Jim Jeffords

Mr. JEFFORDS

Mr. JEFFORDS. I move to lay that motion on the table. The motion to lay on the table was agreed to. Amendment No. 1213 (Purpose: To revise the boundaries of the Arkansas Post Memorial, and for other purposes)

Mr. JEFFORDS. I move to lay that motion on the table. The motion to lay on the table was agreed to. Amendment No. 1216

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

Mr. JEFFORDS. Mr. President, my amendment is a critically important amendment to make sure that we preserve the Civil War battlefields for those people who will be in the next millennium to better understand this Nation. Mr. President, I am proud to be joined today by Senator Torricelli in offering this amendment of national historic significance. The American Civil War is thought by many historians to be the fundamental event shaping the character of the United States. This amendment takes a giant stride at preserving our history by establishing that it is these funds that be made available to protect the threatened American Civil War battlefields. I am proud to say that there is in this land a great wellspring of caring for the places where freedom was won and defended. Millions of Americans have, in recent years, become aware of the hallowed ground of our Civil War battlefields, have visited them, read of them, many have written of them. The clear and eloquent message I hear is that these treasured places should be saved, intact, for future generations. The preservation message goes forth from Gettysburg, Antietam, Manassas, Cold Harbor, Malvern Hill, Cedar Creek, Petersburg, Stones River, and dozens more Civil War places. When battlefields become severely threatened there quickly develops a continuity of Americans that spreads nationwide. The American people care about their history, look on these places as national treasures, and speak eloquently and effectively for their preservation. Preserving our Nation's battlefields is a subject very close to my heart. My efforts to preserve our Nation's historic places actually began in my State of Vermont several years ago when the Vermont Legislature unanimously passed a resolution asking Congress to save the places where Vermonters fought in the Civil War. The resolution was presented to me, and I went to work finding out all I could about the battlefields and what was needed. It quickly became apparent that the Civil War battlefields were in need of protection. Over 7 years ago, Congress responded to the growing awareness of our Civil War heritage and the concern for the sites where that heritage took form, by passing legislation that created a national Civil War Sites Advisory Commission. Composed of distinguished historians, supported by a staff of National Park Service experts, the commission for 2 years studied the remaining Civil War battlefields. Civil War sites were visited, public meetings held, and in the end a report was written. The report presented a plan of action for protecting what remain of the Civil War battlefields. It is a plan that has recognized the need to act, a plan that I strongly favor. Mr. President, as a proud American, preserving our great history is an opportunity I am always ready to seize. Congress should do what we can to help meet the recommendations of the Civil War Advisory Commission by preserving the country's most endangered Civil War sites. In fighting to preserve Civil War battle sites, we have aimed to create the chance for our citizens to travel from battlefield to battlefield and to relive the brilliant Jackson campaign of 1862, and the successful Union campaign of 1864. By preserving these sites, we will allow people to enjoy the beautiful surroundings such as the Shenandoah Valley and give area economies an important boost. Several years ago, I had the privilege to travel from battlefield to battlefield with several Civil War historians and Civil War buffs. We saw those battlefields pretty much as they were during the Civil War. We relived Jackson's battles of the 1862 campaign, one of the most studied campaigns in history. We also retraced the Union campaign of 1864. At that time the election was not looking so good for President Lincoln, and the Union was in dire need of battle victories. General Sheridan marched the Union forces up to the valley and won a series of battles culminating in the Battle of Ceder Creek. Many historians believe that this was the turning point in the war. Mr. President, I came away from this trip with the strong feeling that it is my responsibility as U.S. Senator to help preserve this part of our national heritage. Bruce Catton, one of our Nation's most eminent historians has written: Any historian who confronts a gap in the record of bygone days knows moments of despair when he complains bitterly that no one took the trouble to dig out and assemble all of the facts while those facts where still available. To use unlimited resources in as broad and as all-inclusive as it possibly can be, to do it while everything is still fresh, and to do it with no other earthly motive than a desire to establish the full truth--this is the sort of thing that only governments can do, and they almost never dream of doing it. Mr. Catton's words are more important than just an expression of the historian's frustration at not having access to ``all the facts.'' His words constitute a challenge, a challenge to government to preserve and protect the fragile bits and pieces of our Nation's history that remain with us today, but which tomorrow could vanish forever. Just this past weekend, the Battle of Antietam or Sharpsburg, as it was referred to by the Confederates, was relived as over 15,000 civil war enthusiasts reenacted this bloody battle before over 100,000 spectators. On this day, 135 years ago, over 23,000 brave Americans lost their lives at the Battle of Antietam. The number of casualties was three times greater than the number of Americans killed at Normandy on D-day. Left for the dead on the battlefield, but surviving, was a young captain from Massachusetts who became one of the nation's most respected Supreme Court Justices, Oliver Wendell Holmes, Jr. General McClellan sent a message to Washington of a great victory, however the Confederates escaped across the Potomac and retreated into the lower Shanandoah Valley with little interference. Many believe that the victory prompted Abraham Lincoln to unveil his preliminary Emancipation Proclamation on September 22, 1862. Mr. President, if we persist, we could give to future generations of Americans a gift of history, the opportunity to see, to walk, the hallowed ground of one of the most beautiful places on earth where this Nation's history was written. If we fail, we must answer to future generations who go in vain to seek places of our heritage. On October 19, 1864, with victory in his grasp, Jubal Early declined to launch a last attack. Early believed his valiant Confederate troops had won an adequate victory for the day along the banks of Cedar Creek. ``But this is the Sixth Corps,'' an aide protested, ``and they will not go unless we drive them.'' Early did not attack and his day was soon lost. To those who would act too cautiously here, I say, ``But this is the eleventh hour. The battlefields will be lost unless we act now and decisively.'' Mr. President, I ask unanimous consent that an editorial from the New York Times of July 4, 1997, on the ``latest battle of Gettysburg'' be printed in the Record, along with a letter from James M. McPherson, of Princeton University, supporting my amendment.

Mr. JEFFORDS. I move to lay that motion on the table. The motion to lay on the table was agreed to. Amendment No. 1215

Mr. JEFFORDS. I move to lay that motion on the table. The motion to lay on the table was agreed to. Amendment No. 1214

Mr. JEFFORDS

Mr. JEFFORDS. I could not help but come in and join you, associate myself with your remarks for Bob, because I worked with him both in the House and the Senate. I agree with everything you said. He did so much to assist all of us who wanted to benefit those in the most needy situations. I agree with you. If it wasn't for him--and also of course Patricia Morrissey on my side, those two who worked so very closely together all during that period of time--we would not have accomplished so much. Bobby was incredible. I know he is going to have even, perhaps, a more useful role now that the basic work is done in the profession he is going into. But he is one wonderful person. You are to be commended for recognizing that and utilizing him, of course, to benefit all of us. I thank the Senator for his comments.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Select Committee on Intelligence be authorized to meet during the session of the Senate on: Tuesday, September 16, 1997, at 4 p.m. to hold a closed conference on the fiscal year 1998 Intelligence Authorization bill; Thursday, September 18, 1997 at 10 a.m. to hold an open hearing on China; and Thursday, September 18, 1997 at 2:30 p.m. to hold a closed hearing on intelligence matters.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Subcommittee on Financial Services and Technology of the Committee on Banking, Housing, and Urban Affairs be authorized to meet during the session of the Senate on Tuesday, September 16, 1997, to conduct a hearing on financial instrument fraud.

Mr. JEFFORDS

Mr. JEFFORDS. I yield the remaining time to Senator Coats.

Mr. JEFFORDS. To inflame this issue into being one of false information and filing of misleading information is totally incorrect. The issue here is not that. The issue here, on each of these medical devices, is whether or not they must file every conceivable, possible use that FDA thinks might be made of it. FDA should focus rather on the use that it is intended for or any other use that the manufacturers know it will be intended for. There is nothing involving false or misleading information. That, of course, is under the control of the FDA and that would be a serious matter with the FDA. It could, and should deny approval of a device where a manufacturer deliberately files false and misleading information. Let us set the record straight. Manufacturers cannot file false and misleading language. To raise that as the issue is to really differ from what the important issue is, and that is how long do Americans have to wait to get access to important, new medical devices. In Europe it takes much less time and it is much more expeditiously handled. We can have the same kind of treatment here while ensuring that they are safe and effective for their intended use. For any device that is intended for a particular use and it is known by doctors to be effective for another use, that's fine. That is the practice of medicine. Doctors sometimes find other, valuable uses for medical devices. That is how medical practice and innovation proceeds--and we don't want the Federal Government telling doctors how to practice medicine. But for the manufacturer to search out every conceivable use and then to study every conceivable possible use ends up in delays of these devices coming onto the market. That means that Americans, doctors and patients, are unable to utilize medical innovations that are more readily available in Europe. So I wish we would get away from making this into a ``false and misleading language'' filing. There is no such issue here as that. The question is how much right does the FDA have to require a manufacturer to understand and get involved with the practice of medicine where some other use might be made. That is the issue. I think there are ways we can solve this, but not just by raising it to the issue of emotionalism. That is not the solution here. There is no problem having false or misleading information filed on a medical device approval application, because that is against the law. I yield the floor.

Mr. JEFFORDS. At this time, prior to cloture?

Mr. JEFFORDS. I object at this time.

Mr. JEFFORDS. How much time do I have remaining?

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I spoke at length yesterday. I will try not to beat that record, but I do want to make a few comments. First of all, if you take $100 million and divide it by 250 million, you come up with about 38 cents a person and that represents what the endowment costs. I think we have to put in focus what we spend on the arts and why we spend it there. We had some excellent presentations yesterday and we had some this morning on different views of how the money for the Endowment ought to be spent. I guess if you analyzed the Senate, we would have probably 70 or 80 people who say, ``OK, let's spend the money, but we have a different way to spend it.'' A number would spend it with more going to the States. Some would spend it with all going to the States. Others would spend it in different proportions. But I guess that if it was just a question of whether there ought to be that much money out there available, that we would have a big vote, 70, 80 votes in the Senate, and that is what we need to do--analyze and figure out whether the way we are spending it is the best way. That, I think, is what is being asked of this body, and I think is being asked of the people throughout the country: Are we spending too much on administration? Are we directing too much of the money to the big cities? Are we spending too much in other areas rather than out in the States? So I hope we keep that in mind as we go forward and examine the amendments that we will be faced with. I would also like to point out some of the very excellent points that were made by other Senators yesterday. I think Senator Bennett from Utah probably made one of the best presentations I have heard on why the Endowments are so important and what it does mean to have your particular program get the stamp of approval. As he stated, it is like the Good Housekeeping Seal of Approval for a program. What this does is allow you to not only utilize the money, the small amount of money you get from the Endowment, but to use that as a fundraiser to be able to let people know, ``Hey, this is a good program and it has the sanction of the Endowment and, therefore, you should help us put that program on.'' It was an excellent presentation. We have had others this morning, Senator Tim Hutchinson and others, as well as Senator Hutchison of Texas saying, well, yes, it is a good program, but more of it ought to be distributed to States and a lot less of it ought to be spent from Washington. I spent my time yesterday stating that I might have an amendment which would spend more of the money in the area of education, indicating that the studies demonstrate that those people who participate in programs of art and music do substantially better on SATs than those who do not. I think that is something we should take note of. And there are a lot of reasons for that. Some of the basic problems we have in education is the lack of discipline and respect by students. Both of these qualities come along with the arts and the programs with the arts--I delineated a number of those programs that I have viewed as I traveled around the country where students have done exceptionally well, from the east coast to the west coast. When the authorization bill came out of the committee, we suggested that NEA ought to look at trying to evaluate and assist the rest of the country, understand which programs do work, what programs are helpful in improving the access to the arts in education. Also, as I pointed out yesterday, there are many programs which have been successful in the cities around the country in helping those who are impoverished. I mentioned one program in New York City where there was a horrible situation--so many young people had come from homes of violence, where a member of a family had been killed. Through art and art therapy they were able to bring out the horrible experiences in that child's life and begin to open up a vista of perhaps a life without violence and fear introducing instead hope and other positive things like that. I think there is a general consensus--or close, a substantial number of Members of this body--that we ought to keep the Endowment but perhaps take a look at how those funds are utilized. So I expect that the Senator from Alaska will have an amendment along those lines. Also, I would like to just raise a few things. I did not talk about the importance of the Endowment in extending the benefits of the arts and the benefits of museums around the country. For instance, the Portland Arts Museum moves out to support the Northwest Film Festival, showcasing the works of artists from Alaska, Idaho, Montana, and Washington; the Paul Taylor Dance in New York received a grant to tour through Alaska, Texas, and California; the NEA-supported Educational Broadcasting Corporation in New York to put ``Great Performances'' and ``American Masters'' on TV for the enjoyment of millions. The New England Foundation for the Arts received a grant to bring the ``Dance on Tour'' program to Connecticut, Maine, New Hampshire, Rhode Island, Vermont, and Massachusetts. The YMCA in Chicago received a grant to expand its Writers Voice centers-- writing workshops for young people--to Georgia, New Hampshire, Florida, and Rhode Island. States have little incentive to fund projects which benefit people outside its borders, yet it is those partnerships which enrich our Nation. These are examples of why national leadership is important. So I hope that as we move forward we remind ourselves that there are many activities of the Endowment other than some of the areas of controversy that we have heard of. Mr. President, I yield the floor. Mr. GORTON addressed the Chair.

Mr. JEFFORDS

Mr. JEFFORDS. I yield to the Senator from Indiana 2 minutes.

Mr. JEFFORDS. The Senator can have whatever time he wants.

Mr. JEFFORDS. I yield 10 minutes to the Senator from Connecticut.

Mr. JEFFORDS. Mr. President, I yield myself 10 minutes.

Mr. JEFFORDS. Mr. President, I think I would like to talk a little bit about where we are right now in the process. We had an agreement this last weekend which would have allowed us to dispose of this bill without the necessity of going through the cloture process. But then fen/phen happened. All of a sudden the Nation is alarmed and concerned, and reasonably so. But to bring the pharmaceutical fen/phen issue into the device issue is disingenuous. The situation with fen/phen is that two different, approved drugs were used in combination on the basis that doctors found out that when used in combination they were more effective in achieving their purpose of reducing weight. It was determined by some astute doctors who noted that there were some problems being caused with respect to heart valves that there was a relationship between those problems and the drug combination. This was brought by the doctors to the attention of FDA, and the FDA immediately alerted the marketplace and called for a prompt in-depth evaluation. On the basis of further data the companies voluntarily removed them from the market. Now we are talking about a very, very different issue when it comes to the device issue discussed by the Senator. For instance, let's go back to fen/phen. If a drug company had to test its drug in combination with every other drug that is on the market with which it might reasonably be expected to be used in combination, it would take decades before anything would be approved. Right now I have had a whiplash. I am taking two different drugs to manage the injury. But I don't think anybody has done a study to figure out whether Ibuprofen and the other drug I am taking is going to create some problem for me. I hope they don't spend all of that time researching that question because we would never get anything approved. That is certainly the case with the devices, we must not allow the FDA to endlessly question device manufacturers about how physicians might or might not use their product in the future, especially if the manufacturer does not seek permission to market or promote for that use. Again, we had an agreement going into this week that we would argue this device thing out, and then we would vote on it. Now that is off because of fen/phen. So we are now in the a post-fen/phen situation. But let us remember that we just had a vote. It was 94 to 4 that we ought to go forward. Why? Last week we were delaying consideration over 6 pages of a 152-page bill, we are now talking about 2 pages of a 152- page bill. I agree that section 404 is an important issue. We need section 404 to correct problems at FDA. Also, I am concerned that my good friend from Massachusetts is getting into an emotional argument about the security of people in this Nation, and that somehow we are threatening their security by this particular provision--I have been chastised in my own State, and perhaps the country, saying I am threatening the lives of all Americans with this bill. That is life in politics. You have to take that. Let me talk about the issue that we have with respect to the devices. While the past has been marked by advances for both patients and the economy, the present is increasingly troublesome, and the future is by no means assured. For both premarket-approved products and the 510(k) product--that is, nearly identical products--the FDA's review requirements have become more burdensome and are taking more time. This has resulted in the delay of approving new devices. That is the issue here. Should we have to wait years to get something which will help us, help our health, help save our life, because FDA wants to explore hypothetical uses of the product by physicians, acting on their own initiative? This has resulted in the delay of approving new devices. Furthermore, the current regulatory system is not keeping pace with medical innovation. U.S. patients face delayed access to the newer, more advanced generations of devices. In some cases, Americans are going abroad to take advantage of these technologies. U.S. device firms are themselves moving production and research facilities to other countries. A study conducted by Medical Technology Consultants, MTCE Ltd., found that patients in the United States wait up to three times as long as their European counterparts for Government approval of new medical devices. The study also found that higher risk, breakthrough medical devices were approved in Europe within 80 to 120 days, provided the manufacturer has passed an EU facility inspection, which is completed within 120 days. Similar devices take an average of 773 days to be approved in the United States. New lower risk devices entered the European market with no delay once a manufacturer has passed the initial facility inspection. Similar devices take an average of 178 days to be approved in the United States. The FDA already takes four times as long to approve breakthrough medical devices as is allowed by U.S. statute--it has to do them faster--according to the Health Industry Manufacturers Association, HIMA. The approval times for these devices have nearly doubled since 1990. The FDA's record on approving incremental improvements to existing devices is similar, with approval times also nearly doubling since 1990. Manufacturers will not continue to research and develop devices in the United States--they will all be overseas--if they face such egragious delays. Patients presently have to wait for devices stuck in the FDA's pipeline, and manufacturers have little incentive to bring new devices into that pipeline in the first place. According to another study conducted by the Wilkerson Group, a New York-based independent consulting firm, FDA delays in approving devices will lead to the loss of U.S. jobs to nations where approval processes are more streamlined--an estimated 50,000 jobs over the next 5 years. Governments in Ireland, the Netherlands and elsewhere have already begun to highlight the impediment of FDA regulatory delay in their marketing materials to attract United States businesses overseas. Such actions will erode our Nation's medical research infrastructure over time. So we are going to be getting them all from Europe. That is not going to help us obtain better health care for our citizens. I would say one of the problems we have had, and the reason we have PDUFA and everything else, is to try to help the FDA be more efficient and effective in getting through their duties. It is important that we become more effective and efficient in reviewing these devices. I point out we here in this country have a wonderful record, but it can be a better record. Certainly another thing I would like to point out--why are the patients' representatives in favor of amendments that we have and consumers opposing them at times? Because consumers, obviously, are looking at it from a different perspective. They are not ill. They don't need it. So they say, ``Don't do anything that might hurt us. It is better to be safe and take a long time and delay it, than it is to put it on the market.'' That's fine. But if you are a patient, you say, ``Hey, wait a minute. I am willing to take a little risk. I am willing to take a little risk. I'm in bad shape.'' So you have to keep those things in mind when you listen to the arguments. In most all the cases, the patients certainly are on one side, in a sense, and the consumer is on the other. With that, I reserve the remainder of my time.

Mr. JEFFORDS. Mr. President, I will say, we will continue to cooperate to bring this to an expeditious ending. I thought we had that agreement. I am ready to enter another one. I hope by the time the Interior bill is over, we will have one. I urge us to work together. I yield back whatever time I have. Mr. COATS addressed the Chair.

Mr. JEFFORDS. Mr. President, I ask unanimous consent for 1 minute.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I rise today to pay tribute to the Proctor Maple Research Center in Underhill Center, VT on the occasion of its 50th anniversary. It is the oldest maple research facility in the country with a mission that embraces research, demonstration, and education. The center employs basic, as well as, applied research in studying various aspects of the sugar maple tree, its products and methods to improve syrup production. In addition, the facility monitors long-term meteorogical as well as air pollution data in close cooperation with a number of State and Federal agencies. Operations on site demonstrate the latest technologies from which the public and industry can learn the best methods available for manufacturing. The center's state-of- the-art laboratory promotes crucial communication among researchers. Over the years, research conducted at the center has provided new techniques for efficient sap collection and evaporation systems. It has, and will continue to play an integral role in the success of our region's maple sugar industry so very critical to the local economy. I am sure that the impact of work completed at the center is realized not only in New England, but across the country, as many have had the pleasure of tasting the fruits of their labor. As a Vermonter and one of millions of Americans that enjoys maple sugar products each year, I would like to extend my best wishes to the Proctor Maple Research Center for many more years of continued success.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask unanimous consent that when the Senate reconvenes at 2:15 there be an hour for debate only on the FDA bill to be equally divided between Senators Jeffords and Kennedy, and immediately following that hour the Senate will resume the Interior appropriations bill.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I know we all join in expressing those feelings about Wiley. They were so adequately and eloquently expressed. We appreciate that.