Jim Jeffords

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I must answer that charge.

Mr. JEFFORDS. Mr. President, I yield myself such time as I may consume. Mr. President, we are here to discuss yet again the need for cloture on S. 830, the FDA Modernization and Accounting Act. We have already had 14 hours of floor debate on this measure and we have not yet discussed this amendment. This will be the second time that cloture has been voted on regarding this measure. The first vote was 89 to 5 to invoke cloture. The Senate has spoken. And, yet, we are here to repeat ourselves again and again. My colleagues have already heard repeatedly from both sides of the aisle about the strong bipartisan commitment to crafting this measure, about the months of negotiations, deliberation and collaboration with the administration, the minority, and outside groups. Literally dozens of accommodations have been made and agreements reached. No one disputes that this is a good bill. No one should dispute that we have moved forward, or that we should move forward, with our debate on the remaining issues. Now we should move forward on that debate. This measure accomplishes two very important objectives. First, it modernizes the way that the Food and Drug Administration accomplishes its mission. It streamlines the review and approval process for medical devices, pharmaceutical, and biological products. In so doing, it helps to ensure that the best and safest medical technology available in the world would be available to the American people. In so doing, it helps ensure that the best medical technology jobs will continue to be available for the American people. Second, this measure authorizes the Prescription Drug User Fee Act-- or PDUFA, as it is known. Everyone agrees that PDUFA has been immensely successful in helping FDA do its job better and more efficiently. Mr. President, congressional authorization for PDUFA expires in 15 days. At the end of September this successful and innovative program will be at serious risk. It is the height of irony that a program like PDUFA that was designed to reduce delay at the FDA is now at risk of becoming bogged-down in a procedural delay on the Senate floor. I would argue that the time for delay is over, and that the time for the Senate to do its work it was sent here to do is now. Almost 50 amendments have been filed on this measure. And, frankly, virtually all of them are nongermane, or they have been worked out, or they can be worked out. A single provision remains that may require some extended debate, and we should move to its consideration and an up-or-down vote on it as soon as possible. Last week we spent almost 15 hours talking about uniformity for cosmetics. We have an agreement on that provision, thanks to the efforts of Senator Gregg. I say that we should move on. I say we complete this debate, and finish this measure, and let's vote. Mr. President, I yield the floor. Mr. KENNEDY addressed the Chair.

Mr. JEFFORDS. I reserve the right to object. What is the regular order here with respect to amendments?

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the previously scheduled cloture vote be postponed to occur at 12:15 p.m. today, and further, that second-degree amendments may be filed up to 10 a.m. this morning. I further ask consent that following debate this morning regarding the FDA reform bill, the Senate resume consideration of the Interior appropriations bill until the cloture vote.

Mr. JEFFORDS. Mr. President, as to the Senator from Iowa, I apologize that we are in an awkward situation this morning. I have assured him that we will have a hearing in October on NIH with respect to alternative forms of medicine. I look forward to that because I agree with him on that issue. Unanimous-Consent Agreement

Mr. JEFFORDS

Mr. JEFFORDS. Yes. If the Senator will yield, my understanding was when we went home this weekend that we would be ready to close the bill and have all amendments with time agreements. Now my understanding from the minority is that they are not in agreement on one particular provision of the substitute. Thus, I would believe we should go forward with the cloture vote. We are ready, though, with a number of amendments for which I believe we have agreements. We could address those in the interim while we try to work out the final amendment.

Mr. JEFFORDS. I do, too. I understood that all matters were taken care of. But now I understand from the leader of the minority that is not the case--that they still have this problem with respect to one provision. But we are ready to go ahead with all of the other amendments and believe we should expeditiously go to the cloture vote whenever the situation presents itself, as the leader outlined.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Committee on Armed Services be authorized to meet on Tuesday, September 16, 1997, at 10 a.m. in open session, to consider the nominations of Gen. Michael E. Ryan, USAF, to be Chief of Staff, U.S. Air Force; Adm. Harold W. Gehman, Jr., USN, to be Commander in Chief, U.S. Atlantic Command; and Lt. Gen. Charles E. Wilhelm, USMC, to be commander in chief, U.S. Southern Command and for appointment to the grade of general.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Committee on Commerce, Science, and Transportation be authorized to meet on Tuesday, September 16, 1997, at 9:30 a.m. on tobacco advertising and youth.

Mr. JEFFORDS. Mr. President, I ask unanimous consent on behalf of the Governmental Affairs Committee Special Investigation to meet on Tuesday, September 16, 1997, at 10 a.m. for a hearing on campaign financing issues.

Mr. JEFFORDS

Mr. JEFFORDS. First of all, Mr. President, I want to thank the Senator from New York, the ranking member of the Finance Committee, for his excellent presentation on the history of the Endowment. I think it is important that we dwell on that a while, or just a few minutes here anyway, because we have heard some rather severe condemnations of a program of which, in the final analysis, after review, would show has been very helpful in enhancing the availability of the arts in this Nation. I find it problematic that even though we seem to have eliminated all of the policies that have caused problems as part of the 1996 appropriations act, to some, they still seem to exist. Let me talk a little bit about that, after again, thanking the Senator most sincerely for that historical presentation, which was most helpful. Back in 1996, when we passed the appropriations legislation, we placed prohibitions on policies that have caused difficulty with the Senator of North Carolina and others, on the utilization of funds from the Endowment. First, we placed a prohibition on subgranting. Now, subgranting was a practice in which the Endowment itself would give a grant to an institution and that institution would in turn make grants for other things or to individual performances. An example of such a practice was raised with regard to a program mentioned by the Senator from North Carolina with respect to the Whitney Museum. It is illustrative because it points out how far we would have to go in order to satisfy those who are concerned about painting the Endowment out to be making inappropriate grants--some time, some place, somewhere, some performance will be what someone might call pornographic. Most often, it is that subgrant or another activity, separately funded, which was not issued by the Endowment, like the example of a performance at the Whitney Museum. The Whitney Museum did get a grant for its building, but not for the performance that the Senator from North Carolina mentioned. Now, the Senator from North Carolina would say that because a performance was done in that building, which had received a grant for its construction, it should have been prevented because it, in his determination, would have been offensive. That is an unrealistic standard and I would hate to think that of the programs that we fund in the United States, that we would go to the extent of censoring what people there participated in or what happens in our places of enjoyment, museums, or any place else. Another thing we did to prevent some of the types of programming which had become offensive was to prevent seasonal support. Institutions must now specify what specific projects they will support with the funds they receive from the Endowment. And also, even more important from the perspective of trying to prevent the kinds of performances which the Senator from North Carolina was pointing out, was to prevent grants to individuals. In the House when the issue of some of these grants was raised, Jane Alexander, the Chairman of the NEA--and I will make this a part of the Record--pointed out in the House definitively that they were not grants made by the NEA. Still, those are the ones that are used to condemn the NEA. I ask unanimous consent that a copy of the letter from Jane Alexander to Representatives in the House be printed in the Record.

Mr. JEFFORDS. Mr. President, I want to point out that we should not get off track of what the Senator from New York has attempted to do, and that is to remember why the Endowment was created and what is the importance of the arts, what is the importance of the Federal support for the arts. We have a huge Nation, a wonderful Nation, and a nation with diverse cultures with wonderful things occurring from one coast to the other, from the North to the South. The arts help us understand life and the NEA help the Nation learn about the good things that are going on in the arts across the country--the good things that will help us understand where we are going, what our society is about, and what we need to do to be happy, to have a good life, and to be able to solve our problems. The purpose of the Endowment is to allow those areas--those things that are successful, those things that appeal to us, that make our culture rich--our art--to be shared from State to State. The Federal role encourages this exchange and supports all States by collecting, disseminating, and allowing programs to tour all around the country, making sure that programs which are important and essential to education or to assist those in depressed areas that are impoverished are shared. So I will be offering an amendment which will say that at this time in our Nation we recognize that we have two very serious problems, and they are very closely related: Education. We know that we must improve education in our Nation. It is essential that we do that. It is essential because in this day and age competition from international economies has created real problems for us, with jobs in the thousands leaving this country and going to others, threatening our Nation's ability to compete right now. For instance, we have 190,000 jobs in the technology area that are going unfilled because we do not have the young people or older people with the skills necessary to perform those jobs. We had one CEO who testified before the Labor Committee who said that he had seriously considered, like others are moving centers of their manufacturing from this Nation to other nations because people there have the skills, they are ready, they are available, and the cost is cheaper. So one of the purposes and an important function of the Endowment is to try to see how we can help solve that problem of education. In addition to that, we also have the problem of welfare reform. Some of the greatest problems this Nation faces are in the inner cities with our poor, with violence, and with the incredible problems that people face trying to find direction and meaning in their lives. What can you do? How can you escape from the pressures that you have in the ghettos? I have traveled around this Nation and have observed education and welfare programs. Many of these are programs were enhanced by programs put on or financed in part by the National Endowment for the Arts. Let me give you a few of those to demonstrate what I mean. The thing I would like to talk about first is education; and learning. It is so much easier to understand and to learn if what you are doing is relevant, or in some way relevant, to your life, making it a little bit better, or giving you a way to make it a little bit better. Let me go through some of the programs that I have witnessed. These were funded by the Endowment, or assisted by the Endowment. Let me take you to the inner city of New York City in the Hispanic area where some of the highest crime rates and some of the highest poverty rates exist. I visited Ballet Hispanico on a weekend morning where young kids of 5, 6, 7, or 8 years old received instruction in ballet, participating with all the enthusiasm that young kids can have, knowing that when they left there they were going to have just a little bit more hope. This program provided a way that they could see a window through all of the chaos that they live in to be able to take them to a better life. A more dramatic exhibition of that, also in New York City was a program that I visited--again, a program which was supported by the Endowment--where I saw these young children all drawing kind of frantically on the papers that were in front of them. I asked, ``What is going on here?'' The teacher informed me that each one of those children had lost a member of their family, by violence, that they had blocked off reality, and they could not communicate about what happened to them. But by drawing and by artistic expression they could let their feelings out, they could break through, there was hope for those children that their life could break away from this poverty and violence which they were in. Also, one only has to go to listen to the Harlem Boys Choir or so many other demonstrations of what has gone on with the individuals who have participated in NEA funded activities. I also went out to San Diego, CA, and went to a school out there which was an incredible one, a music magnet school, but again in one of the depressed areas of San Diego. This was a middle school of seventh, eighth, and ninth grades, where they had an orchestra, a band, a jazz band. Almost everyone in that school had arrived there in the seventh grade without any skills in music. When I listened to them play, it brought tears to my eyes. To think that these young people when they came to that school did not see a purpose in life but perhaps now saw that there could be some beauty in their lives. I could go right here to Washington, DC. In Washington, DC, we have a school that is under the tutelage of the Kennedy Center. I was amazed with that one. I found they had artists there who were teaching, but they weren't teaching art. They were teaching math, and they were teaching science. How were they doing that? I went, and I watched these young kids making little pianos. They were learning how to measure them, construct them, and learning their geometry. Then they learned how the sounds came out differently from the little thing they hit it with. They could make music. They understood why the frequencies were different and why the frequencies were made different by the lengths of those strings. What happened to those students? The math rates went up in that school--not so much for the reading scores, but the math rate went climbing upward. So we know that using the arts, there are ways in which we can break through to things which are interesting and relevant--music as well as the performing arts and the graphic arts. So we have a way to realize improvement here. So that is why my amendment would say that what we need in this country is to identify each of these programs all throughout the country and to let other people know in other States what programs are working, what are the ones that break through to those young kids who had suffered from violence and loss in their families. Which ones broke through to help? Is there further evidence of how this could work? Statistics based on College Board figures, the organization that performs the SATs, show a difference between those students who participated in music and the arts as compared with students who did not. They found there was a dramatic difference. With those who had 4 or more years in music or art, verbal SAT scores went up almost 60 points and math SAT scores went up over 40 points. To a young person who is hoping to break out of poverty, to not get caught on welfare, the thought that by participating in music and art, the window of opportunity could be enlarged and the doors of college or university could be opened wide to them gives you an idea of what can happen if we structure the NEA better so that it identifies, helps fund and allows us to share throughout this broad Nation of ours those successful programs. I have done a rough analysis and summary of just a few of the successful kinds of programs that we have like this in this country. They are very different. Some use the arts secondarily. Some in different ways teach math or science. Roughly 1 percent of our schools are good; 1 percent are doing the job; 1 percent of our students are getting that kind of education that we need. Ninety-nine percent need to learn from somebody, somewhere, or somehow how they can improve their results. The way they can do it is by being able to know where those programs are, who has them, so that they can identify and look at them and replicate them. I think the Endowment, by helping identify, perhaps in cooperation and coordination with the States and the Department of Education, can make those programs available for others to see and to utilize. One of the advantages of this great Nation is that we have people who are innovative, who can design and find ways to solve these problems. The disadvantage we have over foreign nations is that of replication, getting the people who are in charge of the programs, who are trying to design these things well to become aware of successful programs that already exist. Let me give you an example of how we differ from other nations, and we have to analyze it as to whether we should be looking at this problem and see if we can correct it. I think we should. We have a program in the area of work force improvement called TECH PREP. It is in combination with the secondary schools and junior colleges or community colleges, and how they can work together and bring some of the courses down into the high school and to pull the students up to the level where when they graduate they will have the ability to get those jobs that I was talking about those $30-, $40-, $50-an-hour jobs paying $100,000 or $90,000 that are available in this Nation. Malaysia came over and took one look at our program, TECH PREP, and said this is a great idea. Look how well it is working. They went back and overnight Malaysia adopted our TECH PREP program. We are still at 1 percent. About 1 percent of the schools in this country have the TECH PREP linkage with other higher educational institutions. Those are just examples of why it is necessary for us to have programs and methodology to be able to share those great things which are occurring throughout the Nation so that they can be available to all. Those things will not be readily located or identified or provided unless we have some way to collect, to identify, to evaluate, and to let others know about them. I believe the Endowment could help us immeasurably in that area. Mr. President, I have gone on longer than I wanted to. I suppose I will be back tomorrow when we take this up. I hope that my colleagues will share some other examples of NEA-funded programs that demonstrate the advantage of a Federal system which tries to enhance the arts and our culture, enhances enrichment and educational activities as well as to show what positive results can be achieved by giving young people, at an early age, an interest in learning. The NEA has been successful in these areas. Mr. President, I yield the floor.

Mr. JEFFORDS

Mr. JEFFORDS. I thank my colleague for his remarks. We share a commitment to ensure that effective Community Schools programs like CITYSCAPE in Vermont are given priority in funding within the new program for at-risk youth. I would also add to my colleague from Vermont's remarks that a key component of the Barre City Program is the development of community ownership and a volunteer base that will ensure the continuation of this program beyond the end of the grant cycle. Our intention is to work with the committee to make sure that CITYSCAPE and other good programs reach the point that they can stand on their own with community support.

Mr. JEFFORDS. Mr. President, I rise in strong opposition to this amendment. This amendment goes under the presumption that the Federal Government controls these programs. The fact that the author of the amendment has already taken three-quarters of the money out of his amendment and continues to give it to the States recognizes that. The additional funds that would go for these programs will no longer go to these programs, but will go directly to local governments--Goals 2000; school-to-work; technology; reading, school improvement programs like ``Reading is Fundamental''; arts education; magnet schools; women's equity, et cetera, et cetera, et cetera. Drug-free schools will just go to local governments. Indian education, bilingual education, vocational rehabilitation--50 percent going to rehab will instead go to local governments to do with as they want. Vocational education, they will do the same. Yes, it goes to education, but there is no maintenance of effort here, therefore, the local governments may well decide to replace their present educational money.

Mr. JEFFORDS. I ask for the yeas and nays.

Mr. JEFFORDS. Mr. President, I rise only to commend those who have brought about this very reasonable compromise. This could have been a very divisive issue, but Senator Bingaman, especially Senator Coats and Senator Gregg have worked very long and hard to make this into a reasonable compromise which will be of assistance to us rather than something that could have been detrimental. I yield the floor.

Mr. JEFFORDS

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

Mr. JEFFORDS. Mr. President, I send a modification of the committee amendment to the desk.

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

Mr. JEFFORDS. Mr. President, this legislation is the result of a well-considered process to consult with all points of view and to benefit from the expertise needed to craft legislation on this complex matter. The substitute before us today stands on the shoulders of four hearings and a committee markup of a comprehensive Food and Drug Administration reform bill in the 104th Congress. This year we held two more hearings, taking testimony from Food and Drug Administration, industry experts, physicians, and consumer groups--and I emphasize ``and consumer groups.'' Staff held dozens of meetings with Food and Drug Administration, experts and patient groups, discussing in detail every issue of this bill. The negotiation process with Food and Drug Administration, and the minority started in the drafting phase of the bill and continued up to and right through the markup, and has continued right up to this moment. This has been a process marked by openness and consultation. The philosophy of this bill is to codify recent efforts of the self- reform of the Food and Drug Administration, and a great deal of that is self-reform which we are codifying, and to provide the Food and Drug Administration with the tools to do even better in certain areas. We recognize that Congress cannot micromanage an agency like the Food and Drug Administration, nor do we want to. But we must set realistic performance goals to ensure the public is protected and well served and that the industry is fairly treated. In an era of flat or declining resources, we must give the Food and Drug Administration the management tools it needs to manage an increasing workload without the expectation of ever-increasing appropriations to assist them. The first title of S. 830 establishes in statute that the mission of the Food and Drug Administration is to protect the public health, promptly and efficiently review clinical research, and take appropriate action on the marketing of regulated products in a manner that does not unduly impede innovation or product availability. From the 1906 Food and Drugs Act through the 1990 Safe Medical Devices Act, food and drug law has emphasized the duty of the Food and Drug Administration is to protect the public against unsafe or ineffective products. This legislation, as reflected in the mission statement, strengthens protection of the public from unsafe or ineffective products and provides a better balance in the law by ensuring timely access to safe and effective products. It is simple: Safe and effective products can be made available more quickly--and they should be. That is what this bill does. The legislation reauthorizes the Prescription Drug User Fee Act of 1992, commonly referred to as PDUFA, to allow the continued collection of user fees from prescription drug manufacturers for 5 additional years. PDUFA I represented a consensus among the Food and Drug Administration, the prescription drug industry, and Congress that the industry would pay user fees to augment the resources of the Food and Drug Administration devoted to the review of human drug applications. PDUFA I has succeeded in substantially reducing review times for human drug applications, bringing those drugs to the market sooner than before. At some point in the debate I would like to engage a colloquy with Senator Mikulski, a cosponsor of S. 830, to discuss the importance of the performance enhancements that PDUFA will bring to the drug review process. We have all benefited from Senator Mikulski's determination to bring the Food and Drug Administration into the 21st century for the benefit of her own constituents who work at the FDA, for the betterment of the burgeoning biotechnology sector in Maryland, and for the parties throughout America who are served by the technologies developed by those companies. Title VII of S. 830, or PDUFA II, would build on the original legislation by codifying new commitments from FDA to implement more ambitious and comprehensive improvements in the regulatory process. PDUFA I focused on reducing the length of time taken by FDA in reviewing an application. The committee commends FDA for successfully meeting, and at times exceeding, the performance goals established at PDUFA I. However, while review times for submitted applications have improved, the period of time taken to get the drug through the drug development phase has recently increased from 5 to 7 years. Appropriately, PDUFA II will focus on shortening overall development time. It will streamline interaction with the FDA during the highly regulated drug development phase and also establish new performance levels and procedures for FDA that are designed to reduce the time required to show that a drug is ready for FDA review. The bill provides improved access to new treatments and important information needed by patients. Section 102 establishes a statutory right for any person, acting through a physician, to request an investigational drug, biological product, or device for diagnosis of a serious disease or condition. This provision builds upon current FDA programs that have proved so successful for aids and cancer drugs, and this is an area that is critical to all of us. This section of the bill includes modifications urged by the FDA and patient groups, that codify important patient protections. These provide patient access under their physician's supervision, to unapproved therapies, under the existing emergency use, and investigational device and drug treatment exemption programs. Another important provision advocated by the patient groups as one of their top priorities is section 808, which establishes a registry of clinical trials, both publicly or privately funded, of experimental drugs and biological or serious life-threatening medical conditions. Registry information must be understandable to the general public and include the purpose of experimental protocol, trial eligibility criteria, and sites and contact points for people wishing to enroll in a clinical trial. It is critical that those people who are suffering from the diseases of this nature be able to find out how they can get involved and be able to take part in a program which is designed to bring them back to health. Patients, health care providers, researchers, and the public would access the registry through toll-free telephone communications and other informational systems. This provision was included in the bill as an amendment offered by Senator Dodd, based on legislation introduced by Senator Snowe and Senator Feinstein. We are all grateful for their leadership in this area. I should add that Senator Dodd, who is a cosponsor of S. 830, must be recognized for his early and unflagging support for enacting broad- based reform this year. He has worked incredibly hard and has been one of the most steadfast leaders in bringing forth a bipartisan bill. Yet another provision designed to speed new drugs to patients who need them is section 613. The FDA currently has a number of mechanisms aimed at streamlining the development and approval process for new therapies for serious and life-threatening conditions. Section 613 establishes a statutory mechanism for identifying breakthrough drugs early in the product development phase. It provides sponsors of such drugs a reasonable opportunity for early interaction with the agency to further help streamline the development and approval process for such drugs. This provision is intended to clarify and to coordinate some of FDA's mechanisms for new drugs and biological products that are intended for the treatment of serious and life-threatening conditions and that demonstrate the potential to address unmet medical needs for such conditions. It defines and clarifies a process pursuant to which sponsors of these drugs may interact with the FDA, and includes provisions that will ensure that these processes are well known and well understood. I want to mention other changes made in the substitute that have been the subject of discussion between the committee markup and floor consideration. I want to make sure that everyone has an opportunity to know what we will be voting on and that they will have an opportunity to review this and, hopefully, fully understand it. Certainly, my staff, and I am sure Senator Kennedy's staff is available to enlighten them if they have questions. I urge all members to take a look at the bill that is now before the Senate. The third-party review provision has undergone substantial revision since its was first debated in the 104th Congress. This provision has been developed under the leadership of Senator Coats, who has played an important role in advancing FDA modernization throughout this process. This year, he has played a special role in the development of S. 830 from its inception and provided wise counsel on how to achieve the best possible reform at the FDA. The third-party review pilot in this bill moves important expansion to the current FDA third-party review program for medical devices. I should mention that two amendments to the provision on third-party review for medical devices offered by Senator Harkin in committee, which were not agreed to, did form the basis for subsequent compromise reflected in the substitute now before the Senate. To meet the Senator's concerns and the concerns of others, the bill sponsors have agreed to statutory language establishing the right of FDA to review records related to compensation arrangements, and excluding from third- party review class III products, products that are implanted for more than 1 year, products that are life sustaining or life supporting, and products that are of substantial importance in the prevention of impairment to human health. This was an important provision which brought peace of mind to many and allowed us to come forward with the bill in the form we have now. These changes in scope and the additional safeguards to protect against conflict of interest broaden public confidence in this pilot and provide FDA with a needed tool to manage an increasing workload of medical device reviews. Two other critical provisions to improve the medical device review program will make the review process more efficient and collaborative for high-technology products--those which offer the greatest benefit for patients and which also experience the longest review times at FDA. Senator Wellstone is the sponsor of legislation to reform the medical device approval process that includes these two provisions and others in S. 830, and I applaud his leadership on these issues. Section 301 creates the opportunity for a manufacturer to meet with FDA to establish the type of scientific evidence necessary to demonstrate effectiveness for a device. FDA had earlier concerns about binding determinations of device data requirements needed to show efficacy. In response to the FDA, the provision has been modified to ensure that the agency will receive sufficient information to make such a determination and is provided authority to modify the determination where appropriate. Manufacturers should not have to spend months wondering if their application is still on track in the review process. Section 302 requires the agency to meet with manufacturers 100 days after a premarket approval application is submitted to discuss deficiencies and any additional information required for approval. This provision, too, was modified to address FDA's concerns that the agency only be required to identify deficiencies known at the time of the 100-day meetings. And FDA would only be required to identify information needed to correct those deficiencies. In recognition that the mandatory postmarket surveillance authority established in the 1990 Safe Medical Devices Act was overbroad and inconsistently applied, S. 830 made the current mandatory postmarketing surveillance discretionary and limited surveillance to a 24-month period, unless FDA showed that longer time is needed to track device after marketing. Concerns of the FDA and patient group are further addressed in the substitute by striking the portions of the provision establishing new duration and scope limitations on postmarket surveillance--under the agreement the only change to the existing surveillance authority is to make it discretionary, allowing FDA the flexibility to impose surveillance requirements as appropriate without leaving itself or companies in technical violation of the law. Another area of disagreement prior to markup was the manner in which S. 830 proposed to handle certain types of manufacturing changes for medical devices. Senate bill 830 proposed to allow these changes to proceed on the basis of a notification rather than a full supplemental application. The substitute modifies the provision in the manufacturing changes section so that FDA may in some cases still require the submission of a supplement for a manufacturing change, and such supplement must be approved prior to implementation of the change. These manufacturing change supplements shall be reviewed in 135 days. This compromise will still allow many, if not most, manufacturing changes to proceed under a streamlined process. Senator Gregg, who worked very, very hard on this bill, has been certainly one of those who deserves a great deal of credit for bringing it to the body in the form it is in, which I believe is most satisfactory. He is to be also commended for his proposals to streamline the FDA process for the consideration of health claims based on Federal research and his amendments to establish uniformity for over-the-counter [OTC] drugs and cosmetics. He has modified this provision to exempt California's proposition 65 and allow States to regulate cosmetic labeling and packaging issues where FDA has not acted. Senate bill 830 authorizes truthful, nonmisleading health claims for food products that are based on published authoritative statements of scientific bodies of the U.S. Government such as the National Institutes of Health. FDA expressed concern regarding the length of time the agency had to assess these proposed claims and the mechanism by which they might prevent a particular claim from going forward. Agreement with FDA was reached on the basis that FDA is given 30 additional days to review a health claim under the provision, for a total of 120 days to review a health claim. FDA is able to prevent the claim from being used in the marketplace by issuing an interim final regulation. FDA may also block a claim from going forward, if the conditions established under the provision governing claims are not met. Again, I thank the Senator for his excellent work in crafting this provision and reaching agreement with the FDA. The committee adopted an amendment by Senator Frist which conforms the statute with FDA's current practice and today's science with regard to the quality of data required to show drug efficacy. I am especially grateful to Dr. Frist, a cosponsor of the S. 830, whose medical expertise has lent credibility to the decisions we have made in the complex area of medical technology regulation. Senator DeWine, joined by Senator Dodd, offered an important amendment to establish incentives for the conduct of research into pediatric uses for existing and new drugs. The bill was improved by Senator Hutchinson's amendment, to establish a rational framework for pharmacy compounding, which respects the State regulation of pharmacy while allowing an appropriate role for FDA. I look forward to participating in a colloquy with the Senator and the ranking minority member on this topic. The ranking minority member, Senator Kennedy, has played a vital role in bringing this compromise to the floor. In markup, he offered two important amendments adopted by the committee. One amendment, developed in consultation with Senator Gregg, improved a provision from last year's legislation governing the regulation of radiopharmaceuticals. The second improved the bill's provision setting forth a streamlined process for the review of supplemental applications for new uses of approved drugs. I commend the Senator for his hard work and willingness to compromise on a number of issues which threatened to hold up proceeding on the bill. We reached agreement on the distribution of health care economic information. This data is the essential information ingredient in the drug selection process in the growing managed care sector of the health insurance marketplace. We agreed to require pharmaceutical companies to report annually on their efforts to comply with postapproval studies. This is essential information needed to provide the assurance that these studies will in fact be completed. Again, I thank the Senator for his willingness to work out these and other compromises. Finally, I would like to comment on the involvement of patient and consumer groups: They testified at one of our committee hearings. Also, our staff met a dozen times with representatives of these groups to discuss their proposals, share our ideas and drafts, and debate policy issues. Representatives of these groups were in key meetings with industry, FDA, and bipartisan staff to discuss the resolution of issues they identified as critical--pharmacoeconomics and the requirement of drug companies to comply with postapproval, or phase four, study requirements are examples of where we relied heavily on their advice and were pleased to have their information. The bill reflects changes to address their concerns: Companies must report on their compliance with phase four studies; FDA is given express authority to inspect compensation records of third-party reviewers; patients will have access to a registry of clinical trials information; and additional safeguards were built into the provision allowing expanded access to products under clinical investigation. It is clear that these groups have played an active and important role in drafting this bill. Mr. President, I stand before the body today with a sense of relief because, for the first time, I feel we are really, without any further delays, coming toward completion. It is also still my purpose and my goal to ensure that all Members will still have an opportunity to express themselves, and that when we come back next time, I hope that we will have an agreement or unanimous consent that we can proceed without the necessity of invoking cloture, and have amendments established to be considered in reasonable lengths of time, so that this bill can move forward. Certainly, I ask those who are desiring to propose amendments, when we come back here next week, to get in touch with us today, tomorrow, and during the weekend and the first of the week so we can try to accommodate all Members who desire to have amendments that they desire to have expeditiously considered. I urge all of the body to recognize that this is an important piece of legislation. It has to be acted upon yet by the House. They are anxiously awaiting us to move, so hopefully the bills can be as close together as possible, so that we can have the bill signed into law expeditiously, within a month. With that, Mr. President, I suggest the absence of a quorum.

Mr. JEFFORDS. That is correct.

Mr. JEFFORDS. Mr. President, I make a point of order that a quorum is not present and ask unanimous consent that it be evenly divided between the minority and majority.

Mr. JEFFORDS. Mr. President, the amendment that I sent to the desk is a modification of the committee amendment, and it is the amendment we desire to move forward on.

Mr. JEFFORDS. Thank you, Mr. President. First, filing a cloture motion sort of indicates a serious situation which requires its action. I am pleased to report that I am more optimistic now than I have been at any time that a vote will not be necessary to have cloture and that we are all working very long and hard upon resolving the remaining questions. The most difficult one that we were facing appears to be resolved. So it is my firm belief that by the time we come before this body again, other than today's debate, we will have an opportunity to expeditiously pass an FDA bill for the Food and Drug Administration to ensure that we have it passed in time to prevent the problems which might occur by failing to do so. Legislation to reform and modernize the Food and Drug Administration has been under consideration by Congress for over 3 years. At least six hearings have been held over the past 2 years in the Senate. Last year, our measure was reported out of committee but never reached the floor for full consideration. This year, we have held hearings and worked through months of negotiations with my colleague from Massachusetts and with the administration. S. 830 passed out of the Labor Committee on a vote of 14-4, a strong statement as to the bipartisan support this moderate measure enjoys. Last week we had a vote on the motion to proceed, and the vote was 89-5 that we begin consideration of this measure. We are here today to do that. The Senate spoke loud and clear last week: ``Let's move on the bill. Let's consider amendments. And let us vote.'' We have now had over 15 hours of debate on this measure stretching back to before the August recess. Most recently, we spent a good part of Friday and Monday debating essentially 6 pages out of the 152-page bill. The time to move forward on this measure is now. I urge Senators to examine this measure, and I believe they will agree with me that it provides moderate, incremental but important improvements to the FDA while continuing the agency's ``gold standard'' of public safety. I have never worked harder on a bill, and I say the same for the members of the committee, than we have on this one. The number of hours that have been spent bringing about consensus is incredible. I thank my ranking member and our staff for their cooperation and for placing us in a position where I believe we can expeditiously pass this next week without the necessity of having to invoke cloture. So at this point, Mr. President, I yield the floor. Mr. KENNEDY addressed the Chair.

Mr. JEFFORDS. The minority representative and myself are sitting here. There is some time left. However, we also want to move the calendar forward as best we can. I just want to alert all Members, minority and majority, if we do not receive a communication from a Member or staff within 10 minutes, it is our intention to yield back the remainder of our time in order that we may move the process of the Senate forward. I just let everyone know that. We will be sitting here, awaiting the news. I suggest the absence of a quorum.