Support for Injured Servicemembers Act

Mr. President, I am pleased to join my good friend and colleague Senator Baucus to introduce the Continuing the Advancement of Quality Improvement Act.

The purpose of this legislation is to reform Medicare's troubled Quality Improvement Organization, QIO, program. QIOs and their predecessor organizations have long been responsible for ensuring that the care Medicare beneficiaries receive is medically necessary, meets recognized standards and is provided in appropriate settings. They are currently tasked with a wide variety of important roles ranging from investigating beneficiary complaints of poor quality care to giving technical assistance to Medicare providers for improving health care quality.

I have been an advocate of reforming the QIO program for quite some time. About 2 years ago, I initiated an investigation into a number of the QIOs. Those investigations revealed a program that is in desperate need of reform. This program was running with little or no oversight, and it was expending more than $1 billion every 3 years with little measurable results. In other words, I found trouble. Let me elaborate on a few disturbing things that I discovered. I found that one QIO leased residential properties for board members and a CEO. That same QIO also used Federal funds to lease automobiles for its top executives. I also found other QIOs who had board members and staff attend conferences, many at lavish resorts.

I was not the only one to identify serous concerns with the QIOs. Others identified concerns too. Specifically, the Institute of Medicine, IOM, the General Accountability Office, GAO, and the Department of Health and Human Services, HHS, Office of the Inspector Geheral (OIG) all identified numerous concerns about the effectiveness of this program. These independent organizations also voiced their concerns with the manner in which it is operated and have made recommendations for major reform. Their findings clearly show the need to hold the Centers for Medicare and Medicaid Services, CMS, and the organizations that serve as QIOs accountable for the important tasks they must perform.

The Continuing the Advancement of Quality Improvement Act will ensure that the QIO program is not only effective in improving the quality of care provided to our Medicare beneficiaries, but also that it operates in an effective, efficient and accountable manner. Much of this legislation is based on the investigations that I conducted and the troubling findings that I came across and on the work of the IOM, the GAO, and the HHS OIG.

First, the Continuing the Advancement of Quality Improvement Act would focus the mission of the QIO program on quality improvement. QIOs currently have many diverse responsibilities. As a result, they served conflicting roles of both ``regulator'' and ``technical assistant.'' This conflict poses significant barriers to QIOs effectively serving either role, and we have come to learn that they really don't perform either function particularly well.

The legislation would also address this conflict by following the IOM's recommendation to make the sole purpose of QIOs to be technical assistants for quality improvement and performance measurement. The HHS Secretary would be required to transfer all other QIO: responsibilities to other entities called Medicare Provider Review Organizations, MPROs, in a manner that will support the needs of beneficiaries and be accountable to them.

Second, the legislation would improve the beneficiary complaint review process that I think is in desperate need of reform. You may recall that in 2006 we read about the plight of Mr. Schiff. Mr. Schiff went to a QIO and filed a complaint about the care provided to his wife, who died. The QIO in that case was unresponsive to Mr. Schiff. He was forced to take legal action to learn what the QIO found out about his wife's death. He should not have had to do that. After all, he was the one who filed the complaint with the QIO in the first place because he thought that someone did something wrong that lead to his wife's death. It was at that juncture that I learned that the beneficiary complaint review process was too opaque and ineffective. More importantly, beneficiaries were not being properly served. In fact, I came to learn that complainants often do not receive the findings of the investigation conducted by the QIO. Now I ask; what sense does that make?

The Continuing the Advancement of Quality Improvement Act would require MPROs to report the investigational findings to the complainant and refer the provider to a QIO for technical assistance and/or the appropriate regulatory body for sanctions. In other words, this part of the bill would bring transparency to a process now shrouded in a cloud of silence.

Third, the Continuing the Advancement of Quality Improvement Act would ensure that limited resources go to providers that need them the most. The GAO recently found that QIOs prioritized their assistance to providers who would be easiest to help rather than the providers who were most in need of help. In other words the QIOs decided it was easier to take a B plus student and make them into an A student rather than putting their resources into the D student to bring them up to par. I guess that way they thought that they would look better and more successful. But if you ask me; that is not the best way to spend limited taxpayer resources. Now, this bill will insure that if demand for technical assistance exceeds available resources, the QIOs would give priority to providers that are in rural or underserved areas, in financial need, have low performance measures or have a significant number of beneficiary complaints. In other words the help is going to go to those who need it most.

Fourth, the Continuing the Advancement of Quality Improvement Act would make QIO data more available to CMS and providers for quality improvement and patient safety purposes. Amazingly enough, QIOs are currently restricted from sharing such data despite the obvious value of this data for improving health care quality. This legislation would permit the sharing of QIO data with providers for quality improvement and patient safety purposes and require CMS to make recommendations on how to improve the data sharing process.

Fifth, the Continuing the Advancement of Quality Improvement Act would promote competition in the QIO program. This is a giant leap forward. These organizations are currently not subject to significant competition because of limitations on who can be a QIO and the availability of noncompetitive contract renewals. This lack of competition has led to a gross lack of accountability and stagnation in the QIO program. This legislation would promote competition by allowing other types of organizations to serve as QIOs and eliminate noncompetitive renewals.

Sixth, the Continuing the Advancement of Quality Improvement Act would enhance governance at the QIOs. During the course of my investigations I identified repeated failures in governance. I exposed board members who were more interested in helping themselves than helping others.

This bill will also address board member conflicts of interest. My investigations identified numerous incidents of questionable QIO governance practices and board member conflicts of interest. Since the QIO program receives over $400 million in taxpayer funding every year, it is reasonable for us to expect not only that QIOs are governed in an ethical manner free of conflicts of interest, but also that CMS appropriately oversees the program. This

legislation would require QIOs to comply with board governance requirements and would require CMS to establish procedures to address conflicts of interest and follow those procedures.

Finally, the Continuing the Advancement of Quality Improvement Act would increase much needed accountability in the QIO program. The I0M, the GAO and the HHS OIG have all questioned the effectiveness of the QIO program. This legislation would require the Secretary to perform interim and final evaluations of program effectiveness not only at the individual QIO level, but at the overall QIO program level as a whole. Also, high performing QIOs would receive financial rewards while low performing QIOs would receive financial penalties. Finally, the Secretary would be required to submit a more detailed annual report showing performance results of QIOs and MPROs and details on how taxpayer dollars are spent.

We have been placing more emphasis on the quality of care that our Medicare beneficiaries receive from providers. You see this as we require more transparency in the Medicare program with the public reporting of provider quality measures. You also see this as we transform Medicare from being a passive payer of services of any quality to a value-based purchaser. These are important reforms that will help improve the quality of care provided in the Medicare program and work toward ensuring that limited resources are used more efficiently and wisely.

As we move toward a payment system based on quality, the reforms in this bill will position the QIO program to support that transformation in Medicare to a quality-based purchaser by making the tools and assistance available to help Medicare providers improve the quality of the care they provide. The Continuing the Advancement of Quality Improvement Act would ensure the QIO program's ability to provide this assistance in an effective, efficient and accountable manner and correct the problems currently plaguing the program.

Mr. President, I am pleased to join my good friend and colleague Senator Baucus, as well as Senators Lincoln, Roberts, Conrad, Enzi, Schumer, Cochran, Salazar, Smith, Bingaman, and Snowe, to introduce the Pharmacy Access Improvement Act.

I am pleased with how well the Medicare Part D program is working. It has demonstrated how effectively private sector competition can work in delivering an entitlement benefit. The program has defied official predictions and come in under budget by $113 billion compared to the baseline projected in 2006. Premiums, initially estimated at $37 for 2006, in fact averaged $23; in 2007 they fell to an average of $22. We understand that this year's bids are even lower and that premiums are expected to fall again next year. The vast majority of Medicare beneficiaries have enrolled in the program, and while there were some troubling start-up problems initially, beneficiaries are very pleased with their plans.

At the same time, the first years of implementation of the Part D program have revealed some areas in which the program can be improved. One is related to pharmacy participation in the program. Changes are needed to ensure that Part D treats pharmacies as Congress intended and to make the program friendlier to pharmacists and independent pharmacies.

As Senator Baucus, Senator Lincoln, and my other colleagues and I talked to beneficiaries, pharmacists, pharmacy owners and prescription drug plans about changes that would make Medicare Part D work better, many of our discussions centered around how to make sure that Part D works not just

for the beneficiaries, the chain drug-stores, and the plans, but also for the local, independent pharmacies, the long-term care pharmacies, and the safety net pharmacies that many beneficiaries rely on. That is exactly what this bill is intended to do.

My colleagues and I hope with this bill to improve contracting for pharmacies, increase CMS's and prescription drug plans' customer service, and give beneficiaries better access to pharmacies. Let me give you some of the specifics of the bill.

First, the Pharmacy Access Improvement Act would strengthen standards for ensuring convenient beneficiary access to pharmacies. During the first two years of implementation, CMS has permitted some plans to meet the pharmacy access requirements in the law by counting non-preferred and out-of-network pharmacies. The plans charge higher cost-sharing at these pharmacies to discourage their use and drive utilization to preferred pharmacies. Counting non-preferred and out-of-network pharmacies to meet the access requirements is clearly not what Congress had in mind in establishing the beneficiary access guarantees in the law. To correct this problem, this bill would require that plans, with certain exceptions, count only ``open'' pharmacies, those that are accessible to the general public, in meeting the Medicare pharmacy access standard.

It also would require plans to count only their preferred in-network pharmacies, not the non-preferred pharmacies, in determining whether they meet the access standard.

The bill would allow pharmacies to initiate negotiations with plans under the ``any willing pharmacy'' provision regardless of whether they had already rejected, or failed to act on, previous offers from the plan.

The bill also would help ensure the inclusion of safety-net pharmacies in a prescription drug plan's network by preventing plans from specifically excluding 340B entities in the terms of their contracts. 340B entities include federally qualified health centers, migrant health centers, health centers for residents of public housing, school health centers, as well as black lung clinics, entities receiving grants for early intervention for HIV under the Ryan White Act, disproportionate share hospitals, and others. They serve more than ten million people.

Many of these entities operate their own pharmacies, which operate under different constraints than other retail pharmacies. They may have abbreviated hours or be available only to patients of the 340B entity. If 340B entities' pharmacies are not available as in-network pharmacies in Part D, these patients may have difficulty getting their prescription drugs.

The Model Safety Net Pharmacy Addendum was developed by the Centers for Medicare and Medicaid Services and the Health Research and Services Administration to facilitate 340B entities' participation in Medicare Part D. Because it takes the 340B entities' special circumstances into account, it has appropriate contract language for Part D plans to use when contracting with safety net pharmacies. Under the bill, plans would have to apply the Model Safety Net Pharmacy Addendum to their contracts if a 340B entity so requests.

The bill also would require plans to include a contract provision to allow these safety net pharmacies to waive cost-sharing if the entity so requests. Many safety-net pharmacies waive cost-sharing for their patients, but the Part D plan contracts typically prohibit this. Given that 340B entities serve low-income and poor populations, we believe those entities should be able to waive cost sharing for drugs, and our bill would facilitate that.

We have found that long-term care pharmacies similarly operate under conditions different from those of retail pharmacies serving the general population. For institutionalized populations, each resident's daily drugs must be specially packaged to help ensure that each gets the drugs meant for her, not for other residents. Long-term care pharmacies specialize in this, but the Part D rules to date do not adequately reflect how long-term care pharmacies work with long-term care facilities, which affects residents' access to these pharmacies. Our bill would require the Secretary to establish rules that include pharmacy access standards for long-term care residents.

Another problem that has arisen in the implementation of Part D concerns the ability of beneficiaries to obtain extended supplies of their drugs from a local pharmacy. Our bill therefore would ask the Secretary to establish standards for access to pharmacies that dispense extended supplies of covered drugs.

We have also heard from our local independent pharmacies that many, despite contract terms, face delayed payments from prescription drug plans. Given that the pharmacies must pay for their drugs on a more abbreviated schedule, these delays have created cash-flow crises for some pharmacies and put some at risk of closing. As much as I hate to legislate contract terms, I would hate more for the independent pharmacies in my State to close and my beneficiaries to be left without a pharmacy. In our bill, we would require plans to pay most pharmacies within 14 days upon receipt of an electronically submitted clean claim. For paper claims, they would have 30 days. If they were late, the prescription drug plans would have to pay the pharmacies interest. If a pharmacy submitted claims electronically and requested electronic payment, the plan would have to pay electronically.

Because long-term care pharmacies operate under unusual circumstances compared with retail pharmacies, our bill would allow pharmacies in long-term care facilities, or that contract with long-term care facilities, at least 30 days but no more than 90 days to submit their claims for reimbursement to the plans.

Another problem involves how plans use maximum allowable prices as the upper limit of what they will pay a retail pharmacy for the cost of a drug. What has come to light is that some plans will not disclose to the contracting pharmacies exactly what the maximum allowable prices are either when the contract is proposed to them or even after they sign the contract.

It seems unconscionable to me that a pharmacy would be expected to sign a contract where the price term is hidden and not disclosed. In the Medicare program, no other health care providers are subject to signing a contract in which they don't know what they will get paid.

Another abusive practice by some plans occurs when they do not update their maximum allowable prices in a timely manner. When a pharmaceutical company raises its price for a drug the pharmacy has to pay that new higher price right away. But the plan might not update what it pays for weeks. That leaves the pharmacy to absorb the difference. The plans that do this know exactly what they are doing. They know they are making the pharmacies eat the higher cost while they delay updating their payment rates. To address these concerns, the bill would require plans to disclose to pharmacies their ``maximum allowable cost'' pricing, and also to update those prices as they change, through an Internet website and a toll-free phone number.

Similarly, the bill would require plans to update their prescription drug pricing standard at least every seven days. The drug pricing standard changes frequently, and the price the pharmacy is paid is based on that standard, and so it seemed fair to us that the prescription drug plans' payments should reflect recent changes.

Our bill is intended to improve CMS's and prescription drug plans' service to pharmacies. It would require the HHS Secretary to establish a pharmacists' toll-free hotline. Prescription drug plans would have to establish separate pharmacists' and physicians' toll-free hotlines, and would have to comply with customer service standards established by the Secretary. We hope this will prevent pharmacists being placed on long holds when they have customers standing at the counter waiting for their drugs.

We have some questions about pharmacists' average dispensing fees, and under the bill the HHS Inspector General would conduct a study of dispensing fees, including studying whether the pharmacist is dispensing a standard prescription or an extended one; whether the pharmacist is in a chain store or an independent pharmacy; whether the pharmacy dispenses specialty pharmacy products, or is a

long-term care pharmacy. The Inspector General's report would be due October 1, 2008.

I believe that with these changes, the Medicare Part D program will work even better for beneficiaries and for the pharmacies that serve them. As we refine the Medicare Part D program, we want to build on its success even as we hope to make it fairer to all the stakeholders involved, the beneficiaries, the pharmacies, the PDP plans, and the manufacturers. I believe this bill does just that.

Mr. President, today I am introducing the Federal Death Penalty Abolition Act of 2007. This bill would abolish the death penalty at the Federal level. It would put an immediate halt to executions and forbid the imposition of the death penalty as a sentence for violations of Federal law.

Since 1976, when the death penalty was reinstated by the Supreme Court, there have been 1,060 executions across the country, including three at the Federal level. During that same time period, 123 people on death row have been exonerated and released from death row. These people never should have been convicted in the first place.

Consider those numbers. One thousand and sixty executions, and one hundred and twenty-three exonerations in the modern death penalty era. Had those exonerations not taken place, had those 123 people been executed, those executions would have represented an error rate of greater than 10 percent. That is more than an embarrassing statistic; it is a horrifying one, one that should have us all questioning the use of capital punishment in this country. In fact, since 1999 when I first introduced this bill, 46 death row inmates have been exonerated throughout the country.

In the face of these numbers, the national debate on the death penalty has intensified. For the second year in a row, the number of executions, the number of death sentences imposed, and the size of the death row population have decreased as a growing number of voices have joined to express doubt about the use of capital punishment in America. The voices of those questioning the fairness of the death penalty have been heard from college campuses and courtrooms and podiums across the Nation, to the Senate Judiciary Committee hearing room, to the United States Supreme Court. The American public understands that the death penalty raises serious and complex issues. The death penalty can no longer be exploited for political purposes. In fact, for the first time, a May 2006 Gallup Poll reported that more Americans prefer a sentence of life without parole over the death penalty when given a choice. If anything, the political consensus is that it is time for a change. We must not ignore these voices.

In the wake of the Supreme Court's decision in 1976 to allow capital punishment, the Federal Government first resumed death penalty prosecutions after enactment of a 1988 Federal law that provided for the death penalty for murder in the course of a drug-kingpin conspiracy. The Federal death penalty was then expanded significantly in 1994, when the omnibus crime bill expanded its use to a total of some 60 Federal offenses. And despite my best efforts to halt the expansion of the Federal death penalty, more and more provisions seem to be added every year. While the use of and confidence in the death penalty is decreasing overall, the Federal Government has been going in the opposite direction, making more defendants eligible for capital punishment and increasing the size of its Federal death row. Moreover, there are now six individuals on Federal death row from States that do not have capital punishment. The Federal Government is pulling in the wrong direction as the rest of the Nation moves toward a more just system.

On this very day eight years ago, Governor George Ryan took the historic step of placing a moratorium on executions in Illinois and creating an independent, blue ribbon commission to review the State's death penalty system. The Commission conducted an extensive study of the death penalty in Illinois and released a report with 85 recommendations for reform of the death penalty system. The Commission concluded that the death penalty system is not fair, and that the risk of executing the innocent is alarmingly real. Governor Ryan later pardoned four death row inmates and commuted the sentences of all remaining Illinois death row inmates to life in prison before he left office in January 2003.

Illinois is not alone. Seven years ago, then Maryland Governor Parris Glendening learned of suspected racial disparities in the administration of the death penalty in Maryland. Governor Glendening did not look the other way. He commissioned the University of Maryland to conduct the most exhaustive study of Maryland's application of the death penalty in history. Then faced with the rapid approach of a scheduled execution, Governor Glendening acknowledged that it was unacceptable to allow executions to take place while the study he had ordered was not yet complete. So, in May 2002, he placed a moratorium on executions. Although Governor Bob Ehrlich lifted that moratorium and allowed executions to resume during his tenure, Governor Martin O'Malley has indicated that he would approve a legislative repeal of the death penalty and that he, like the majority in this country, favors life without parole.

Other States also have taken important steps. New York's death penalty was overturned by a court decision in 2004 and has not been reinstated by the legislature, and New Jersey enacted a moratorium in 2006. Along with New York and New Jersey, four other States that still have the death penalty technically on their books have not executed any individuals since 1976. In addition, there are 12 States, plus the District of Columbia, whose laws do not provide for capital punishment at all. And following in the footsteps of Illinois and Maryland, North Carolina and California both began legislative studies of their own capital punishment systems this past year.

The more we learn about the death penalty through studies like those, the more reasons we have to oppose it. For example, the Maryland study--released in January 2003--contained findings that should startle us all. The study found that blacks accused of killing whites are more likely to receive a death sentence than blacks who kill blacks, or than white killers. According to the report, black offenders who kill whites are four times as likely to be sentenced to death as blacks who kill blacks, and twice as likely to get a death sentence as whites who kill whites.

The Maryland and Illinois studies cannot be brushed aside as atypical or dismissed as revealing state-specific anomalies in an otherwise perfect system. Years of study have shown that the death penalty does little to deter crime, and that defendants' likelihood of being sentenced to death depends heavily on illegitimate factors such as whether they are rich or poor. Since reinstatement of the modern death penalty, 80 percent of murder victims in cases where death sentences were handed down were white, even though only 50 percent of murder victims are white. Nationwide, more than half of the death row inmates are African Americans or Hispanic Americans. There is evidence of racial disparities, inadequate counsel, prosecutorial misconduct, and false scientific evidence in death penalty systems across the country.

At least Maryland, Illinois, North Carolina, and California have begun the process of investigating the flaws in their own systems. But there are 36 other States that have death penalty provisions in their laws, 36 other States with systems that are most likely plagued with the same flaws. And these systems come at great additional cost to the taxpayers. For example, a 2005 report found that California's death penalty system costs taxpayers $114 million in additional costs each year. Similar reports detailing the extraordinary financial costs of the death penalty have been generated for States across the Nation.

Moreover, there are growing concerns about the most common method of execution, lethal injection. These concerns are so grave that eight States and the Federal system all halted individual executions in 2006 to work through these problems. And these numbers are growing. Just this last week, executions in North Carolina were halted because of challenges to lethal injection. More and more research is emerging that suggests that lethal injections are unnecessarily painful and cruel, and that this method of capital punishment--however sanitary or humane it may appear--is no less barbaric than the more antiquated methods lethal injection was designed to replace, such as the noose or the firing squad, no less horrific than the electric chair or the gas chamber.

Nothing is more barbaric, of course, than the execution of an innocent person, and it is clearer than ever that the

risk is very real. Already, information has surfaced that suggests that two men put to death in the 1990s may have been innocent. This is a chilling prospect, one that illustrates the very grave danger in imposing the death penalty. The loss of just one innocent life through capital punishment should be enough to force all of us to stop and reconsider this penalty.

And while we examine the flaws in our death penalty system, we cannot help but note that our use of the death penalty stands in stark contrast to the majority of nations, which have abolished the death penalty in law or practice. There are now 123 countries that have done so. In 2005, only China, Iran, and Saudi Arabia executed more people than we did. These countries, and others on the list of nations that actively use capital punishment, are countries that we often criticize for human rights abuses. The European Union denies membership in the alliance to those nations that use the death penalty. In fact, it passed a resolution calling for the immediate and unconditional global abolition of the death penalty, and it specifically called on all States within the United States to abolish the death penalty. This is significant because it reflects the unanimous view of a group of nations with which the United States enjoys close relationships and shares common values. We should join with them and with the over 100 other nations that have renounced this practice.

We are a Nation that prides itself on the fundamental principles of justice, liberty, equality and due process. We are a Nation that scrutinizes the human rights records of other nations. Historically, we are one of the first Nations to speak out against torture and killings by foreign governments. We should hold our own system of justice to the highest standard.

As a matter of justice, this is an issue that transcends political allegiances. A range of prominent voices in our country are raising serious questions about the death penalty, and they are not just voices of liberals, or of the faith community. They are the voices of former FBI Director William Sessions, former Justice Sandra Day O'Connor, Reverend Pat Robertson, George Will, former Mississippi warden Donald Cabana, the Republican former Governor of Illinois, George Ryan, and the Democratic former Governor of Maryland, Parris Glendening. The voices of those questioning our application of the death penalty are growing in number, they are growing louder, and they are reflected in some of the decisions of the highest court of the land. In recent years, the Supreme Court has held that the execution of juvenile offenders and the mentally retarded is unconstitutional.

As we begin a new year and a new Congress, I believe the continued use of the death penalty in the United States is beneath us. The death penalty is at odds with our best traditions. It is wrong and it is immoral. The adage ``two wrongs do not make a right,'' applies here in the most fundamental way. Our Nation has long ago done away with other barbaric punishments like whipping and cutting off the ears of criminals. Just we did away with these punishments as contrary to our humanity and ideals, it is time to abolish the death penalty as we seek to spread peace and justice both here and overseas. It is not just a matter of morality. The continued viability of our criminal justice system as a truly just system that deserves the respect of our own people and the world requires that we do so. Our Nation's goal to remain the world's leading defender of freedom, liberty and equality demands that we do so.

Abolishing the death penalty will not be an easy task. It will take patience, persistence, and courage. As we work to move forward in a rapidly changing world, let us leave this archaic practice behind.

I ask my colleagues to join me in taking the first step in abolishing the death penalty in our great Nation. I also call on each State that authorizes the use of the death penalty to cease this practice. Let us together reject violence and restore fairness and integrity to our criminal justice system.

I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I am pleased to be working once again with my partner in reform, the senior Senator from Arizona, Senator McCain, to introduce the 527 Reform Act.

Our purpose is simple--to pass legislation that will do what the FEC could and should do under current law, but, once again, has failed to do. Current Federal election law requires these groups to register as political committees and to stop raising and spending soft money. But the FEC has failed to enforce the law, so we must act in the Congress. This bill will make it absolutely clear that the federal election laws apply to 527 organizations.

We had to something similar with BCRA, the Bipartisan Campaign Reform Act, which passed in 2002, closing the soft money loophole that the FEC created in the late '70s and expanded in the '90s. That struggle took seven years. We have now been seeking to bring 527s within the law for four.

This bill will require all 527s to register as political committees unless they fall into a number of narrow categories. The exceptions are basically for groups that Congress exempted from disclosure requirements because they are so small or for groups that are involved exclusively in State election activity. Once a group registers as a political committee, certain activities, such as ads that mention only Federal candidates, will have to be paid for solely with hard money.

Under current rules, the FEC permits Federal political committees to maintain a non-Federal account to pay a portion of the expenses of activities that affect both Federal and non-Federal elections. Our bill sets new allocation rules that will make sure that these allocable activities are paid for with at least 50 percent hard money.

Finally, the bill makes an important change with respect to the non- federal portion of the allocable activities. We put a limit of $25,000 per year on the contributions that can be accepted for that non-federal account. This means no more million dollar soft money contributions to pay for get-out-the-vote efforts in the presidential campaign.

Nothing in this bill will affect legitimate 501(c) advocacy groups. The bill only applies to groups that claim a tax exemption under section 527.

Having laid out the central components of the bill, let me discuss how this bill has evolved, and the differences between this bill and the bill we introduced in 2005. In the last Congress, we made a great deal of progress working with the Senator from Mississippi, who at the time chaired the Rules Committee. Prior to taking the bill to a markup in the spring of 2005, Senator Lott worked with us to clarify the bill and address some of the concerns that had been raised about it. The bill we are introducing today is identical to the ``Chairman's Mark'' that Senator Lott brought before the Rules Committee last year.

While the original bill exempted 527s engaged exclusively in state elections from the registration requirement, it denied the exemption to groups that carry out ``voter drive activities''--defined as get-out- the vote, voter ID, or voter registration--during a federal election year. This made the exemption too narrow, so we looked for another way to ensure that state 527s that only work on behalf of non-Federal officeholders will not have to become Federal PACs.

The Chairman's Mark, and this year's bill, completely exempt organizations of State and local candidates or officeholders. Groups such as the Democratic Governors Association, Republican Governors Association, or a state legislative caucus would be exempt, as long as their voter drive activities only mention state candidates or ballot issues. These groups do not qualify for the exemption, however, if they mention Federal candidates in their communications.

Second, the bill provides a slightly narrower exemption for State PACs that are active only in State elections. The only additional requirements for these PACs to qualify for an exemption are that they can only be active in a single State, and they cannot have a candidate for Federal office or Federal officeholder controlling or participating in the organization or raising money for it.

Finally, we made a number of changes to ensure that Federal PACs that allocate expenditures can use non-Federal money for expenditures designed only to assist State candidates even if they make an incidental reference to a Federal candidate or political party.

The changes to the legislation that we made last year working with Senator Lott prior to the Rules Committee markup have been carried forward in the bill we introduce today. They improved and strengthened the bill. Unfortunately, other amendments were added during the Rules Committee consideration of the bill that we could not support. So the bill that we are introducing today is the same as the bill that went to markup in 2005, not the bill that was reported.

In closing, let me remind my colleagues that the soft money loophole was first opened by FEC rulings in the late '70s. By the time we started work on BCRA, the problem had mushroomed and led to the scandals we saw in the 1996 campaign. When we passed BCRA, I said we would have to be vigilant to make sure that the FEC enforced the law and that similar loopholes did not develop. That is what we are trying to do here.

I have no doubt that if we don't act on this 527 problem now, we will see more problems explode into scandals over the next few election cycles. In the 2004 cycle, Federal-oriented 527s spend $423 million. In fact, there were two donors who each contributed over $20 million. We cannot afford to wait until another presidential campaign season is in full bloom before addressing this problem. This FEC-ordained loophole threatens to further undermine the federal election laws. We must close it this year.

Mr. President, I rise today to introduce the Fair Access to Clinical Trials (FACT) Act. I want to begin by thanking Senators Grassley, Wyden, Bingaman, Durbin, and Harkin for joining me in introducing this legislation. I also would like to recognize the leadership of Senator Johnson who was involved in the crafting of this legislation from the beginning and who has been a long-standing supporter of the FACT Act.

Our bill will create an electronic databank for clinical trials of drugs, biological products, and medical devices. Such a databank will ensure that physicians, researchers, the general public, and patients seeking to enroll in clinical trials have access to basic information about those trials. It will require manufacturers and other researchers to reveal the results of clinical trials so that clinically important information will be available to all Americans, and physicians will have all the information necessary to make appropriate treatment decisions for their patients.

Events of the past few years have made it clear that such a databank is needed. For example, serious questions were raised about the effectiveness and safety of antidepressants when used in children and youth. It has now become clear that the existing data indicates that these drugs may very well put children at risk. However, because the data from antidepressant clinical trials was not publicly available, it took years for this risk to be realized. In the meantime, millions of children have been prescribed antidepressants by well-meaning physicians. While these drugs undoubtedly helped many of these children, they also led to greater suffering for others.

The news is similarly disturbing for a popular class of painkillers known as Cox-2 inhibitors. These medicines, taken by millions of Americans, have been associated with an increased risk of cardiovascular adverse events, such as heart attack and stroke. It has been suggested that one of these medicines, which has since been pulled from the market, may have been responsible for tens of thousands of deaths.

Most recently, a drug manufacturer acknowledged that it did not inform the Food and Drug Administration (FDA) or the public about the results of a 67,000 person study it conducted of an FDA-approved drug used commonly during heart surgery to reduce the need for a transfusion. The study revealed the drug may increase patients' risk of death, serious kidney damage, congestive heart failure, and stroke.

Unfortunately, these are just a few examples of stories that have become all too common. It has been suggested that negative data might actually have been suppressed; and if this is discovered to be the case, those responsible should be dealt with harshly. However, because of what is known as ``publication bias,'' the information available to the public and physicians can be misleading even without nefarious motives. The simple fact is that studies with a positive result are far more likely to be published, and thus publicly available, than a study with a negative result. Physicians and patients hear the good news. Rarely do they hear the bad news. In the end, the imbalance of available information hurts patients.

Our bill would correct this imbalance in information, and prevent manufacturers from suppressing negative data. It would do so by creating a two-part databank, consisting of an expansion of clinicaltrials.gov--an existing registry that is operated by the National Library of Medicine (NLM)--and a new database for clinical trial results.

Under the FACT Act, the registry would continue to operate as a resource for patients seeking to enroll in clinical trials for drugs and biological products intended to treat serious or life-threatening conditions--and for the first time, it would also include medical device trials. The new results database would include all trials (except for preliminary safety trials), and would require the submission of clinical trial results data.

Our legislation would enforce the requirement to submit information to the databank in two ways. First, by requiring registration as a condition of Institutional Review Board (IRB) approval, no trial could begin without submitting preliminary information to the registry and database. This information would include the purpose of the trial, the estimated date of trial completion, as well as all of the information necessary to help patients to enroll in the trial.

Once the trial is completed, the researcher or manufacturer is required to submit the results to the database. If they refuse to do so, they are subject to monetary penalties or, in the case of federally-funded research, a restriction on future federal funding. It is my belief that these enforcement mechanisms will ensure broad compliance. However, in the rare case where a manufacturer does not comply, this legislation also gives the FDA the authority to publicize the required information.

Let me also say that any time you are collecting large amounts of data and making it public, protecting patient privacy and confidentiality is

paramount. Our legislation would in no way threaten patient privacy. The simple fact is that under this bill, no individually-identifiable information would be available to the public.

I believe that the establishment of a clinical trials databank is absolutely necessary for the health and well-being of the American public. But I would also like to highlight two other benefits that such a databank will have. First, it has the potential to reduce health care costs. Studies have shown that publication bias also leads to a bias toward new and more expensive treatment options. A databank could help make it clear that in some cases less expensive treatments are just as effective for patients.

In addition, a databank will ensure that the sacrifice made by patients who enroll in clinical trials is not squandered. We owe it to patients to make sure that their participation in a trial will benefit other individuals suffering from the same illness or condition by making the results of the trial public, no matter the outcome of the trial.

The problems associated with publication bias have recently drawn more attention from the medical community, and there is broad consensus that a clinical trials registry is one of the best ways to address the issue. Accordingly, the American Medical Association (AMA) has recommended creating such a databank. Additionally, the major medical journals have established a policy that they will only publish the results of trials that were registered in a public database before the trial began. Our legislation meets all of the minimum criteria for a trial registry set out by the International Committee of Medical Journal Editors. In fact, our bill closely follows recommendations issued by the Institute of Medicine (IOM) in its recent report on drug safety.

To its credit, the pharmaceutical industry has also acknowledged the problem, and has created a database where manufacturers can voluntarily submit clinical trials data. I applaud this step. However, if our objective is to provide the public with a complete and consistent supply of information, a voluntary database is unlikely to achieve that goal. Some companies will provide information, but others may decide not to participate. We need a clinical trials framework that is not just fair to all companies, but provides patients with the peace of mind that they will receive complete information about the medicines they rely on.

The American drug industry is an extraordinary success story. As a result of the innovations that this industry has spawned, millions of lives have been improved and saved in our country and around the globe. Due to the importance of these medicines to our health and well-being, I have consistently supported sound public policies to help the industry succeed in protecting the public's health and well-being. This legislation aims to build upon the successes of this industry, and help ensure that the positive changes to our health care system that prescription drugs have brought are not undermined by controversies such as the ones surrounding antidepressants and Cox-2 inhibitors, which are at least in part based on a lack of public information. This bill will help ensure that well-informed patients will use new and innovative medicines.

Creating a clinical trials databank is a critical step toward ensuring the safety of drugs, biological products, and medical devices in this country--but it should not be the end of our efforts. However, other steps are necessary to fully restore patient confidence in the safety of the medicines they rely on.

That is why today I am also introducing the Food and Drug Administration Safety Act (FDASA) with Senator Grassley. We are joined by Senators Mikulski and Bingaman in introducing this legislation and thank them for their support for reforming our nation's system to ensure that FDA-approved drugs being used by millions are safe and effective.

Our legislation would enhance the FDA's drug-safety monitoring system by setting up an independent center within the FDA called the Center for Postmarket Evaluation and Research for Drugs and Biologics (CPER). This Center would be responsible for monitoring the safety of drugs and biologics once they are on the market, in consultation with other existing Centers at the FDA, and would have the authority to take corrective action if a drug or biologic presents a risk to patients. Under the bill, the Center Director is authorized to require manufacturers to conduct post-market clinical or observational studies if there are questions about the safety or efficacy of a drug or biologic once it is already on the market. The Center Director can take corrective actions to include labeling changes, restricted distribution, and other risk management tools if an unreasonable risk is found to exist. The bill also gives the Center Director the authority to review drug advertisements before they are disseminated, and to require certain disclosures about increased risk, and in extreme cases, the authority to pull the product off the market. Our bill authorizes $500 million over the next 5 years to provide the new center with the resources necessary to carry out the critically important provisions of this legislation.

Under our legislation, the Director of CPER will report directly to the FDA Commissioner. Our bill will ensure that CPER consults with the other Centers at FDA as it conducts risk assessments, benefiting from their knowledge and expertise, but not being beholden to them if corrective action is needed.

These new authorities will allow the FDA to act quickly to get answers when there are questions about the safety of a drug, and to act decisively to mitigate the risks when the evidence shows that a drug presents a safety issue. With these authorities, we will never again have a situation where a critical labeling change takes 2 years to complete, as was the case with Vioxx. When we are talking about drugs that are already on the market and in widespread use, any delay can put millions of patients in harm's way.

By creating CPER we hope to restore confidence in the medicines that so many Americans rely on to safeguard their health and well-being. Patients should have the peace of mind that the drugs they take to help them will not hurt them instead. We must restore public confidence in the words ``FDA-Approved.'' Unfortunately, events of the past few years have seriously tarnished the FDA's image and put millions of patients at undue risk. Recent developments have cast into doubt the FDA's ability to ensure that the drugs that it approves are safe--especially once they are on the market. These concerns are bad for patients, bad for physicians, and bad for the pharmaceutical industry.

Like many Americans, I have been deeply disturbed by the revelations of the significant risk associated with widely-used medications to treat pain and depression. These revelations raise legitimate questions about the safety of drugs that have already been approved. It would be one thing if these drugs were in a trial phase, but safety issues are being identified in drugs once they are on the market and in widespread use. Health risks significant enough to remove drugs from the market or significantly restrict their use are becoming clear only after millions of Americans have been exposed to real or potential harm.

It has been estimated that more than 100,000 Americans might have been seriously injured or killed by a popular pain medication, while millions of children have been prescribed antidepressants that could put them at risk. This recent spate of popular medicines being identified as unsafe underscores the need to take additional steps to monitor and protect patient safety after a drug has been approved. Allowing the status quo on drug safety at the FDA is unacceptable. Real reform is needed now.

An internal study conducted by the Department of Health and Human Services (HHS) Office of the Inspector General in 2002 revealed that approximately one-fifth of drug reviewers were pressured to approve a drug despite concerns about safety, efficacy, or quality. In addition, more than one-third said they were ``not at all'' or only ``somewhat'' confident that final decisions of the Center for Drug Evaluation and Research (CDER) adequately assessed safety. A more recent survey of 997 FDA scientists conducted by the Union of Concerned Scientists and the Public Employees for Environmental Responsibility found that 420

FDA scientists reported that they knew of cases in which HHS or FDA political appointees inappropriately injected themselves into FDA determinations or actions.

I look forward to working with industry, physicians, medical journals, patient groups, and my colleagues--including the Chairman and Ranking Member of the Health, Education, Labor, and Pensions Committee, Senator Kennedy and Senator Enzi--to move this legislation forward. These bills have already been endorsed by Consumers Union, the U.S. Public Interest Research Group (PIRG), the National Women's Health Network, and Public Citizen. I thank these organizations for lending their expertise as we crafted these bills. I also want to recognize the New England Journal of Medicine and the American Psychiatric Association for their support in the crafting of the FACT Act.

Clinical trials are critically important to protecting the safety and health of the American public. For this reason, clinical trial results must not be treated as information that can be hidden from scrutiny. Recent events have made it clear that a clinical trials databank is needed. Patients and physicians agree that such a databank is important to our public health. At the same time, there have been disturbing reports that suggest the FDA does not place enough emphasis on drug safety, and that concerns raised by those in the Office of Surveillance and Epidemiology (formerly the Office of Drug Safety) at CDER are sometimes ignored and even suppressed. Our legislation will ensure that those who are responsible for monitoring the safety of drugs already on the market at the FDA will have the independence, resources, and authority to ensure medicines intended to help patients won't instead end up causing them harm. I urge my colleagues to support these bills, and I am hopeful that they will become law as soon as possible.

I ask unanimous consent that a letter from the American Psychiatric Association supporting the FACT Act be printed in the Record.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise to introduce legislation to reauthorize the U.S. Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, known as the Leadership Act, the largest international health initiative in history dedicated to a single disease.

Five years ago, there was little hope in Africa and the developing world of an effective response to HIV/AIDS. Tragically, many of the nations hardest hit by this disease are among those with the fewest resources to draw on for a response. There appeared to be little basis for hope.

Today, the pandemic continues. Yet there has been a change, and the American people have led that change.

The original Leadership Act authorized $15 billion in appropriations over 5 years. And in a significant departure from earlier approaches to development, it linked that funding to accountability for goals: support for treatment of 2 million people, prevention of 7 million new infections, care for 10 million people, including orphans and vulnerable children.

As many Senators will recall, when this legislation was first enacted in 2003, it was done with a certain amount of haste and after a request from the President for quick action. The G-8 summit was fast approaching, but even more importantly, rapid Senate action meant that the program could be established quickly, so that money could start to flow quickly to the fight. Given this, the Senate acted swiftly, passing the bill almost without amendment.

Now we are approaching the expiration of that 5-year authorization at the end of fiscal year 2008. Whatever our misgivings about the Leadership Act as we enacted it in 2003, at this point we need to judge it by the results it has enabled us to deliver. Those results are simply remarkable.

At the time the Leadership Act was announced, only 50,000 people in all of sub-Saharan Africa were receiving antiretroviral treatment. Yet through March of this year, the act has supported treatment for over 1.1 million men, women and children, over a million of them are in Africa, in those 15 countries where AIDS was on the verge of wiping out whole generations. In addition to these focus countries, we are working with one hundred other countries as well touching millions of other lives. Five years ago, HIV was a death sentence. Now there is hope.

During the first 3\1/2\ years of the act, U.S. bilateral programs have supported services for pregnant women to avoid transmission of HIV to their babies during more than 6 million pregnancies. In over 533,000 of those pregnancies, the women were found to be HIV-positive and received antiretroviral prophylaxis, preventing an estimated 101,000 infant infections through March 2007.

Before the advent of the Leadership Act, there was little concerted effort to meet the needs of those orphaned by AIDS, or of other children made vulnerable by it. We have now supported care for more than 2 million orphans and vulnerable children, as well as 2.5 million people living with HIV/AIDS, through September 2006.

Effective prevention, treatment and care all depend to a large extent on people knowing their HIV status, so they can take the necessary steps to stay healthy. The U.S. has supported 18.7 million HIV counseling and testing sessions for men, women and children.

Across the act's programs, the majority of services have been provided to women and girls, and a growing number of services are reaching children.

Our financial investment in this fight has been critical to our success, and thanks in large part to the flexibility of the Leadership Act, we have been able to obligate over 94 percent of its available $12.3 billion appropriated through this fiscal year.

In addition to support for the U.S. bilateral programs, the Leadership Act has also authorized support for the Global Fund to Fight AIDS, Tuberculosis, and Malaria. The Global Fund provides an important avenue for the rest of the world to substantially increase its commitment, as we have done. The U.S. is the largest supporter of the Global Fund, having provided some $2 billion so far. It is important for the American people to understand and for the rest of the world to remember, that the American people are responsible for approximately \1/3\ of all the funding received by the fund.

As we survey the results achieved by this legislation, it is apparent that our efforts have been exceptionally successful. But to build on that success, we must reauthorize the legislation for another 5 years. As we consider how to accomplish that reauthorization task, it is important to note that the vast majority of the authorities needed for the next phase of our effort are already contained in the current Leadership Act.

The necessity for new authorities is in the eye of the beholder. Many Senators may wish to enhance issues such as TB/HIV, gender, nutrition, human capacity, infrastructure and health systems, and education. But the current law already articulates and authorizes activities in these very same areas, as evidenced by the many activities in these areas that the act has undertaken under existing authorities.

In this case, I believe we should follow the old adage, ``If it ain't broke, don't fix it.'' We have a good, if not perfect, law that is succeeding. In lieu of drafting an entirely new bill, today I introduce a reauthorization which preserves the bulk of the authorities that have enabled the program succeed and makes only minor modifications.

The U.S. Global AIDS Coordinator has interpreted the existing authorities well and has listened to the Congress and many stakeholders. As the Institute of Medicine recently said, the Global Leadership Act is a ``learning organization.'' The Coordinator is the first to admit, as he has before Congressional committees, that we can do better in every area of implementation. But new authorities are not needed; these are issues of implementation. In short, rather than absorbing the time of Congress, the coordinator, as well as stakeholders in drafting an entirely new bill, we should empower them to continue the work they are doing to improve upon program implementation utilizing the experience of these past 3\1/2\ years.

Let me highlight the basic changes I am suggesting to the existing legislation. First, it would increase to $30 billion the authorization for the next five fiscal years 2009-2013, a doubling of the initial commitment. I recognize that Senators may wish to revisit that funding level, and I trust that there will be opportunities for them to do so, in committee and on the floor.

Second, as the Institute of Medicine and others have argued, I believe we need to keep the bill as free of funding directives as possible in order to ensure maximum flexibility for implementation. I am proposing that only two funding directives be included, one modified from its current form, the other maintained as is.

The first modification would seek to address the abstinence directive in current law. The current Leadership Act requires that 33 percent of all prevention funding be spent on abstinence-until-marriage programs. The problem with this directive is that some countries need to focus their efforts not on abstinence per se but on, for example, mother-to- child transmission, an activity which is considered to be nonsexual transmission of HIV/AIDS. The original directive thus forced theses countries to either spend money in areas where they did not necessarily need to spend it or to divert funds from areas where they truly needed to.

The administration had interpreted and implemented this provision so as to include both abstinence and faithfulness programs, the `AB' of `ABC,' which stands for Abstinence, Be faithful, and the correct and consistent use of condoms. The directive has been helpful in ensuring an evidence-based, comprehensive approach to prevention. The ABC paradigm for prevention was developed in Africa by Africans, in order to address the wide range of risks faced by people within their nations, particularly in the context of generalized epidemics where HIV is widespread throughout the population. Recent evidence from a growing number of African countries shows a correlation between the adoption of all three of the ABC behaviors, and a clear association with declining HIV prevalence.

Before the creation of the U.S. Global Aids Coordinator, the U.S. Government had relatively little experience implementing behavior change programs for global HIV/AIDS that included the whole array of ABC behavior change. This was the rationale for the directive, and I believe it has served a useful purpose. However, I agree with many others that we can improve upon it as we look to the future.

The language I propose would provide that 50 percent of funding for prevention of sexual transmission of HIV, a sub-set all prevention funding, be dedicated to abstinence and faithfulness. This will enable greater flexibility to countries whose situation mirrors the one just described.

At the same time, the language would ensure the continuation of funding for abstinence and faithfulness programs as part of comprehensive, evidence-based ABC activities. I think this compromise approach is the right one that can win support from across the political spectrum and provide increased flexibility while ensuring continued support for comprehensive, evidence-based prevention.

There are a number of other directives in the current law that need no longer be maintained and the new bill does not contain them. The one other directive that I believe must be maintained is that 10 percent of funding be devoted to programs for orphans and vulnerable children, or ``OVCs''. As I have noted, there were few programs focused on the needs of these children before the Leadership Act of 2005 and we remain in the early stages of the essential effort to serve them. This is one of the aspects of our effort that is most strongly supported by the American people, the maintenance of this directive will help to ensure that this effort remains focused on those who need our support the most. The directive will also help ensure the success of the Assistance for Orphans and Other Vulnerable Children in Developing Countries Act of 2005, a bill I drafted, one cosponsored by eleven of my Senate colleagues, and which the Congress passed in October 2005.

Finally, let me describe some new language proposed for the inclusion regarding the Global Fund, an organization that enjoys wide support here in Congress. The Global Fund is a critically important partner of the U.S. in our fight against HIV/AIDS. Our contributions are not only financial, we are also active on its board, and our U.S. personnel overseas provide the technical assistance needed for the Global Fund's grants to work.

However, the fund is subject to pressures from many donors and in many directions. It has become clear that it would benefit from greater transparency and accountability. In keeping with my concerns with transparency and accountability of international organizations that receive U.S. funding, including the World Bank and International Monetary Fund, my proposed language would establish similar benchmarks for U.S. funding for the Global Fund. I don't believe any of these proposed benchmarks will be controversial, but if Senators have concerns about any of them, I look forward to working with them to address them.

It is also worth noting that the bill would maintain the limitation in the existing Leadership Act that U.S. contributions to the fund may never exceed 33 percent of its funding from all sources. This limitation has proven to be a valuable tool for increasing contributions to the fund from other funding sources, such as other governments, and I believe there is wide agreement that this provision should be maintained as we move forward.

In closing, let me turn to the issue of legislative timing. It is critical to the contents of my approach to reauthorization. It is critically important to reauthorize this bill during 2007, as opposed to awaiting its expiration September 2008.

The US Global Aids Coordinator depends on his implementing partners, including host governments and nongovernmental organizations, including faith- and community-based organizations, to scale up programs rapidly to reach as many people as possible. They have been a critical part of programs success to date.

But HIV and AIDS are different from many diseases: once HIV-positive persons are provided treatment or orphans enrolled in care programs, their treatment and care become ongoing commitments for program partners. Thus, for partners to continue to scale up programs in 2008, they need assurances of a continued U.S. commitment beyond 2008. These partners recognize that at this point, they have only a Presidential proposal, not actual reauthorization.

In fact, some of my staff on the Foreign Relations Committee have recently returned from countries receiving our assistance and verified this concern. Various ministries of health are refusing to expand the number of patients currently receiving antiretroviral medication for fear that they will not receive enough money in the years to come to purchase next year's doses for these new patients.

Without reauthorization in 2007, partners have indicated that they will be unable to scale up programs in 2008, and as my staff have confirmed, there is already evidence that some have begun to slow enrollment in programs. Without continued rapid scale-up this year and next, we may not achieve the ambitious goals for the first phase of PEFPAR, treatment for 2 million, prevention of 7 million new infections, care for 10 million, including orphans and vulnerable children. However, time will be needed to develop sustainable programs with commitments from our partner countries as we move into the next 5- year commitment from the American people.

Thus it is essential that we act before we go out of session this year. I recognize that we face a crowded calendar. But we can do it if we will take the most direct path to passage, a clean bill.

This body can be proud of its contribution to the remarkable turnaround on the issue of global HIV/AIDS, from concern to action. We have represented well the compassion and generosity of the American people and the demand for accountability by the American taxpayer. I call on my colleagues to join me in sponsoring this bill to reauthorize the Leadership Act in 2007, and to extend the authorities that have enabled the American people to make such a difference in the lives of others.

I have no pride of authorship. But we need to start the reauthorization process now. I welcome the involvement

and inputs of my colleagues. We should let the mark-up and amendment process work. Secondly, I would welcome the assistance of other Committees and their memberships. Thirdly, I look for strong support and guidance from the NGO and faith-based communities. These organizations will be key to the reauthorization effort. We will require the constructive engagement of the administration in this reauthorization effort.

If we pull together and display the spirit of compromise necessary for good legislation, we can complete the job in 2007.

I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I am pleased to join Senator Hatch and a bipartisan group of at least 15 original cosponsors in introducing comprehensive antiaging legislation--the Gang Abatement and Prevention Act of 2007.

This bill will provide a comprehensive approach to gang violence by: helping those on the front lines of enforcement, by adopting new criminal laws and tougher penalties against those who commit gang- related and other violent acts; authorizing hundreds of millions of dollars for gang-related investigations and prosecutions, and new funds for witness protection; and identifying successful community programs, and investing significant resources in schools and civic and religious organizations to prevent teenagers and other young people from joining gangs in the first place.

On January 10 of this year, officials in Van Nuys, CA, reported that two teenage boys were shot in a reported gang-related shooting.

A few weeks earlier, on December 29, Visalia, CA, law enforcement officials reported two separate shootings and the wounding of two minors.

On December 24, San Diego officials noted how a 16 year old was shot in the leg in gang violence.

On December 22, a 9-year-old girl in Los Angeles was just washing dishes with her mom inside her home--until gang members exchanged fire across the street, and a bullet tore through the front wall of her house and struck her in the head.

And that came 5 days after Cheryl Green, a 14-year-old black girl who was talking to friends, was shot and killed by two Hispanic gang members.

The New York Times just reported on the Cheryl Green shooting, but unfortunately, I see gang violence in the news almost every day in California, with gang-related shootings of children almost too numerous to count. Perhaps the worst occurred last September, when Los Angeles experienced a new low.

Three-year-old Kaitlyn Avila was shot point-blank by a gang member who mistakenly thought her father was a member of a rival gang. The gang member shot and wounded her father, then intentionally fired into little Kaitlyn's chest.

It is the first time ever that law enforcement officials remember a young child being ``targeted'' in a gang-related shooting.

Unfortunately, this shooting is only a symptom of the disease that has taken hold of our cities--gang violence. The violence perpetrated by gang members affects not only those associated with gangs, but also police officers and innocent bystanders. It impacts not only individuals, but also our communities.

It stops mothers from allowing their children to play outside. It prevents

the elderly from taking walks in their neighborhoods. And it creates an environment of fear.

It is past time for the Federal Government to provide a hand of assistance to state and local law enforcement. And it is past time to come to grips with our country's escalating levels of gang violence.

Just last month the FBI released its Uniform Crime Report for the first half of 2006. The news was disturbing.

The report showed an alarming increase in homicides, assaults, robberies and other violent crimes across the U.S.--a surge of nearly 3.7 percent for the first 6 months of 2006.

This, of course follows on the heels of the FBI's 2005 figures, which had showed a 2.5 percent jump in violent crime.

At the time, those 2005 figures had represented the largest increase in violent crime in the U.S. in 15 years. But this newly announced increase for the first half of 2006 is almost 50 percent higher.

Of course, a big part of this increase is due to gang violence. Just as we heard when the 2005 figures were released, criminologists point to the spread of violent street gangs as a major cause of the 2006 increase in violent crime as well.

The warnings we have received about the links between the increase in violent crime and gangs have been steady and consistent.

When the FBI announced its 2005 figures last June, the Washington Post reported how criminal justice experts specifically identified ``an influx of gangs into medium-sized cities'' as a big reason for this increase. According to the Los Angeles Times, Houston police attributed their 2005 increase to gang members who evacuated New Orleans after Katrina.

When the 2006 figures were announced, the Washington Post quoted criminologist James Alan Fox, who described how ``[w]e have many high- crime areas where gangs have made a comeback.'' The L.A. Times noted how ``[e]xperts said the crime upsurge reflected an increase in gang violence, particularly in midsized cities.'' Cities like Houston, which experienced a massive 28 percent increase in violent crime.

The headline for the Sacramento Bee, reporting on the FBI's 31 percent reported increase in violent crime for that county, said it all: ``Gangs blamed for increase, which is part of [a] national hike in mayhem in '06.''

Even among the cities that experienced a 2006 reduction in violent crime--such as Los Angeles, which moved into the ranks of the safest cities in the U.S.--Mayor Villairaigosa described gang violence as the ``glaring exception.'' Gang crime was up by 14 percent in Los Angeles-- and up 40 percent in San Fernando Valley, and 57 percent of Los Angeles' 478 homicides for 2006 were attributed to gangs--up 50 percent from 2005. And 86 percent of those murder victims were African American or Latino.

There can no longer be serious debate that gang violence is a big part of this problem.

The problem of gang violence in America is daunting. According to the FBI, there are now at least 30,000 gangs nationwide, with 800,000 members.

In California, the State attorney general now estimates that there are 171,000 juveniles and adults committed to criminal street gangs and their way of life. That's greater than the population of 28 California counties.

From 1992 to 2003, there were more than 7,500 gang-related homicides reported in California.

In 2004, more than one-third of the 2,000 homicides in California-- 698--were gang-related.

And it is worse among teens and young adults. In that same year, nearly 50 percent of the murders of 18 to 29 year olds were gang related. And nearly 60 percent of the murders of teens under 18 were gang related.

The list of people murdered by gangs includes some of our finest law enforcement officers:

Oceanside Police Officer, Dan Bessant, gunned down from behind just last month, in an incident described as eerily similar to a similar killing in 2003, when Oceanside Police Officer, Tony Zepetella, was shot and killed by a known gang member.

Los Angeles Police Officer Ricardo Lizarraga, killed while responding to a domestic violence call, by a man who drew a gun and shot him twice in the back. The suspect was a known member of the Rollin20s Bloods.

Merced Police Officer Stephan Gray, a member of his department's gang violence unit. Gray was shot and killed when a suspect--a gang member he had encountered before--fired two bullets into his chest.

Los Angeles Sherriff's Deputy Jeffrey Ortiz: As a member of his department's anti-gang task force, Ortiz had been going door to door in a gang-plagued neighborhood of L.A. He had just knocked on a door and was checking IDs when he was shot in the head at point-blank range. The alleged gunman is a suspected gang member wanted on an outstanding warrant for attempted murder.

Burbank Police Officer Matthew Pavelka: Two gunmen whom he had stopped for driving without license plates got out and showered him with gunfire. They were allegedly affiliated with the Vineland Boys gang.

California Highway Patrol Officer Thomas Steiner, killed after walking out of the Pomona courthouse after testifying in a series of traffic cases, by a 16-year-old intent on ``killing a cop'' to prove himself to the Pomona 12th street gang.

San Francisco Police Officer Isaac Espinoza: The first San Francisco police officer slain on duty in more than a decade, killed when an apparent ``Westmob'' gang member fired 14 rounds from an AK-47 assault rifle.

Gang killings also impact children and families. Unfortunately, 3- year-old Kaitlyn Avila is not alone: There is also 11-year-old Mynisha Crenshaw of San Bernardino, CA, a little girl shot and killed in November 2005;

Seven-week-old infant Glenn ``Baby G'' Molex, shot and killed on September 28, 2003, by one of the ``Down Below'' Gang after 28 bullets penetrated his family's apartment in San Francisco's Bayview District;

Joseph Swift, a 13-year-old boy shot outside a home after attending church in Los Angeles in 2003; and

Eight-year-old Sunny Elijah Peralez, shot in East Los Angeles by the Ghetto Boyz in 1999.

And this problem extends far beyond California--as evidenced by 8- year-old Kyron Butler, killed by a stray bullet during a Jersey Park Boys gang shootout in Smithfield, VA, in 2003, and 9-year-old Genesis Gonzalez, a little girl shot by a car of Crips gang members in Nevada in 2002.

As gangs have continued to spread across our country, increasing in violence and power in every State, they are no longer just a big city problem. They have metastasized from Los Angeles and Chicago to the medium and smaller cities where they face less competition.

The FBI now estimates that gangs are having an impact on at least 2,500 communities across the nation.

In the latest FBI statistics, violent crime and murder grew fastest in the midsized and smaller cities--not in our largest urban areas. The average midsized city, in fact, had a surge in overall violent crime of more than 5 percent in a single year.

It is clear that gangs engage in drug trafficking, robbery, extortion, prostitution, gun trafficking, and murder. They destroy neighborhoods, cripple families and kill innocent people.

Los Angeles Police Department Chief Bill Bratton put it bluntly:

There is nothing more insidious than these gangs. They are

worse than the Mafia. Show me a year in New York where the

Mafia indiscriminately killed 300 people. You can't.

Our national gang problem is immense and growing, and it is not going away. Our cities and States need help. The many law enforcement officers that have spoken to me and others in my office say one thing clearly--short-term infusions are great, but what they really need is a long-term Federal commitment to combat gang violence.

A massive report just prepared for the City of Los Angeles even suggested that what is needed is a ``Marshal Plan'' initiative to combat gang violence.

Senator Hatch and I have been introducing comprehensive Federal gang legislation for over a decade. Our gang bills have been modified and refined over the years, most recently in legislation that we negotiated with the House for possible inclusion in the DOD Authorization bill last year.

The bill that we introduce today essentially takes that bill, but removes

all of its new death penalties. It has no mandatory minimums, and we have eliminated juvenile justice changes that previously proved to be an impediment to the larger bill's passage.

The bill that we offer today will provide a comprehensive solution to gang violence, combining enforcement and prevention efforts in a collaborative approach that has proven effective in models like Operation Ceasefire, and in Modesto, CA.

This bill would establish new Federal gang crimes and tougher Federal penalties.

Today's Federal street gang laws are frankly weak, and are almost never used. Currently, a person committing a gang crime might have extra time tacked on to the end of their Federal sentence. That is because Federal law currently focuses on gang violence only as a sentencing enhancement, rather than a crime unto itself.

The bill that I offer today would make it a separate Federal crime for any criminal street gang member to commit, conspire or attempt to commit violent crimes--including murder, kidnapping, arson, extortion-- in furtherance of the gang.

And the penalties for gang members committing such crimes would increase considerably.

For gang-related murder, kidnapping, aggravated sexual abuse or maiming, the penalties would range up to life imprisonment.

For any other serious violent felony, the penalty would range up to 30 years--which in the Federal system means without parole.

And for other crimes of violence--defined as the actual or intended use of physical force against the person of another--the penalty could bring up to 20 years in prison.

The bill would also create a new crime for recruiting juveniles and adults into a criminal street gang, with a penalty of up to 10 years, or if the recruiting involved a juvenile or recruiting from prison, up to 20 years;

Create new Federal crimes for committing violent crimes in connection with drug trafficking, and increase existing penalties for violent crimes in aid of racketeering;

Enact a host of other violent crime reforms, including closing a loophole that had allowed carjackers to avoid convictions, increasing the penalties for those who use guns in violent crimes or transfer guns knowing they will be used in crimes, limiting bail for violent felons who possess firearms, and in a number of other respects cracking down harder on those who commit violent crimes; and

Make a long-term Federal commitment to fight gangs, by authorizing over $1 billion in new funds over the next 5 years for enforcement, prevention, and witness protection.

This would include $500 million for the development of High Intensity Interstate Gang Activity Areas, or HIIGAAs.

These HIIGAAs would mirror the successful HIDTA--High Intensity Drug Trafficking Area model--under which Federal, State and local agents coordinate investigations and prosecutions. And this $500 million would also be split 50/50, so that for every dollar spent on law enforcement, a dollar would be spent on prevention and intervention.

This balanced approach--of prevention and intervention plus tough penalties--will send a clear message to gang members: a new day has arrived. This bill will provide them with new opportunities, with schools and social services agencies empowered to make alternatives to gangs a realistic option. But if gang members continue to engage in violence, they will face new and serious Federal consequences.

I am pleased to report that this bill has already been endorsed by the National Sheriff's Association, the International Association of Chiefs of Police, and the National Association of Police Officers.

For more than 10 years now, Senator Hatch and I have been trying to pass Federal anti-gang legislation. There have been times when we have gotten close. Unfortunately, while Congress has failed to act, violent street gangs have only expanded nationwide and become more empowered and entrenched in other States and communities.

I believe this bill can pass the Senate and be enacted into law, especially after these changes that we have made and our previous negotiations conducted with members of the House and Senate.

The time has arrived for us to finally address this problem, and this bill is well-suited to help solve it. I urge my colleagues to support this legislation.