Ted Kennedy

Mr. KENNEDY

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

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. KENNEDY. Mr. President, to review where we are in this debate and discussion, we will be meeting again on Monday next, making critical choices and decisions about the way we are going to proceed. We have made good progress over the course of this week. Some of us were hopeful that we would be able to move toward the completion of this legislation. But this legislation is enormously complex and enormously important. We have made, as I say, good progress. We have a number of different areas we have worked through over the period of these past days. We will propose a managers' package and we will make the final judgments about the determination of this legislation on Monday next. Again, we thank all of our colleagues who have worked with us on the legislation. Very quickly, to say again why this legislation is important, and that is because, as we know, the FDA effectively protects the prescription drug supply and our pharmaceutical supplies, medical devices, vaccines, food supply and cosmetics; about 25, almost 30 percent of all of the consumer products. So, it is enormously important that we have the FDA be the gold standard to protect American families, particularly with regard to prescription drugs and with regard to food and other items as well. So very quickly, and finally, to review exactly what this legislation does and why it is so important, why it is so urgent, why it is so necessary--and this legislation falls in that category--that is why we are urging that we reach conclusion on Monday next. One of the notorious recent examples of fear that took place in many households this past year, over the period of the last year, was the Vioxx scare, the whole issue and question about those whose lives may very well have been shortened because of Vioxx. The best way to illustrate what we are talking about in terms of patient safety is how this legislation would deal with a future kind of a Vioxx that might endanger the health of our fellow citizens. First, can the FDA quickly detect a safety problem with a drug? With the Vioxx situation, the answer was no. Now we have a completely new system, a sort of an information technology system with regard to post- marketing surveillance. We draw on all of the public as well as private systems--the Mayo system, the veterans system, the myriad different systems that will be collecting information. It will be collected in one central place--the FDA--so the Food and Drug Administration can demonstrate that there is a safety problem. There will be notice for the Agency. Can the FDA require the label changes to warn of safety problems? Under the existing circumstances, there was a negotiation for some 14 months before they were able to resolve that issue. Finally, the drug was withdrawn by the company. If the company doesn't deal with the Agency, the Food and Drug Administration has the authority and power to withdraw the approval and effectively repeal the drug. But that has very important safety considerations because there may be certain populations where this particular drug may be suitable. That is probably true with Vioxx. It is not suitable for the general population but suitable for a particular population. What this does is give the FDA the kind of opportunity for labeling changes to warn of safety problems. It has other alternatives which I will refer to lower in the chart. Are companies stopped from hiding safety problems? It is extremely difficult because we include the publication of clinical trials so they will be available to the public. This transparency included in this legislation is enormously important. The value of clinical trials is not only important from a safety point of view but also for individuals who are affected by disease and illness. They may make a judgment that they want to enroll in a particular clinical trial and try to remedy their particular health challenge. There will be the registry and the opportunity for them to do that. That has not existed in the way we have done this. That opens up enormous kinds of opportunities for many people who have many of the illnesses and sicknesses we know affect so many of our families. So, we have the safety provision and also the opportunity for people who have those illnesses and diseases to take advantage of this program. Does the FDA have flexible tools to enforce safety decisions? The answer is yes. This was described well by my friend from Wyoming, Senator Enzi. He talked about the toolbox available to the FDA. It can be included in labeling. It can be included in terms of training of various personnel to administer the drug. It can be included in terms of specialized targeting, particularly groups in the medical profession who have the skills to dispense those drugs. There are a variety of different tools that are in there that do not exist today. Finally, is the FDA the gold standard for protecting the public health and assuring access? We believe the answer is yes. These are practical examples of how we protect families. We have another chart which makes this point as well. We had an excellent study done by the Institute of Medicine, an extraordinary group of individuals who reviewed the powers of the FDA and made recommendations. This chart shows we have incorporated in this legislation, by and large, the recommendations made by the Institute of Medicine, with respect to drug safety. We built in the epidemiology and the informatics capacity to improve post- marketing assessment, using information technology; to make public the results of the post-clinical trial; to regularly analyze post-market study results; to give FDA clear authority to require post-marketing risk assessment and management. If there are additional kinds of requirements in terms of the drug itself, the FDA will have that authority and give better enforcement tools. We also include some civil penalties to make sure this is going to be enforced--that is important--and conduct regular evaluation of a new drug's safety profile. We will continue with post-marketing surveillance. This will be a continuing process to protect the American consumer. It is an enormously important concept to implement this. We will also increase drug safety resources available to the FDA. We have done all of these in this legislation. We have enhanced the Office of Science, and we have improved significantly the conflict of interest and other provisions. This gives you some idea. We have an excellent statement from groups who represent 30 million patients: This legislation gives the FDA the ability to continue to study the safety of drugs after approval, flexible enforcement tools necessary to ensure compliance with these new safety protections, and additional funding to support these new activities. Allowing the Agency to act on clear safety signals could actually allow the FDA to approve drugs more quickly, knowing it will have the ability to respond on behalf of patients if safety concerns appear post-market. That is important. With breakthroughs in the life sciences and different opportunities that are now available, the Agency will feel more comfortable in approving drugs which they may have a speck of doubt about, but they will know that with the kind of review processes we have insisted on in this legislation, they can get on the market quicker and that it can improve the quality of health and safe lives. This is very important: ``knowing it will have the ability to respond on behalf of patients if safety concerns appear post-market.'' This is from the Alliance for Drug Safety that represents 30 million patients, a very solid endorsement of what this legislation is all about. We have done a similar protocol with regard to food safety as well, of the importance of surveillance. As we would with some bioterrorist threat, it is enormously important that we understand what is happening in a number of these countries around the world, early survey labs, and the follow-on provisions that we have included. A final point, we have had a debate with regard to the differential that has taken place in the different countries. The presentation has been made. There has now been the pending Dorgan amendment which recognizes this disparity to make some adjustments on this issue in terms of the medicines. We will move ahead on this. We have other items which have been proposed by our colleagues and on which we are prepared to make some recommendations. We have worked very closely during the evening, early morning with Senator Enzi and our colleagues. We are hopeful we will be able to see a conclusion of this legislation, which is so vitally important to the American people during the early part of next week. Again, we are enormously thankful to all and extremely grateful to my friend and colleague, Senator Enzi. We look forward to a good discussion and debate and continued progress on this very important bill at the beginning of the week. I suggest the absence of a quorum.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I am pleased today to introduce the Keeping Parents and Communities Engaged or Keeping PACE Act, to foster greater involvement of parents in their children's education, engage community partners in supporting the comprehensive learning needs of students in school, as well as to address our Nation's high dropout rate. It is clear that engaged parents can make a positive difference in students' achievement. Parents are their children's first teachers, and they have immense influence over their children's attitudes, focus, priorities and goals. Well-informed parents are more likely to be involved, to ask questions, to suggest constructive changes and to make a difference in their child's education. They deserve to know what their children are learning and being tested on, what their children's grades and assessment scores mean, and how assessment data may be used for improvement. Informed and engaged parents can help turn around struggling schools. We crafted the No Child Left Behind Act to recognize parents as full partners in their children's education. The Act includes essential requirements to develop parent involvement policies and programs, develop and release school report cards, and to establish a team of parents and community representatives to construct a plan to improve schools if they are identified as struggling. We should build on these important reforms. But in the upcoming reauthorization of the law, we must also explore new and innovative strategies to engage parents and communities in helping kids succeed in school. Better coordination among parents, schools, and the community can also help create a network that enables and empowers students to take advantage of every opportunity to learn. That's particularly important for students needing the greatest help and attention in their learning and those who need more challenging schoolwork to keep them engaged and progressing, as well as students at risk of dropping out of school. Today, more than one million students who enter the ninth grade fail to receive a high school diploma 4 years later and approximately 7,000 students drop out of school every day. We've made great advances in recent years to improve the education of every student, but it remains clear that more must be done to respond to this challenge. We must support and strengthen our elementary and secondary schools and do more to attend to the learning and nonacademic needs of our most at-risk students, which make such a difference in how well they master their subjects. That means support for community programs to meet children's social, intellectual, emotional, and physical needs. It means making parent involvement a top priority, and offering support to schools to involve parents and families more effectively in their children's education, including postsecondary education planning. The Keeping PACE Act will address these fundamental issues. This bill amends the Elementary and Secondary Education Act of 1965 to encourage and support parent, family, and community involvement in schools, to provide needed supports and services to children, and to ensure that schools are centers of communities. Educators recognize, on the basis of abundant research and common experience, that parental involvement is a critical element in children's academic and social development. Unfortunately, as noted in a recent report by Appleseed, too often, schools and districts continue to face challenges that impede efforts to effectively advance parental involvement. My bill enables States to award grants to local education agencies to assist schools in hiring and maintaining Parent and Community Outreach Coordinators. These coordinators will build critical partnerships among families, schools, and the community. They'll work with school principals, teachers, and staff to encourage parents to become more involved in their child's education and give them the tools necessary to become successful advocates for their children. Last year, a Massachusetts pilot initiative placed 17 full-time Family and Community Outreach Coordinators in Boston Public Schools. The Coordinators were responsible for supporting families, teachers, and the community in a common effort to help students excel academically and socially. Their efforts have worked. The Family and Community Outreach Coordinator at the Condon School in Boston, Massachusetts, has offered workshops for parents on middle school transition and math curriculum; coordinated parent participation on the School Climate Committee, an anti-bullying initiative at the school; helped teachers and parents make connections for parent-teacher conferences; and brought in over 200 parents to participate in the fall open house, where some teachers reported having contact with over 80 percent of their students' families. The Coordinator has also leveraged donations to the school through the generosity of local businesses. The success of the coordinators led the Boston School Committee to approve its budget for the next school year with the addition of 14 more full-time Family and Community Outreach Coordinators. All together this means that almost 22 percent of Boston Public Schools will have a coordinator by September 2007-2008. The director of the Harvard Family Research Project notes that many years of research confirm that ``now is the time . . . for action. The question we must ask is, in addition to quality schools, what non- school learning resources should we invest in and scale up to improve educational outcomes, narrow achievement gaps, and equip our children with the knowledge and skills needed to succeed in the complex and global 21st century.'' The bill answers that question and responds directly to these needs by creating new grants for community-based organizations to work in partnership with schools to bring essential comprehensive and integrated services to children in need. These support services may include health care, counseling, social services, enrichment, mentorship, and tutoring, services that can often spell the difference between a dropout and a graduate. Rather than giving teachers, counselors, and principals more to do as they address the non-classroom needs of students, every school should have a resource they can turn to for help with identifying student needs and leveraging community services to help all students succeed. We know that comprehensive, integrated supportive services increase graduation rates and improve student achievement. In one national report: 82 percent of tracked students improved their attendance in school; 86 percent of tracked students had fewer behavior incidents; 89 percent of tracked students had fewer suspensions. In addition, 98 percent of tracked students stayed in school and 85 percent of eligible seniors graduated. Students who are identified as needing these services, but do not receive them are more likely to drop out of school. The Lucy Stone School in Boston, Massachusetts, demonstrates the effectiveness of student supports on learning. The once failing school took action and focused on improving core learning skills, a broad array of enrichment activities and health and social supports. Lucy Stone is making strong progress. Students in Grades 3 and 4 are passing the literacy MCAS at rates well above the Boston Public School average percentages, and are approaching State averages. Grade 4 math MCAS passing rates are approaching Boston and State averages as well. In other communities, diverse community partners have played an important role in providing accelerated learning and mentoring opportunities that have made all the difference for students. For example, a comprehensive evaluation of nine schools in New England found that classroom participation in community service outdoor learning projects increased student engagement and retention of science knowledge. And the ``Being Enthusiastic about Math and Science'' (BEAMS) enrichment program at the Jefferson National Lab in Virginia, which serves 1,800 inner-city students and their teachers, has resulted in increased achievement and attendance rates, and a better understanding of academic subjects, careers and applications among participating students. The National Commission on Service Learning found that mentorships and internships with caring adults in a workplace resulted in higher grade point averages and better attendance than for students who spend less time with adult mentors. There is one particular organization that has a demonstrated track record in helping leverage the integrated services and supports that students need to succeed in school. Communities in Schools (CIS) is the Nation's largest dropout prevention organization, and has a nearly 30- year track record of helping connect students, families and schools with supportive services to help them graduate and prepare for life. With affiliates operating in 27 States and the District of Columbia, Communities in Schools helps about 2 million students every year. Community involvement means real help for children in need, and the evidence shows. For instance: In Georgia, CIS currently supports graduation coaches directly serving approximately 37,000 high school students who are at risk of dropping out. In the wake of Hurricane Katrina, CIS stepped in to provide morning classes and afternoon activities for students whose parents had lost their social support systems after they were forced to relocate to Houston, Texas. There are also countless individual stories of community-based integrated services making a difference. In Texas, CIS helped 14-year- old Yeana Carbajal, who was born with cerebral palsy, to obtain proper medical attention and social services, enabling her to return to school after hip surgery when her doctors had told her that would be impossible. Yeana is now back in school and thriving academically and socially. Another student, who at 14 became the primary caregiver of a mother who eventually died with AIDS, overcame homelessness and became the first in her family to graduate high school. A turning point for her came when she participated in a career exploration program coordinated through the community-based program office at her school. She discovered her special talents in the culinary arts, and is now an honor student at Johnson and Wales University. Finally, a growing body of educational research suggests that student achievement improves in environments where learning is a community value, and where schools have the ability to address a broad range of educational needs. Many school districts have gone even further to respond to this research, by establishing full-service community schools that directly involve parents, families, and the entire community in education. The Keeping PACE Act also responds to this research by providing new avenues to establish and support full-service community schools. These efforts have wide-ranging positive impacts, including ``better family functioning and parental involvement, healthy youth development and improved social behavior, improved academic achievement and learning outcomes, and enhanced community life.'' Two prominent researchers in the field further note, ``In community schools . . . schools are transformed into much more than just a portfolio of programs and services. They become a powerful agent for change in the lives of young people and their families and improve the climate of the entire school.'' This bill enables States to provide incentives to local education agencies that coordinate with mayors, community-based organizations, for-profit organizations and other community partners to re-design and modernize their current school plans and facilities to better link students with community resources. School districts across the country are beginning to recognize the benefits of planning a school not only as an academic center for students, but also as a neighborhood center that serves the entire community. Designing schools from the onset to leverage integrated services to students helps meet multiple local needs such as educational, health, social service, and recreational needs. It's time for America to make a real commitment, and give real opportunity and real fairness to address the comprehensive learning needs of children and families, guarantee a place for parents and families in schools, and provide real hope to our students most at-risk of dropping out. Engaging parents and communities in the success of students enrolled in our public schools is critical to the future and prosperity of our entire Nation. This bill is supported by 15 organizations representing education communities. I ask unanimous consent that their letters of support be printed in the Record.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I am pleased today to introduce the Keeping Parents and Communities Engaged or Keeping PACE Act, to foster greater involvement of parents in their children's education, engage community partners in supporting the comprehensive learning needs of students in school, as well as to address our Nation's high dropout rate. It is clear that engaged parents can make a positive difference in students' achievement. Parents are their children's first teachers, and they have immense influence over their children's attitudes, focus, priorities and goals. Well-informed parents are more likely to be involved, to ask questions, to suggest constructive changes and to make a difference in their child's education. They deserve to know what their children are learning and being tested on, what their children's grades and assessment scores mean, and how assessment data may be used for improvement. Informed and engaged parents can help turn around struggling schools. We crafted the No Child Left Behind Act to recognize parents as full partners in their children's education. The Act includes essential requirements to develop parent involvement policies and programs, develop and release school report cards, and to establish a team of parents and community representatives to construct a plan to improve schools if they are identified as struggling. We should build on these important reforms. But in the upcoming reauthorization of the law, we must also explore new and innovative strategies to engage parents and communities in helping kids succeed in school. Better coordination among parents, schools, and the community can also help create a network that enables and empowers students to take advantage of every opportunity to learn. That's particularly important for students needing the greatest help and attention in their learning and those who need more challenging schoolwork to keep them engaged and progressing, as well as students at risk of dropping out of school. Today, more than one million students who enter the ninth grade fail to receive a high school diploma 4 years later and approximately 7,000 students drop out of school every day. We've made great advances in recent years to improve the education of every student, but it remains clear that more must be done to respond to this challenge. We must support and strengthen our elementary and secondary schools and do more to attend to the learning and nonacademic needs of our most at-risk students, which make such a difference in how well they master their subjects. That means support for community programs to meet children's social, intellectual, emotional, and physical needs. It means making parent involvement a top priority, and offering support to schools to involve parents and families more effectively in their children's education, including postsecondary education planning. The Keeping PACE Act will address these fundamental issues. This bill amends the Elementary and Secondary Education Act of 1965 to encourage and support parent, family, and community involvement in schools, to provide needed supports and services to children, and to ensure that schools are centers of communities. Educators recognize, on the basis of abundant research and common experience, that parental involvement is a critical element in children's academic and social development. Unfortunately, as noted in a recent report by Appleseed, too often, schools and districts continue to face challenges that impede efforts to effectively advance parental involvement. My bill enables States to award grants to local education agencies to assist schools in hiring and maintaining Parent and Community Outreach Coordinators. These coordinators will build critical partnerships among families, schools, and the community. They'll work with school principals, teachers, and staff to encourage parents to become more involved in their child's education and give them the tools necessary to become successful advocates for their children. Last year, a Massachusetts pilot initiative placed 17 full-time Family and Community Outreach Coordinators in Boston Public Schools. The Coordinators were responsible for supporting families, teachers, and the community in a common effort to help students excel academically and socially. Their efforts have worked. The Family and Community Outreach Coordinator at the Condon School in Boston, Massachusetts, has offered workshops for parents on middle school transition and math curriculum; coordinated parent participation on the School Climate Committee, an anti-bullying initiative at the school; helped teachers and parents make connections for parent-teacher conferences; and brought in over 200 parents to participate in the fall open house, where some teachers reported having contact with over 80 percent of their students' families. The Coordinator has also leveraged donations to the school through the generosity of local businesses. The success of the coordinators led the Boston School Committee to approve its budget for the next school year with the addition of 14 more full-time Family and Community Outreach Coordinators. All together this means that almost 22 percent of Boston Public Schools will have a coordinator by September 2007-2008. The director of the Harvard Family Research Project notes that many years of research confirm that ``now is the time . . . for action. The question we must ask is, in addition to quality schools, what non- school learning resources should we invest in and scale up to improve educational outcomes, narrow achievement gaps, and equip our children with the knowledge and skills needed to succeed in the complex and global 21st century.'' The bill answers that question and responds directly to these needs by creating new grants for community-based organizations to work in partnership with schools to bring essential comprehensive and integrated services to children in need. These support services may include health care, counseling, social services, enrichment, mentorship, and tutoring, services that can often spell the difference between a dropout and a graduate. Rather than giving teachers, counselors, and principals more to do as they address the non-classroom needs of students, every school should have a resource they can turn to for help with identifying student needs and leveraging community services to help all students succeed. We know that comprehensive, integrated supportive services increase graduation rates and improve student achievement. In one national report: 82 percent of tracked students improved their attendance in school; 86 percent of tracked students had fewer behavior incidents; 89 percent of tracked students had fewer suspensions. In addition, 98 percent of tracked students stayed in school and 85 percent of eligible seniors graduated. Students who are identified as needing these services, but do not receive them are more likely to drop out of school. The Lucy Stone School in Boston, Massachusetts, demonstrates the effectiveness of student supports on learning. The once failing school took action and focused on improving core learning skills, a broad array of enrichment activities and health and social supports. Lucy Stone is making strong progress. Students in Grades 3 and 4 are passing the literacy MCAS at rates well above the Boston Public School average percentages, and are approaching State averages. Grade 4 math MCAS passing rates are approaching Boston and State averages as well. In other communities, diverse community partners have played an important role in providing accelerated learning and mentoring opportunities that have made all the difference for students. For example, a comprehensive evaluation of nine schools in New England found that classroom participation in community service outdoor learning projects increased student engagement and retention of science knowledge. And the ``Being Enthusiastic about Math and Science'' (BEAMS) enrichment program at the Jefferson National Lab in Virginia, which serves 1,800 inner-city students and their teachers, has resulted in increased achievement and attendance rates, and a better understanding of academic subjects, careers and applications among participating students. The National Commission on Service Learning found that mentorships and internships with caring adults in a workplace resulted in higher grade point averages and better attendance than for students who spend less time with adult mentors. There is one particular organization that has a demonstrated track record in helping leverage the integrated services and supports that students need to succeed in school. Communities in Schools (CIS) is the Nation's largest dropout prevention organization, and has a nearly 30- year track record of helping connect students, families and schools with supportive services to help them graduate and prepare for life. With affiliates operating in 27 States and the District of Columbia, Communities in Schools helps about 2 million students every year. Community involvement means real help for children in need, and the evidence shows. For instance: In Georgia, CIS currently supports graduation coaches directly serving approximately 37,000 high school students who are at risk of dropping out. In the wake of Hurricane Katrina, CIS stepped in to provide morning classes and afternoon activities for students whose parents had lost their social support systems after they were forced to relocate to Houston, Texas. There are also countless individual stories of community-based integrated services making a difference. In Texas, CIS helped 14-year- old Yeana Carbajal, who was born with cerebral palsy, to obtain proper medical attention and social services, enabling her to return to school after hip surgery when her doctors had told her that would be impossible. Yeana is now back in school and thriving academically and socially. Another student, who at 14 became the primary caregiver of a mother who eventually died with AIDS, overcame homelessness and became the first in her family to graduate high school. A turning point for her came when she participated in a career exploration program coordinated through the community-based program office at her school. She discovered her special talents in the culinary arts, and is now an honor student at Johnson and Wales University. Finally, a growing body of educational research suggests that student achievement improves in environments where learning is a community value, and where schools have the ability to address a broad range of educational needs. Many school districts have gone even further to respond to this research, by establishing full-service community schools that directly involve parents, families, and the entire community in education. The Keeping PACE Act also responds to this research by providing new avenues to establish and support full-service community schools. These efforts have wide-ranging positive impacts, including ``better family functioning and parental involvement, healthy youth development and improved social behavior, improved academic achievement and learning outcomes, and enhanced community life.'' Two prominent researchers in the field further note, ``In community schools . . . schools are transformed into much more than just a portfolio of programs and services. They become a powerful agent for change in the lives of young people and their families and improve the climate of the entire school.'' This bill enables States to provide incentives to local education agencies that coordinate with mayors, community-based organizations, for-profit organizations and other community partners to re-design and modernize their current school plans and facilities to better link students with community resources. School districts across the country are beginning to recognize the benefits of planning a school not only as an academic center for students, but also as a neighborhood center that serves the entire community. Designing schools from the onset to leverage integrated services to students helps meet multiple local needs such as educational, health, social service, and recreational needs. It's time for America to make a real commitment, and give real opportunity and real fairness to address the comprehensive learning needs of children and families, guarantee a place for parents and families in schools, and provide real hope to our students most at-risk of dropping out. Engaging parents and communities in the success of students enrolled in our public schools is critical to the future and prosperity of our entire Nation. This bill is supported by 15 organizations representing education communities. I ask unanimous consent that their letters of support be printed in the Record.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, we yield back all morning business time.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I thank the Senator from Mississippi for his cooperation. For the information of our colleagues, if we get cloture on the Dorgan amendment tomorrow, sometime prior to the expiration of the 30 hours, we will vote on the Cochran amendment. That is a notice for Members about when we will address this issue. I thank the Senator. The Senator from Colorado raised important issues during the markup, and he has a very significant amendment to offer to the Senate. I hope we will hear from him at this time.

Mr. KENNEDY. Mr. President, in a few moments we will hear from Senator Dodd, who was the architect for the whole undertaking in terms of testing for children, and also for the children's prescription drug program which has been immensely successful. He deserves great credit for it. I am sure he gets a great deal of satisfaction from it. It was bipartisan, with Senator DeWine, going back many years, and certainly Senator Clinton has added an additional dimension to this whole proposal. But Senator Dodd has studied this issue very carefully, and he really is the originator of the concept. He has followed it closely, and he will speak to the Senate on this matter in a very short time. I see my friend from Ohio on the Senate floor, who also wishes to address it, but I will just say a brief word. I believe what we have in the legislation, which was earlier fashioned by the Senator from Connecticut, is the way to go, and I would hope the Allard amendment will not be accepted. One of the major elements in the FDA bill is the program providing incentives for developing the new drugs, and Senator Dodd, Senator Clinton, Senator Alexander, and many others have been champions of this program, as was our former colleague, Senator DeWine. The reauthorization of an effective program is an opportunity to strengthen those aspects that work well and to improve those that need adjustment. Senator Dodd took up this challenge and renewed the information about how the program has worked over the years since Congress last reviewed it. He found that companies were sometimes rewarded with billions of dollars in additional sales in return for doing studies that cost them only a few million. Clearly, one must provide incentives to develop new drugs for children, but we must be responsible in doing so. That is why in this reauthorization, Senator Dodd included a proposal to adjust the period of market exclusivity for drugs that generate over a billion dollars in sales. If they generate over a billion dollars in sales, these blockbuster drugs will receive only 3 months of exclusivity instead of 6 months, available to other drugs. The Allard amendment would delete this sensible provision and give all drugs the full 6 months. That could be worth billions of dollars for a major medication. Those extra 6 months don't just apply to sales for use in children, they apply to all sales. That means a heart drug tested in children would get 6 months protection from competition, so it can wrack up big returns. The amendment we face embodies a policy that has no proportionality. It gives the same broad protection to a drug such as Lipitor or Xanax as it does to a specialty drug that might be helpful in treating ear infections in children. Senator Dodd's proposal has that sense of proportional reward, but the amendment overturns it. That is the wrong approach, and I hope the Senate will reject it. Mr. President, I see my friend and colleague from Ohio wishes to address this issue, and I yield the floor.

Mr. KENNEDY. Reserving the right to object, I think it would be useful if we rotate it back and forth.

Mr. KENNEDY. If the Senator from Delaware is satisfied, that is fine with me.

Mr. KENNEDY. We still have the Pastore rules in effect, which means the debate on the first 2 hours is supposed to be on matters which are subject to it. I mean it is not generally enforced, but Senator Enzi and I are trying to move forward.

Mr. KENNEDY. Mr. President, for the benefit of the Members and the greatest convenience, we will vote on the Allard amendment at 12:25. What I would like to do is propose a consent agreement that we vote at that time. I know the Senator from Oklahoma and the Senator from Michigan want to talk. We have 35 or 40 minutes. Probably Senator Allard and Senator Dodd would want to make a comment before we get to the vote. I ask unanimous consent that at 12:25 the Senate vote in relation to the Allard amendment 982 and that the time until then be for debate with respect to the amendment, with the 40 minutes divided as 20 minutes being divided equally between Senator Allard and Senator Dodd and 20 minutes between the Senator from Michigan and the Senator from Oklahoma; furthermore, that no amendments be in order to the amendment prior to the vote.

Mr. KENNEDY. Mr. President, I ask unanimous consent that we be able to proceed for 2 minutes. I yield myself 1 minute and 1 minute to the Senator from Wyoming.

Mr. KENNEDY. Mr. President, for the benefit of the membership, we are having a good, substantive debate this morning. We are going to vote on this amendment in a few minutes. Because of the meetings of the leadership at the White House, we will not be able to have votes until 4 o'clock this afternoon. That doesn't mean that Senator Enzi and I are not prepared to move ahead in lining up some other amendments. We have that intention. After this vote, the next vote will be at 4 o'clock. If there are those who have additional amendments, we ask them to come over. We are moving along. We have several items that are almost complete, which we will include. If there are any final amendments, we hope Senators will be in touch. I thank my friend and colleague from Wyoming for his good cooperation and for making progress on a very important bill for the health and safety of American families.

Mr. KENNEDY. I move to lay that motion on the table. The motion to lay on the table was agreed to. Amendment No. 990

Mr. KENNEDY. Madam President, I wish to join with Senator Enzi and thank our friend and colleague, Senator Durbin, for his strong leadership on this issue. This is an issue of enormous importance to families across the country. As Senator Enzi just mentioned, over a year ago we made a strong commitment to the Senate that we were going to work on this drug safety issue, and we have come here in a bipartisan way to put forward a very strong bill that will ensure greater safety for American families in the area of prescription drugs. I think we are here to say that we will join with our friend and colleague from Illinois to build on what is an enormously important amendment and commitment to ensuring that we are going to have food safety as well as pet food safety in this country. I think this amendment, as has been outlined by Senator Durbin and Senator Enzi, reaches the heart of the challenges we face. One is on the issue of surveillance. We understand that is an essential aspect, whether it is food safety or prescription drugs, or whether it is in the area of avian flu, bioterrorism--whatever the challenge that is out there, surveillance is the first thing that needs to be done. We know that today the system is grossly inadequate. Second, we know the information about food and food safety is scattered through a number of agencies and through a number of different kinds of delivery systems, and that the coordination between the Federal and State is loose. In all of these areas, this amendment addresses these issues and questions in a very effective way, to bring common sense to and put real teeth into the safety provisions. The pet food standards that are in this legislation are strong and effective and would be very much appreciated by all Americans who are concerned about this issue. The standards are variable at the present time. The reporting is not good today, and this particular amendment is particularly responsive to that kind of challenge. Finally, this addresses the central concern all of us have read about and are concerned about, which the Senator has spoken to, and that is the issue of importation. When you add up all of those kinds of elements, we find this is a very solid and meaningful amendment. I think it strengthens the legislation immensely. We have every purpose, as we move forward, to find ways we can provide even a greater kind of protection and safety to the food supply for American families. I commend the Senator from Illinois. I think we will be ready to have a vote on this at the earliest time.

Mr. KENNEDY. Madam President, we expect the vote at 4:30, for our colleagues. After that, we are going to have a conversation with those who have been primarily interested and concerned about the whole issue of biologics. So I give the assurance we are going to address that issue in a timely way. That will ultimately be part of this legislation. We also will be able to report on progress we have made on several other amendments. There are a few items that are going to necessitate our attention through the evening. We had a very good debate earlier today on the children's provisions; we had an important vote and discussion on that. This addition this afternoon is enormously important, and I think the time that has been taken to work through this legislation has made it even stronger and better than I think it otherwise might have been. I am grateful to all of our colleagues who are working with us on both sides of the aisle, and particularly the staffs. We are moving forward. We are going to be busy this evening trying to work through some of the items, and we will have the cloture vote tomorrow and the follow-on Cochran amendment. There is a glimmer in sight about reaching a conclusion to this legislation. Again, we are very appreciative of all who have helped us up to this point. I suggest the absence of a quorum.

Mr. KENNEDY. Reserving the right to object, I suggest the absence of a quorum.

Mr. KENNEDY. I object to the unanimous consent request.

Mr. KENNEDY. Madam President, I suggest the absence of a quorum.

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

Mr. KENNEDY. I thank my colleagues and I agree that creating a pathway for follow-on biologics is an important issue worthy of our consideration.

Mr. KENNEDY. I assure the Senators from New York that the conference report on the FDA Revitalization Act will include a pathway to follow- on biologics that has been reported out of the HELP Committee and that is acceptable to the Senators from New York. I plan to hold a markup on this issue on June 13.

Mr. KENNEDY. Mr. President, I move to reconsider the vote by which the amendment was agreed to.

Mr. KENNEDY. Mr. President, I thank all of our colleagues for their cooperation and their help on this particular subject matter. It is a matter of enormous importance, incredible consequence, and enormous complexity. We thank them for all of their help and assistance in bringing us to where we are so that the Members understand better where we are. We are absolutely committed to having that hearing and having the results of that go into our conference. I am enormously appreciative of the patience and the cooperation we have received. I am grateful again to all of those here, colleagues on both sides, for their cooperation in helping us move this forward. I thank the Senator from Utah. I want to congratulate him. He is receiving an honorary degree tomorrow from a great university in his State. We were talking about biologics. We think of the Hatch-Waxman proposal and acknowledge his work, attention, and help in the fashioning of that important piece of legislation, particularly when we are thinking about his involvement in the biologics, a clear indication we are going to have some good bipartisan support and we are going to have a team that has a breadth of knowledge and understanding of these kinds of subject matters. We wish him well on his trip to Utah and congratulate him on his degree tomorrow.