Christopher Dodd

Mr. DODD

Mr. DODD. I move to reconsider the vote.

Mr. DODD. Madam President, I urge the adoption of the amendment.

Mr. DODD. Madam President, on behalf of Senator Hutchison and myself--and I ask my colleague from Texas to make the comments she wants to make--this amendment for 1 year would impose a moratorium on the drug certification process only for the Western Hemisphere. Interested colleagues--Senator Feinstein, Senator Grassley, and Senator Helms--have all indicated they support this amendment. Those are the Members who have the most interest particularly with regard to the larger proposal. We believe this is a very important message to be sending. We know our colleagues have a deep interest in it. The administration supports this amendment, and we urge its adoption. As my colleagues know, the issue of how to construct and implement an effective international counternarcotics policy has been the subject of much debate in Congress over the years. Earlier this year, I introduced legislation with the goal of seeing if there is some way to end what has become a stale debate that has not brought us any closer to mounting a credible effort to eliminate or contain the international drug mafia. Thanks to the chairman and ranking member of the Foreign Relations Committee we were able to develop an effective alternative to the current certification process, and that bill was reported out of the committee unanimously. We all know that, by and large, the drug cooperation issue has been focused on our relations with Mexico. We know as well that it is a new day in United States-Mexico relations. President Fox has been enormously supportive of the U.S. across the board. He wants very much to work cooperatively with the United States in fighting drugs and believes that the certification process could get in the way of that effort. It is important that we make a change in that process as quickly as possible. It is not likely that we will get to the free-standing bill this year and therefore I have decided to offer the substance of this bill today with slight changes to conform to the appropriations requirements. First the current certification process will be altered for only fiscal year 2002, consistent with the scope of this bill. Second, it will be limited to countries in the Western Hemisphere. Other than those modest changes the thrust of the amendment is virtually identical to the committee bill. We can all agree that drugs are a problem--a big problem. We also can agree that the international drug trade poses a direct threat to the United States and to international efforts to promote democracy, economic stability, human rights, and the rule of law throughout the world, and most specifically, in our hemisphere. While the international effects of the drug trade are important, what concerns me the most personally is the effect of the drug trade here at home. Last year, Americans spent more than $60 billion to purchase illegal drugs. Nearly 15 million Americans over the age of 12 use illegal drugs, including 1.5 million cocaine users, 208,000 heroin addicts, and more than 11 million smokers of marijuana. And, the menace of drug abuse is not confined to just the inner cities and the poor. Illegal drug use occurs among members of every ethnic and socioeconomic group in the United States. The human and economic costs of illegal drug consumption by Americans are enormous. More than 16,000 people die annually as a result of drug induced deaths. Drug related illness, death, and crime cost the United States over $100 billion annually, including costs for lost productivity, premature death, and incarceration. The drug trade is extremely lucrative, generating estimated revenues of $400 billion annually. The United States has spent more than $30 billion in foreign interdiction and source country counternarcotics measures since 1981, and despite impressive seizures at the border, on the high seas, and in other countries, foreign drugs are cheaper and more plentiful in the United States today than two decades ago. I believe, and I hope that the Senate agrees, that for a variety of reasons the time is right to give the incoming Bush administration some flexibility with respect to the annual certification process, so that it can determine whether this is the best mechanism for producing the kind of international cooperation and partnership that is needed to contain this transnational menace. I believe that government leaders, particularly in this hemisphere, have come to recognize that illegal drug production and consumption are increasingly threats to political stability within their national borders. Clearly President Pastrana of Colombia has acknowledged that fact and has sought to work very closely with the United States in implementing Plan Colombia. Similarly, President Vicente Fox of Mexico has made international counternarcotics cooperation a high priority since assuming office last December. These leaders also feel strongly, however, that unilateral efforts by the United States to grade their governments' performance in this area is a major irritant in the bilateral relationship and counterproductive to their efforts to instill a cooperative spirit in their own bureaucracies. The legislation I introduced recognizes that illicit drug production, distribution and consumption are national security threats to many governments around the globe, and especially many of those in our own hemisphere, including Mexico, Columbia, and other countries in the Andean region. It urges the administration to develop an enhanced multilateral strategy for addressing these threats from both the supply and demand side of the equation. It also recommends that the President submit any legislative changes to existing law which he deems necessary in order to implement this international program within 1 year from the enactment of this legislation. In order to create the kind of international cooperation and mutual respect that must be present if the Bush administration's effort is to produce results, the bill would also suspend the annual drug certification procedure for a period of 3 years, while efforts are ongoing to develop and implement this enhanced multilateral strategy. I believe it is fair to say that while the certification procedure may have had merit when it was enacted into law in 1986, it has now become a hurdle to furthering bilateral and multilateral cooperation with other governments, particularly those in our own hemisphere such as Mexico and Colombia--governments whose cooperation is critical if we are to succeed in stemming the flow of drugs across the borders. Let me make clear, however, that while we would not be ``grading'' other governments on whether they have ``cooperated fully'' during the 3-year ``suspension'' period, the detailed reporting requirements currently required by law concerning what each government has done to cooperate in the areas of eradication, extradition, asset seizure, money laundering and demand reduction during the previous calendar year will remain in force. We will be fully informed as to whether governments are falling short of their national and international obligations. The annual determination as to which countries are major producers or transit sources of illegal drugs will also continue to be required by law. The President is also mandated to withhold U.S. assistance from any country that has been deemed to have failed to meet its international obligations with respect to counter narcotics matters, although he may waive that mandate if he deems it will serve U.S. interests. I believe that we need to reach out to other governments who share our concerns about the threat that drugs pose to the fabric of their societies and our own. It is arrogant to assume we are the only nation that cares about such matters. We need to sit down and figure out what each of us can do better to make it harder for drug traffickers to ply their trade. Together, working collectively, we can defeat the traffickers. But if we expend our energies playing the blame game, we are certainly not going to effectively address their threat. We are not going to stop one additional teenager from becoming hooked on drugs, or one more citizen from being mugged outside his home by some drug crazed thief. During the Clinton administration, Barry McCaffrey, the Director of the Office of National Drug Control Policy did a fine job in attempting to forge more cooperative relations with Colombia, Mexico, and other countries in our own hemisphere. The OAS has also done some important work over the last several years in putting in place an institutional framework for dealing with the complexities of compiling national statistics so that we can better understand what needs to be done. The United Nations, through its Office for Drug Control and Crime Prevention has also made some important contributions in furthering international cooperation in this area. However, still more needs to be done. I believe my legislation will build upon that progress. It is my hope that a change in the certification process coupled with new administrations in the United States and Mexico provide a window of opportunity for the United States working with Mexico to spearhead international efforts to find better and more effective ways for multilateral cooperation. That is why I hope my colleagues will support this bill.

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

Mr. DODD. Madam President, on behalf of myself and the distinguished Senator from Texas, Mrs. Kay Bailey Hutchison, I send an amendment to the desk and ask for its immediate consideration.

Mr. DODD. Mr. President, I spoke a few weeks ago about my belief that the United States needs to more actively and constructively involve itself in educating the citizens of the Muslim world about our culture, values, and everyday life, and that, likewise, Americans need to become better educated about Muslim countries and the religion of Islam. As I have stated before, it seems to me that the time has come to be honest with ourselves about why international terrorism has become such a growing threat. Our citizenry does not understand the Muslim world, and citizens of Muslim countries do not understand us. I believe that if both the East and the West had a true understanding of the similarities inherent in our value systems that the world would be a safer place. We need only look into the oppressed faces of the citizens of some of the governments we have supported over the years, despite their less than acceptable treatment of their own citizenry, to see why some of the residents of these countries continue to cling to misguided perceptions of America's vision and values. The young people in many of these countries grow up hating their leaders for their oppression and, subsequently, they begin to hate our own country for keeping them in power. It is then easy for the likes of the Osama bin Ladens of this world to persuade these young people to become terrorism's footsoldiers convinced that violence is the answer to their grievances. I hope that as we analyze what we need to do to protect our country at home, we also examine ways that the United States can play a more constructive role internationally. We need to come to grips with the Muslim faith. That doesn't mean trying to keep secular governments in place in countries where the will of the people is otherwise. It means beginning to understand the underlying premises of Islam, and conveying our respect for a population's right to practice it. In addition, we need to reach out to individuals in Muslim countries on a one-on-one basis to educate them on what America really stands for. One way to do this is to send our citizens to work with citizens of Muslim countries on constructive projects in their home countries. This type of mutual understanding is what President Kennedy was trying to accomplish when he created the Peace Corps 40 years ago. The Peace Corps mission as stated by Congress in The Peace Corps Act, P.L. 87-293, is to promote world peace and friendship. Within that mission, the Peace Corps has three goals: to help the people of interested countries in meeting their need for trained men and women; to help promote a better understanding of Americans on the part of the peoples served; and to help promote a better understanding of other peoples on the part of Americans. The Peace Corps has had significant success in meeting these goals in the countries in which it operates, and has already established mechanisms to put volunteers in place and sustain them abroad. However, it has not been as active, in my view, as it could be in Muslim countries where the need for mutual understanding, and basic infrastructure, may be the greatest. It is not an easy task for the Peace Corps to go everywhere, but the focus should be on those areas where the need is the greatest--places like Jordan, Pakistan, Indonesia, Syria, and others. In addition, the Peace Corps should take the time to recruit people with the language skills, ability, and knowledge of these cultures. Sending civic-minded individuals with these skills as emissaries to Muslim countries could do an awful lot to change some of the anti-American attitudes we see around the globe, in my view. The Peace Corps should start investigating ways to do this now so that in the aftermath of the military actions already occurring we will be ready to show a different face of our country, one that isn't simply militarily strong, but one that is also willing to learn and willing to help. Yes, we need to act in the coming days to address the immediate threats and challenges confronting our nation. But we have to take a long and hard look at ways, at home and abroad, to make ourselves and the world safer for our citizens and the citizens of this globe. We need to explore ways to reach out to the international community and rebuild after the military strikes are over. We also need to begin a process of mutual understanding between the United States and the Muslim world. In my view, the Peace Corps is best suited to this mission. For that reason, I am introducing an amendment to the foreign operations appropriations bill today that directs the Peace Corps to undertake a study to examine ways it can better serve Muslim countries while increasing recruitment efforts of qualified Arab-speaking individuals in the United States. This amendment mandates that the Peace Corps deliver a report to Congress 6 months after this legislation is signed into law, and I hope that this report will suggest legislative remedies that will help the Peace Corps undertake this important task.

Mr. DODD

Mr. DODD. Madam President, a second subject matter I want to address is that with the bad news that we have daily been subjected to in this country since September 11 regarding international and domestic terrorism and finding and bringing those to justice who are responsible it is refreshing to be able to report on some good news. Today, it appears that a major obstacle to the full implementation of the Good Friday accords on the Northern Ireland peace process has been removed with the announcement by the IRA that it has begun to permanently put beyond use all its weapons. I believe that General de Chastelain, on behalf of the International Commission on Decommissioning, will shortly confirm that this has, in fact, been done. For those of us, and there are many in this Chamber and the other body who have been involved in these issues over the past 8 or 10 years, this is a very significant moment indeed. It means that the sectarian differences which have torn Northern Ireland apart for nearly thirty years, and shed the blood of too many Irish men, women and children can now be addressed through dialog and compromise rather than by bullets and bombs. In many ways the issue of decommissioning has been an unfortunate distraction that has delayed the implementation of key provisions of the 1998 Good Friday Accords--provisions that were specifically designed to address the problems that have plagued the six counties of the North for decades. Now Northern Ireland's political leadership should no longer be paralyzed by this side issue. Finally they can begin to deal with injustice and inequality--the real causes of the Troubles, as those who signed the Peace Accords committed themselves to do within the context of that agreement. There is no mystery as to what needs to be done--the issues of police reform, domestic security, human rights and equal opportunity for all the citizens of Northern Ireland must be tackled in good faith. It has taken a great deal of courage on the part of Ireland's political leaders to bring us to where we are today. Many have done so at great personal risk to themselves. They have been willing to do so because they are mindful of the historical significance of their actions. I want to commend Gerry Adams and Martin McGuinness of Sinn Fein for their tireless efforts to convince the IRA to trust in the political process as the only way to remedy past grievances. I commend as well David Trimble--Ulster Unionist Leader--for his courage in standing up to those elements of unionism who will not or cannot accept that all the peoples of the North are equal in the eyes of God and man. I cannot fail to mention the role that British and Irish political leaders Tony Blair and Bertie Ahern played in this drama--they stuck with the peace process even when it seemed as though it seemed at times that the obstacles were insurmountable. I believe that President Bush also should be commended for continuing President Clinton's policy of prodding all the parties to move forward to implement the Good Friday Accords so that Irish weapons will be silenced once and for all. I would be remiss if I did not also mention our former colleague, the former majority leader of this body, Senator George Mitchell of Maine, who played a key and pivotal role in crafting those Good Friday accords. I have not had the chance to speak to him today, but I am sure he is gratified by these recent developments. But most of all I want to heap praise on the individual who had the vision and determination to work for the last thirty years so that this day would happen, I am speaking of John Hume, among the greatest civil rights activists of his generation. Obviously there are others, Albert Reynolds, Jean Kennedy Smith--who played very significant roles in moving this process along step by step over the last many years. I hope that the significance of this event does not get lost in other news today. I would ask our colleagues to take time out and reflect upon the significance of today's announcement. Sometimes we think problems are intractable that we will never be able to solve them-- problems of the Middle East, problems of central Asia--that there is no hope of ever resolving civil conflicts. Certainly many put Northern Ireland in that category as well. Just as the signing of the 1998 Peace Accords created new opportunities for the people of Northern Ireland to find peace, so too does today's announcement by the IRA. But let me stress that it is just that, an opportunity, which can be made the most of or squandered. It can be approached with generosity and reciprocity or it can be denigrated as insufficient. The people of Northern Ireland have suffered for too long. They are desperate to live in peace--desperate for a better life for themselves and for their children. I hope and pray that the political leaders of Northern Ireland will find that spirit of generosity as well as the vision and courage that the people of Northern Ireland expect from them and move forward to fully implement the Good Friday Accords. If that comes to pass, then we will be able to look back on this day--a day otherwise clouded by threats of terrorism--and recognize that there was a ray of light breaking through that cloud. I hope, Mr. President, that this ray of light can someday shine brightly in all corners of the globe so that matters which can affect us so deeply here at home, in the Middle East, and central Asia can also be the beneficiaries of that light, and that one day we will stand here and talk about the end of terrorism and peace in all quarters of the world where people today believe peace and security are not achievable. I yield the floor. Mr. President, I suggest the absence of a quorum.

Mr. DODD

Mr. DODD. Madam President, I thank my colleague from Ohio. As I said before, he not only brings an intellectual commitment to this issue but, with eight children and six grandchildren, he is a wellspring of good practical advice as well. If you have a bill about children and you want to know whether or not it is practically going to work, Mike DeWine is the fellow you want to talk to, given his family. I thank him and point out, as he has said so eloquently here, that we have learned a lot in the last several days and weeks. The thing we have learned the most I guess is how little we know and how ill- prepared we are in many ways and how vulnerable we are. People take advantage of our freedoms to use those freedoms against us in many ways. The best answer to that is to not give up these freedoms but be better prepared to face the challenges. That is what Senator DeWine advocated in his outline of four or five points that are to be included in any bill on bioterrorism where children are concerned. Senator Kennedy graciously has provided some time for us to have some hearings. It may not be possible this Friday. We had hoped to this Friday, but a couple of key witnesses we wanted to have testify may not be able to appear because of the demands that are being placed on them dealing with the present situation here in the Halls of Congress. But we may postpone it a week or so. We want to look at this issue in a broad way. I have always thought some of the most important functions we engage in are not only legislating but providing a forum where people can be heard in order to educate people. So we would like to craft as well a comprehensive bill as we can to deal with children. We may not get it all done in a bioterrorism bill. We may look further than that in the coming months, as to how best prepare America--families, parents, schools, childcare centers, others, as the Senator pointed out--how to deal with these situations, how to be well educated in their own response. The Subcommittee on Children and Families, which I serve now as chairman and on which I worked very closely with my colleague from Ohio on a number of bills in the past, will be holding a number of hearings on children and the effects of recent events in New York and Washington, the savage attacks on September 11 and then, of course, the most recent attacks here in Washington, Florida, New York, New Jersey, and elsewhere with anthrax. It is just an indication of the kinds of exposures to which we are all vulnerable. We have a lot of work to do here but we welcome the challenge. I can't tell you how much I look forward to working with my colleague from Ohio and others. The Senator from Ohio properly pointed out there are a lot of our colleagues who are interested in this subject matter. Certainly Senator Kennedy is, Senator Frist has done a lot of work here, our colleague from New York, Senator Clinton, has a deep interest in the subject matter and has made various proposals. We hope to be able to marshal all of this together and come out with the best ideas we can to deal with the immediate problems, and then recognize this must be an important part of our agenda in the coming months. It is regretful to say that, but the world has changed. You can pretend it didn't happen, pretend it doesn't exist and leave yourself vulnerable to further attacks. Or you can address it. I think what the Senator from Ohio and I are suggesting this afternoon is that we address these problems. I thank my colleague from Ohio for his comments and kind words.

Mr. DODD. Madam President, I have two subject matters I want to address. I will take the first 10 minutes or so with my colleague from Ohio to talk about the issue of children and bioterrorism, a matter I shared for many years working with the Senator from Ohio particularly dealing with pharmaceutical products and testing for pediatric cases, children. I want to take a few minutes to talk about some thoughts we share together about the subject matter. The second subject matter is about the recent, very positive news today coming out of Northern Ireland. In the midst of a lot of bad news, we have heard the news today out of Northern Ireland that a decommissioning process has begun and is underway as I speak, and that finally, the real opportunity for lasting peace in Northern Ireland is at hand. I am sure my colleague from Massachusetts, Senator Kennedy, who spent has worked tirelessly over many years to reach this day, will shortly have some comments and thoughts he would like to express on this subject matter as well. Let me express, on this first subject--and I see my colleague from Ohio--and talk about the issue of bioterrorism and children. We know there is a lot of work going on right now in trying to put something together. Last week, as some of our colleagues may know, Senator DeWine and I were able to pass unanimously in this body--by the way, we thank all of our colleagues for their support. Certainly, the chairman of the committee, Senator Kennedy, deserves a great deal of credit for working out a package for which we were able to garner the unanimous support of our colleagues to pass the Best Pharmaceuticals for Children Act, which is designed, as I think many of our colleagues know, to induce the industry to develop products specifically designed for children. Less than 20 percent of all pharmaceutical products on the shelves today are for children. Senator DeWine and I thought we ought to fix that. We, in 1997, passed a 3-year bill as a trial more than anything else. We had no idea whether or not it would work, but by providing a very limited 6-month period of exclusivity, we hoped we might induce the industry to do a lot more in this area. In the previous 7 years before 1997, there had been 11 clinical trials and two new products on the shelves of America for children. In the 36 months since we passed that bill in 1997, there were 400 clinical trials and 40 new products on the shelves. As a result of that tremendous, beyond-our-wildest-imagination result, the other day, we were able, with the full support of this body, to pass a 5-year bill that will extend that very concept, with some additional provisions in it. Why do we mention that particularly? It is because we believe today, in this era of bioterrorism we are now very painfully aware of, that we want to make sure children are going to get properly tested, that products will be developed for children that will be especially vulnerable to release of chemical or biological toxins. So we outlined some provisions. That is first of all. We want to see legislation that will certainly take into account children's needs. We identify antibiotics or vaccines to prevent or treat illnesses related to bioterrorism. We adults certainly need to know how children will be affected as well, particularly during the critical growth periods for children and the development that occurs then that could lead to detrimental effects later in life. So we must have proper medications to prevent those risks. Secondly, we want to make sure the public health community will have emergency response personnel, doctors, and nurses who are properly trained to address the special needs of children. Thirdly, we think our children's mental health is as important as their physical health. There are a lot of issues we cannot even begin to calculate yet. Certainly, everyone in this Chamber can speak about the great fear many in our Nation are experiencing as a result of the recent bioterrorism attacks. Just imagine the fear our children are experiencing as a result of those same acts. We need to do everything in our means to address those particular anxieties. Fourthly, we need to make sure all places where children gather, from schools, child care centers, Head Start, and the like, are going to be prepared to deal with these emergency situations. The old way would have been for them to be prepared for a fire, but today, as we know only too well, emergency situations require a new response. In times of bioterrorism, the children may not need to just exit the building and stand on the sidewalk. We need to plan to potentially address a far more grave crisis, as we have painfully learned in the Congress of the United States in the last several days. We know people are working on this. We know the Senator from Massachusetts is working on it. The Senator from Ohio and I have some very strong feelings about children and their need to be protected in this area, and we wanted to take a few minutes today to share those thoughts with our colleagues. I yield to my friend from Ohio for whatever time he may need to respond to make some comments.

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. DODD. Madam President, I ask unanimous consent that the Committee on Foreign Relations be authorized to meet during the session of the Senate on Tuesday, October 23, 2001 at 10:15 a.m. to hold a hearing. Agenda International Convention for the Suppression of Terrorist Bombings (Treaty Doc. 106-6) and International Convention for the Suppression of the Financing of Terrorism (Treaty Doc. 106-49). Witnesses: The Honorable Francis X. Taylor, Coordinator for Counter- terrorism, Department of State, Washington, DC; the Honorable William H. Taft, IV, Legal Adviser, Department of State, Washington, DC; the Honorable Michael Chertoff, Assistant Attorney General, Criminal Division, Department of Justice, Washington, DC.

Mr. DODD

Mr. DODD. I will show pictures, if you like.

Mr. DODD. I will be happy to yield.

Mr. DODD. Mr. President, I thank my friend from Ohio. He has been a great partner in numerous efforts we have made together on behalf of children. S. 838 is something for which both of us are tremendously proud, the Best Pharmaceuticals for Children Act. Let me briefly describe the bill, why it is a bit different than the bill we passed 3 years ago, and why it is important. This bill would reauthorize the pediatric testing incentive legislation we passed in 1997 as part of the Food and Drug Administration Modernization Act. This important program has gone a long way toward ensuring that doctors and parents have the most up-to- date and critical information on medications for our children. It has been an important achievement. According to the American Academy of Pediatrics, about 20 percent--I think a little less--of the drugs on the market have been tested and labeled specifically for their safety and effectiveness for children. Children are simply not smaller versions of adults, as I hope most people are aware. The bodies of infants, toddlers, and adolescents are very different and react very differently to drugs than adults do. The absence of pediatric labeling poses some very significant risks for children. Without adequate information about how a drug works in children of different ages and sizes, they are more likely to be either underdosed or overdosed or to experience dangerous side effects. Mr. President, again, years ago--in fact, in fairly recent history-- there were a lot of products out there for adults and children, but for many years there were just the basics, and parents, over the years, would take the old family aspirin and the children's dosage was to cut it into quarters or halves and take it. It was pretty safe. Nobody suffered terribly. Trying to calculate a child's dosage of traditional medicines in times past was not that difficult. There were some hazards. But we have seen a wonderful explosion of new products. I note the Senator from New Jersey is presiding. Both in his State and mine, we have literally thousands of constituents who have dedicated their lives to the research and development of products to make us all healthier, live better lives, and live longer. In the process, however, only about 20 percent, as I mentioned--a little less--have actually been tested and designed to serve children's needs. Despite the fact that children represent in excess of one- quarter of the population of this country--25 percent--only a tiny fraction of the products on the shelves to be prescribed by doctors are actually labeled and designed to meet their needs. It seems sort of staggering to me that we have waited so long to do this. We have labels on the food that children can eat. We now have labels on the music to which they listen. We have labels that will tell you what movies you ought not to let your child go to. But when it comes to pharmaceutical products, we have very little of that. With that as a background, Senator DeWine and I, in 1997, as part of the Food and Drug Administration modernization bill, crafted this legislation as a way to see if we could not induce --there was a debate on whether we should mandate it and say you have to do it whether you like it or not, which is one approach, or should we say we will give you a chance to prove to us you can do it by providing 6 months of exclusivity in the marketplace. There was a debate about that. I had my own doubts about whether or not this was going to work very well. I must say the success of this legislation has been beyond anyone's wildest imagination. If I can, I will share some of the comments made about the success of the 1997 act, which would go out of existence, by the way. Why did we need to pass this legislation, and why am I so appreciative of the Members who helped make this happen? It didn't happen just with Senator DeWine and I. A lot of people were involved, and I am grateful to them all. The bill would have gone out of existence; it expires at the end of December. The period of exclusivity would be over and the question of whether or not we would be able to see the continued development of children's products in the area of pharmaceuticals would become less attractive. Look at some of the comments. This is from the Food and Drug Administration status report to Congress in January of this year: The pediatric exclusivity provision has done more to generate clinical studies and is more useful in prescribing information for the pediatric population than any other regulatory or legislative process to date. That is a pretty remarkable statement. I am grateful for that. Further down here, this is from the National Association of Children's Hospitals: This is a remarkable achievement for children's health. We know from talking with pediatric researchers at children's hospitals across the country that the effect of the pediatric exclusivity provision has been very positive for children and their families and their providers of care. Further down is a letter from the American Academy of Pediatrics. These are the pediatricians across the country: We cannot overstate how important this legislation has been in advancing children's therapeutics. It is allowing children to have the same kind of drug safety and efficacy information that was only available previously to adults. There is also a letter from the Elizabeth Glaser Pediatric AIDS Foundation: Regarding costs, the FDA estimates that consumer prices of drugs have increased by one-half of one percent annually as a result of the initiatives of pediatric testing. As individuals who have fought for decades for better health care for children, we firmly believe this is a legitimate price to pay to ensure our children's well-being. I don't know of anybody who will argue with that when you consider the difference we can make in children's lives. If I can, let me share with my colleagues more specifically what has happened. In light of the extraordinary times we find ourselves in today, the national debate on how to prepare and protect all Americans from bioterrorism further highlights the importance of drug safety and the efficacy of information when it comes to treating children. Children are especially vulnerable to the release of chemical or biological toxins. As we identify antibiotics or vaccines to prevent or treat illnesses related to bioterrorism, we are going to need to know the proper dosing information, possible side effects or risks of this kind of medicine, and the effectiveness of the various agents children would be ingesting. Any antidotes used for children will be affecting them at critical periods of childhood growth and development. We need to have proper medications to prevent or reduce those risks. This bill could help ensure that essential treatments for exposure to hazardous materials are studied. I will work with the FDA and my colleagues, Senators Clinton of New York, Kennedy, and Frist. In fact, I thank Senator Frist and Senator Clinton for their contribution to this effort today. Our hope is that we will get it done in conference and strengthen some language to require that the industry start developing children's vaccines and antibiotics in the area of bioterrorism. So this bill is a timely piece of legislation. I am confident the House will act. I urge them to do so quickly, to incorporate some of the changes that we think can make a difference in terms of children's health. I will say what was going on before we passed this bill. In the 3 years, 36 months, since we passed this legislation--prior to the passage of this bill, there had been a total in the previous 7 years of 11 clinical trials for products designed for children. I think there may have been 2 or 3 products that had come on the market designed specifically for children in 6 or 7 years. In the 36 months, since the bill that Senator DeWine and I wrote, there have been 400 clinical trials. In 36 months, there have been 400 clinical trials as opposed to 11 in the previous 7 years in children's pharmaceutical products. Today, there are 40 new products in 36 months being prescribed for children. They did not exist 36 months ago. It occurs specifically because of the legislation we adopted--this body and the other body--in 1997. That bill was about to go out of existence. The bill we passed today--and every Member ought to take pride in it because every Member allowed this bill to go forward. Many, such as my friend from North Dakota, Senator Conrad, are cosponsors. I will leave the record open for others who would like to be associated with it. In the midst of all of these terrible events going on--this body is working today, by the way, and we did excellent work today, this body passed a bill that will make a difference in people's lives. So we are not just meeting for the sake of meeting to have a good show, but actually we adopted this legislation by unanimous consent. It would not have occurred without the cooperation of Democrats and Republicans--the 100 Members in this body who allowed this legislation to go forward. In 36 months, there have been 400 clinical trials and almost 40 new products on the shelves. That is the record of this little bill attached to the FDA Modernization Act. Let me talk about one product and make this case more clearly. I am talking about a product that, as a result of pediatric studies, would make any parent's heart skip a beat; it is called Versed. Versed is one of the most commonly used sedatives for children undergoing surgery or other hospital procedures. As a result of these pediatric studies, the label has been changed to indicate a higher risk of serious life-threatening situations in children with congenital heart disease and pulmonary hypertension who need lower doses than predicted to prevent respiratory compromise. Can you imagine doctors using Versed without knowing that information? Until we got these studies underway, it was unknown. But as a result of 36 months of effort, this product today is being used in a way that is saving lives and making a difference. Maybe it does not get banner headlines and it will not lead the news tonight, but it is something that will make a difference in the lives of children and their parents who care about their health. I heard from a doctor from Children's Mercy Hospital about a 6-year- old boy, Darryl, who required metal pins to be inserted in his leg after his femur was broken in a bicycling accident. Darryl was prescribed Versed to relieve his anxiety and discomfort when the doctors and nurses each day cleaned the wounds resulting from his injury. This new information on Versed allowed health care providers to treat this young man safely and effectively with this drug. The second chart is before and after effects of our legislation. It is in small print. I will try to describe it. We get the products, indications, what labeling was prior to the adoption of this bill 36 months ago, and what has occurred afterwards. I will run down from everything dealing with diabetes, hepatitis, hypertension, juvenile arthritis, seizures, and the like. This is just a partial list to give my colleagues some idea of the drugs to treat hepatitis B, hypertension, diabetes, juvenile rheumatoid arthritis, and epilepsy, just to name a few. They previously had labels that simply read: Safety and effectiveness in children not established. That was the guideline a doctor or parent had in these areas. Now we have dosing information, safety information, and the information on adverse side effects. In fact, in one drug study for epilepsy, Neurontin was found to be most effective in higher doses for children under 5 years of age. I heard from Dr. Philip Walson at Children's Hospital Medical Center in Ohio who told me: Some children with previously uncontrolled seizures now are controlled with higher doses of this drug than [what] would have been used [prior to pediatric testing] if adult doses were just ``scaled down.'' In this case, instead of breaking off the aspirin and getting a smaller dose, as a result of the studies, we learned Neurontin, which is a seizure controlling medication--people who have had strokes know about Neurontin--for children makes a difference. Increasing the dosage actually made a difference. Far more significant than the number of studies and drugs tested are the stories of kids who can be helped by this increased information. This past June I met with a group of five young children from my State of Connecticut; they were suffering from juvenile diabetes. In fact, almost every office had a visit from kids from their State suffering with juvenile diabetes. One young man who came to my office was from Bethel, CT, 12-year-old Jason Baron. I put his picture up. I am giving him TV time. He was so eloquent and remarkable. He could run for the Senate. He is a wonderful, eloquent person with juvenile diabetes. He just blew me away. We got to talking. He aspires--and I see my friend from Tennessee, and he will appreciate this--as he told me, without missing a syllable--and I may--that he intends to be a pediatric endocrinologist at 12 years of age. That is his life goal as a young man with juvenile diabetes. I was amazed and impressed at the maturity and sense of responsibility of this young man who is managing his disease and educating others, as he was doing on Capitol Hill and as he does at school. Part of his civic activity is to teach about juvenile diabetes. One of the drugs studied and labeled as a result of the bill we passed 3 years ago is Lantus. It is a new and recombinant form of insulin for type I diabetes which requires only once-a-day administration and results in less allergic reactions. This drug, and others similar to it, could help children such as Jason improve the quality of their lives by introducing more flexibility into their treatment regimes. While tremendous progress has been made, still more needs to be done, obviously, to make sure children are not an afterthought when it comes to pharmaceutical research. Hundreds of drugs are on the market today that are used in children but still have not been tested for pediatric needs. We reauthorized earlier this morning the pediatric testing incentive, and the explosion of research it has promised, which was set to expire on January 1, 2002. I am very grateful to my colleagues for the bipartisan support we received. I mentioned the presence of Senator Frist. I mentioned his name once before, and I will mention it again. He was tremendously helpful 3 years ago when we originally wrote the bill and then when we watched the success of this legislation, which I already described. We inserted some language to encourage the industry to develop the vaccines and antibodies in the bioterrorism field. Senator Frist is working with the administration and others of us to develop more comprehensive legislation dealing with bioterrorism. We thought this bill was an attractive vehicle to put on something dealing with this issue. I thank Senator Kennedy, the chairman of the committee, for his terrific work, Senator Frist who I mentioned already, Senator Wellstone of Minnesota, Senator Hatch who has been tremendously helpful, Senator Clinton, Senator Reid, Senator Jeffords, Senator Bond was involved; Senator Corzine, the Presiding Officer, I know cares about this as well, and Senator Bingaman for their important contributions. I thank Senator Conrad and Senator Domenici who were helpful today in moving this bill along. I thank Senator Durbin who offered some good suggestions on the legislation as well, and I thank him for those thoughts. If I am leaving someone out, I apologize. I will add the names accordingly at the appropriate time. I also thank Deborah Barrett of my office, who has been a tireless staff person working with the staff of Mike DeWine, with Senator Clinton, Senator Frist, and so many others, to iron out some of the disagreements we were wrestling with on this legislation. Lastly, let me tell you some of the improvements we made in the bill. We ensure that the new safety information for pediatric studies is promptly added to drug labels. We require that the Food and Drug Administration quickly disseminate information gathered from pediatric studies to pediatricians and parents. We authorize Federal dollars to study older off-patent drugs which are not eligible for the existing pediatric testing incentive through a new off-patent fund and creating a mechanism for private contributions from manufacturers to support the study of off-patent drugs through an existing NIH foundation. We request frequent and thorough evaluations of the program so we can monitor our effectiveness in getting the needed drugs studied and, importantly, to have a sense of which needed drugs are not being studied despite FDA requests. In fact, to ensure that vital drugs are not being left unstudied, the bill includes a mechanism to ensure that if a company declines to study an on-patent drug that is a continuing benefit to children, the Secretary will make public the names of those must-study drugs that have not been picked up and refer them to the NIH foundation for funding. As a backstop, these drugs can also be referred to the off- patent fund. The bill creates a new Office of Pediatric Therapeutics at the Food and Drug Administration to coordinate activities related to children. It authorizes the existing Pediatric Oncology Subcommittee to provide recommendations and guidance so children with cancer can have timely access to promising new therapies. Finally, because the bill will lead to increased participation of children in clinical trials--I mentioned 400 already in the last 36 months--we have requested a study of the appropriateness and adequacy of current Federal research protections for children in clinical trials. I will continue to work with Senator DeWine and my colleagues to ensure the strongest protections are in place for this vulnerable part of our population. We have relied generously on the expertise and counsel of Elaine Holland Vining of the American Academy of Pediatrics; Mike Isaac and Natasha Bilimoria of the Elizabeth Glaser Pediatric AIDS Foundation, who worked tirelessly on behalf of children; Helen Rhee with Senator Frist; David Dorsey, David Nexon, and Paul Kim with Senator Kennedy deserve tremendous thanks for their work in negotiating and working out the fine details of this bill. I again thank our colleagues for their contribution today. I see the distinguished majority whip in the Chamber. I know the media may report nothing much happened today. Well, maybe it did not get a lot of debate, but we passed this children's bill. And I see my friend from Maine, Senator Collins, and I want to thank her as well for her help on this bill. The distinguished majority leader has arrived. I say to the majority leader, this bill did not generate huge debate. We did it unanimously. This bill has already made a huge difference in the lives of millions of children: 400 clinical trials in 36 months as opposed to 11 in the previous 7 years. So we think we have done something worthwhile today, in the midst of other news, which will not likely generate a headline. The Senate put it on the agenda and did a good job.

Mr. DODD. Mr. President, earlier today this body passed, by unanimous vote, the Best Pharmaceuticals for Children Act. This is a bill I authored a number of years ago with my good friend from Ohio, Senator Mike DeWine. He is presently occupied at a Judiciary Committee hearing, and he will come to the floor and offer his own statement. I ask unanimous consent that whatever time he seeks, the Chair would provide him with an opportunity to be heard on this bill.

Mr. DODD. I thank the majority leader.

Mr. DODD

Mr. DODD. I thank my colleague. I have found in my years of service with the distinguished Senator from North Dakota, every time he proposes something in the area of agriculture, I follow. I have found myself to have a good record on farm policy because of his leadership. I thank him for his comments today. He not only speaks for his own State and region of the country; he speaks for all Americans who care about this most critical issue.

Mr. DODD. Mr. President, before my colleague from North Dakota leaves the floor, there is something worth pointing out. I don't claim to have great knowledge about the farm bill. I am from a consuming State. We have our farmers in Connecticut, not to the extent they do in the Midwest--obviously the Farm Belt of the country--but they play a very important role. As consumers, of course, it is very much in our interest that we encourage domestic production of agricultural products. Many of us were told the other day something that maybe I had known before, but in the context of September 11 and the events that occurred since then, it surprised me I hadn't thought about it. I must mention it here and ask my friend for a response. I was stunned to learn, once again, that less than 1 percent of all the food that we import is inspected. Again, we were talking about all the other problems we face, but I was sort of taken aback by the fact that such a tiny percentage of the produce or products we as Americans consume that comes from offshore--and many do, particularly in cold- weather months, particularly we import an awful lot of food from overseas--we are not talking about stopping that, but it seems to me in the context of what the Senator is talking about, a farm bill, it is in all of our interests, whether you are from a farm State or not--putting that issue aside but with that issue in mind--we would not be doing everything we could to encourage domestic production of our food supplies. I don't know if he had any comments he wanted to make in that regard. It struck me that this would be an important point to raise at this time.

Mr. DODD

Mr. DODD. Madam President, I ask unanimous consent that the Senate now proceed to the consideration of Calendar No. 184, S. 838; that the only amendment in order other than the committee-reported substitute be a Dodd-DeWine amendment; that the amendment be agreed to, the committee substitute, as amended, be agreed to, the bill, as amended, be read three times, passed, and the motion to reconsider be laid upon the table, with the above occurring with no intervening action or debate.

Mr. DODD

Mr. DODD. Madam President, I add my voice to that of the two Senators from Virginia. I did not know Emily Couric, but having listened to the distinguished junior Senator from Virginia speak about her, and the senior Senator, not only did Virginia lose someone of great value but the country did as well. I am sure her family and friends appreciate immensely the words spoken in this Chamber this afternoon. I am sure all of us would like to associate ourselves with them. We express our sympathies to them.

Mr. DODD

Mr. DODD. Madam President, we are about to go into recess. I ask unanimous consent that when the Senate reconvenes and after the remarks of Senator Byrd and Senator Voinovich, Senator DeWine and I be recognized for a half hour with the time equally divided.

Mr. DODD

Mr. DODD. Mr. President, I would like to take a brief moment to draw my colleagues' attention to the horrific situation facing women and children in Afghanistan. As we heard at a Senate Foreign Relations Committee hearing last week on the Humanitarian Crisis in Afghanistan, Afghanistan is a country that has been in crisis for years. Indeed, there was concern even as far back as 1997, when I sponsored a resolution that passed the Senate, but was not acted upon in the House, that condemned the Taliban for its treatment of women and children and urged the President to be vigilant in monitoring this situation. When a country faces such hardships as severe drought, military action, and oppresive leadership, women and children are always the first to suffer. Save the Children, the international relief organization headquartered in my home State of Connecticut, has been working to improve conditions in Afghanistan for years, and has identified several important ways in which we can help Afghanistan rebuild. I have said before that we need to increase mutual understanding between the Afghan and American people, and a recent Save the Children op-ed seems to agree. Nilgun Ogun, the deputy director of Save the Children Programs in Afghanistan and Pakistan, writes that the education of young girls is key to reducing anti-American sentiment in the region, and I tend to agree. As we struggle to determine the best way to help the Afghan people rebuild, we should be mindful of the important contributions of organizations such as Save the Children, and we should listen to their experienced voices. I urge my colleagues to read the following article, and to begin to think about the important task of rebuilding civil society in war-ravaged Afghanistan. I ask unanimous consent that the Op-ed from Save the Children be printed in the Record.

Mr. DODD

Mr. DODD. I understand the sense of urgency to get this done. I am sure my friend from South Carolina would not argue with that coming up rather quickly as we did with the airline bailout. That didn't take long. We managed to find the time around here to come up with the time to debate it, discuss it, and work it out. Again, I voted for that bill. I would again today. I don't argue with that at all. But I am stunned that we can't find the time somehow to say to those thousands of workers--baggage handlers, flight attendants, and mechanics--who have lost their jobs and are wondering how they are going to make ends meet--we have time for everybody but you. Everybody else got in line. But you don't. We are sending the message that we don't have enough time to take care of you. I am terribly disappointed that our colleagues have decided to reject this cloture motion. But I tell you that people out there have lost their jobs. Millions of other Americans are watching this vote to see what we did to average people out there on this day, 1 month later. We memorialize those who lost their lives but this Chamber couldn't find in its heart to come up with a few extra dollars to help some people who have lost their work. That is a sad day. That is not the way to commemorate those who gave so much 1 month ago. I am deeply disappointed in my colleagues.

Mr. DODD. I think the Senator from California raises a very good question, and one that she provides the answer for in her question. Obviously, over the years, we have said to people, if you lose your job because of trade policies--which we think have a long-term beneficial effect on the country and we see something good come out of that--if you lose your job because we are trying to achieve a greater good, we will step into that breach and provide some assistance to you and your family. How ironic that when something terrible happens and you lose your job, we can't provide benefits to help you and your family during difficult times. I am stunned by this. I thought this was going to be a non-issue. I could see where people might want to modify this a bit. Instead of 52 weeks, make it 45 weeks; instead of 100 percent of Medicaid, we will make it 90 percent. I can understand people making a case that we need to modify the Carnahan amendment. But not to provide for any kind of alternative is something that just gets away. We have to finish the bill. I know the distinguished chairman of the committee has an awful burden to get this done. He has argued very persuasively that we have a responsibility to meet the security needs. Mr. President, I ask for 1 additional minute.

Mr. DODD. I am happy to yield.