will review those applications 15 percent slower than last year, 250 days of review as opposed to 220 days, that they will complete only 35 percent within the first 180 days--that is the statutory limitation--as compared with 53 percent last year, and they will have a 17 percent increase in the backlog. If there has ever been justification for reform of FDA, it is in looking at their own estimates of what they will be able to do next year as compared to previous years. And so they are certainly not reforming themselves, certainly not going in the right direction. They are going in exactly the opposite direction. What we are trying to do here with this legislation that Senator Jeffords is leading the effort on--I might add with a lot of bipartisan support, both Republicans and Democrats, as indicated by the cloture vote last week with I think only five votes in support of Senator Kennedy's support of a filibuster. People want to move forward here. We know that hanging in the balance are decisions that can affect people's health and safety and their very lives. We want to do this in a more efficient and effective manner. So I think there is certainly justification for going forward with this reform bill. I just point out, for the benefit of my colleagues, that even after extensive debate and markup in the committee, which produced a vote of 14 in favor and only 4 against on the legislation that we are discussing today, there has been considerable negotiation. I have in my hand here a list of 33 separately negotiated compromises to try to accommodate the Senator from Massachusetts, four pages of single-spaced negotiations on 33 separate items to try to address the concern of the Senator from Massachusetts and a couple of other Senators on the committee who thought that perhaps we should have addressed these in committee. In good faith, we sat down with them and attempted to address their concerns. I know that Senator Harkin had a particular concern during the markup, and we were very close to getting an agreement on that. And I take responsibility for not accepting it at the time. In retrospect, I think Senator Harkin was correct. I think what he was suggesting in terms of how we classify medical devices and what devices will be eligible for outside third-party review was correct. And so we notified him of that. We worked with his staff, and we made the change. So the bill before us incorporates the change that he thought we should have made in committee. In retrospect, I wish I had made that change in committee. I think it probably would have changed the Senator's vote. And I think it would have been wise for us. We would have then had a 15 to 3 vote or maybe even a 16 to 2 vote if that was the case. In review of that action, that was one of the compromises or one of the negotiations that were made. But to say that, you know, we are standing here on the floor unwilling to look at reasonable requests for some of the concerns and objections of the Senator from Massachusetts, or from others, I think this undermines that assertion. Mr. President, 33 changes have been made to address the concerns raised by the Senator from Massachusetts and from others. Mr. President, I sincerely hope that we do not have to engage in another filibuster effort as we move to the bill itself and open the bill up for amendment and consideration. With that vote on Friday, only five votes in favor of proceeding with discussion of the bill, I think it would be a disservice to the American people, a disservice to the FDA, and to this body for us to engage in additional lengthy filibusters of this where we have to go to another cloture vote. So I hope that as soon as we finish the Labor-Health and Human Services appropriations bill, we can move with a definitive timetable which will allow amendments to be offered, hopefully debated with some kind of limitation on the time so we can move and then vote on, and then move forward with this. It makes no sense to continue to delay it. Mr. President, let me just talk a little bit about what the bill includes--we talked about why we need it--about what the bill includes. Back in 1990, I authored legislation which would allow some expedited provisions within FDA for review of what is called humanitarian devices. These are devices that affect only a small class of people and really are not in the manufacturer's financial interest to proceed with these devices because there is not a broad enough market for them. But yet there are individuals that can benefit from these devices, and it makes no sense to have the same convoluted, time-consuming process, and particularly some of the specifics of what the FDA requires for approval of these devices, if the sum total of all of that discourages the manufacturer from going ahead because there is such a limited class for whom these devices are applicable. Then the only losers in this are the people for whom the devices could have improved their quality of life or perhaps have been of great benefit to their health. And so in 1990 we enacted some humanitarian device provisions. But since that time, as a result of I think what can only be described as bureaucratic delay and inefficiency, since that time only one company has been able to take advantage of this provision. The bill that we have before us expedites certain agency procedures. It allows a waiver of prior hospital review committee approval if the patient would suffer harm or death while waiting for supervised approval. So if a patient is in a position where waiting for approval could result in their death, it allows for the provision for a waiver of the agency procedures. In addition, the agency is ordered under this legislation to review the application in 75 days, and that is one of those compromises. We originally had 60 days. The agency thought they needed a little more time. We agreed to allow them to have 75 days. And the agency was no longer allowed to arbitrarily force the manufacturer to seek reapproval of the product. In the past legislation the approval was only good for a limited period of time and then they had to go through the whole procedure again to get reapproval. We are saying once the agency approves it, absent evidence to the contrary, that approval sticks. In addition, the humanitarian device provision is made permanent whereas before it had a sunset. Now, perhaps one of the most important parts of this legislation is the increased access to expertise, outside expertise, to allow the agency to accomplish its reviews and approval process in a much more expeditious timeframe. We, in the bill, require the FDA to enter into contracts with nongovernmental experts--non-FDA scientists and reviewers--to assist in product approvals. We are still talking about medical devices here to assist in product approvals if the agency determines that doing so would improve the timeliness or the quality of the review. It is important to understand that the agency is going to retain final approval authority over the review, but for the first time we are requiring them to utilize outside experts, outside resources to help them with that review. They are saying, ``We're overwhelmed. We have all these applications. We don't have enough employees to review it. And that's why we have the delay.'' We are saying, ``There are organizations, institutions, agencies outside of the FDA that can help provide these reviews. We are asking you to look to these to provide some assistance. But you, the FDA, have approval authority.'' In other words, it does not automatically go to an outside reviewing group, but it can go to a group that the FDA approves of. I do not see what the problem is with that. I mean, final authority rests within the FDA. But if there is an organization outside the FDA that the FDA can contract with or that the manufacturer can contract with, to expedite it, as long as FDA retains approval authority, then why not utilize this? It is going to expedite the process. The agency currently has a pilot program in place with which it is testing out this concept. We want to expand that pilot program. We would like to require that 60 percent of the nonexempt 510(k) submissions be included in the pilot. We also have language in here which limits the agency's ability to write all the guidance documents for these organizations. Sometimes the writing of the guidance documents takes months, if not years, and in a sense is unnecessary because the agency can allow the outside organization to go forward without that as long as it retains authority. We are concerned about a manufacturer contracting with an outside agency just to seek approval. And if the manufacturer were allowed the contract with that outside agency, and they just said, ``OK, we reviewed it. Here is the approval. You have to take it,'' there would be legitimate grounds for objection to that. But we have built in total oversight authority and control into the FDA so that they really are not giving up jurisdiction here, they are just utilizing that outside source to help them do their work. It is not like somebody subcontracting work out if they do not have the capacity to do it within their factory or within their business. But because public safety and public health is at risk here, we want to make sure that FDA retains sufficient authority to oversee all of this. FDA is given the authority in the bill to establish conflict of interest protections because we do not want to get into a situation where there is a conflict of interest between the manufacturer and the review authority. FDA decides what those protections are. FDA accredits the pool of qualified organizations. In other words, a manufacturer cannot go to any organization unless FDA has preapproved that organization, that outside agency for review. They have to get FDA's stamp of approval, good seal of approval, before they are even eligible to do the work to assist FDA. FDA selects from a pool of two or more accredited parties from whom the product sponsor may select. In other words, FDA says these agencies are certified to do this work; the company selects one or two or a pool of accredited parties, and FDA then makes that selection. FDA has authority to revoke the accreditation if it feels that it is not proceeding according to the way they want it to go. It has the ability to investigate any kind of conflict of interest and it has final approval authority. Now, this is important, this final approval authority. At one point, I threw up my hands and said the FDA has so much authority why are we going outside? Are we not just defeating the purpose? But in order to get the legislation addressed, we built in all these protections, additional protections, and of course the best protection of all for FDA is that it has final approval authority. If it does not like what comes back from the outside agency despite all these other steps where it accredits and so forth it can say we do not approve because we do not think the agency did such and such. So it has preapproval authority. It has process approval authority. It has final approval authority. That is plenty of protection. All of what you hear about how risky it is to American health and so forth, some agency which is not part of the Federal Government is involved in approving a particular product, that is not the case, because we have built into the legislation approval authority for FDA all up and down the line. Title III improves the collaboration and communication between FDA and the various drug and device companies. There is a list of items that I will not take time to detail. Title IV clarifies a lot of the rules currently in place and improves the certainty of the process. We address the whole question of policy statements. In recent years, FDA has increasingly developed informal policy statements without involving the public and has failed to make the policies available to the public. In response to a petition from citizens in my State, a group of Indiana manufacturers, the agency published guidance that radically changed these practices. The bill requires the FDA to make this ``Good Guidance Practices" document permanent by promulgating it as a final regulation in 2 years. In the area of labeling claims for medical devices, in the past the agency has looked beyond a manufacturers' legitimate labeling claims and requires that the company making the product provide extensive data on a variety of claims for which the company never intended the product to address. The product was designed for a specific purpose. The FDA said we want you to conduct all kinds of trials and provide extensive data for what other things it might be used for, not for what the company is marketing it for, not for what the company has designed it for, but what it might be used for. That has clearly delayed the ability to review products and to get them approved. The bill clarifies the relationship of labeling claims to approval and clearance of products, and it further limits FDA's review of device submissions to the intended use of the device set forth in labeling. We tried to build in certainty of review timeframes. I will not go through the details of that, but that is extensive and brings some certainty to the process. We have placed some limitations on initial classification determinations. Recently the agency denied due process of law to manufacturers by withholding a substantial equivalence determination even when the product was in fact substantially equivalent whenever the manufacturer was determined to have even a technical defect in the GMP inspection. The bill prohibits the FDA from withholding the initial classification of a device based on failure to comply with unrelated provisions of the act, including good manufacturing practices. The agency is directed to use its ample existing enforcement authority to ensure that products that have the GMP violations at the time of classification do not reach the market. Title V, improving the accountability. It sets an agency plan for statutory compliance in an annual report so we have a better handle on what is going on within the FDA. Title VI, better allocation of resources by setting priorities. We exempt certain classes of devices from premarket notification requirements. This really expands on the administration's reinventing Government initiative that exempts class I and class II medical devices that pose little risk by exempting all class I devices, the least risk devices, except those that are important in preventing impairment of human health or presents potential unreasonable risk of illness or injury. We had extensive discussion on this. This is an area where Senator Harkin raised what I believe are legitimate concerns and we have tried to address those concerns in this legislation. We have evaluation of automatic class III designations. Current law requires that all new devices not substantially equivalent to a device already on the market must be automatically classified in a highest- risk category. This does not make sense. If a very simple device that would otherwise be a class I or class II device is not substantially equivalent to a device already on the market, it has to be automatically classified as the riskiest of all devices and therefore falls into class III for the review process, and the approval process, which takes an extraordinary amount of time and requires an extraordinary amount of data, clinical trials and so forth. That is not necessary. So we have changed that so that it does not automatically fall into class III. It says ``if it is not substantially equivalent,'' what we have done here is allow the agency to make a determination as to which category it would fall in rather than automatically go to class III. So the agencies could look at it and say we think this is class I or class II and is subject to those review procedures rather than automatically moving into class III. It is a sensible change in the current status of how this is handled. We made changes regarding health care economic information, health claims for food products, and pediatric studies of drugs. Title VII, we have extended, and of course this is the engine that drives the train here, and another reason why it is so necessary to move forward with this legislation. We have reauthorized the Prescription Drug User Fee Act for 5 years. That is the so-called PDUFA legislation which the prescription drug companies have agreed to support. It is a tax on those companies for the specific purpose of providing extra funds for FDA to hire personnel to expedite the reviews of drugs which are submitted for review and approval to the FDA. It has worked out very, very well in response to an overwhelmed FDA who could not begin to meet their statutory requirements for review of drugs. A proposal was made that we would enact a tax against the companies submitting the product and the proceeds of that tax will be used to hire personnel and establish procedures whereby we could expedite the approval drugs. It was needed. It was supported. It has worked. We need to reauthorize it because it expires October 1 this year. That is why it is so important to move forward with this legislation. There are other things in the bill, Mr. President, but in the interests of time I will not detail them unless the President wants me to go through them point by point, but I do not think we have the time still allotted. I know the majority leader is anxious to move back to the Labor-Health and Human Services appropriations bill. Again, I thank the Senator from Vermont for his leadership on this issue. It has been a cooperative effort that has reached across the aisle and involved Members from both parties in a very substantial number. Hopefully, we can move forward now in getting to the bill itself and the amendments and move this very needed legislation forward. I will be involved in this. I know there are a number of discussions coming up with some of these amendments. I appreciate the leadership and support of the Senator from Vermont, who is not testing but actually utilizing a medical device to address an unfortunate accident he had just last week. I yield the floor.

Mr. COATS

Mr. COATS. Mr. President, I would like to add my support, in a bipartisan way, to the remarks as stated by the Senator from Connecticut and the Senator from Maryland and the efforts that have been undertaken by the chairman, Chairman Jeffords, and all of us on the committee over the past 2\1/2\ years to move this bill forward. There has been extensive debate on this in committee, 2\1/2\ years' worth. There has been extensive hearings on this. There has been extensive negotiation, and there has been extensive compromise on the part of those of us who are advocating FDA reform. We have made concession after concession after concession to Senator Kennedy and the administration and to those who have opposed our efforts in an attempt just to get the bill to the floor. Every time we solved one issue, a new one pops up that we had discussed over and over and over and voted on in committee, but it does not mean that we should not move forward with the process. All we are asking for today is to move this bill forward so that Senator Kennedy and others who have concerns with it can raise their objections, can debate it once again, can negotiate some more. But to stop the bill from going forward, to keep the drugs from being approved, to keep funds from going into FDA, to deny people the benefits from FDA approval of drugs and devices, simply because a Senator has a problem with one portion of the bill, I think certainly does not serve this body well. So I urge our colleagues to support the effort to invoke cloture so that we can move ahead with this.

Mr. COATS. I would like to yield some of that time to the Senator from Maryland, if she is interested in making some comments. I have a limited amount of time, but I would be happy to yield a portion of it.