Jim Jeffords

Mr. JEFFORDS

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. JEFFORDS. Mr. President, speaking on behalf of the leader, I ask unanimous consent that the cloture vote with respect to FDA occur at 10 a.m. on Tuesday, September 16, the mandatory quorum call under rule XXII be waived, and the time between 9:30 and 10 a.m. be equally divided for debate, prior to the vote.

Mr. JEFFORDS. Therefore, under rule XXII, all first-degree amendments must be filed at the desk by 1 p.m. on Monday, September 15. I ask unanimous consent that all second-degree amendments may be filed up to the time of the vote on Tuesday.

Mr. JEFFORDS. Mr. President, at this time, and I have the permission of the minority, I will yield back the remainder of our time, both minority and majority time; and I so do.

Mr. JEFFORDS. Mr. President, I make a point of order a quorum is not present.

Mr. JEFFORDS. Mr. President, I will yield on my time. I thank the Senator for all the work he has put into this bill. I know he is probably one of the strongest consumer advocates this Senate has ever seen. I would like to chat with the Senator just a bit because there is some concern of consumer advocates in my State who say how come we are getting all these editorials? And I would have to say in fairness to this committee they are based upon information which may have been true a month or 2 months or 3 months ago, but we have gone out of our way to put on the web pages--in fact, the most recent agreement which we have reached on cosmetics is now, or will be this afternoon, on the web pages so that all they have to do is tune in and they can see the exact wording. So I urge those who are still nervous about what is in the bill to find out. It is available. In the modern age of being able to have information available, it is available instantly around the country. I hope that we would continue to work on the basis of what the bill is instead of what it used to be. I acknowledge the Senator's contribution to this effort entirely. The Senator has been instrumental in proposing innovative ideas and finding solutions. He has done an outstanding job in helping myself and Senator Kennedy bring this bill to where it is. The Senator is looked upon by many as a person they can trust to protect the interests of the consumer. So I thank the Senator for his very active participation in this bill.

Mr. JEFFORDS. I certainly yield to the majority leader.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise in opposition to the amendment. I know the intentions of the Senator are certainly the best in wanting to assist our local governments in having a better handle on their educational situation. However, I want to point out several problems with the amendment. I will also say that, given the modifications that have been made, my opposition, as far as the energy involved, has been diminished substantially. Now, we are now talking about only $4 billion, whereas originally the figure was closer to $12 billion. Even with those modifications having been made, I still want to raise my colleagues' understanding of what this amendment does. A lot of the discussion has been about doing away with Federal involvement, but what the amendment really tends to do is to turn over to local governments functions that are now handled by the States. With the modifications, this is somewhat less the case. As a Republican, I have the feeling that the States are better able to control, to help, and otherwise assist local schools than is the Federal Government. This amendment shifts some responsibilities back to the local governments, but also shifts a great bulk of it back to the Federal Government. For that reason, I am a little bit ambivalent as to how serious I consider this amendment. I would like to point out one thing that does alarm me, as someone who believes that the States should have more control over things, and that is the fact that the control that we give back to the local governments is very precarious. If you read the amendment, the amendment says: Notwithstanding any other provision of law, the Secretary of Education shall award the total amount of funds described. I will recount a problem I once had. I had a wonderful amendment to reorder the Nation's priorities in energy. I worked with the committee that handled energy. They adopted all my points, and I thought I had a great victory. Then they said, ``Gee, Jim, all we did was change one word in the amendment.'' I said, ``What was that?'' They changed ``shall'' to ``may.'' Now, if you were to take your language here and change ``shall'' to ``may,'' then the Secretary of Education would have complete control of all these funds. It leaves us in a precarious situation when, with one word, you can change the total impact of this amendment. As far as the full impact now, as I mentioned earlier, when you take out title I, you take out a huge, huge chunk of money. When you add to that the programs which were excluded from the original amendment, such as IDEA and 50 percent of voc-ed and several other programs, you end up with this amendment affecting a mere $4 billion of the roughly $20 billion made available under this bill for elementary and secondary education programs. So my vigor has diminished substantially. But let me also point out that, without any guidelines to the local governments, funding for those programs which are included in the amendment and which is now targetted to try to help special bodies of individuals--Indians or whomever else--can be used in any way whatsoever. I remember back when we had revenue sharing. What an embarrassment that turned out to be. I was a great one for revenue sharing: Send it back to the local governments. We found that, instead of doing the things we thought they would do with it, they built skating rinks, fish ponds and others things. So we said, ``Gee, we better take it back.'' I wish I had that much confidence that local governments would make the optimum use of general Federal funds for education. However, they have tight budgets. In my State, almost every town in the State is having a problem with its education budget because of its impact on property taxes. There is nothing in the amendment about a maintenance of effort. You don't have to use the funds for additional education programs. You can take that money and replace the tax funds now being used. You don't have to improve your schools at all. You can just merely reduce the property taxes to the people in the community. I bet you, if we pass this and it becomes law, that a few years from now we will find out almost all the money went to property tax relief. The problems of education are at the local level. They are not at the Federal level. They are at the local level. We argue about how much the Federal Government should influence the decisions of local governments, but what we have to do is give the local governments the ability, through professional development and assistance from the States, to try to make sure that they are living up to the obligation of educating our children. In this Nation right now, 51 percent of the kids who graduate from high school graduate functionally illiterate. We are way in the back, almost last among the more developed nations, in math. We have right now 190,000 jobs in the information-technology area alone for which we can't find people who have the skills to fill them. In Europe and Asia, those skills are taught in high school. Is giving money back to localities going to make a difference? I don't believe so. So I am afraid what we have here is a well- intentioned amendment which could backfire completely by a change in one word. Let me also say that, although this amendment will not get enacted because it is veto bait, imagine yourself back home after you have voted for this amendment. You are out there, you are debating your opponent, and you say you are in favor of this amendment. He then brings up the amendment and reads it, without knowing the implications: ``Notwithstanding any other provision of law, the Secretary of Education shall award all the money.'' You can argue, but you know how it is trying to argue in a political situation by saying that the language is not really what it meant; that's what it says. So, I just think we are not going to accomplish anything of any great dimension in terms of the intent of the amendment--to give the local communities more flexibility with spending. We have cut the States out, and we have a direct linkage now between the Secretary of Education and every local school district--with language just open, ripe for being changed from ``shall'' to ``may'' if we should ever lose the majority here. Reluctantly, I have concluded that this amendment would be a very serious mistake if we were to pass it. I yield the floor.

Mr. JEFFORDS. I withdraw my objection.

Mr. JEFFORDS. Reserving the right to object, I wonder if the Senator would be so good as to explain what the modifications are.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise today to pay tribute to Vermont's Shelburne Museum on the occasion of its 50th anniversary. The museum, sometimes referred to as New England's Smithsonian, will celebrate its anniversary on September 27, 1997 with a myriad of activities for people young and old. The museum's founder, Electra Havemeyer Webb, was a pioneer collector of Americana and American folk art. Today, the museum collects, preserves, and studies art as well as history with an emphasis on the New England area. Thirty-seven exhibit buildings spanning across 45 scenic acres include three galleries, 7 furnished historic homes and over 80,000 objects. The historic buildings and collections reflect our transition from an agricultural to an industrial nation. The Shelburne Museum has become an important cultural resource for Vermont and the Nation. In a rapidly changing world its collections as well as its programs provide the public and scholars alike with an opportunity to reflect on and explore the central themes of ingenuity, craftsmanship and creativity. The museum embodies a spirit of celebration which provides visitors from across the country and around the world with a unique perspective into the region's history. As a learning tool, it plays a significant role in reminding patrons that the past can often provide a key to the future. Mr. President, I wish the Shelburne Museum many more years of continued success in service to our community.

Mr. JEFFORDS

Mr. JEFFORDS. I will make a couple more comments here. Let us just think about what would happen if we did this, what it would do for education. All of a sudden, without any qualifications or requirements, or anything else, if we were to send checks to our local governments, with a hope they would spend it on education--I know what would happen in my State. We have just gone through property tax reform. Everybody is up in arms over the cost to the local governments from property tax reform. I bet if you were to do it, this would end up in property tax relief. Maybe that is a good thing. Maybe it is a good thing to relieve the local property tax in communities around the country. But it is not going to tackle or do anything to solve the very basic problems we have in education. There is nothing in here that would in any way determine that the local governments are going to spend it on education. Now, ``above'' can mean the superintendent of a region, they are knocked out. The State's school system has no control or no suggestions in any way how to spend this money. We are just sending checks to the local communities and saying, ``Gee, we would kind of like you to spend this on education, but there's no requirement, or you can say you do, but then you just cut yours back and you spend this money on education, but you cut back on the local money, on what you're spending on education now, and you can cut your property taxes.'' It might be very popular. I think it would be. I expect it would sell very well with the taxpayers of local communities saying, ``Wow, finally we can start going down on the cost of education in this community.'' Will it benefit the students? Not at all. This is, again, authorization of the grossest kind in the appropriations process. So I say to Members that this is one area where we have huge needs trying to change what is going on in this country in education, to raise the levels to be able to meet international competition, to make sure we are not embarrassed again as we have been for years now on international tests with our young people, especially in math and science. We know we have to make changes. Anyone here who believes that just throwing money at the local communities is going to bring about these kinds of changes, I do not think you will find anyone who can consider this is seriously the way to go. Mr. President, I yield the floor. Mr. GORTON addressed the Chair.

Mr. JEFFORDS. I withdraw my objection.

Mr. JEFFORDS. Mr. President, reserving the right to object, is the Senator going to explain the modification?

Mr. JEFFORDS. I wish to speak against the amendment. I think the desires and the hopes of the Senator from Washington are certainly admirable, but I think if one examines where the problems are in education right now the thought that it will be solved by just giving a blank check to the local agencies to correct these problems I think would find itself quite misdirected. First of all, it goes without saying and everybody must recognize that this is probably the grossest exercise of changing the situation from what is normally considered the authorization process that I have seen to date. Now, I do not disagree with the fundamental problem that the Senator from Washington recognizes, and that is we have an awful problem in this Nation educationally. When 51 percent of the students in this country graduate functionally illiterate, when we find ourselves trailing way behind other nations in competition for the type of work that is necessary in our country, we know we have a problem. Right now, for instance, we have 190,000 jobs available in this Nation that we cannot fill because schools have not produced students with the skills to take them, whereas our competitors do not have that problem. But where is the problem? The problem is at the local level because they have not had the guidance from above or whatever to increase the mathematical skills and to ensure that we do not push young people through the school systems by what is called social promotion. Those are the big problems. Giving blank checks to the local governments is not going to solve the problems. I would guess it would probably exacerbate them. For instance, one of the programs that we have which is more aimed at the problems than anything is the Eisenhower math program. It is designed to provide professional development. Congressman Goodling, who is chairman in the House, and I agree on one thing, that the most important thing we can do now is to improve the professional development of our teachers. If they don't know what the standards are they should meet in order to meet worldwide competition, then it is difficult to expect that they are going to change to meet those standards. The Eisenhower program has been very successful in the math area, but it is so small that it cannot possibly do all the work. If we were to take and throw more money, if you want to call it throw, into the Eisenhower program and things like that, it might make some sense. But just to give it carte blanche to the districts dependent on the wealth, not on the quality of education, this makes a presumption that is not accurate in many cases, and that is, the quality of your education will be determined by the amount of money that is spent; therefore, if you give more money to the poor areas, they are going to end up with better education, and if you take it away from the ones with higher expenditures on education, they are not going to be hurt. There is no basis for making that kind of conclusion. Title VI, a block grant, which is chapter 2, is the best hope we have for getting the kind of professional development which Congressman Goodling and I agree is the greatest need of this Nation today that would eliminate the money that goes toward that direction of trying to make sure that we improve the ability of our teachers to meet modern needs of our society. You can argue about some of the other programs, but School to Work is another one. School to Work is putting its finger on the basic problem in this country, and that is that we do not train our young people for work; we ignore that. The educational institutions, in most cases, are just making some progress now with bringing the school into the work area and letting them know what the young people need for skills in order to get those very well-paying jobs that are out there. School to Work is aimed at that. To cut the funding for that and give more money to the local agencies to do what they want with it is not going to solve the problems of this Nation. We are going to try to in the Work Force Improvement Act, which we will be moving out of committee very soon, consolidate a lot of these programs that perhaps eat up more money in bureaucracy than they do in producing results. I don't have a problem with that, but that should be done during the reauthorization process. To make such a fundamental change now on an appropriations bill where we would take away from the States--remember, the States distribute title I money and things like that in accordance with not only financial problems, but educational need. This would do away with that aspect and give that role to the Secretary of Education. I am amazed to think the Senator from Washington would suggest we ought to give the money to the Department of Education to distribute. Granted, it is a formula distribution, but still right now it is the States that make the decisions based upon the educational need as well as economic need. So I think for all these reasons I would have to strongly oppose this amendment. I encourage, though, as the Senator from Washington has done, to raise the level of understanding of what the problems of this Nation are in education. The basic problem is very fundamental, and that is that the schools in this country are not equipped now to handle the demands made upon them by the competition in the world economic situation which requires us to produce kids that have better skills. There is certainly no excuse for allowing young people to go through the school system and come out the other end, like half of our kids do, without knowing how to read. That is why emphasis is being placed by the administration, myself, Congressman Goodling and others on that. We have to face up to the problem. Facing up to the problem is not going to solve it by throwing more money and taking it away from any direction at all, but just giving it to the local school system. I must strongly oppose the amendment of the Senator from Washington, but I do praise him in the sense of raising again the awareness of this body and the Nation to the serious problems we have with education at the local level. Mr. President, I yield the floor. Mr. GORTON addressed the Chair.

Mr. JEFFORDS

Mr. JEFFORDS. Madam President, I commend the Senator. His expertise in this area has helped us greatly and I am sure will lead us to a final conclusion here. I would also like to point out as another member of a small State, how we would suffer if we had to rely upon others, since we have no resources to do any of this investigation ourself. We would be placed in a position without uniformity to have to rely on some big State or something to tell us what we should or should not do. We really have no ability in ourselves to protect our citizens, that we would like to. I wonder if you would agree with that as well?

Mr. JEFFORDS. I commend the Senator from Indiana who has been extremely helpful on this whole bill in helping us bring it to conclusion. He made many offers, very reasonable, and I hope we can find the magic one to bring us to fruition very quickly. I yield the floor and I suggest the absence of a quorum.

Mr. JEFFORDS. Mr. President, I yield the Senator such time as he may consume.

Mr. JEFFORDS. First, I want to thank the majority leader for, I think very aptly and appropriately and eloquently, expressing our thoughts about Mother Teresa. All of us were moved by her life, and all feel similarly as to his feelings about what she did for all the people of the world. Mr. President, today, we move forward again on the motion to proceed with respect to the reform of the FDA bill, S. 830. Under the Federal Food, Drug, and Cosmetic Act, Food and Drug Administration commonly known as FDA, has two important functions: First, the review and approval of important new products that can improve the public health, such as lifesaving drugs, biological products, and medical devices; and second, the prevention of harm to the public from marketed products that are unsafe or ineffective. Since 1938, the Federal Food, Drug, and Cosmetic Act has been amended numerous times to expand the FDA's mission to ensure that only safe or ineffective products are marketed. But the act has been changed only once, by the Prescription Drug User Fee Act of 1992, commonly called PDUFA, to strengthen the FDA's ability to review and approve expeditiously important new products that can improve the public health. Food and Drug Administration Modernization and Accountability Act of 1997, S. 830, is designed to ensure the timely availability of safe and effective new products that will benefit the public and to ensure that our Nation continues to lead the world in new product innovation and development. The legislation accomplishes three major objectives: It builds upon recent administrative reforms that both streamline FDA's procedures and strengthen the agency's ability to accomplish its mandate in an era of limited Federal resources; it requires a greater degree of accountability from the agency in how it pursues its mandate; and third, it provides for the reauthorization of PDUFA. The FDA acknowledges that its mandate requires it to regulate over one-third of our Nation's products. Within its purview the FDA regulates nearly all of the food and all of the cosmetics, medical devices, and drugs made available to our citizens. This legislation identifies areas where improvements can be made that will strengthen the agency's ability to approve safe and effective products more expeditiously. It builds upon the numerous investigations by Congress, the FDA, the General Accounting Office, and other organizations that have identified problems with the current FDA product approval system and have recommended reasonable reforms to streamline and strengthen that system. The major provisions of S. 830 accomplishes, among others, the following purposes. The legislation: First, establishes a clearly defined, balanced mission for the FDA; Second, it improves patient access to needed therapies and provides expedited humanitarian access to medical devices; Third, creates new incentives for determining better pharmaceuticals for children; Fourth, gives patients access to new therapies more quickly through a new fast-track drug approval process; Fifth, increases access to information by health professionals and patients; Next, increases agency access to expertise and resources; Also, improves the certainty and clarity of rules; And further, improves agency accountability and provides for better resources allocation by setting priorities; It also, simplifies the approval process for indirect food contact substances and provides a more reasonable standard for some health claims; and, The legislation reauthorizes the PDUFA Program thus ensuring additional resource availability for the agency to conform with its necessary missions. Mr. President, let us explore these objectives in greater detail. First, the legislation establishes a clearly defined, balanced mission for the FDA. Congress has never established a mission statement for the FDA. This bill does. The FDA in March 1993 adopted a formal statement declaring that the agency ``is a team of dedicated professionals working to protect and promote the health of the American people.'' Although this statement defines the agency's mission in terms of ensuring that the products it regulates comply with the law, there is no reference to the importance of approving new products that benefit the public. The legislation amends the Food Drug and Cosmetic Act by adding an agency mission statement focused on: First, protecting the public health by ensuring that the products it regulates meet the appropriate FDA regulatory standards; second, promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a manner which does not unduly impede innovation or product availability; and, third, participating with other countries to reduce regulatory burdens, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements with other countries. The legislation improves patient access to needed therapies and provides expedited humanitarian access to medical devices. The FDA has no crosscutting program that ensures access by patients with serious or life-threatening diseases to drugs or devices in clinical trials--even when that unapproved therapy may be the only way to save the patient's life. The legislation would create new law whereby manufacturers may provide, under strictly controlled circumstances and in response to a patient's request, an investigational product for those patients needing treatment for a serious or life-threatening disease. The legislation also improves the existing program for the humanitarian use of medical devices for patient populations of fewer than 4,000. The legislation creates new incentives for determining better pharmaceuticals for children. Children have for years been wrongly considered small adults when estimating the effect of prescription drugs on their overall health. Currently there is no systematic means for testing the safety and efficacy of drugs on the pediatric population. The legislation gives the Secretary authority to request pediatric clinical trials for new drug applications and provides 6 extra months of market exclusivity to drugs when the manufacturer voluntarily meet certain conditions under the program. The Secretary must determine in writing that information relating to the use of a drug in the pediatric population is needed. In addition, the FDA may establish time frames for completing such pediatric studies before additional exclusivity is granted. The legislation gives patients access to new therapies more quickly through a new fast-track drug approval process. I think this is important. For several years the FDA has allowed the expedited review and approval of drugs but such review has been largely confined to treatments for HIV/AIDS or cancer. This provision facilitates development and expedites approval of new drugs for the treatment of any serious or life-threatening diseases. The legislation increases access to information by health professionals and patients. For years, sophisticated users of health related economic information, like health maintenance organizations, have had constrained from access to important information that could help them reduce health care costs. The legislation would apply the Federal Trade Commission's ``competent and reliable scientific evidence'' standard for FDA review of health care economic statements distributed by manufacturers to sophisticated purchasers. In the past, only a few patient groups have had access to information about ongoing clinical trials for lifesaving therapies. The legislation expands patient access to information by requiring the creation of data bases on ongoing research related to the treatment, detection, and prevention of serious of life-threatening diseases. The legislation increases agency access to expertise and resources. Current law contains no provisions to assure that the FDA can access expertise housed at the National Institutes of Health [NIH] and other science-based Federal agencies to enhance the scientific and technical expertise available to FDA's product reviewers. The legislation requires FDA to develop programs and policies to foster such collaboration. The legislation also authorizes the agency to contract with outside experts to review all or parts of applications when it will add to the timeliness or quality of a product review, and provides for the use of accredited outside organizations for the review of medical devices. The legislation improves the certainty and clarity of rules. The legislation makes a series of changes related to the classification, review and approval of FDA regulated products designed to ensure that sponsors of new products face consistent and equitable regulatory requirements. In addition, the legislation gives FDA 2 years to evaluate the success of its recently issued ``Good Guidance Practices'' guidance after which FDA is required to implement this policy as a regulation, making any modifications necessary to reflect experience during the 2-year trial period. The legislation provides medical device manufacturers with the ability to make recommendations to the FDA respecting initial product classifications. It facilitates the reclassification and/or approval of device applications by allowing FDA to consider historical data in making its determinations, and the legislation more clearly states the relationship of labeling claims to approval and clearance of medical devices. It increases the certainty of review time frames by providing a definition of a day with respect to the agency's review timeclock and by requiring the agency to approve or disapprove a device application within 180 days. The legislation also prohibits FDA from withholding the initial classification of a device because of a failure to comply with any provision of the unrelated to making a determination of substantial equivalence, and it clarifies that FDA has discretion in determining the number of clinical trials required for the approval of a drug or device. FDA would retain total discretion to require a sufficient number of trials to show safety and efficacy. The provision introduces the concept that two trials are not always necessary, establishes the primacy of quality data over quantity of data, and requires the FDA to consider the number and type of trials on a product-by-product basis. The legislation improves agency accountability and provides for better resource allocation by setting priorities. Except as required under PDUFA, the FD&C Act provides no form of public accountability by the FDA for its performance of its statutory obligations. The legislation requires FDA to develop a plan designed to: First, minimize deaths and injuries suffered by persons who may use products regulated by the FDA; second, maximize the clarity and availability of information about the product review process; third, implement all inspection and post-market monitoring provisions of the act by 1999; fourth, ensure access to the scientific and technical expertise necessary to properly review products; fifth, establish a schedule to bring the FDA into compliance by 1999 with the product review times in the act for products submitted after the date of enactment of this section; and sixth, eliminate the backlog of products awaiting final action by the year 2000. The legislation also requires FDA to submit an annual report to assist Congress in assessing the agency's performance in accomplishing the objectives laid out in the agency plan. The legislation streamlines several FDA functions with respect to certain review and inspection processes thus allowing the agency to focus its limited resources on areas of greatest need. The legislation establishes reasonable data requirements for new product approval applications, petitions, or other submissions. The legislation provides FDA with the discretion to approve drugs and biologics on the basis of products manufactured in pilot and small-scale facilities. FDA is also directed to establish policies to facilitate the approval of supplemental applications for new uses for an approved product. Further, the legislation establishes procedures and policies to foster a collaborative review process between the agency and the sponsors of medical device applications. Finally, the legislation streamlines the review of minor modifications to medical devices. The legislation simplifies the approval process for indirect food contact substances and provides a more reasonable standard for some health claims. Current law requires the agency to preapprove food contact substances, most of which pose little if any risk to human health. The legislation replaces the preapproval process for these substances, primarily packaging materials, with a simple notification requirement. The legislation also provides for health claims for foods, with premarket notification, when the claims are based on authoritative recommendations by an authoritative scientific body of the U.S. Government such as the National Institutes of Health, the Centers for Disease Control and Prevention, or the National Academy of Sciences-- very reliable agencies. The legislation reauthorizes the PDUFA Program thus ensuring additional resource availability for the agency. PDUFA is reauthorized for 5 years. Performance goals beyond those set for the 1992 act will be identified in side letters between the FDA and the Senate Committee on Labor and Human Resources. The bill assumes that FDA will receive for fiscal year 1998 the 1997 level of appropriated funds for the agency. This is important to keep in mind. For fiscal year 1999 through 2002, the bill assumes an annual inflation adjustment. I mention this because there in the present proposal by the administration is a request to cut back on the use of PDUFA. Mr. President, I think after all of us have had time in this body to go through this legislation, Members will understand why there is so little dispute over almost all of the bill. We will be talking again today, as we did last Friday, about two areas in the bill for which there has not been agreement, but the disagreements are not very complicated to understand. First of all, we had a vote of 89-5 on Friday to allow us to end the filibuster under the circumstances we faced. That approval indicates what I am saying now, that for almost all of this bill there is no dispute between us and the minority or Senator Kennedy or the Office of the President or the Secretary of HHS. What we do have are two problems in which there is dispute. This makes up 6 pages out of a 152-page bill. Keep in mind, because we will have some vigorous arguments in those two areas, everyone agrees with the rest of the bill--almost. There will always be somebody, but there is hardly any disagreement on the matters I discussed in my statement. The two remaining matters refer, first of all, to cosmetics. There is an increasing need, at least felt by especially some States and also by the FDA and others, that there has to be more work done in approving cosmetics or ensuring that cosmetics that are injurious to health do not get on the market. At present, most of that has been left sort of ambiguous whether the FDA should do it or not. On the other hand, because of the realization that uniformity would be helpful, it would be useful if we could have uniformity throughout the States on cosmetics so that the people all over the country do not have to worry about going from place to place. And thus the bill does establish the FDA predominance in the field with respect to the use of cosmetics. Now, this is met with some difficulties because some States, California in particular, had voted and had passed laws on cosmetics. Let me go through the present authority. The FDA now has substantial authority to ensure the safety of cosmetic products. It can ban or restrict ingredients for safety reasons, mandate warning labels, inspect manufacturing facilities, issues regulatory letters, seize illegal products, enjoin unlawful activities, and prosecute violators of the adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act. In addition, cosmetic products are subject to one of the most comprehensive set of Federal labeling requirements for consumer products. A cosmetic label must include the name and address of the manufacturer, packager, or distributor; a statement of product identity; net quantity of contents; a list of all ingredients in the products; adequate directions for use; and mandated warnings for specific products. In addition to this substantial Federal regulatory authority, the cosmetic industry supports a variety of programs to ensure the safety of cosmetic ingredients. Most important is the Cosmetic Ingredient Review, a 20-year program that has reviewed the safety of almost 620 cosmetic ingredients. The safety evaluations are conducted by an independent expert panel of seven leading academic scientists and physicians. The panel also includes three liaison representatives from the FDA, the Consumer Federation of America, and private industry. Along with this regulatory authority, the agency has sufficient resources to police the safety of cosmetics. This year, Congress appears ready to approve nearly a billion dollars for the agency. Yet of that amount, the FDA will likely spend no more than about $6\1/2\ million on cosmetics safety and labeling. Why? Why would the agency devote less than 1 percent of its budget? Because of the outstanding safety record of cosmetic products. Numerous FDA Commissioners-- including David Kessler, have stated that cosmetics are among the safest products under the FDA's jurisdiction. Let me turn now to the language of the national uniformity provision for cosmetics included in the latest version of S. 830. First, let me emphasize that this provision in no way affects State enforcement powers, such as seizure, embargo, or judicial proceedings, that the States can now use to guard against adulterated, misbranded, or otherwise unsafe products. Let me repeat this point: The national uniformity provision would not block any State from exercising its police powers against unsafe cosmetic products. Second, the national uniformity provision provides only limited preemption of State safety standards. Preemption would apply only when the FDA has an applicable safety standard affecting cosmetic already in place. If the FDA has not acted in a safety area, the States would still be free to impose their own particular safety regulations affecting cosmetic products. For example, individual States could ban particular ingredients or could set specified concentrations levels for ingredients used in cosmetic products when the FDA has not acted. Preemption does apply to State labeling and packaging for cosmetic products that are in addition to or not identical with Federal standards. This is designed to ensure a single, nationwide system for regulating the labeling for cosmetic products. This will promote efficient product distribution in interstate commerce, assure the ready availability of products in all States, and hold down costs for consumers. Third, under this provision States and localities are clearly permitted to petition to impose a State-specific requirement if they have a situation where an important public interest is at stake, and the requirement would not violate a Federal law or unduly burden interstate commerce. Fourth, the existing right of States, or entity or person is preserved to petition the FDA to make an certain regulation on over- the-counter drugs or cosmetics a national requirement. And finally, the regulation of the practices of pharmacy and medicine, areas traditionally and appropriately the responsibility of the States is not modified or preempted by this provision. This is a sensible compromise that guards against the possibility of 50 different labels in 50 different States but at the same time preserves the ability of States to protect the public against any problems that may arise over the safety of cosmetic products. Mr. President, we will go forward with another lengthy dissertation on this aspect of this. I hope people will keep in mind that there is broad, broad agreement among all of us--Senator Kennedy and those who support it--that this bill has come a long way. It has gone a great distance toward bringing together what we can pass and be very proud of. There are just two areas where there is disagreement, which we will hear about, I am sure, now. But I hope that everybody will keep in mind that this is in the area of 6 pages of a 152-page bill. Mr. President, I yield the floor. Mr. KENNEDY addressed the Chair.

Mr. JEFFORDS. Mr. President, I suggest the absence of a quorum.

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

Mr. JEFFORDS. I suggest the absence of a quorum.

Mr. JEFFORDS. I have the authority to yield back the balance of the time for the minority, as well as the majority on this side.

Mr. JEFFORDS. Mr. President, I only anticipate speaking for a few minutes. I know Senator Coats will follow me. This legislation to modernize the Food and Drug Administration and reauthorize the Prescription Drug User Fee Act will, upon enactment, streamline the FDA's regulatory procedures. This modernizing will help the agency review medical devices and drugs more expeditiously and will let the American public have access sooner to newer, safer, and more effective therapeutic products. I am disappointed that some of my Democratic colleagues are still attempting to block this bill. I am especially chagrined given the months of bipartisan negotiating that have led to this bill. Each major provision--every drug issue and all but one medical device provision of this measure, represents long- sought agreements with the minority and with the FDA itself. We have made significant concessions on the uniformity provision objected to by the Senator from Massachusetts to ensure that a State may act on cosmetic safety issues in the absence of FDA action. I do not understand this continued objection and delay. In particular, I am disappointed that after countless hours and many concessions to his point of view, the ranking minority member is opposing progress in passage. And I must add that I wish to applaud his willingness--and his tenacity--in working through several difficult issues to reach a consensus on 99 percent of this legislation. In addition Secretary Shalala and the FDA itself, has worked diligently, to reach reasonable, sensible agreements. This is a good, bipartisan measure that represents moderate, yet real reforms. There is no reason for further delay. On June 11, prior to the committee markup of S. 830, I received a letter from Secretary Shalala outlining the Department's key concerns. In her letter the Secretary stated: I am concerned that the inclusion of non consensus issues in the committee's bill will result in a protracted and contentious debate. Before and since our committee markup, we have worked hard to achieve a consensus bill. And the measure before us today accomplishes that goal. Bipartisan staff have worked diligently with the agency to address each of the significant nonconsensus provisions raised by the Secretary. The American people will hardly believe that anyone would suggest that disagreement over 6 pages out of a total of 152 is grounds for holding up consideration of this important bill. A little over a month ago, we all joined together to further the economic health of the country by voting for an historic budget bill, despite our many misgivings, on each of our part, on far more than 6 pages of that legislation. We must do no less here to promote the physical health of our citizens by moving forward to approve S. 830. In her letter, Secretary Shalala felt the legislation would lower the review standard for marketing approval. Key changes have been made to the substitute to address these concerns. With respect to the number of clinical investigations required for approval, changes were made to assure that there is not a presumption of less than two well controlled and adequate investigations--while guarding against the rote requirement of two studies. The measure clarifies that substantial evidence may, when the Secretary determines that such data and evidence are sufficient to establish effectiveness, consist of data from one adequate and well-controlled clinical investigation and confirmatory evidence, totally under the control of the FDA. Concerns were raised also about allowing distribution of experimental therapies without adequate safeguards to assure patient safety or completion of research on efficacy. Changes to accommodate those concerns were made. We tightened the definition of who may provide unapproved therapies and gave the FDA more control over the expanded access process. Other changes will ensure that use of products outside of clinical trials will not interfere with adequate enrollment of patients in those trials and also give the FDA authority to terminate expanded access if patient safeguard protections are not met. The provision allowing manufacturers to charge for products covered under the expedited access provision was deleted also. In mid-June, the Secretary argued that S. 830 would allow health claims for foods and economic claims for drugs and biologic products without adequate scientific proof. In response, Senator Gregg agreed to changes that would allow the FDA 120 days to review a health claim and provide the agency with the authority to prevent the claim from being used in the market place by issuing an interim final regulation. In addition, the provision allowing pharmaceutical manufacturers to distribute economic information was modified to clarify that the information must be based on competent and reliable scientific evidence and limited the scope to claims directly related to an indication for which the drug was approved. That problem is taken care of. This bill was further changed to accommodate the Secretary's opposition to the provision that would allow third party review for devices. Products now excluded from third party review include class III products, products that are implantable for more than 1 year, those that are life-sustaining or life-supporting, and products that are of substantial importance in the prevention of impairment to human health. In addition, a provision advocated by Senator Harkin has been incorporated that clarifies the statutory right of the FDA to review records related to compensation agreements between accredited reviewers and device sponsors. I would add that FDA's existing stringent regulations which protect against conflicts of interest in today's third-party review program would apply to the expanded program created by this bill. Finally, the Secretary was concerned about provisions that she felt would burden the Agency with extensive new regulatory requirements that would detract resources from critical agency functions without commensurate enhancement of the public health. This legislation now gives FDA new powers to make enforcement activity more efficient, adds important new patient benefits and protections, and makes the review process more efficient. First, we give FDA new powers and clarify existing authority, including mandatory foreign facility registration, seizure authority for certain imported goods, and a presumption of interstate commerce for FDA regulated products. Second, to assist patients with finding out about promising new clinical trials, we establish a clinical trials database registry accessed by an 800 number. Patients will also benefit from a new requirement that companies report annually on their compliance with agreements to conduct post-approval studies on drugs. Third, FDA's burden will be eased by provisions to make the review process more collaborative. Collaborative review will improve the quality of applications for new products and reduce the length of time and effort required to review products. We also expressly allow FDA to access expertise at other science based agencies and contract with experts to help with product reviews. Lastly, by expanding the third-party review pilot program for medical devices, we build on an important tool for the agency to use in managing an increasing workload in an era of declining Federal resources. In closing, I would echo another part of Secretary Shalala's June 11 letter: I want to commend you and members of the Committee on both sides of the aisle on the progress we have made together to develop a package of sensible, consensus reform provisions that are ready for consideration with reauthorization of the Prescription Drug User Fee Act . . . . . . a protracted and contentious debate . . . would not serve our mutual goal of timely reauthorization of PDUFA and passage of constructive, consensus bipartisan FDA reform. From the beginning of this process, all of the stakeholders have been committed to producing a consensus measure--and we have accomplished that goal. There is overwhelming agreement on this bill. For those who still oppose a few pages of this bill I can only say that we will continue to bend over backward to accommodate their concerns and to bring about an even closer consensus. Dozens and dozens of changes have been made. The Secretary of Health and Human Services knows that we will continue to work with her--this is not the end of the line. But at some point, the Senate must move on, and we have reached that point, Mr. President. Mr. COATS addressed the Chair.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise in support of the amendment offered by my colleague from Rhode Island, Senator Reed, which restores $35 million to the State Student Incentive Grant [SSIG] Program. SSIG is an effective Federal/State partnership program which leverages State dollars for need-based student aid. Ensuring that students have need-based grant aid available to them is very important--especially when one considers the extraordinary debt that many college students have taken on to pay for school. In 1995-96 SSIG benefited 688,000 students through the country and the median family income of those students was $12,000. In Vermont, 4,260 students received assistance through SSIG. It is my hope that the Senate will vote in support of this important program. As chairman of the Labor and Human Resources Committee, I look forward to a thoughtful review and strengthening of SSIG as part of the reauthorization of the Higher Education Act. So again, I thank my colleague from Rhode Island for offering this amendment and thank my colleague from Pennsylvania, Senator Specter, for his support.