Mike DeWine

Mr. DeWINE

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. DeWINE

Mr. DeWINE. Mr. President, on behalf of the leader, as in executive session, I ask unanimous consent that at the hour of 11 a.m., on Wednesday, October 29, the Senate proceed to executive session to consider calendar No. 312, the nomination of William E. Kennard to be a member of the FCC. I further ask unanimous consent that there be 20 minutes of debate, equally divided, between the chairman and the ranking member, with an additional 5 minutes under the control of Senator Burns and 5 minutes under the control of Senator Helms. I finally ask unanimous consent that following the expiration or yielding back of time, the Senate proceed to a vote on the confirmation of the nomination, and following that vote the President be immediately notified of the Senate's action, and the Senate then return to legislative session.

Mr. DeWINE

Mr. DeWINE. Mr. President, again on behalf of our leader, I ask unanimous consent that the Senate immediately proceed to executive session to consider the following nominations on the Executive Calendar: No. 263, No. 265, No. 266, No. 267, No. 268, No. 311, No. 313, No. 315, No. 316, and No. 331. I further ask unanimous consent that the nominations be confirmed, the motion to reconsider be laid upon the table, any statements relating to the nominations appear at the appropriate place in the Record, the President be immediately notified of the Senate's action, and the Senate then return to legislative session.

Mr. DeWINE

Mr. DeWINE. Mr. President, if there is no further business to come before the Senate, I now ask that the Senate stand in adjournment under the previous order following the remarks of Senator Brownback.

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

Mr. DeWINE

Mr. DeWINE. Mr. President, I rise today to discuss a bill I have introduced. That bill is called the Ricky Ray Hemophilia Relief Fund Act. I introduced this legislation in the last Congress and again this year. I introduced it along with my distinguished colleague from Florida, Senator Bob Graham. A House companion measure has been introduced by our friend, Congressman Porter Goss. Mr. President, the purpose of this bill is to deal with the terrible tragedy within the hemophilia community that was brought about by the HIV contamination of the blood supply and blood products during the 1980's. A number of Americans suffered terrible harm because they relied on the Federal Government to protect the blood supply. Mr. President, those of us who are backing this legislation believe that the Federal Government has a moral duty to help these Americans. Let me first talk about the role of the Government in this tragedy. The Ricky Ray Hemophilia Relief Fund Act of 1997 recognizes that the Federal Government has a responsibility for protecting the safety of the blood supply in this country and a responsibility for regulating blood products. Mr. President, during the 1980's, our Government failed to meet this obligation to the hemophilia community of this country. The Federal Government failed in its obligation. People affected by hemophilia-- children, adults, and the family members who cared for them--had a right to expect the Nation's blood supply system to work. That system relies upon many organizations, both public and private. It relies on many organizations to collect and process, distribute, monitor, and regulate the blood supply and blood products. Unquestionably, the Federal Government bears the greatest and the ultimate responsibility for blood safety through its surveillance, research, and regulation functions. That is why, Mr. President, in 1973 the Assistant Secretary for Health announced the national--national-- blood policy which then became, according to a report by the Office of Technology Assessment, ``The focal point around which blood banking policy has evolved over the last decade.'' Mr. President, this is the U.S. Government's national blood policy-- the U.S. Government's national blood policy--a policy the U.S. Government undertook, a policy on which the American people should have been able to rely. The very fact that we have a national policy indicates a level of responsibility, a level of importance and involvement that we really don't see in most other areas of consumer protection. This policy is what gives the Federal Government a unique responsibility for the blood supply in this country. Mr. President, these functions--surveillance, regulation, and research on blood--are carried out through the Public Health Service. The Centers for Disease Control hold responsibility for surveillance of potential threats to blood safety. The National Institutes of Health are responsible for biomedical research on emerging threats and improved technologies for prevention. Mr. President, these two agencies work in conjunction with the Food and Drug Administration, the FDA, which through its regulatory authority and powers of inspection, product recall, guidelines, and fines, holds primary responsibility for the safety of the blood supply and blood products under the Food, Drug and Cosmetic Act. Together, Mr. President, these agencies form the backbone of our Nation's blood safety system. Mr. President, the awful truth is that this system failed. It failed to protect people with hemophilia or their families from deadly disease. That is why we have introduced this bill. Members of the Senate don't have to just take my word for it nor just the word of the families in the hemophilia community. Rather, in 1993, Mr. President, the Secretary of Health and Human Services opened an investigation, an investigation into the events leading to the transmission of HIV to individuals with hemophilia. One of the key questions that was asked and that they were asked to address at the time was this: Did the Government provide an adequate and timely response to the warning signs of the 1980's, the warning signs of HIV as it related to the blood supply in this country? The Secretary contracted with the Institute of Medicine, IOM, a private nonprofit organization that provides health policy advice under a congressional charter granted to the National Academy of Sciences. Mr. President, after 18 months of investigation, the IOM published its report in 1995. This report was entitled ``HIV and the Blood Supply: An Analysis of Crisis Decisionmaking.'' Mr. President, the report found inadequacies in the Government's effort. It found ``a failure of leadership'' that led to the HIV infection of more than one-half of the Nation's hemophilia population. This IOM report and its panel of experts from across the country found that the transmission of the HIV virus and AIDS revealed a weakness in the Federal Government's system for ensuring the safety of the Nation's blood supply. The Institute of Medicine was specifically not charged with laying blame, but in its final report it was highly critical of the Government agencies responsible for protecting the safety of the blood system in this country. It identified several areas where the Federal Government specifically failed to curtail the impact of HIV. Mr. President, the IOM found that the Government ``consistently adopted the least aggressive options for slowing the spread of HIV within the hemophilia community.'' Let me repeat: This report, this official report, found that the Government ``consistently adopted the least aggressive options for slowing the spread of HIV within the hemophilia community.'' Time after time when decisions were made in the face of the unfolding HIV crisis, tragically, the wrong decisions were made about the blood supply. When faced with decisions about deferring donors or recalling products or testing for other known diseases, we know now that the Government officials made the wrong decisions. Let me talk about these decisions and about what happened. First, the Federal Government failed to take adequate steps to screen blood donors. Knowing that AIDS was transmitted through blood, the Government did not do all it could, did not do all it could have done to screen blood donors. In January 1983 experts at the Centers for Disease Control met with representatives from the other Government agencies to consider available data on the spread of HIV and to develop at that time strategies for prevention. Those experts in the Centers for Disease Control concluded that AIDS was transmitted by sexual contact and through blood, and they made recommendations for enhanced screening of blood donors, including the use of a surrogate hepatitis test to screen for potentially HIV-infected blood. In other words, Mr. President, in January 1983 the Government knew that AIDS was transmitted through blood. Now, by that time 12 persons with hemophilia had already been diagnosed with HIV and some 10 deaths had already occurred. Let's go back now to that specific meeting in January 1983 that I just referenced. At that meeting, experts from the Centers for Disease Control estimated that intensified screening of blood donors would eliminate over 75 percent of AIDS-infected donors from the blood pool, and they estimated that requiring a surrogate blood screening test would detect 90 percent of donors with AIDS. Tragically, however, Mr. President, both of these recommendations were rejected by the other Government officials at this meeting. These two very specific recommendations were rejected again later that year in December 1983, rejected by the Food and Drug Administration's Blood Products Advisory Committee. These recommendations were never implemented. Let me talk about the second fact. Second, Mr. President, the Federal Government failed to recall potentially contaminated blood and blood products. In two separate instances, the FDA missed opportunities to get potentially dangerous products off the shelf. In the first instance, knowing that a blood product might have been made with AIDS- tainted blood, the Government failed to automatically recall that product. In January 1983, the FDA decided not to automatically recall hemophilia clotting-factor products linked to donors suspected of having AIDS supposedly because of concerns about the impact on the availability of clotting factor and its cost. In July 1983, FDA failed to act. By the following year, 1984, 83 cases of persons with hemophilia were diagnosed with HIV, and 81 deaths had, by that point in time, occurred. In the second instance, Mr. President, knowing that there was now a way to make the blood products safe, the Government failed to take the potentially unsafe products off the market until, incredibly, 4 years had passed. Mr. President, by 1985, heat-treated product was available--heat- treated product, meaning that the virus was inactivated. Back in the late 1970's, the process of heat treatment of clotting factor had been developed in Europe, providing hope that the HIV virus could be inactivated. Now, while FDA moved quickly through 1983 and 1984 to license new manufacturing processes for the heat treatment of clotting factor, by 1985, heat-treated factor had been as effective in inactivating HIV. However, Mr. President, tragically, the FDA did not act to recall the untreated products. It waited until 1989, some 4 years later. Meanwhile, those dangerous products were left on the shelf to cycle through the system, and all that time a method of making those products safe was readily available. Let me turn to the third essential fact. Third, Mr. President, the Federal Government failed to act quickly to trace and to notify potential recipients of AIDS-contaminated blood and blood products. Knowing that transmission of HIV-infected blood products led to HIV infection, knowing some of the blood was contaminated, and knowing people were using it, the Government failed to immediately notify the people who were at risk. Recipients became infectious immediately, but appeared healthy, of course, for approximately 4 or 5 years, during which time their spouses or sexual partners were at risk of acquiring HIV. If nothing else, Mr. President, once the signals were clear, the Government should have done more to alert people to these risks not just to their own health, but to the health of their loved ones, their spouses, and their children. It was in 1988 that President Reagan issued a Presidential directive to formulate Federal policy for tracing the recipients of possibly infected blood products. However, tragically, the FDA did not issue recommendations for patient notification until 1991--some 3 years later. Now, by that time, 2,040 persons with hemophilia had been diagnosed with HIV, and more than 1,500 members of the hemophilia community in this country had died of HIV. For the hemophilia community, Government action came too late-- much too late. Mr. President, these are the reasons why I believe that this country and this Congress has a moral obligation to help these families. Our Ricky Ray bill would authorize the establishment of a trust fund to provide $125,000 in compassionate payment to eligible individuals or families of persons with hemophilia and AIDS. The trust fund would be administered by the Secretary of Health and Human Services and would sunset 5 years after it is funded. Mr. President, approximately 7,200 people with hemophilia--nearly half of all persons with hemophilia in the United States--were infected with HIV through the use of blood clotting products. These products came from as many as 20,000 donors, sometimes even more. These concentrates expose individuals with inherited bleeding disorders to a high risk of infection by blood-borne viruses, such as hepatitis. Because of the hemophilia community's reliance on blood products, the Centers for Disease Control monitors the hemophilia community to aid in the detection of emerging viruses or pathogens that could affect all Americans. Problems in the blood supply tend to show up in the hemophilia community first--so they serve really as a kind of ``distant early warning system'' for our blood supply. It is a crude but accurate comparison to say that this community is the proverbial ``canary in the mine shaft.'' They serve in that function for the rest of us. During the 1980's, when the Nation's blood supply and blood-derived products became contaminated with the AIDS virus, HIV was detected in three men with hemophilia, providing early evidence that this disease could be transmitted through blood--thus affecting a far broader cross- section of our population. We now know that this was to mean the devastation of the hemophilia community. Mr. President, more than 80 percent of people with severe hemophilia and half of all persons with hemophilia were infected with HIV during the 1980's through the use of HIV-contaminated blood products. In some cases, due to a lack of education and outreach, their wives, husbands, children, and partners became infected as well. The impact of HIV on the Nation's hemophilia population has been truly devastating. The HIV contamination of the blood supply has caused significant emotional and financial losses to these families. Our bill would make a gesture of compassion to these American families. It would also acknowledge that the Government played a role in this crisis and, therefore, has incurred some obligation. Eligible individuals, or their families, would be required to document the use of blood products between July 1982 when the first cases of persons with hemophilia contracted AIDS were reported to the Centers for Disease Control and December 1987, when the last manufacturer recall of blood products occurred. This bill, which has been referred to the Labor and Human Resources Committee, already has the bipartisan support of 35 Members of this body. In coming to the Senate floor this evening, it is my hope that I will be able to answer some of the questions that have been raised about this bill, and to ask those of our colleagues who have not yet cosponsored this bill to consider doing so after hearing the facts that I will be laying out in a moment. Let me talk for a minute about how I came to introduce this bill. In doing that, let me tell you a little bit about the bill's name sake-- Ricky Ray. Ricky Ray and his brothers were born with hemophilia. This is a rare genetic condition, impairing the ability of blood to clot effectively. This disorder affects, today, about 20,000 Americans. People with hemophilia historically had a short lifespan and typically faced numerous hospital stays and complications. Hemophilia was also frequently associated with crippling. Persons with hemophilia would suffer internal bleeding, leading eventually to the destruction of their joints and muscle tissues, because no effective treatment existed. But this changed in the 1970's, with the development of clotting factor concentrates, which are derived from blood. It was also changed by the introduction of comprehensive care that allowed many individuals with hemophilia to begin to manage their bleeding episodes at home. Clotting factor eliminated the need for frequent and costly hospitalization and ensured that even persons with severe hemophilia would be able to attend school, obtain full-time employment, and enjoy greatly increased life expectancy. Clotting factor changed the lives of persons with hemophilia, especially for children like the Rays, who, unlike their grandfathers and uncle, could now see a future involving a long and healthy life. When clotting factor was introduced, it was treated as a miracle drug. People were encouraged to use it not just in case of a life- threatening bleed but also as a part of their daily lives--a preventive measure. It is just a slight exaggeration to say that people were encouraged to treat early and to treat often. The great promise of this new treatment, however, proved short lived when, tragically, it was found to be an effective means to transmit the virus known as HIV. Ricky Ray was diagnosed as HIV positive in 1986. He was only 9 years of age. He had contracted HIV through the use of this remarkable new treatment, this clotting factor. His two brothers contracted HIV as well and so did 72 other members of the hemophilia community across this country. Ricky Ray and his brothers were kicked out of school. They were kicked out of school because of their HIV status, and then, when their parents won a decision in court to readmit them, arsonists set their house on fire. Instead of giving in to anger, Ricky Ray became a spokesperson promoting understanding about HIV. And he did this until his death in 1992 at the age of 15. I personally became involved with the hemophilia community when I met a father from Ohio whose son Christopher had severe hemophilia. John Williams was the primary caregiver for his son. John accompanied Christopher to his doctor's appointments and learned how to infuse his child with the medicine that would control his bleeding disorder. John also shared anguish and pain with his 8-year-old little boy when he then later was diagnosed with AIDS. John was determined, as all parents would be, to help Christopher survive. John accompanied Christopher to the National Institutes of Health campus every few weeks for the latest in treatment options and breakthrough technologies. Throughout this experience, the constant thought in the father's mind was that he had infused his own son with the medicine that would eventually kill him. He often thought that he had been negligent in some way. Had he perhaps missed a crucial piece of information that could have saved Christopher? Had he missed an important news story or warning? Was there anything he could have done to save his son? For 5 years, the father, John, shared in his young son's battle. Then in October 1994, Christopher died of complications from AIDS. He had just entered the 10th grade and was contemplating college plans, a dream that, of course, was never fulfilled. This legislation is really about people. It is about people and their strength in facing tragedy, the devastation of an entire community of people that today has come to be represented by a courageous boy from Florida by the name of Ricky Ray. The concerns that I raise today have been raised repeatedly by the hemophilia community in this country. Unfortunately, the legal system has not been an effective means to address these concerns nor to provide the assistance to infected individuals, and there are several reasons why. The first has to do with what's called blood shield laws. Whenever the Federal Government writes product liability laws of any kind, we in the Congress insert a standard exemption for blood and blood products. We, therefore, defer to the States to regulate in this area, and in doing so we affirm the State blood shield laws that are prevalent throughout this country. Forty-seven different State jurisdictions have exempted blood and blood products from strict liability or implied warranty claims on the basis that blood and blood products are services, not products. Now, this classification is more than just a question of semantics. It means that plaintiffs must prove negligence rather than simply use of the blood was the proximate cause of the injury they suffered, which is the standard for other products. In 1976, blood banks began receiving exemptions from liability even under a negligence standard with the passage of blood shield laws. In 1977, the courts began extending this exemption from liability to blood product manufacturers on similar grounds. They did all of this because the States believed the need for an available blood supply, for surgery and other medical procedures, outweighed the relatively minor risk of hepatitis. The rationale was that blood product manufacturers should be exempt from product liability, since blood products are unavoidably unsafe, because the risk of hepatitis simply could not be eliminated. There is a much higher standard of proof for consumers of blood and blood products. The ability of individuals in this community, the hemophilia community, therefore, to seek resolution in the court system has been severely curtailed by these State blood shield laws. If that were not enough, there are other legal problems confronting these hemophilia victims and their families. Just a couple of examples. First, collecting evidence for suits against manufacturers is extraordinarily difficult. Most individuals that became infected with HIV had a severe form of hemophilia that meant they were infusing thousands of units of clotting factor on a monthly and sometimes weekly basis. These individuals were understandably unable to determine exactly from which manufactured lot the product that infected them came. Second, hemophilia families also face the problem of statute of limitations. All States have them, and they prohibit individuals from prevailing in litigation if the suit was not filed within a few years of the alleged tort. To the hemophilia community, many individuals were diagnosed after the prescribed period in the statute of limitations and were unable to take any action. Just as significantly, they are also battling a disease with a long and often symptom-free incubation period. This makes statutes of limitation even less defensible and imposes a much greater burden on this community. All this does not mean that the hemophilia community, these people who have suffered so, has not tried. They have. Hundreds of suits have been filed against the manufacturers of clotting factor. In some States the hemophilia community has even been successful in rolling back the statute of limitations. Recently, many members of the hemophilia community gave up their right to continue to pursue the manufacturers through the courts, and they did this by agreeing to a class action settlement. This settlement brings recognition to the HIV infection of the hemophilia community and provides some relief to the community for their suffering. But this is not to say that the community was holding out until recently for something better. Victims were unable to meet the especially high liability standards established by the blood shield laws. It appears that increasing momentum for the Ricky Ray bills in the House and Senate pushed the negotiations into a final phase. Senators may ask about the private settlement proposal as offered by four manufacturers of clotting factor concentrates in 1996, an offer that was made in April 1996. This settlement, which has been approved by the U.S. District Court of Northern Illinois, will provide each person infected with HIV through the use of clotting factor $100,000. The settlement proposal was drafted so the payment would be contingent upon obtaining certain protections for recipients receiving means-tested benefits such as Medicaid. So for this reason, when we reintroduced the Ricky Ray bill this year, I included a second title in the bill to protect the eligibility for individuals receiving Medicaid and SSI upon receipt of the settlement claim. The Balanced Budget Act of 1997 included a provision related to the private settlement protecting the eligibility of individuals receiving Medicaid benefits. Unfortunately, no similar protection for SSI eligibility was included. I support the settlement between the hemophilia community and the manufacturers of clotting factor and see it as the first step in addressing the ongoing responsibility that the companies have to the community they serve. I do not believe that the victims--in looking for compensation--should be limited to seeking from private companies. This should not be an exclusive remedy. It should not be seen as an exclusive remedy, very bluntly, because the Government shares the blame. And private settlements are inadequate. As to the specific figure at which we have arrived--$125,000--I think this is an eminently reasonable compensation, when you consider that the average cost of care for patients with severe hemophilia--per year--is $100,000. Let's look at how some other governments have dealt with this problem. Compensation in other Countries Many other developed countries have established compensation programs to assist individuals with blood-clotting disorders who were infected with HIV by contaminated blood products. In some countries, such as Australia, France, Germany, Japan, Spain, and the United Kingdom, assistance has come from combined public and private sources. Specifically, in Japan, the government--and the same pharmaceutical companies we are dealing with here in the United States--agreed to provide, together, payments of $430,000 to victims of hemophilia-related AIDS. The government shouldered 44 percent of the burden, and the pharmaceutical companies paid the rest. In other countries, such as Canada, Denmark, Hong Kong, Italy, Portugal, and Switzerland, assistance has been provided directly from the government. Precedents Some of my colleagues have raised concerns that passage of the Ricky Ray relief legislation may set a legal precedent. What kind of precedent is there? In fact, the U.S. Congress has a history of recognizing the country's responsibilities to aggrieved individuals and has provided relief for these victims. It is my intention, in the next few minutes, to lay out the precedents in some detail. But I would like to point out, first and foremost, that blood is unique. The Federal Government and, by its permission, State governments, regulate the blood supply in a unique way. Because the Government has a unique responsibility in the case of blood, passage of the Ricky Ray Relief Act will not set a precedent. It would, rather, represent another extraordinary circumstance in which Congress has determined that injured parties should receive compensation for injuries sustained as a result of Government action or inaction. Individuals in the hemophilia community are prevented from recovery from the Federal Government under the Federal Tort Claims Act [FTCA], which is designed to be the exclusive means of compensation for injuries sustained as a result of the negligence of the Federal Government. Because the Federal Tort Claims Act includes an explicit exemption from claims that arise directly as a result of the ``exercise or performance or the failure to exercise or perform a discretionary function,'' victims are barred from recovery for the inaction of the FDA in its regulation of blood products. They are barred under this act. But Congress has acted to compensate individuals when it determines that remedy under the Federal Torts Claims Act and other statutes is inadequate. Congressional passage of the Ricky Ray Act would represent another instance of Congress recognizing the appropriateness of compensating victims unable to recover under the Federal Tort Claims Act. Let me discuss two relevant precedents. One of the first major claims made after the passage of the Federal Tort Claims Act was the claim made on behalf of the victims of the explosion of two cargo ships containing ammonium nitrate fertilizer in the harbor of Texas City, TX, in 1947. In this case, the Supreme court held, in Dalehite v. United States, 346 U.S. 15 (1953), that the Federal Government was not liable because the plaintiffs could not prove negligence. Additionally, a claim of absolute or strict liability was rejected because the Court found that the Federal Tort Claims Act did not allow recovery on that basis. Despite--and, in part, because of--the Supreme Court's explicit rejection of the claim under the Federal Tort Claims Act, 2 years later, the Congress passed legislation providing settlement of claims resulting from the explosion. This legislation established the precedent that Congress may pass legislation authorizing compensation without finding the Government at fault. Let me turn to another example that closely reflects the hemophilia situation in the mid-1980's in this country. Congress combined relief for two different populations of victims in one statute--the Radiation Exposure Compensation Act. One group was made up of uranium miners who were seeking compensation for the adverse health effects they had experienced while working in private mines--private mines. The second group, known as ``downwinders,'' was made up of individuals who lived downwind of atomic test sites and were exposed to radiation. Neither group was able to recover from the Federal Government in court. Both failed. The courts had previously ruled against the uranium miners in Begay v. United States, 591 F.Supp. 991 (1984), and against the downwinders in Allen v. United States, 816 F2d 1417 (1987). The courts found that the Government could not be held liable for injuries because its policies were protected by the discretionary function exception in the Federal Tort Claims Act. In Begay, the plaintiffs had asserted that various government agencies were actionably negligent in leaving the responsibility for uranium mine safety--outside Federal enclaves like Indian reservations--to the States. They also asserted that these agencies were negligent in failing to enforce rigid radiation safety levels in the Indian reservation mines--and that all the Federal agencies involved were themselves negligent in failing to establish and enforce rigid radiation safety standards in the underground uranium mines in the 1940's, 1950's, and early 1960's. The court in Begay suggested that the miners seek redress from the U.S. Congress. This is what the Court said: This tragedy of the nuclear age . . . cries for redress. Such relief should be addressed by the Congress as it was in the Texas City explosion following the decision of the Supreme Court in Dalehite. In the Allen case, the downwinder plaintiffs had singled out the alleged failure of the Government to fully monitor offsite fallout exposure, and to fully provide the necessary public information on radioactive fallout. As in the Begay case, the court found no obligation to compensate on the basis of failing to monitor or warn. A concurring opinion in Allen noted that the court's hands were tied: While we have great sympathy for the individual cancer victims who have borne alone the costs of the Atomic Energy Commission's choices, their plight is a matter for Congress. Only Congress has the constitutional power to decide whether all costs of government activity will be borne by all the beneficiaries or will continue to be unfairly apportioned, as in this case. In 1990, Congress did in fact provide relief to these two groups through the Radiation Exposure Compensation Act, Public Law 101-426. The circumstances that led to the passage of the Radiation Exposure Compensation Act are, I believe, very instructive. In that case, the States failed to require that the private mine operators follow Federal health and safety standards. As a result, people got sick. They could not recover from the private mine operators--nor could they recover from the Federal Government. Those individuals were compensated later through congressional legislation, through action by the House and the Senate. The facts are clear. In that case, little or nothing was done by the States to force the private mine operators to improve ventilation in their mines. Although the Public Health Service demonstrated that adequate mine ventilation would be relatively inexpensive--and the Atomic Energy Commission had developed effective radiation level controls, which were available for all State and Federal agencies--the mine operators successfully resisted efforts to substantially reduce radiation levels by improved ventilation techniques. Through legislation, compensation was ultimately made to individual miners who worked for private mine operators that were not subject to Federal radiation safety requirements. These precedents bring us directly to the Federal Government's responsibility for the blood supply in this country and bring us directly to this bill. The evidence in the IOM study that I referenced previously on blood safety clearly demonstrates that, in a number of instances, FDA failed to mandate certain Federal patient safety requirements for private processors of blood products, failed to act on recommendations from the Centers for Disease Control concerning screening blood donors, failed to mandate recall of hemophilia clotting factor, and failed to implement a 1988 Presidential directive to trace recipients of possibly infected blood, failed to do that for 3 long years. Passage of the Ricky Ray Hemophilia Relief Act does not set a new precedent, but--on the contrary--is fully consistent with the earlier precedents set by Congress to provide compensation for injury when remedy could be found by no other means. how to pay for ricky ray As this bill is written, the Ricky Ray Act provides $125,000 for each eligible individual, and so, with an estimated 7,200 affected individuals, the total cost of the bill is estimated at $900 million. In order to identify individuals and determine their eligibility, payments authorized by the legislation will likely occur over several years. This would result in at least two smaller annual appropriations requests. Support for This Legislation As I stated earlier, the Ricky Ray Hemophilia Relief Fund Act has the support of 35 of our Senate colleagues and the support of 257 Members of the House of Representatives. The legislation is also endorsed by the American Red Cross, the American Association of Blood Banks, America's Blood Centers and AIDS advocacy organizations such as the National Association of Persons with AIDS and the AIDS Policy Center. In her letter to the National Hemophilia Foundation, American Red Cross President Elizabeth Dole stated: The American Red Cross supports a comprehensive approach to addressing the needs of those infected with HIV or other transmissible agents through the use of blood components or blood products. For individuals with hemophilia who were infected with HIV before 1985, the American Red Cross believes that finalization of the manufacturers' settlement offer, coupled with the government-funded compensation program outlined in the Ricky Ray legislation, will provide an effective means of immediate help. A host of other developed countries have established compensation programs to assist individuals with blood-clotting disorders who were infected with HIV by contaminated blood products. I believe it is now time for the United States--and for this Congress--to take action as well. I encourage my colleagues to cosponsor this legislation, to join the 35 other Members of this body who have already signed on as cosponsors. The Senate Labor Committee is scheduled to have a hearing on this bill on Thursday of this week. Chairman Hyde will be bringing the House bill before the full House Judiciary Committee tomorrow. I would invite my colleagues to examine the hearing record, and learn more about the need for this bill. I believe the case has been made and the case is clear: The Federal Government has a moral duty to help those Americans who counted on the Federal Government to protect the blood supply. No, Mr. President, this bill cannot reverse the tragedies, but it can serve to demonstrate that the Federal Government can be held accountable for its actions. Mr. President, we often hear that bad things happen to good people. That is something that governments and Congresses will never be able to cure. But in this case, when bad things happened to good people, the U.S. Government played a part in the problem. The U.S. Government should now play a part in the solution--and do something to help these American families. I thank the Chair.

Mr. DeWINE

Mr. DeWINE. Mr. President, I further ask unanimous consent to speak for up to 45 minutes.

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

Mr. DeWINE

Mr. DeWINE. Again on behalf of the leader, tomorrow morning at 11 a.m., under the previous order, the Senate will proceed to executive session to consider the nomination of William Kennard to be a member of the Federal Communications Commission. Under the order, there will be 30 minutes of debate on the nomination with a rollcall vote occurring at the expiration or yielding back of that time. Therefore, Members can anticipate a vote at approximately 11:30 a.m. At 12 noon, it will be the leader's intention for the Senate to turn to consideration of H.R. 1119, the national Defense authorization conference report. The Senate may also begin consideration of Senator Coverdell's legislation dealing with education IRA's. Subsequently, Members can anticipate further rollcall votes throughout Wednesday's session of the Senate.

Mr. DeWINE

Mr. DeWINE. Mr. President, again on behalf of the leader, I ask unanimous consent that when the Senate completes its business today it stand in adjournment until the hour of 11 a.m., on Wednesday, October 29. I further ask unanimous consent that on Wednesday, immediately following the prayer, the routine requests through the morning hour be granted and that the Senate immediately begin consideration of Calendar No. 312, the nomination of William E. Kennard to be a member of the Federal Communications Commission under the order.

Mr. DeWINE

Mr. DeWINE. I thank the Chair.

Mr. DeWINE

Mr. DeWINE. Mr. President, I rise today to call my colleagues' attention to a resolution introduced by the Governor of Ohio, George Voinivich, to commemorate National POW/MIA Day, which took place on September 19, 1997. That day last month and more important, the issue itself, are of great importance to all Americans, especially to those that served our country in military missions abroad. As of today 2,116 Americans are classified as either prisoners of war or missing in action (POW/MIA) from the Vietnam war. Thousands more remain missing and unaccounted for from the Korean war and even the Second World War. The families and friends of these soldiers still have to endure the awful uncertainty concerning their fate. Every effort must be made to determine the fate of these soldiers. In the case of Vietnam, I am hopeful that the normalization of diplomatic relations with Vietnam and the reopening of the American Embassy will encourage the government of Vietnam to fully cooperate with American officials in their search to gain the fullest possible accounting of POW/MIA's. I strongly encourage the President and the Ambassador to Vietnam to give the POW/MIA issue top priority and insist that the Vietnamese Government disclose all pertinent information on American POW/MIA's. Mr. President, I am hopeful that last month's POW/MIA Day, and Governor Voinivich's eloquent resolution will serve to heighten American awareness and inform foreign governments of the United States' serious commitment to bringing our soldiers home. Mr. President, I ask unanimous consent that the State of Ohio's POW/ MIA Recognition Day resolution be inserted in the Congressional Record.

Mr. DeWINE

Mr. DeWINE. Mr. President, I rise today to call the attention of my colleagues to a story that appeared last week in the Cincinnati Post. This is the story. The headline is: ``Woman Torched Nephew, Police Say--Youngster's Burns Untreated for Weeks'' Mr. President, the article tells the story of the awful abuse of an 8-year-old child in the Cincinnati area. The boy was set on fire--set on fire--with nail polish remover, and then sent to school for 3 weeks with his burns unattended. Cincinnati police investigated what happened to this little boy. They have now charged his aunt with child endangering. They charged his aunt with setting him on fire--and also with abusing him with a belt, an extension cord, and shoes. Mr. President, this is an obscene crime. After this woman's arrest, it was revealed that she had been charged with a similar crime involving the same little boy 2 years before. Don't we have to ask, Mr. President, what on Earth was that woman doing taking care of that child or any child? Why in the world was that child put back into that same home, put back with that abusive woman? Mr. President, 3 weeks ago, I rose on the Senate floor to tell a similar tragic story. That story took place in Washington, DC. It was the story of a little 4-year-old girl named Monica Wheeler who was found dead, beaten to death in the bathroom of a man who was an acquaintance of her mother. Three years ago, one of Monica's siblings, her brother Andre, then aged 2, was also found dead in the same man's bathroom. Mr. President, as I have come to the floor and cautioned before, it is up to the police and the courts to find out the truth about these particular cases. And we should not be interested in prosecuting anyone here on the Senate floor, no matter what we think. That certainly is what the courts are for. But I cannot stress enough that these awful crimes point to a responsibility that lies with us here in Congress, the responsibility to make sure we do all we can to stop these crimes from ever happening. One thing we know for certain about these two cases--the Cincinnati case and the Washington case, and far too many other cases--is that there are too many children in this country today being returned to the care of people who have already abused and battered them, people who should not be allowed to take care of these children. Children are being returned to homes that are homes in name only and to parents who are parents in name only. Every day in this country, three children actually die of abuse or neglect at the hands of a parent or their caretakers. That is approximately 1,200 children a year who die. And almost half of these children, shockingly, Mr. President, are killed after--after--their tragic circumstances have come to the attention of the child welfare agencies. At the end of 1996, Mr. President, over 525,000 children were in foster homes across this country. Over a year's time, it is estimated that 650,000 children will be in a foster home for at least a portion of that year. And shockingly, roughly 25 percent of the children in the foster care system at any one time will languish in foster care longer than 4 years. And 10 percent of these children will be in foster care longer than 7 years. Mr. President, this problem has been growing for many years. It is at least in part the very unintended consequence of a law passed by Congress in 1980, a law that I have spoken on this floor I suppose at least a dozen times about since I came to the Senate. It is a law that was passed in 1980 that requires that reasonable efforts always be made to reunify families. In practice, Mr. President, this law has resulted in unreasonable efforts, unreasonable efforts being made to reunite families that are families in name only, families that never should be reunited. Children are being sent back to abusive parents, abusive care givers, and many times the result is death. Mr. President, I have been working to change this for almost 3 years now. Last month, along with Senators Chafee, Craig, and Rockefeller, and others, I introduced a bill that I hope will represent the culmination of this effort. The PASS Act--the Promotion of Adoption Safety and Support for Abused and Neglected Children Act--would make a difference. It would save young lives. It would change this 1980 law that I referenced. It would put an end to a tragic policy that has put parents' interests above the health and safety and even the survival of innocent children. It would help child welfare agencies move faster to rescue these children. Mr. President, every child deserves a better fate than being shuttled from foster home to foster home for years on end. That is why, Mr. President, we are working to pass this very important bill. Let us work together, after we pass the bill, then on the next step, which will be to continue to try to improve the system. But the work that is in front of us today, Mr. President, is to pass the PASS Act, a bill that has been worked on extensively, a bill that will in fact benefit children in two ways: One, by moving them quickly through the system once they are in fact in foster care so that they do not languish in foster care for years on end so that they can have what every child needs, which is a caring and loving family; and the second thing the bill would do is save lives. We will never know what child's life will be saved or how many, but I am convinced, after talking with caseworkers throughout the State of Ohio, children service agencies, and after having talked to many people throughout this country, that the 1980 law that our bill will amend will in fact, by amending that law, save lives. So I urge my colleagues, when this bill is brought to the floor, as I hope it will be in the next several weeks, to look at this bill, to pass it, and to move on so that we can make a very strong statement and do something very positive for America's children. Mr. President, I yield the floor. Mr. CHAFEE addressed the Chair.

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

Mr. DeWINE

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

Mr. DeWINE. Mr. President, I rise this morning to draw the attention of my colleagues to a very sad, unnecessary controversy involving the Government of the United States and the Government of China, a controversy which also involves a little 3-year-old girl. Mr. President, this is the sad story. A Chinese woman living in Cleveland was diagnosed with schizophrenia. For many reasons, including this diagnosis, it was clear that this woman was not capable of taking care of her daughter. In fact, they had both been evicted from a Salvation Army shelter because of concerns that the mother was mistreating the daughter. Evidence showed that the child had been seriously neglected. So the court stepped in and sent this child into foster care. By the time this little girl was 16 months old, tragically, she has been in four foster homes. The natural mother was allowed visiting rights. During one of these visits she abducted the child and took her to the People's Republic of China. In June 1997, Mr. President, the Ohio court permanently terminated the birth mother's rights and awarded legal custody of Mei Mei--this little girl's name--to Mei Mei's foster mother. Since last October, the foster mother, the legal guardian of this child, has been trying, naturally, to get Mei Mei back. She wants to adopt Mei Mei, but her efforts thus far have not been successful. Mr. President, I urge President Clinton to raise the issue of this little child with the Chinese President when they meet. There is an adoptive family waiting in Ohio for Mei Mei. They love her and they will be able to take good care of her. I hope this problem can be resolved in a positive and expeditious way. Therefore, I urge the President to raise this at the highest level between our countries. A few minutes ago on the floor I circulated a letter--and a number of my colleagues have already signed it--to send to President Clinton urging him to bring the matter up. Mr. President, sometimes it is easy, as we debate issues, to lose the personal sense about these horrible cases. Sometimes we hear about statistics and sometimes we hear about stories of bad things occurring, such as I have just related. To try to bring it home, though, and put a more personal face on it, let me read just one paragraph that was written by the foster mother who wants to adopt Mei Mei. This is what she writes: We have been applauded for our dedication and uninterrupted love for Mei Mei. I can honestly tell you, however, that it was not difficult. When a child enters your life and needs to be held, you hold them. You teach them to laugh, you teach them that you are there, you teach them to be gentle, you teach them that everything in life is beautiful. And then when they start to see that life is not something to be just tolerated but rather to be enjoyed, they develop a sparkle in their eye, which fuels your love further for them. That's what happened with us and with Mei Mei. So I urge, again, Mr. President, that our President, President Clinton, bring this matter up with the Chinese. It is a small matter, I suppose. But it is a little girl; it is her life. She has an opportunity for a loving family to raise her. She was snatched away from that opportunity by a woman who has clearly demonstrated that she is unfit to take care of this little girl. So I urge the President, as he discusses issues with the Chinese, to raise the issue of Mei Mei. Mr. President, I yield the floor, and at this point I suggest the absence of a quorum.

Mr. DeWINE

Mr. DeWINE. Mr. President, I want to discuss today an important issue involving the FDA. First, let me congratulate my colleague from Arkansas, Senator Tim Hutchinson, for his fine work on the legislation that he has just introduced. This bill that Senator Hutchinson has introduced would prevent the FDA from implementing a proposed rule that is harmful and unnecessary. Mr. President, this is the story. Earlier this year, the Food and Drug Administration issued a proposed rule to accelerate the phaseout of metered-dose inhalers that are propelled by chlorofluorocarbon gases, commonly known as ``CFC's.'' Essentially, Mr. President, the FDA has proposed to ban from the market safe and effective medicines that millions of Americans use to help them breathe. For many patients, these medicines mean, quite literally, the difference between life and death. This FDA proposed ban is not based on concerns of safety, but rather the ban on these inhalers was put forward on the grounds that inhalers that use CFCs deplete the Earth's ozone layer. Now, the fact is, Mr. President, that these inhalers have only a minimal effect on ozone depletion. Asthma inhalers account for only a very small part of this problem. It is estimated that asthma inhalers account for less than 1.5 percent of the total problem. Perhaps more important, Mr. President, the companies that make these inhalers have already agreed to develop new CFC-free devices by the year 2005--the deadline that was previously set forth in the international Montreal Protocol. These companies are working hard to bring these products to the market quickly and, in fact, they think they will beat the 2005 year deadline. So I think, Mr. President, it's clear that the FDA's proposed rule to accelerate the phaseout of these products yields no significant benefit to the global environment. What it will do, however, is take away essential medications from Americans who depend on these inhalers to manage serious respiratory illnesses. Mr. President, over 30 million Americans suffer from some type of respiratory disease, including asthma. Many of these patients rely on a combination of inhalers to be able to function normally. The FDA's proposed policy would limit their treatment options and force them to switch from proven treatment regimens that have been carefully adjusted to control their symptoms. Mr. President, asthma is a serious national health problem. The morbidity and mortality rates from asthma continue to increase in the United States, particularly among minority and inner-city children. Mr. President, I think we have to question the FDA's judgment in putting forth a proposal that puts these patients at further risk. I hope others will agree with me as well. Mr. President, the FDA has already received over 10,000 letters from patients, providers, and health care organizations expressing concern about this issue. In a letter to Health and Human Services Secretary Donna Shalala, Dr. C. Everett Koop, former Surgeon General of this country, wrote the following: This proposal will adversely impact patient health, while providing negligible environmental benefit. Dr. Koop went on to state: Any efforts to limit the medications available to asthma patients and their physicians would be a serious mistake that would lead to severe consequences for American asthmatics. Mr. President, there is another aspect to this whole issue. Under the proposed guideline, the FDA would remove from the market products that have been tested and labeled for use in children and replace them with CFC-free versions that while containing the same active ingredients have not been tested or approved for use by children. They have not been tested or approved for pediatric use. Mr. President, asthma is the leading cause of chronic illness among children--5 million children suffer from asthma today. How in the world can the FDA remove products from the market which are proven to be safe and effective for children while at the same time the FDA laments the lack of adequately labeled products for children? It just doesn't make sense. Mr. President, the Food and Drug Administration is charged with protecting the health and well-being of American citizens. It seems incomprehensible to me that it could put forth a proposal that secures really negligible environmental benefits at a potentially steep cost to human lives and health. I urge the FDA to reconsider its proposal. The health of millions of Americans who depend on metered-dose inhalers is too important. Mr. President, I thank the Chair. I yield the floor. Mr. BYRD addressed the Chair.

Mr. DeWINE

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

Mr. DeWINE

Mr. DeWINE. I thank the Chair.

Mr. DeWINE

Mr. DeWINE. Mr. President, I make the following statement this morning on behalf of the majority leader. Today the Senate will be in a period of morning business until the hour of 2:30 this afternoon. At 2:30 the Senate will resume consideration of S. 1173, the ISTEA legislation. As the leader announced before the recess, no rollcall votes will occur during today's session. The leader further hopes the Senate will be able to make progress on this important legislation regarding highway construction and highway safety programs. As Members are aware, the first session of this Congress will be concluding before too long and there is much work left to be done. This week the Senate must act on a continuing resolution as we attempt to pass the remaining appropriations bill and conference reports. As the conferences finish their work, the full Senate awaits these conference reports. The majority leader encourages all Senators to cooperate as we schedule the remaining legislative period. The majority leader also reminds colleagues that typically these closing weeks of session are some of the busiest. Senators should be prepared, therefore, for busy sessions with rollcall votes occurring each day unless other notification is given. The majority leader thanks all Senators for their attention. I suggest the absence of a quorum.

Mr. DeWINE

Mr. DeWINE. Mr. President, I rise in strong support of the Mack amendment. I, of course, therefore will oppose the motion to table. This amendment will ensure that fundamental principles of fairness are respected in regard to the cases of some 316,000 immigrants, some of them from Central America. In the immigration bill Congress passed last year, we changed the criteria for suspension of deportation. Certain retroactive changes in that bill, at least as they have been interpreted by the INS, had the unintended effect of applying these new criteria to applications of suspension for deportation which were already in the pipeline when the bill was passed. The Mack amendment will ensure that those immigrants whose cases were in the pipeline when the 1996 immigration law took effect will have their cases decided according to the criteria in effect at the time that the law actually passed. It is only fair that we should not change the rules in midstream for these worried immigrants. Let me take us back to the 1980's when we granted these 316,000 Central American immigrants temporary protection from deportation. We knew at that time the terrible consequences of war--the grinding poverty, human rights abuses that had driven these men, women, and, yes, children, to our shores. At that time, we told these immigrants that their protection from deportation would be permanent if certain conditions were met--that is what we told them then--7 years of continuous residency, good behavior, proof of extreme hardship awaiting them in their native country. We basically said, ``As long as you can prove that, then this will be permanent.'' When Congress changed the law in 1996, we clearly did not intend to change the rules for these people who already, at that time, were in the pipeline. We, in essence, had made a commitment to them. We, in essence, had made a deal with them, and I don't believe we should go back on that deal today. Mr. President, the Mack amendment would keep faith with these individuals. It is not, as my colleagues from Florida have already pointed out, an automatic grant of amnesty, nor is it an automatic grant of permanent residency. Far from it. It is merely a restoration of the original conditions these immigrants have to fulfill if we are going to allow them to remain in this country. I had the opportunity this morning to participate in a press conference concerning this issue. I also had the opportunity a few months ago to travel to Nicaragua. I had made several visits to Nicaragua in the 1980's, about a decade ago. For me to go back to Nicaragua a few months ago was a very pleasant experience, and it was pleasant because I had seen where Nicaragua was. I had the opportunity a few months ago to see where Nicaragua is today. Yes, it is still the second-poorest country in this hemisphere and, yes, there is high unemployment and, yes, there are many, many problems. But what we see in Nicaragua today is a fledgling democracy. We see a country that is becoming what we envisioned and had hoped for and worked for in the 1980's, and that is a democracy. Today, for the first time in history, all five Central American countries are democratic; all five are working to bring about the reforms that truly are an example of democracy. When I traveled to Nicaragua, I had the opportunity to speak with then President-elect, now President Aleman and talked to him about his vision for his country. One of the unintended consequences of the bill we passed in 1996, and one of the unintended consequences of the deportation of these 316,000 immigrants would be that we would strike a hard blow against democracy in Nicaragua and El Salvador and the other Central American countries. Anyone who has looked at these countries today understands what an economic impact and political impact it would have if all these citizens, all of these individuals were instantly returned to their native countries. The ability to absorb these individuals simply does not exist. It does not exist from an economic point of view. Further, this would take away a major source, frankly, of income to these countries, a major source of help to the economy, not United States foreign aid, but rather the remittances that are sent back by Nicaraguans who are living in the United States. Those remittances are a major contribution to the Nicaraguan economy today. To take that away, I think, would have a very severe and devastating blow to the economy of Nicaragua and the economy of the other Central American countries. That is not the principal reason to support the Mack amendment, but it is a fact, and it is a fact of life. The central reason to support the Mack amendment is what has been stated on this floor by Senator Mack on several occasions, as well as Senator Graham, and that simply is this is a matter of equity, it is a matter of fairness, it is a matter of keeping our word, and it is a matter of doing what is right. I urge my colleagues to support the Mack amendment and, therefore, vote against the motion to table the Mack amendment. Mr. President, I yield the floor. Mr. COATS addressed the Chair.

Mr. DeWINE

Mr. DeWINE. Mr. President, I rise today to call the attention of my colleagues to a story on the front page of last Thursday's Washington Post. This article tells the story of the beating death of a little 4- year-old girl, a little girl by the name of Monica Wheeler in Washington, DC. Monica was found dead in the bathroom of a man who was an acquaintance of her mother's. The police have ruled her death a homicide. In addition to being severely battered, Monica was suffering from malnutrition and showed signs of genital bleeding. Now, Mr. President, 3 years ago, one of Monica's siblings, her brother, Andre, then age 2, was also found dead--in the same man's bathroom. That earlier death was ruled at that time an accidental drowning, but the police now are reopening that case. Mr. President, it is up to the police and the courts to find out the truth about this particular tragedy. But one thing we know for certain is that there are far too many children returned to the care of people who have already abused and battered them, people who should not be allowed to take care of children at all. We know this occurs time and time again across this great country of ours. Mr. President, every day in America three children actually die of abuse and neglect at the hands of their parents or their caretakers. That is over 1,200 children every year. And almost half of these children are killed after--after--their tragic circumstances have already come to the attention of local child welfare agencies. Mr. President, at the end of 1996, over 525,000 children were in foster homes. Over a year's time, it is estimated that over 650,000 children will spend some time in foster homes. Shockingly, 25 percent of the children in the foster care system at any one given point in time will languish in foster care longer than 4 years--25 percent of the kids. Ten percent will be in foster care longer than 7 years. This problem has been brewing for many years. It is, at least in part, the unintended consequence of a law passed by this Congress in 1980, a law requiring that reasonable efforts be made to reunify families. In practice, this law has resulted in unreasonable efforts, unreasonable efforts, Mr. President, being made to reunite families that are really families in name only, families that simply never should be reunited. I have been working to change this for almost 3 years now. About 10 days ago, along with Senator Chafee, Senator Craig and Senator Rockefeller, I introduced a bill that I hope will represent the culmination of this effort. The PASS Act--the acronym we have given to it stands for the Promotion of Adoption Safety and Support for Abused and Neglected Children Act--would make a difference. It would, Mr. President, save young lives. It would put an end to a tragic policy that has put parents' interests above the health, the safety, and yes, even the survival of innocent children. Mr. President, it would help child welfare agencies move faster to rescue these children. Every child deserves a better fate than being shuttled from foster home to foster home for years on end. That is why, Mr. President, we are working to pass this important bill. Once this bill is passed, Mr. President, then let's work together on the next step in the continuing battle for our children's right to live in safe, stable, permanent and loving homes. Mr. President, the tragedy of this little child who died in Washington, DC, a few day ago, this little 4-year-old girl, Monica Wheeler, should not be repeated. I think we have an obligation in this Congress to move as quickly as possible to change a 1980 law that has done a lot of good but that frankly had an unintended consequence. That unintended consequence is that children, even after there is evidence of abuse, even after there is not just evidence, even after there is overwhelming indication of abuse, children are placed back in homes time and time and time again. One of the reasons that occurs is because of the 1980 law. We must act, Mr. President, to clarify that law, to clarify the reasonable efforts requirement of the law, so that the safety of children will always be paramount, and that these tragedies will be eliminated. I yield the floor and I suggest the absence of a quorum.

Mr. DeWINE

Mr. DeWINE. Mr. President, I rise today to recognize the achievement of a very valuable community organization in Cincinnati, OH. The group--known as Black Career Women, or BCW--has been serving the African-American community in Cincinnati and throughout the United States for 20 years. Back in the early 1980's, BCW provided word processing assistance and office-skill development services to unemployed and underemployed women--to help them get decent jobs with a living wage. This nonprofit organization provides an extremely valuable service to corporations and managers who are trying to develop and support successful skills-development strategies for African-American women. Working in partnership with executives, BCW has helped improve the lives of countless women from corporate executives to entrepreneurs. Over the last two decades, more than 10,000 women have benefited from the service of Black Career Women. Black Career Women has been helping the African-American women in the Cincinnati area and throughout the Nation achieve the goals of self- help and self-determination. They deserve the praise of all people who believe in diversity, economic progress, and independence for working people. I ask all my colleagues to join me in extending our warmest congratulations on their 20th anniversary. They are making a big difference for the better in the life of the Cincinnati area and the entire nation.

Mr. DeWINE

Mr. DeWINE. Mr. President, let me first make a unanimous-consent request that my congressional fellow, Jan Burrus, be granted floor privileges during the duration of this debate.

Mr. DeWINE. Mr. President, I wish to make some comments about one particular element of this year's FDA reform bill--one that I believe is especially important and valuable. I want to thank Chairman Jeffords and my colleagues for including in this bill a revised version of the Better Pharmaceutical for Children Act (S. 713). Senator Dodd and I introduced this bill earlier this year because an overwhelming majority of pharmaceuticals currently on the market have not been tested for safety or effectiveness in children. In fact, Mr. President, a shocking 80 percent of the drugs that are on the market today have never been tested for children. We need to provide our young people with prescription drugs that have been studied for their effects on children's bodies and appropriately labeled with doses suitable for young ages. Too many children today are taking adult-size drugs because we don't have a comprehensive strategy to test drugs to determine appropriate dosages for children. Children deserve better than this. Children deserve he same assurance adults have--that the drugs they take are safe and effective. Section 618 of the FDA reform bill includes a modified version of the bill Senator Dodd and I have worked so hard on. It provides an additional 6 months of market exclusivity to drug manufacturers who complete requested or required pediatric studies on drugs that are useful for children. This exclusivity will act as financial incentive for manufacturers to do research on their products for young patients. As our legislation with incentives came close to final passage, the FDA proposed a rule to mandate pediatric studies. The rule was proposed last month and would require pediatric studies for most new drugs and for many drugs that are already on the market. When the administration released its new regulation, I applauded their decision to join Senator Dodd and myself in trying to fix this problem. I offered to work with them in a bipartisan way to combine the proposals for the benefit of the Nation's children. The legislation before us today does just that, and in essence combines our bill along with the administration's proposal. We have adapted the legislation that Senator Dodd and I originally introduced so that it will work with the FDA's regulation. To ensure that we do the best that we can for children, we have combined the two approaches to this problem: the financial incentives from the better pharmaceuticals for children bill and the mandates from the proposed FDA rule. We're now moving in the right direction. This combined approach may not yet be perfect, but we can still work on it. I have extended an invitation to all interested parties to continue to work toward a better compromise between now and conference. The most important thing is to get it right. I think this compromise between a market-based approach and mandates goes a long way toward that. Time is of the essence in ensuring that children and their doctors have the information they need to safely and effectively use pharmaceuticals. Providing market incentives to manufacturers will help speed this process along. In closing, Mr. President, I would like to again congratulate Chairman Jeffords for the tremendous job that he has done over a long period of time in bringing this bill to the floor. This is a good FDA reform bill. The ``Better Pharmaceuticals for Children'' section is only one of many creative, practical steps this bill makes and takes in the right direction. The reform bill makes commonsense changes that will help patients get access to new medical technologies. At the same time, Mr. President, it maintains assurances that products are safe and that they are effective. Again, I applaud Chairman Jeffords for this bill. I look forward to its speedy passage.