Christopher Dodd

Mr. DODD

Mr. DODD. Madam President, let me begin by expressing my appreciation to our colleagues who rejected the proposal to eliminate the National Endowment for the Arts in its entirety by a vote of 23 to 77. I think it was a good vote and a strong vote, one in which the Senate can take legitimate pride. I think that vote expresses the feelings of most of us here that the National Endowment for the Arts has been a very successful agency that has made a significant contribution, and continues to do so, to the vitality, health, well-being, and cultural heritage of our country. I know it has been said that there have been examples cited of where NEA grants or subgrants or subcontracts over the years, from time to time have been given that have supported or produced or been involved with some productions of art that have been distasteful to many people in this country. I am not here to argue the merits or demerits of those particular cases. In fact, in several instances, I, too, was sort of stunned that certain productions were provided with that kind of financing and backing. But I think it is important for everybody to understand and to put this into context, if we can. As I understand it now, since the creation of the National Endowment for the Arts, going back more than a quarter of a century ago, there have been over 100,000 grants that have been extended by the NEA. Of that 100,000, I am told, if you take all the controversial grants that have been given, the number is around 40 or 45 maybe. That, many would argue, goes beyond the ones that were the most controversial, which number in the single digits. I wanted to put that into perspective.

Mr. DODD. If my colleague would give me a chance to respond to the question, he raises the issue in the committees. He is not just raising it here on the floor. First, let me--I should have mentioned these in my remarks--comment here. I happen to believe that Jane Alexander has done a brilliant job at NEA--a remarkable individual, truly a national treasure. I recall the specific questions being raised about these issues. Certainly legitimate questions should be raised about how well an agency functions, whether or not we are getting much for the dollar for the purposes intended, or how much gets consumed by administrative costs. I think that is a legitimate question raised in ways in which we make an agency function better. Certainly we have seen this administration focus a great deal of its attention on so-called ``reinvention of Government''--trying to streamline 180,000 fewer jobs at the Federal level, and fewer pages of Federal regulations. I think we all applaud that. I think it is a legitimate issue to look to see how we can make this agency perform better so that the American people will be the greater beneficiary, if you will, of the role of and the purpose of the NEA. But I would respectfully say to my colleague from Arkansas, as legitimate as those questions are, it seems to me that we ought not to try to eliminate in effect, through either block grant or total elimination, a Federal agency that has played such a critical role in giving national voice, as I said earlier, to the arts efforts, not to mention regional aspects, and the like. My fear is that, of course, by doing this through a block grant we would achieve just that--rather than an appropriate examination of how we can make the NEA work better, respond better, reduce its overhead costs so that more of those dollars will actually reach the artists, the communities, and the artistic efforts that we all would like to see happen. That is my concern here. We seem to be saying that no matter what you try to do, there is nothing that could be done here--that there is no way whatsoever to make this agency work better. I believe there are ways. I think Jane Alexander has certainly demonstrated that over the last several years under her leadership. So, I urge that, rather than discarding in a sense de facto--that would be the result here--with all due respect the NEA, we ought to look at ways in which the Senator might suggest how we can improve the NEA's performance rather than certainly suggesting its elimination. My colleague I see may have another question.

Mr. DODD. If I can just finish my remarks, I will be glad to yield at that time. The reason I cite those statistics is I think it is important, as we look at these agencies, that we keep this in context. No agency is perfect. There have been questionable grants given by the Housing Administration, by the Defense Department, and by the Commerce Department. In fact, I would match up the total amount of grants given by the NEA, those that are controversial or distasteful, and compare that with almost any other agency of the Federal Government and compare their track record in terms of cases where there has been fraud, abuse, or waste of millions of dollars. So nobody is standing here suggesting perfection at all. What we are arguing about is whether or not there is a legitimate purpose in having a National Endowment for the Arts, a federally chartered agency that tries to express the importance of the cultural contribution of the arts. I have often said to students in my State, or elsewhere, when this issue comes up--I think almost every grade school student can tell you the name of the artist who painted the roof of the Sistine Chapel. But I defy anybody to tell you who the Pope was at that time, or to name the Emperor of Rome. We don't remember the political figures throughout history, but artists have given us a definition, a signature, in many cases, of a generation or a time. Certainly, we have seen that in our country. We define our own heritage by literature, art, and music. To have our Government, in a sense, speak to that and try to provide guidance, assistance, and support for areas of the country that would not otherwise get that assistance, I think is something we ought to build upon and perpetuate. We build stadiums for sports with taxpayers' money. These stadiums today can cost $100 or $115 million to house 30,000 or 40,000 people to watch a sporting event. The entire budget we are talking about here for the National Endowment for the Arts is $100 million for all 50 States, to support our cultural activities. There has been a tremendous burst and blossoming of activities in the last 30 years in this country in the arts area. The number of nonprofit theaters has grown from fifty-six 30 years ago to over 400 in the country today. Orchestras have quadrupled in number, to over 200 in our Nation. Public arts agencies in small towns and cities have climbed to over 3,000 in the last 30 years. Yet, today, we see another attempt here to try, in one way or another, to get rid of the agency, to either vote it out of existence or, with all due respect, to block grant the money to eliminate it. We also know that this very agency has been the one which has served as the impetus, the spark, if you will, that has aided in the flourishing of the arts we have seen over these past three decades. With a deep commitment and a meager beget, the NEA has provided vital support to States, local communities, schools, artistic and cultural institutions, artists, and others for over 30 years. While always limited, these dollars do make a difference. It is hard to leverage out of a block grant, if you will, the kind of private contributions NEA has been able to generate. So by removing the kind of programs that we have seen here and leaving things up to sort of the political vagaries, we leave this commitment that we have made over the years in great, great jeopardy. Currently, 35 percent of the NEA's budget flows directly to the States--in effect, a block grant, if you will. I understand that the States deserve a role, but it needs to be a partnership with the Federal Government. The success of the NEA is rooted, obviously, in its national presence--once that is lost, I think we all lose in this country. Why is the Federal leadership role important? First, I happen to believe that Federal leadership allows better access to the arts for all Americans. It assures all Americans, regardless of income or geography, that they will have access to the arts. Grants allow quality orchestras and theater groups to travel throughout the country. The NEA helps communities with few resources to develop local talent through exposure to operas, theaters, and orchestra groups. Second, the NEA develops public-private partnerships that work. NEA grants, as I said a moment ago, help raise and leverage private dollars. Also, it is the prestige of an NEA grant that, on average, attracts money from other public and private funding sources. There is no guarantee that these same sources will risk supporting a festival or exhibit sponsored by an unknown State art council with no track record and without the stature of the NEA. In essence, NEA grants raise money; block grants do not. Third, support for programs with a national impact is a goal and commitment of the NEA and can only be forwarded by an organization with resources and the kind of clout and prestige of a Federal agency. It puts us on record, as a nation, that we stand and support these efforts. The NEA supports such nationally important work as the Vietnam Veterans Memorial, or public television shows; these are national in scope not State by State, or community by community. We lose that if we don't have a national focus and direction. National studies into the importance of arts education can be lost. Supporting American artists that represent the United States as a nation in cultural festivals overseas are supported by the NEA. Who is going to do this if we, in fact, distribute the resources around the country and lose the national presence of the National Endowment for the Arts? The National Endowment for the Arts dollars go to regional projects-- not just State and local ones--such as exhibiting the traditional folk arts of the Delaware Valley. Only the NEA, as a fully funded Federal agency, can garner the resources and provide the leadership for such nationally important work. Fourth, NEA dollars receive economic returns. These dollars create $37 billion in national economic activity, and $1 billion alone in my home State of Connecticut. Grants spur economic activity throughout the country. NEA grants generate tourism, stimulate business development, drive urban renewal and contribute to our Nation's economic vitality. Over 1.3 million jobs are supported by the arts. Finally, the NEA is a leader. The NEA provides cultural leadership for the Nation in such areas as education, crime prevention initiatives, city design, public arts, and preservation of the Nation's cultural heritage. By giving the majority of funds to the States, by cutting out the so- called middleman here in Washington, you are not helping, necessarily, the local artist, the local orchestra, or the local theater. In many cases, I suggest that you are actually hurting them. The NEA is the keystone here. Once removed, I think we all lose. Mr. President, the arts adds to our culture, to our Nation and our economy. I believe it is time that we look for a source of funding, in addition to Federal funds, to maintain the NEA's vital role. Our colleague from Alaska, Senator Stevens, has a proposal--a sense- of-the-Senate resolution--that we conduct some extensive hearings in the coming Congress to look at ways in which we might supplement the Federal funding for the NEA. It is time we do more to ensure the future viability of the NEA and the NEH. I am looking at a way in which we might get beyond the debate, and create a true endowment to supplement federal funds. I suggest looking into an innovative way to create this true endowment. I propose tapping revenue from a copyright extension to fund this true endowment. My idea is to extend, or rather to terminate the copyright period--whatever it may be, 50 70, or 90 years--that there be a period of say 20 years after that period in which the Government would auction off these copyrights. Individuals would bid on the copyrights. And the resources that came in from the bids would support a national arts endowment, a true endowment. But this would allow one generation of artists supporting future generations; in a sense, a true endowment. This is no endowment. I don't know why we call this a National Endowment for the Arts. It is not an endowment. It is an appropriations that we have year in and year out. The idea of a true endowment is not a perfect one at all. But it would be a way of us getting away, if you will, from the constant battle of appropriations to a way of having the arts in effect generate revenues. You may not get much immediately. But I suspect with all the technology that is being developed--the preservation, the ability to preserve works of art and many art forms emerging--that in the 21st century, long after all of us are gone, there might be a substantial amount of revenues that would be generated to support arts activities in the country. I raise the idea of a true endowment as a mere suggestion and I hope the Senate will look into the suggestion. It is time to endow the NEA and the NEH with a future and secure a national cultural endowment for generations to come. With that, I thank my colleagues for their patience in listening. But I know my colleague from Arkansas wanted to raise a question. I would be glad to at least try to respond.

Mr. DODD. Second, I will conclude my remarks so others may have a chance to speak on this issue. In the reauthorization bill, which passed 14 to 4 by the Labor and Human Resources Committee, we adopted an amendment by our colleague that codifies the inspector general's recommendations that the Senator from Arkansas has identified before the committee today. So that the suggestions that are being made are ones that we think ought to be made a part of making NEA perform better. That is a legitimate function of a congressional committee--to examine all of our agencies to determine how they can function better. We did that pretty overwhelmingly in the committee. I commend my colleague for the amendment and the suggestion that codified those ideas. Second, Mr. President, administrative costs were lower at the agency when, frankly, the appropriations were higher. You shrink a budget down and, of course, if you are trying to maintain a programmatic level, what can happen is you find your percentage costs rise with the shrinkage of dollars, so that more and more of it gets eaten up in administration. When we actually appropriated more for the NEA, those administrative costs were a lower percentage of the overall budget. Audit findings were from a group of grants recommended by the staff of the NEA for audit because of concerns about the grant administration, and they were not randomly selected, I might point out as well. At any rate, Mr. President, just to make the final point on this from my perspective here, I think we ought to be celebrating the success of the agency. To have had 100,000 grants in 30 years with 40 controversial ones, I defy any other Federal agency to have a track record even remotely close to that record. Any other agency that provides grants to anyone, where they have had only 40 that fall into the category of controversial, that is a remarkable record and one I think we ought to applaud. We ought to be celebrating the National Endowment for the Arts and its contribution to our country and what it has stimulated, what it has brought to enrich our heritage, our culture, our time. Someone was pointing out to me earlier today there was a great debate in the Congress over whether or not we ought to accept the library of Thomas Jefferson when he offered it to the United States. Of course, the successor of that it is the Library of Congress, but it was the Jefferson library that was offered. The debate was a raging debate, and some suggested we only ought to accept the Jefferson library if we extracted from it any books which spoke about atheism or other questions which were not mainstream or popular or certainly rejected the values of our society as a whole. It was a relatively close vote, but that idea was rejected and we bought the entire Jefferson library. Today, I think our Library of Congress and the contribution that Thomas Jefferson made is something all of us applaud. We might find it even somewhat amusing today to have heard there was that kind of debate. I would suggest today that even with these highly controversial performances that people do not like, that offend them, we can focus on that if we want, but why not focus as well on the over 100,000 grants that have enriched our society, have brought a great wealth to this Nation, opportunities to people in areas of this Nation that never would have had that benefit. My hope is that when our colleagues vote on this particular amendment, they will be mindful of that contribution, of this great success and of the great fortune we have as a Nation to have someone of Jane Alexander's abilities and background and qualities to help lead this agency, as sensitive as she is, listening to the concerns of any Member who cares to have her time in how to make this agency work better. I hope we would keep that in mind as we cast our votes, so future generations look back on this time and say that in this Congress at the close of the 20th century the Senate insisted, a majority of us here, to keep the National Endowment for the Arts, to prepare for the 21st century and to leave a legacy of riches, of cultural riches. We lose that, Mr. President, if we abandon this agency and turn this into a block grant. Mr. President, I yield the floor. Mr. SESSIONS addressed the Chair.

Mr. DODD. Madam President, I ask unanimous consent that an article by Lewis Hyde that appeared in the Los Angeles Times, a MacArthur Fellow and Professor of Art and Politics at Kenyon College, that talks about concept and idea, that I mentioned in terms of establishing a true endowment, be printed in the Record.

Mr. DODD. Reserving the right to object, I want to inquire of the leadership. I have no objection.

Mr. DODD. I yield for the purposes of making a request.

Mr. DODD. Madam President, if I may, I still have the floor.

Mr. DODD. Madam President, I yield myself 7 minutes. If I need an additional minute or so, I may ask unanimous consent for that. Will the Chair notify me when 7 minutes have expired and maybe we can work something out here.

Mr. DODD. Madam President, how much time remains?

Mr. DODD

Mr. DODD. Mr. President, it gives me great pleasure to congratulate the great city of Stamford, Connecticut, and Mayor Dannel Malloy, for having been ranked on the Children's Environmental Index as one of the most ``kid-friendly'' cities in the United States. Normally we consider the number 13 to be an unlucky number, but Stamford ranked number 13 of 219 cities in the nation on the quality of life for its children. Stamford was also ranked second in the nation in the education category which included student-teacher ratio and drop-out rate. This index, measured by the organization Zero Population Growth (ZPG), is the sixth in a series of bi-annual studies used to focus attention on the quality of life in the nation's largest cities. It is the third index which directly addresses the social and physical environment of children, measuring such areas as infant mortality, teen pregnancy, childhood poverty, high school drop-out rates, air quality, and crime rates. Mr. President, I was recently appointed by Minority Leader Tom Daschle to chair the Senate Democratic Strike Force for Kids named ``Right Start 2000''. The purpose of this strike force is to develop constructive ways for us in Washington to best address the educational, health, and safety needs of America's children in the first six years of life. It is very clear from this index that we have much to learn from many of our Nation's cities. Clearly Stamford and other cities are taking bold and innovative steps to nurture our Nation's children. The children of today are the leaders of the next millennium. As such, it is critical that we ensure they grow up in surroundings which protect, nurture, educate, and care for them. Stamford has shown its willingness to invest the resources necessary to produce the next generation of leaders. We can only hope that this index will give the impetus to other cities to focus upon what is really critical for our future, healthy and happy children today. The road toward a better future for our kids will be a collective effort on the part of parents, schools, religious institutions, community, State, and national leaders. But this effort will be made easier in an environment where groups and individuals work in partnership with one another. I am delighted to know that this work is going on in my home State of Connecticut, and I particularly congratulate Mayor Malloy and all of the people of Stamford for their achievements on behalf of Stamford's children.

Mr. DODD

Mr. DODD. Mr. President, I thank the Chair and I thank my colleague from Vermont, the chairman of the committee. Let me begin these brief remarks by commending all of our colleagues on the Labor and Human Resources Committee. This has been a long process, 2\1/2\ to 3 years. The Presiding Officer is a member of this committee as well and all have worked very hard, I think, to bring a bill which I think most would agree is a very good bill. There obviously still are some issues that will have to be resolved, but this has been a very fine product that has been assembled by both Democrats and Republicans for the first time in several decades of reforming the Food and Drug Administration and the processes by which we bring important pharmaceutical products and medical devices to patient groups and individuals across this country in an efficient, safe, and expeditious fashion. Let me begin as well by thanking our colleagues for their overwhelming support earlier today of the cloture motion to proceed with this bill. Mr. President, 94 Senators, of both parties, loudly and clearly told us they are ready to move forward to reauthorize PDUFA and begin debating the other critical reforms this bill contains. There is no Federal agency with a more direct or significant impact on the lives of the American people than the Food and Drug Administration. The foods that we serve our family, the medicines we take when we are sick, even the drugs we give our pets are all approved and monitored by the Food and Drug Administration. We must not lose the opportunity that we have before the Senate today to enact legislation that ensures that the FDA has the authority it needs to bring safe and effective products to the American people quickly, efficiently and safely. I again thank both Senator Jeffords and Senator Kennedy for their perseverance on this issue. Time after time they have been willing to return to the bargaining table after many others would have just walked away. With open minds and good faith they have extensively negotiated this bill line by line. Mr. President, we have now come to a point where issues on which Members were previously completely polarized--third-party review of medical devices, off-label dissemination of information, health claims for food products, the number of clinical trials needed for drug approval, and just today, national uniformity of cosmetics--we have now reached agreement. I don't know that any of us would have thought unanimity possible on these provisions even a month or two ago. Yet here we are, this afternoon on this day, with full agreement on all but a handful of issues, or less. I know we have a better bill for all the arduous negotiations that have occurred. As an example of how far we have come, let me just briefly describe third-party review of medical devices. The bill would expand the pilot program currently administered by the FDA. This is a program, I should note, that is supported by the FDA as a way to make more efficient use of its resources. In last year's debate on this issue, which many may recall as being one of the more acrimonious, we were told that this provision was a nonstarter, no room for compromise, subject closed. This year, I am pleased to say a spirit of bipartisanship and compromise has prevailed. Senator Harkin, Senator Kennedy, and Senator Coats, the Presiding Officer, worked diligently to draft language that ensures that higher risk devices are not inappropriately included in this pilot program and that strong conflict of interest protections are in place. Late last week, again on an issue that appeared unresolved, national uniformity for cosmetics, we have reached agreement. Senator Gregg of New Hampshire has offered what I think is a very reasonable compromise. In the area of packaging and labeling, States can continue to regulate where the FDA has not acted. Conflicting State requirements that could confuse consumers will be removed. But where the FDA has not chosen to act, where it does not have either the manpower nor the authority to protect the public, States can still play their historic role in regulating cosmetics. This is the kind of effort, Mr. President, made over and over again on this bill--some 30 times just since the markup 2 months ago that we have made improvements in this legislation. A great many of us take pride in the product that we have created --a bill that would speed lifesaving drugs and devices to patients and that clearly retains the FDA as the undisputed arbiter of the safety and effectiveness of the products. I will speak about some of the positive reforms contained in this bill, as well. At the heart of this bill is the 5-year reauthorization of PDUFA, the Prescription Drug User Fee Act, a piece of legislation remarkable for the fact that there is unanimous agreement that it really works. PDUFA has set up a system of user fees which drug companies pay to the FDA. These fees have enabled the agency to hire more staff. As a result, drug approval times have been cut almost in half, getting new and lifesaving therapies to patients more quickly. In addition, by improving the certainty and clarity of the product review process, S. 830 encourages U.S. companies to continue to develop and manufacture their products in the United States, not an insignificant matter. The legislation emphasizes collaboration early on between the FDA and industry during the product development and product approval phases. This will prevent misunderstandings about agency expectations and we think should result in quicker development of approval times. Mr. President, in addition, S. 830 establishes or expands upon several mechanisms to provide patients and other consumers with greater access to information and lifesaving products. For example, the legislation will give individuals with life-threatening illnesses greater access to information about the location of ongoing clinical trials of drugs. Based on a bill originally championed by Senators Snowe of Maine and Dianne Feinstein of California, I offered an amendment in committee, which I was pleased to see adopted, to expand the existing AIDS database to include trials for all serious or life-threatening diseases. Experimental trials offer hope for patients who have not benefited from treatments currently on the market. Currently, patients' ability to access experimental treatments is dependent on their spending large amounts of time and energy contacting individual drug manufacturers just to discover the existence of trials. Mr. President, this is not a burden that we should place on individuals already struggling with chronic and debilitating diseases. This database will provide one-stop shopping for patients seeking information on the location and the eligibility criteria for studies of promising treatments. Mr. President, I am particularly pleased that this legislation incorporates the Better Pharmaceuticals for Children Act, legislation originally introduced by our former colleague from Kansas, Senator Kassebaum, and now cosponsored by myself and Senator DeWine of Ohio, along with Senator Kennedy, Senator Mikulski, Senator Hutchinson, Senator Collins, and Senator Cochran. This provision, Mr. President, addresses the problem of the lack of information about how drugs work on children, a problem that just last month President Clinton recognized publicly as a national crisis. According to the American Academy of Pediatrics, only one-fifth of all drugs on the market have been tested for their safety and effectiveness on children. This legislation provides a fair and reasonable market incentive for drug companies to make the extra effort needed to test their products for use by children. It gives the Secretary of Health and Human Services the authority to request pediatric clinical trials for new drug applications and for drugs currently on the market. If the manufacturer successfully conducts the additional research, 6 extra months of market exclusivity would be given. I recognize that there are a few matters unresolved in this bill despite the best efforts of all involved, and we will need to hold votes on those issues. One issue, which I plan to discuss further when we debate the bill this week, involves section 404 of the bill, which relates to the FDA's medical devices. This provision, the so-called labeling claims provision, clarifies current law by stating that while reviewing a device for approval, FDA should look at safety and efficacy issues raised by the use for which the product was developed and for which it was marketed. Again, this is current law. Unfortunately, in a few instances the FDA has inappropriately expanded the scope of its review by requiring manufacturers to submit data on potential uses of the product. Some have raised concerns that under this provision a manufacturer could propose a very narrowly worded label for a device and that the FDA would be barred from asking for information on other obvious uses. I don't believe this is the case. The FDA retains its current authority to not approve a device if features of the device raise new questions of safety and efficacy. Clearly, if a bad actor device manufacturer attempted to get a misleading label past the FDA, the agency would have full authority to disapprove the product. Again, I urge, on this matter, that some common ground be sought to see if we cannot resolve this, but I do believe the present legislation is more than adequate to protect the concerns that have been raised about a use for a device beyond what its intended purpose would be. I was pleased to join Senator Jeffords, the chairman of the committee, as the first Democratic cosponsor of this bill. I thank him again for the hard work and long hours that he and his staff, as well as Senator Kennedy, Senator Mikulski, Senator Wellstone, Senator Coats, Senator Gregg and others, have contributed. Mr. President, this has been a long process, and while there are still some outstanding issues, I think this committee deserves a great deal of credit for having been open to the suggestions of others. There are about 50-some-odd amendments that are kicking around that may be offered. I don't know how many will actually survive the germaneness test when they are raised, but I hope, for those who are bringing up new matters here that we have not had a chance to look at, that they would reserve those unless there is an overwhelming need for them. In many cases, if the matters had been brought before the committee earlier, we might have been able to handle them. We have a few days left to get the bill done. PDUFA goes out of existence on September 30. We have been 2\1/2\ years at this now. My hope is we will not delay this to such a degree that we lose a historic opportunity to make a difference. When it takes 14 to 17 years to get some cancer treatments approved, there is something fundamentally wrong with that kind of a process. We ought to be able to make it far more efficient than that and also be able to provide people with the safety that they demand. It is a wonderfully encouraging thing in this country, when we think how many places we go and how many products we ingest and how many products we apply to our bodies and to our children and families, that we have a high sense of confidence that when we do that, it is safe and, by and large, efficient and effective. We don't want to lose that. We also believe in this day and age with all the technology available to us that we ought to be able to not give up on safety or efficacy and be able to move that process forward. I thank my colleague from Vermont for yielding.

Mr. DODD

Mr. DODD. Mr. President, I rise today in order to pay a special tribute to Ambassador Raul E. Granillo Ocampo, until recently the Government of Argentina's Ambassador to the United States. Ambassador Ocampo left Washington last month to return to Buenos Aires and another challenging assignment from President Menem. During his nearly 4 years in Washington, Ambassador Ocampo did a superb job representing his country's interests. He understood well what it takes to be an effective diplomat in Washington. Not only did he develop close working relationships with the State Department and the White House on matters of mutual concern to the United States and Argentina, he also made a special effort to establish close ties with the United States Congress. The United States-Argentine relationship has never been better. I believe that Ambassador Ocampo can take a good deal of the credit for this. Certainly issues between our two countries would arise from time to time. That is only natural. But, thanks to Ambassador Ocampo's diplomatic skills, such issues were never allowed to undermine our fundamental friendship and mutual respect. Those of us who had the privilege of knowing Ambassador Ocampo, quickly recognized and appreciated his special talents. So too did President Menem. Hence, it came as no real surprise when in July, President Menem announced the appointment of Ambassador Ocampo to the post of Minister of Justice--a very important position in his Cabinet. That is why Ambassador Ocampo has returned to Argentina. Knowing something about Ambassador Ocampo's background, it makes perfect sense to me that he would be selected to become Minister of Justice. Not only does he have a law degree from the National University of La Plata, a master's degree in Comparative International Law from Southern Methodist University, Dallas, TX; and a doctorate in law from the National University of Buenos Aires. He has also practiced law extensively, served as a judge on the Superior Court of the Province of La Rioja, and as the president, or chief judge, for that court for 2 years. I for one am only grateful that I had the opportunity to get to know Ambassador Ocampo personally during his tenure in Washington. Thanks to him, I have a much better understanding and appreciation of the complexities of the relations between our two countries and of importance of working to maintain those close ties. Before the August recess, I was able to personally bid farewell to Ambassador Ocampo and his charming wife, Chini. However, I also wanted to say a more formal farewell to him as well. I particularly wanted him to know that we in the U.S. Senate have been enriched by his presence in Washington over these last number of years. Finally, Mr. President, it is only fitting that as we say goodby to an old friend, we also prepare to welcome a new one. President Menem has chosen as Ambassador Ocampo's replacement, His Excellency Diego Ramiro Guelar, who just recently presented his credentials to President Clinton. Although I have not yet had the opportunity to meet Ambassador Guelar, I understand that he is both an experienced diplomat and an experienced politician--he has held a number of ambassadorial posts and has been a Representative in the Argentine Congress. I look forward to meeting Ambassador Guelar in the very near future, and to working with him as I did with his predecessor.

Mr. DODD

Mr. DODD. Let me briefly commend our leader, the Democratic leader, for soliciting the support of the 44 others of us who make up this caucus, the Democratic caucus. There are 45 members of this caucus, and all 45 members have signed this letter urging the adoption of the legislation introduced by our colleague, John McCain, from the Republican side and Russ Feingold from our side. I think, as the leader has said, this is not a perfect bill. I have disagreements with it. I do not applaud every single dotted ``i'' and crossed ``t,'' nor do I assume anyone else does, but it is a common vehicle to embrace most of the positions we would like to see adopted as campaign finance reform. The fact that 100 percent of those of us on this side have joined in this letter, I think, is a strong indication of our commitment to this issue. It would not have happened had it not been for our leader on this side. I want to commend him publicly for his leadership on this issue as he has demonstrated in so many other areas and urge that his words be heeded and we try to get some additional sponsors here and see if we cannot bring this up.

Mr. DODD

Mr. DODD. Will my colleague yield?

Mr. DODD. Would my colleague not disagree with me, Mr. President, if this bill comes back from conference with this measure, we ought to filibuster this bill; it ought not to pass?

Mr. DODD

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

Mr. DODD. Mr. President, I consider my role in making recommendations to the President on judicial nominees to be one of the most important parts of my job as a Senator. It is imperative that we fill these lifetime positions with the most able and talented individuals available. That is why I am very pleased that President Clinton chose to nominate Mr. Droney to serve on the Federal bench. Chris Droney is a man of strong character, and I believe that his skills and intellect will enable him to serve the country with honor and integrity as a Federal judge. Since 1993, Mr. Droney has served as the U.S. attorney for Connecticut. During his tenure, he has been well- received by the judiciary and law enforcement agencies and has played a key role in the State's crackdown on street gangs. The Justice Department's last evaluation of his office concluded that Mr. Droney is, and I quote, ``strongly committed to the Department's law enforcement priorities and has demonstrated significant leadership in the law enforcement community, as witnessed by the remarkable cooperation among the law enforcement agencies through the District.'' We are proud that the Justice Department has recognized what we in Connecticut already know: Chris Droney is an outstanding lawyer and public servant. Prior to becoming U.S. attorney, Mr. Droney was in private practice in Hartford specializing in civil litigation. He also served as mayor of West Hartford from 1985 to 1989, where he did an excellent job. He has been very active in a number of charitable organizations, and his community service has earned him several honors and awards. In particular, he was named Citizen of the Year by the Connecticut division of the Boy Scouts of America, and he received the Distinguished Law Enforcement Award from the Hartford Police Union. Christopher Droney is an honest, forthright, and intelligent individual, who is highly qualified to serve on the Federal bench. I am confident that he will serve Connecticut well as a district judge for many years to come, and I strongly urge all of my colleagues to support his nomination.

Mr. DODD

Mr. DODD. Mr. President, Ms. Hall is one of the premier litigators in the State of Connecticut, and I know that her impressive work experience, both in Government service and in private practice, along with her intelligence and character, will enable her to become an excellent Federal judge. After working in the Antitrust Division of the Justice Department from 1975 to 1979, Ms. Hall joined the Hartford law firm of Robinson & Cole, where she has been a partner since 1982. Since returning to private practice, she has handled numerous matters before both Federal and State appellate courts, and her work has focused primarily on complex commercial litigation. Ms. Hall is respected throughout Connecticut's legal community for her intelligence and sense of fairness, but she is best known for her dedicated work ethic. More than one associate at her firm described her as the hardest working, most prepared lawyer that they had ever known. Not only does Ms. Hall push herself, but she also expects a lot from those around her. Her former secretary said that the only time that she was bored during 14 years of working with Ms. Hall was when she was on maternity leave with her third child. However, while Ms. Hall can be tough on others, she always demanded even more from herself. Part of me is actually relieved that I'm no longer an attorney in Connecticut, because I anticipate that trying a case before Ms. Hall would not be an easy day's work. Janet Hall is unquestionably an excellent attorney, but she is also a person of great character and integrity. While Ms. Hall always worked hard to fulfill her responsibilities at her firm, she always managed to keep her career in perspective, and her family was always her top priority. After successfully arguing a case before the U.S. Supreme Court, she was discussing the case with a group of associates. When asked to describe what was the most important thing to remember about arguing the case before the highest Court in the land, she said, ``The most important thing was to bring my family.'' In closing, Janet Hall is an honest, forthright, and intelligent individual, who is highly qualified to serve on the Federal bench, and all of my colleagues should be proud to vote in support of her nomination.

Mr. DODD

Mr. DODD. Mr. President, I want to briefly say to my colleagues, we will vote in a few minutes on two nominees for the Federal district court bench, Janet Hall and Christopher Droney. Senator Lieberman and I have appeared before the Judiciary Committee on their behalf. I see our colleague from Alabama here on the floor, who is a member of that committee and who very graciously heard the two nominees. They are two very highly confident, very qualified nominees. Janet Hall has superlative work experience, both in government service and in private practice. She has worked in the Antitrust Division of the Justice Department from 1975 to 1979. She later joined one of the finest law firms in the State of Connecticut, Robinson and Cole, where she has been a partner since 1982. She has appeared before Federal, State, and appellate courts, and even the U.S. Supreme Court, and her work has focused primarily on complex commercial litigation. In short, she is a very, very fine nominee. She is a graduate of Mount Holyoke College and the New York University School of Law. She has received numerous awards and recognitions including Mount Holyoke's Alumnae Medal of Honor, and she has served on the Board of the Connecticut Bar Foundation since 1993. She also serves on the Parents' Advisory Committee of her hometown high school and has volunteered in numerous other activities in her community. She is a very fine lawyer, a very fine person, very community oriented, and she brings wonderful legal knowledge and expertise to this nomination. I am confident that my colleagues across political lines here will be very proud of their vote in casting it this afternoon for Janet Hall to be a district court judge in Connecticut. The other nominee is Christopher F. Droney. Some of our colleagues know Christopher Droney. He has been our U.S. attorney in Connecticut for the last 4 or 5 years and a very successful one. He is known as one of the leading U.S. attorneys in the country for his anticrime efforts, and in particular for fighting juvenile crime. I might point out that he also knows something about what it is like to be in elective office. He served as the mayor of West Hartford, CT, and did a wonderful job there. He is a graduate of the University of Connecticut Law School, where he was on the Law Review. He was named Citizen of the Year by the Connecticut District of the Boy Scouts of America, and he received the Distinguished Law Enforcement Award from the Hartford Police Union. He also received special recognition award from the Spanish-American Merchants Association. He is very community- oriented and very successful in his community activities. He is a member of the Federal Bar Council, a member of the St. Timothy Roman Catholic Church in his community, and very involved in the YMCA and YWCA in our State, as well. Again, given his background experience as a U.S. attorney, I think my colleagues can feel very, very proud, Mr. President, in casting a vote this afternoon to confirm the nomination of Christopher Droney, as well, to be a district court judge in Connecticut. I urge support for these nominees. I think they will do us all proud. The Senate can be proud of the work they will perform on behalf of all of us. I yield the floor.

Mr. DODD

Mr. DODD. Mr. President, I want to begin by thanking my colleagues for their overwhelming support last week for cloture on the motion to proceed with this bill. Some 89 Senators very loudly and very clearly told us last week that they were ready to move forward to reauthorize PDUFA and to begin debating the other critical reforms this bill contains. There is no Federal agency with a more direct and significant impact on the lives of the American people than the Food and Drug Administration. The foods we serve our family, the medicines we take when we're sick, even the drugs we give our pets, are all approved and monitored by the FDA. We must not lose the opportunity that we have before us now to enact legislation that ensures the FDA has the authorities it needs to bring safe and effective products to the American people quickly and efficiently. I would like to again thank both Senator Jeffords and Senator Kennedy for their perseverance on this issue. Time after time they have been willing to return to the bargaining table after many others would have just walked away. With open minds and in good faith, they've extensively negotiated this bill, line by line. We have come to a point where issues on which Members were previously completely polarized--third party review of medical devices, off-label dissemination of information, health claims for food products, the number of clinical trials needed for drug approval, and just today national uniformity of cosmetics--we've now reached agreement. I don't know that any of us would have thought unanimity possible on these provisions even 2 months ago--yet here we are with full agreement on all but a handful of issues. I know we have a better bill for all of the arduous negotiations that have occurred. Just as an example of how far we've come, let's talk about third party review of medical devices. The bill would expand the pilot program currently administered by the FDA. This is a program, I should note, that is supported by the FDA as a way to make more efficient use of its resources. In last years debate, which many of you will remember as being much more acrimonious, we were told this provision was a nonstarter, no room to compromise, subject closed. This year, I am pleased to say, a spirit of bipartisanship and compromise prevailed. Senator Harkin, Senator Kennedy, and Senator Coats worked diligently to draft language that ensures that higher risk devices aren't inappropriately included in this pilot program and that strong conflict of interest protections are in place. And just last night, again on an issue that appeared unresolvable-- national uniformity for cosmetics, we have reached agreement. Senator Gregg has offered what I think is a very reasonable compromise. In the area of safety requirements, States can continue to regulate where the FDA has not acted. Conflicting State requirements that could confuse consumers will be removed. But where the FDA has not chosen to act, where it does not have either the manpower or the authority to protect the public, States can contain to play their historic role in regulating cosmetics. This is the kind of effort made over and over again on this bill-- some 30 times just since markup 2 months ago we have made improvements to this bill. A great many of us take pride in the product that has been created--a bill that will speed lifesaving drugs and devices to patients and that clearly retains the FDA as the undisputed arbiter of the safety effectiveness of these products. Mr. President, I would like to speak for a moment about some of the positive reforms contained in this bill. At the heart of this bill is the 5-year reauthorization of PDUFA, the Prescription Drug User Fee Act--a piece of legislation remarkable for the fact that there is unanimous agreement that it really works. PDUFA has set up a system of user fees which drug companies pay to the FDA. These fees have enabled the Agency to hire more staff. As a result, drug approval times have been cut almost in half, getting new and life-saving therapies to patients more quickly. In addition, by improving the certainty and clarity of the product review process, S. 830 encourages U.S. companies to continue to develop and manufacture their products in the United States. The legislation emphasizes collaboration early on between the FDA and industry during the product development and product approval phases. This will prevent misunderstandings about Agency expectations and should result in even quicker development and approval times. In addition, S. 830 establishes or expands upon several mechanisms to provide patients and other consumers with greater access to information and to life-saving products. For example, S. 830 will give individuals with life-threatening illness greater access to information about the location of on-going clinical trials of drugs. Based on a bill originally championed by Senators Snowe and Feinstein. I offered an amendment in committee, which I was pleased to see adopted, to expand an existing aids database to include trials for all serious or life-threatening diseases. Experimental trials offer hope for patients who have not benefited from treatments currently on the market. Currently, patients' ability to access experimental treatments is dependent upon their spending large amounts of time and energy contacting individual drug manufacturers just to discover the existence of trials. This is not a burden that we should place on individuals already struggling with chronic and debilitating diseases. This database will provide ``one-stop-shopping'' for patients seeking information on the location of and eligibility criteria for studies of promising treatments. Mr. President, I am particularly pleased that this bill incorporates the Better Pharmaceuticals for Children Act, legislation originally introduced by our former colleague from Kansas, Senator Kassebaum, and now cosponsored by myself and Senator DeWine, along with Senators Kennedy, Mikulski, Hutchinson, Collins, and Cochran. This provision addresses the problem of the lack of information about how drugs work on children, a problem that just last month President Clinton recognized publicly as a national crisis. According to the American Academy of Pediatrics, only one-fifth of all drugs on the market have been tested for their safety and effectiveness in children. This legislation provides a fair and reasonable market incentive for drug companies to make the extra effort needed to test their products for use by children. It gives the Secretary of Health and Human Services the authority to request pediatric clinical trials for new drug applications and for drugs currently on the market. If the manufacturer successfully conducts the additional research, 6 extra months of market exclusivity would be given. I recognize that there are few matters still unresolved on this bill despite the best efforts of all involved. And those we will need to simply address though the traditional process of holding votes on the issues. One issue, which I plan to discuss further when we debate the bill on Tuesday involves section 404 of the bill, which relates to the FDA's review of medical devices. This provision, the so-called labeling claims provision clarifies current law by stating that when reviewing a device for approval, FDA should look at safety and efficacy issues raised by the use for which the product was developed and for which it will be marketed. Again, this is current law. Unfortunately, in a few instances, the FDA has inappropriately expanded the scope of its review by requiring manufacturers to submit data on potential uses of product. Some have raised concerns that under this provision a manufacturer could propose a very narrowly worded label for a device and that the FDA would be barred from asking for information on other obvious uses. This is simply not the case. The FDA retains its current authority to not approve a device if based on a fair evaluation of all material facts, the labeling is false or misleading. Clearly, if a bad actor device manufacturer attempted to get a misleading label past the FDA, the Agency would have full authority to disapprove the product. I was pleased to join Senator Jeffords as the first Democratic cosponsor of this bill. I would thank him again for the hard work and long hours that he and his staff, as well, as Senator kennedy, Senator Mikulski, Senator Wellstone, Senator Coats, Senator Gregg, and others, have contributed. I look forward to further debate on and to joining my colleague next week in enacting this legislation.

Mr. DODD

Mr. DODD. Mr. President. I rise today to pay tribute to the Webster Hose Volunteer Fire Co., which is celebrating 100 years of loyal service to the city of Ansonia, CT. Anyone familiar with the early days of the Webster Hose Co. can truly appreciate how much this unit has evolved during the past century. The Webster Co. started 100 years ago when 20 courageous individuals were authorized by the board of aldermen to undertake all fire-fighting duties for the city of Ansonia. This fledgling fire department was named the Webster Hose Co., in honor of Ansonia's mayor Erwin W. Webster, and in 1903 the name was changed to the Webster Hose Hook & Ladder Co. The number of firefighters quickly grew to 50, and these volunteers overcame many obstacles in order to serve the people of Ansonia. Perhaps their biggest handicap was the rudimentary firefighting equipment that was available to them. Their primary firefighting device was a 550-pound hand-drawn cart, equipped with a large hose. Manually transporting this cart through Ansonia's hilly terrain was difficult to say the least, and many early members of the Webster Co. suffered broken arms and legs as they miscalculated the number of people necessary to slow the vehicle down, or the direction it would take on a hill. To say that these early members had to go above and beyond the call of duty in performing their jobs would be a tremendous understatement. But thanks to the extraordinary efforts of these founding members and other members of the Webster Hose Co., this unit has survived and evolved into a modern fire department that is highly trained to save the lives and property of the people of Ansonia. In celebration of their centennial birthday, the Webster Hose Co. has been chosen to host the 114th Connecticut State Fireman's Convention. This convention will culminate in a parade of hundreds of firefighters through downtown Ansonia on Sunday, September 14, 1997. I am honored to have the opportunity to walk in this parade, and I hope that the day's activities will serve as a fitting tribute to not only Ansonia's firefighters, but to all the men and women of Connecticut who risk their own personal safety as they confront danger to safeguard the well-being of others. The men and women of the Webster Hose Co. exemplify the highest standard of community service. They also serve as role models for their long-standing commitment to their community. Some of the current Webster members are the direct descendants of the fire service's founding fathers, and it is refreshing to see this spirit of public service passed on from one generation to the next. Without these dedicated individuals, the city of Ansonia would be at a tremendous loss. I appreciate this opportunity to commend the Webster Hose Co. for a century of outstanding service, and I wish them well as they continue to serve their community in the years to come.

Mr. DODD

Mr. DODD. Mr. President, I rise today to recognize a remarkable public servant from my home State of Connecticut--Richard B. McCall, who this past month left the Connecticut Department of Motor Vehicles after 31 years of working as the head of its Handicapped Driver Training Program. The Connecticut DMV's Handicapped Driver Training Program is the only one in the country where a licensed state agency provides free driver training for the handicapped. It began in 1945, in order to meet the needs of disabled World War II veterans, and for more than five decades this program has helped handicapped residents of Connecticut to function as independent and productive members of society. No individual is more closely linked to this program and its long-term success than Dick McCall. Since taking charge of the program in 1966, Mr. McCall has personally helped to train more than 3,500 Connecticut residents with disabilities who now hold driver's licenses. He made sure that anyone who wanted to drive would receive an evaluation and have a fair chance to get a license. Performing his duties required great diligence, patience, and compassion. Mr. McCall would sometimes make as many as 50 trips to a trainee's house, while preparing him or her for a test. In addition, he made himself available to help his students at all times including nights and weekends. Dick McCall's attitude toward his job has been described as a one-man crusade to give people with disabilities an opportunity for equality and personal freedom. Mr. McCall recognized that the ability to drive brings with it the dignity of having a job or just being able to drive to the supermarket, library, or church. Dick McCall felt that, short of curing their disability, the greatest gift that he could give to these people was mobility and independence, and he worked tirelessly to help as many people as was humanly possible. While Dick McCall is ending his career with the DMV, he is by no means retiring from public service. He has taken a job with the Easter Seals, where he will continue working with people with disabilities. Too often, the work of people like Dick McCall goes unnoticed by society at large. However, the thousands of people whose lives have been touched by Dick McCall recognize the sacrifices that he has made in his life, and his work has earned him the nickname ``Saint Richard.'' I would like to personally commend him for his ongoing career of public service. He is truly an inspiration to all those people who have been fortunate enough to know him, and I wish him only the best in his future endeavors.

Mr. DODD

Mr. DODD. Mr. President. I rise today to commemorate the 75th birthday of one of the oldest and most respected companies in my home State--the Durham Manufacturing Co. of Durham, CT. Few companies ever enjoy such long-term success, but Durham Manufacturing has been able to thrive for so many years because it is committed not only to manufacturing excellence, but also to its workers and to its surrounding community. The Durham Manufacturing Co. was founded after a fire destroyed the factory for Merriman Manufacturing Co., which had been Durham's largest employer for decades. The residents of Durham were determined to keep their community together, and in 1922, the Durham Manufacturing Co. began operations out of a wooden barn. Durham Manufacturing specialized in the manufacture of tin-coated iron cash boxes and cash boxes with a handle and combination lock which were used to store insurance policies. During World War II, Durham Manufacturing adapted its production to meet the needs created by the war and became the leading supplier of first aid boxes to the Armed Forces. After the war, Durham saw many of its Government contracts expire, and unfortunately, in 1947, the wooden factory was destroyed by fire. While many companies would have folded up their tents under such adversity, there was never any doubt that the Durham Manufacturing Co. would continue. After the fire, the company took on a new direction as its focus shifted from custom contract work to developing proprietary product lines, which have evolved into their current product lines of first aid boxes, storage cabinets and bins, and office products. Today, their products are used throughout North America and Europe, and this company, which began operating out of a wooden barn, now has its own site on the World Wide Web. Clearly, the future of Durham Manufacturing appears even more promising than its past. It is only appropriate that Durham Manufacturing's current factory is located on Main Street, because theirs is an All-American success story. But while there is a Main Street in most every town in the country, companies like Durham Manufacturing have become all too rare-- a business where generations of family members have worked to build not only a profitable company, but a prosperous community, as well. Companies like Durham Manufacturing represent the backbone of small cities all around this country, and it is important that we recognize and celebrate their longevity. Again, I would like to congratulate the Durham Manufacturing Co. on the occasion of their 75th birthday, and I wish many more years of continued prosperity.

Mr. DODD

Mr. DODD. I thank my colleague from Vermont. Mr. President, I urge our colleagues to vote to invoke cloture on this. But let me say at the outset here I want to commend our colleagues, and particularly my colleague from Massachusetts on this matter. He has labored for many, many years on FDA legislation. And he brings up an issue here regarding the cosmetics issue which will certainly be the subject of debate and has been the subject of debate in our committee over the last 2\1/2\ years. In the most recent round of markups--we have been through a couple markups--the bill has had pretty substantial bipartisan support coming out of the committee. I think our vote was something like 14 to 4 in the last markup. This is an important piece of legislation. September 30 is coming. We have to reauthorize PDUFA. This is the first time we have been able to deal with FDA in a way that will not only guarantee that we will have a quicker response on these applications, but also a safe and efficient and effective response for the consumers, the patient groups of this country. This is a very important piece of legislation. I commend my colleague from Vermont, the chairman of the committee, for his leadership on this. The committee has worked very, very hard on this, my colleague from Indiana and others. We have had some very difficult issues over the last 2\1/2\ years to try to reach compromise on and resolve them. And we have, by and large, with the exception of this one issue which is a great testament to the efforts of the members of the committee and the staffs that have worked on this. But I think it is time now that we bring the bill to the floor and try to leave it up to the Members themselves to resolve any outstanding issues that we have or, hopefully, over the next coming days, to achieve a compromise so we can avoid a kind of battle here on the floor over one or two remaining issues. Mr. President, I urge that we move forward on this. We have done a good job I think in the committee. It is not uncommon for there to be an outstanding issue. I urge the invoking of cloture.