Pediatric Research Equity Act of 2003

Mr. President, we have all been devastated by the repeated news flashes of violent crimes being committed against children across the Nation. In June 2002, Elizabeth Smart, a 14 year old from my home State of Utah was kidnapped at gun point from her home in Salt Lake City. Just this past week, the entire Nation rejoiced with the Smart family after Elizabeth was found alive and reunited with her loved ones.

Five year old Samantha Runnion was not so lucky. Just one month after Elizabeth Smart's abduction, Samantha was kidnapped while playing with a neighborhood friend down the street from her home in Stanton, CA. The following day, her body was found along a highway, nearly 50 miles from her home. California authorities have charged Alejandro Avila with Runnion's abduction, sexual assault and murder. Reportedly, Avila was acquitted two years ago of molesting two young girls under the age of 14.

Elizabeth Smart and Samantha Runnion are just two, among many, recent child victims. The list of tragic cases involving minor victims goes on and on.

These horrific incidents illustrate the need for comprehensive legislation--at both the State and national level--to protect our children. We need to ensure that federal and state law enforcement officers have all the tools and resources they need to find, prosecute, and punish those who commit crimes against our youth.

Today, I rise to reintroduce the ``Comprehensive Child Protection Act of 2003'' which enhances existing laws, investigative tools, criminal penalties and child crime resources in a variety of ways. I introduced this important bill with Senator Feinstein last year, but it failed to go anywhere. My unwavering commitment to this issue compels me to introduce it again this year. Let me elaborate on the Act's specific provisions.

By broadening existing laws, the Act enhances the ability of child victims to pursue and prevail in criminal proceedings against their predators.

First, the Act extends the statute of limitations period that applies to offenses involving the sexual or physical abuse of children under 18 years of age. Current law permits such cases to be brought until the victim reaches the age of 25 years. This amendment will allow meritorious cases of child sexual and physical abuse to be brought up until the date the minor reaches the age of 35 years.

It is well-documented that child abuse victims often do not come forward until years after the abuse occurred. Victims fail to come forward because they fear their disclosures will lead to further humiliation, shame, and even ostracism. Abusers should not benefit from the lasting psychological harms they have inflicted on innocent children.

I believe that there should rarely, if ever, be a time when we say to a victim who has suffered as a child at the hands of an abuser: you have identified your abuser; you have proven the crime; yet the abuser will remain free because you, the victim, waited to long to come forward. Our criminal justice system should be ready to adjudicate all meritorious claims of child abuse. This amendment is meant to recognize that the arm of the law should be long in the prosecution of crimes of this heinous nature.

Second, the Act amends an existing Federal evidentiary rule, Federal Rule of Evidence 414, to permit the admission into evidence of prior offenses involving child molestation, or the possession of sexually explicit materials containing actual or apparent minors. The current evidentiary rule permits such evidence to be admitted only where the victim was under 14 years of age. This amendment extends the rule to apply to any minor--any victim who was under 18 years of age at the time the offense was committed.

In addition, the amendment makes clear that even where an individual possesses what may be virtual, as opposed to actual, child pornography, and therefore, may have a valid defense against prosecution in light of the Supreme Court's recent decision in Ashcroft v. Free Speech Coalition, 122 S. Ct. 1389 (2002), such evidence is nonetheless admissible under Rule 414. Like the possession of actual child pornography, the possession of virtual child pornography is highly probative evidence that should be admissible in a case involving child molestation or exploitation.

Third, the Act also limits the scope of the common law marital privileges by making them inapplicable in a criminal child abuse case in which the abuser or his or her spouse invokes a privilege to avoid testifying. Where a child abuser is charged with a crime against the child of either spouse, or a child under the custody or control of either spouse, neither the abuser nor his or her spouse should be permitted a marital privilege to avoid providing critical evidence.

The marital privileges exist because we in society believe that forcing a person to testify against his or her spouse, or permitting a spouse to testify about confidential marital communications, may jeopardize a marriage. While we value trusting, harmonious marriages, our societal interest in the proper administration of justice far exceeds our interest in preserving marital harmony where a spouse has chosen a vulnerable, defenseless child in the home as his or her victim. In my view, it is more important to prosecute and punish child abusers than it is to minimize the potential risk to the life of a marriage in which child abuse is occurring.

The Act increases the investigative tools available to law enforcement agencies in several significant ways.

First, the Act amends the DNA Analysis and Backlog Elimination Act by increasing the categories of offenses that are included in the database of convicted offender DNA profiles, the Combined DNA Index System, CODIS. Without question, DNA--which is unique to each individual and maintains its evidentiary integrity for long periods of time--is a valuable investigatory tool. Time and again DNA evidence has aided in solving difficult criminal cases by linking suspects to crimes and by eliminating others.

This Act expands the class of offenses that are included in CODIS by adding all federal felony offenses to the database. Currently, the DNA Analysis and Backlog Elimination Act includes only select Federal offenses. The successful experiences of approximately 19 States, including Utah, which currently authorize the collection of DNA samples for all felony offenses illustrate the need for this extension. These States have solved numerous crimes where DNA has been found--frequently based on an offender's conviction for a nonviolent offense--such as burglary, theft or a narcotics offense.

Remarkably, not all States currently authorize the collection of DNA samples from all types of child offenders. Thus, the Act also expands the definition of qualifying offense to include all state offenses against children, such as those involving child kidnapping or abuse. This expansion will increase law enforcement's ability to solve such crimes where DNA evidence is found.

Second, the Act extends the Federal wiretap statute by adding sex trafficking, sexual abuse, exploitation, and other sex-related offenses as predicate offenses to the statute. As we all know, the Internet is becoming an increasingly popular means by which sexual predators make contact with child victims. Although predators typically initiate a relationship online, they ultimately seek to make personal contact with the child--both over the telephone and through face to face meetings. But as the law exists today, investigators are restricted in their ability to investigate such predators. This provision will enable investigators, who meet the statutory requirements of the Federal wiretap statute, to obtain court authorization to monitor such communications. This amendment will not only aid investigators in obtaining evidence of these crimes, it will also help

stop these crimes before a sexual predator makes contact with a child.

To obtain a wiretap, law enforcement authorities will still need to meet the strict statutory guidelines of the wiretap statute and obtain authorization from a court. Thus, the legislation will not undermine the legitimate expectations of privacy of law-abiding Americans. This expanded tool will be particularly useful to investigators who track sexual predators and child pornographers.

The Act also strengthens criminal penalties by extending the supervised release period that applies to certain offenders, increasing the maximum penalties that apply to offenses involving transportation for illegal sexual activity, and directing the United States Sentencing Commission to review the guidelines that apply to criminal offenses with which child predators are frequently charged to determine whether they are sufficiently severe.

The Act grants Federal judges the discretion to impose up to lifetime periods of supervised release for individuals who are convicted of sexual abuse, sexual exploitation, transportation for illegal sexual activity, or sex trafficking offenses. Under current Federal law, a judge can impose no more than 5 years of supervised release for a serious felony, and no more than 3 years for a lesser categorized offense. This amendment to the general supervised release statute will not require judges to impose a period of supervised release longer than 5 years; it will simply authorize them to do so where a judge sees fit based on the nature and circumstances of the case.

In my view, if there is any class of offenders on which our criminal justice system should keep a close eye, it is sexual predators. It is well documented that sex offenders are more likely than other violent criminals to commit future crimes. And if there is any class of victims we should seek to protect from repeat offenders, it is those who have been sexually assaulted. They suffer tremendous physical, emotional and psychological injuries. By ensuring that egregious sexual offenders are supervised for longer periods of time, we will increase the chance that they will be deterred from and punished for future criminal acts.

The Act increases the maximum penalties that apply to certain offenses, including sexual offenses that involve the trafficking of children and transportation. Stiffer penalties are needed to punish and deter individuals who commit such offenses.

The Act also directs the United States Sentencing Commission to review the sentencing guidelines that apply to various offenses that apply to kidnappers, sexual abusers and exploiters, to ensure that Federal sentences are sufficiently severe where aggravating circumstances exist, such as where the victim was abducted, injured, killed, or abused by more than one person.

In a number of significant ways, the Act enhances the resources that are available to investigate and prosecute crimes against children.

First, the Act directs the Attorney General to appoint a Deputy Assistant Attorney General to oversee a new section at the Department of Justice designated to focus solely on crimes against children. Among other things, the new section will be tasked with prosecuting crimes against children, providing guidance and assistance to Federal, State, and local law enforcement agencies and personnel who handle such cases, coordinating efforts with international law enforcement agencies to combat crimes against children, and acting as a liaison with the legislative and judicial branches of government to ensure that adequate attention and resources are focused on protecting our children from predators of all types.

In addition, the Act tasks the new Crimes Against Children section to create an Internet site that consolidates sex offender information which States currently disclose under the Federal reporting act. The Act also direct States that have not developed Internet sites to do so. The creation of a national Internet site will enable concerned citizens to find in one, easily accessible place, critical information about sexual predators.

Currently, all 50 States have registration statutes that require sex offenders to register and to share information with the United States Attorney General through the Federal Bureau of Investigation, and over 30 States make offender information available to the public on the Internet. A national Internet site will enhance the public's ability to find and access information that is already available in the public record, and will protect citizens in States where sex offenders move to try to avoid detection of their past criminal acts. In short, the national Internet site will provide parents and other concerned citizens with essential information about the whereabouts and backgrounds of child abusers, so they can take all necessary steps to protect our Nation's children from harm's way.

The Act also increases resources and funding for the Federal Bureau of Investigation. The recent series of tragic events involving child victims has convinced me that we need to take a more proactive approach to prevent, deter and prosecute child predators of all types--abusers, molesters, pornographers and traffickers. And at the same time, we need to provide our children, the vulnerable victims of such predators, with the support systems they need to recover fully from such horrendous crimes and to assist law enforcement in effectively investigating and prosecuting these crimes.

To this end, the Act directs the FBI to establish a National Crimes Against Children Response Center whose primary mission will be to develop a comprehensive and rapid response plan to reported crimes involving the victimization of children. While the National Response Center is to be established by the FBI, in consultation with the Deputy Assistant Attorney General for the Crimes Against Children Office, it will integrate the resources and expertise of other Federal, State, and local law enforcement agencies, as well as other child serving professionals. By creating and training rapid response teams comprised of federal, state and local prosecutors, investigators, victim witness specialists, mental health and other child serving professionals, the Center will greatly enhance our national response and prevention efforts. The combination of valuable expertise and resources provided by such multi-jurisdictional and multi-disciplinary partnerships will increase the likelihood that law enforcement authorities will successfully identify, prosecute and punish child predators, and that child serving professionals will provide child victims with much needed support.

The ``Comprehensive Child Protection Act of 2003'' will enhance our ability to combat crimes against children, but it is by no means an end. Congress needs to continue to explore additional ways in which we can improve our ability on a national level to protect our children. Our children fall victim to many of the same crimes we face as adults, and they are also subject to crimes that are specific to childhood, like child abuse and neglect. The effects of such heinous crimes are devastating and often lead to an intergenerational cycle of violence and abuse.

I want to do all I can to ensure that we devote the same intensity of purpose to crimes committed against children, as we do to other serious criminal offenses, such as those involving terrorism. We have no greater resource than our children. I invite the Department of Justice, the Federal Bureau of Investigation and other non governmental entities and professionals who are charged with protecting our children to work with me to improve our Federal laws and to assist States in doing the same.

Mr. President, I rise today with my colleague from Utah, Senator Hatch, to reintroduce the ``Comprehensive Child Protection Act of 2003''--a bill to help protect our Nation's children from child molestation and other forms of abuse. Senator Hatch and I introduced this bill for the first time on September 10, 2002.

Sexual abuse of children is a pervasive and extremely troubling problem in the United States. I learned that over 25 years ago when I was serving as the County Prosecutor in Greene County, Ohio. I saw what this kind of abuse does to innocent, helpless children and how pervasive the crimes are in our communities. In fact, according to the Congressional Research Service, one of every three girls and one of every seven boys will be sexually abused before they reach the age of 18.

Our local police and prosecutors are on the front line in the fight against these criminals, and they deserve credit and our thanks for their hard work. For example, in Greene County recently, a number of child pornographers were identified and prosecuted when local law enforcement carried out a successful Internet sting operation.

Despite successes like this, however, the data suggest that law enforcement is fighting an uphill battle. In 2001 alone, there were over 5,400 registered sex offenders living in my home State of Ohio--an increase of 319 percent over 1998. Equally troubling, many child molesters prey upon dozens of victims before they are reported to law enforcement. Some evade detection for so long because many children never report the abuse. According to the Bureau of Justice Statistics, between 60 percent and 80 percent of child molestations and 69 percent of sexual assaults are never reported to the police. And, according to the Congressional Research Service, of reported sexual assaults, 71 percent of the victims are children.

For these reasons, it is vitally important that Congress do everything in its power to support law enforcement in its efforts to protect our nation's most vulnerable citizens. Enacting the ``Comprehensive Child Protection Act of 2003'' would be a step in the right direction. By enacting this measure, we would help protect our children from sexual predators, pornographers, and others who abuse children. Among its major provisions, this legislation would: 1. Direct the FBI to establish a new center that creates and trains ``rapid response teams'' (composed of prosecutors, investigators, and others) to respond promptly to reported crimes against children; 2. Establish a national Internet site that would make sex offender information available to the public in one, easily accessible place. Currently, about 30 states make offender information available to the public online; 3. Authorize the collection of DNA samples from registered sex offenders and the inclusion of these DNA samples in the Combined DNA Index System, or ``CODIS;'' 4. Permit the prosecution of child abuse offenses until a victim reaches the age of 35 (as opposed to the age of 25 under current law). This provision recognizes that victims of such crimes often do not come forward until years after the abuse, out of shame or a fear of further humiliation; 5. Make it easier for investigators to track sexual predators and child pornographers and make it easier to prosecute criminal child abuse/molestation cases; 6. Create a new section at the Department of Justice to focus solely on crimes against children; and 7. Stiffen penalties for sex-related offenses involving children.

This is a good bill--a bill that would help ensure that our children are protected from some of the most heinous of criminals. It is a bill that would increase the punishment for those criminals. And, it is a bill that, quite simply, is the right thing to do. I encourage my colleagues to join us in co-sponsoring this important measure.

Mr. President, I rise today to talk about a very important subject--one that affects parents, doctors, hospitals, nurses and our children each and every day. The subject that I am talking about is the safety and efficacy of the medicines that doctors give our children when they are sick.

Nearly six years ago, I was astonished to learn that close to 80 percent of drugs on the market were not tested for use in children-- yet, doctors were prescribing these drugs to our children. Doctors had no choice but to prescribe these drugs for children if they thought the medicines would be helpful. And, sometimes the medicines did help-- sometimes a child's pain was relieved, or a child would be able to breathe easier or digest food better because of the medicines the doctors prescribed them. But, even when the drugs do work, an anxious feeling remains among doctors and parents about whether these medicines are safe for children. How are doctors and parents to know for certain which medicines will work if they haven't been tested for safety and efficacy in children?

There are many examples, of situations where drugs have been misprescribed for children because doctors simply weren't aware of the effects these drugs would have on kids. For example, the drug, Neurontin, which is used to treat chronic pain, was given to children without being properly tested, and doctors eventually learned they were under-dosing children by 50 percent. That means children were suffering from pain because they were being under-dosed. They weren't being given the proper dose of medication to relieve their pain.

Another drug, Lithium, which has been prescribed to treat bipolar disorder since 1940 was never tested for long-term use in children until just a few months ago. This is an example of a drug that doctors have been prescribing ``off-label'' for years, and only now we are finally getting some evidence of its effect in children. According to doctors, the testing of Lithium revealed important information because children who suffer from bipolar disorder cycle between mania and depression quicker than adults, and they can even have signs of both at the same time. Unlike adults, they don't have periods of normalcy. Doctors now know that Lithium can be used to treat bipolar disorder in children.

Doctors have taken a chance in prescribing medicines for children. Doctors tell parents to cut a pill in half or in quarters so it can be given to a child. Doctors use the best information they have to determine how much or what kind of medicines to give a child. That is all they can do when the medicines children need have not been tested for their use.

Doctors and pediatricians should not be left to guess how much medicine our children should receive. And, parents shouldn't have to feel anxious or question whether the half a pill that's been ground up and put in applesauce will still be effective in treating their child-- or whether it's even safe for their child to take.

It's been over a year now since the Senate passed and the President signed into law the Best Pharmaceuticals for Children's Act. As many of my colleagues know, that law has been part of a solution--but just a part of a solution--to address the problem I just mentioned. The law provides a six-month patent extension to pharmaceutical companies in exchange for the testing of medicines in children. And, for as long as the bill has been law, the Food and Drug Administration is reporting its success in ensuring that more medicines are tested for use in children. With the incentive provided by Best Pharmaceuticals, companies are seeing the value of studying their drugs in children and are applying for the patent extension.

But, the Best Pharmaceuticals incentive cannot work alone to ensure that medicines in children do not go untested. The incentive in the Best Act was never intended to work alone. When the Best Act became law, there was already a rule on the books that helped ensure that no medicine used to treat children, including vaccines or other biologics, would go untested. Back in 1997, the Food and Drug Administration proposed what is known today as the Pediatric Rule. The Pediatric Rule allowed FDA to require that the drugs the agency felt are important for children are safe, effective, and properly labeled for children.

Unfortunately, the Pediatric Rule has come under legal challenge, with a District Court ruling just a few months ago stating that FDA lacked the statutory authority to require pediatric studies. This was a troubling step backward for children's health--a troubling step at a time when 75 percent of the medicines on the market still aren't tested and labeled for pediatric use. We've made some improvements from the 80 percent of medicines on the market, but 75 percent is still too much. Without the Pediatric Rule, new medicines and biologics coming onto the market are not required to be tested for use in children. Congress needs to make sure that the FDA continues to have every tool--that includes the market incentives and the pediatric rule--available to them to ensure that drugs for children are tested for safety and efficacy and that they are labeled properly.

Everyday that a drug manufacturer chooses not to participate in the incentive program, the number of medicines

that go untested for use in children increases. Everyday that we don't have the Pediatric Rule, we sacrifice our children's safety. Medicines that are used by children should be tested for safety and efficacy. That is why Senators Clinton, Gregg, Dodd, and Kennedy and I are introducing a bill today--the Pediatric Research Equity Act--that would ensure that the Pediatric Rule continues to work alongside the Best Act, so that children will remain on safe footing when it comes to the testing of the medications they use.

Congress needs to make sure the Pediatric Rule stays in place, because right now, the Pediatric Rule and the Best Act incentive work together to ensure that drugs are tested for use in children. As I said already, the Best Act was never intended to substitute the rule, but rather to reinforce and work with the rule. For example, the Pediatric Rule may be invoked in instances where pediatric information is essential, but the patent exclusivity is no longer available.

The Pediatric Rule also applies to biologics, whereas the Best Pharmaceuticals does not. A significant portion of therapeutics used in children, including many cancer treatments, are biological products (products that include a live agent). Because Best Pharmaceuticals does not apply to biologics, the Pediatric Rule is the only way to ensure pediatric labeling.

Finally, the Best Pharmaceuticals is voluntary. For any number of reasons, including insufficient sales, a manufacturer may choose not to conduct the testing necessary to receive additional exclusivity under the Best Act. But, just because a drug manufacturer chooses not to study the drug in children does not mean that drug is not critical to the proper treatment of our children. Without the Pediatric Rule, there is no way to guarantee that a drug that is used in the pediatric population is tested for children's use.

With the establishment of the Pediatric Rule and the financial incentives of the Best Pharmaceuticals law, there has been a dramatic increase in the number of studies that have been undertaken. Let me quote from the Government's Response to Plaintiff's Notice of Reauthorization of FDA Modernization Act. This is the document that the government filed to defend the lawsuit against the Rule: ``These two options [the Best Pharmaceuticals for Children Act and the Pediatric Rule] have resulted in a number of drugs being labeled for use in pediatric populations. As of March 31, 2002, 94 applications containing complete or partial pediatric use information had been submitted to the agency. Of these 94 applications, 45 are attributable to the statutory exclusivity provisions. FDA attributes 48 of the 94 applications to the authority of the pediatric rule alone.''

The bill that my colleagues and I are introducing today would help maintain that progress--not erode it. Our bill would provide the FDA with the authority it needs to ensure that the medicines children take are studied for safety and efficacy. And, our bill would give FDA this authority in a way so that it does not conflict with the incentives provided in the Best Pharmaceuticals Act.

Our bill would preserve the waiver and deferral process, so that drug companies can get waivers or deferrals for a range of legitimate reasons. Drug companies could get a waiver or deferral of studies for safety or ethical concerns. A drug company could get a waiver or deferral if the pediatric testing would interfere with the drug's availability for adults.

Ultimately, though, our bill would help make certain that children are no longer a therapeutic afterthought by ensuring that all new drugs are studied for pediatric use at the time a drug comes to market. This would put children on a level playing field with adults for the first time. Our children deserve no less, and I encourage my colleagues to join in support of this legislation.

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

Mr. President, I ask unanimous consent the Senate proceed to the immediate consideration of calendar 183, S. 650.

Mr. President, I rise this evening in support of the passage of this bill, the pediatric rule. Passage of this bill will be a very important step in protecting the health of our children. This bill will help keep the pediatric rule in place to help ensure the drugs we give our children when they are sick are actually tested for use by our children. The tragic reality is there are medicines on the market today that are being used by and prescribed for our Nation's children that are oftentimes not being tested for their use. It has been that way for years and years.

For many years, doctors have had to take a chance when prescribing medicines for our kids. Doctors have literally had to tell parents to cut the pill in half or in quarters to be given to a child. The doctors have used the best information they have to literally guess how much medicine to give a child. That is all they could do with the medicines; they have had to guess.

Quite frankly, these medicines have been overprescribed, underprescribed, or maybe not prescribed at all when they should have been prescribed. For example, recently the drug Paxil, which is an antidepressant, has been prescribed without being tested in children at all. Many people have heard of this drug. Many people have heard of the beneficial effects for adults with anxiety and panic disorders. What people did not know, what doctors did not know, was what we have recently found out. Recently the British Government has warned doctors to stop prescribing this drug for children, warning that the medicine increased the risk of suicide or suicidal thinking among children with depression. This action, in turn, spurred the FDA to conduct its own investigation into the safety of this drug for younger patients, resulting in a similar warning to physicians here in the United States: Don't prescribe this drug for children.

That is just one example. We have page after page of examples of drugs that have been prescribed to children in the past and once we then tested them, once the protocols were done, the testing was done, lo and behold, we found they were more effective for children than we thought. Sometimes they were not effective, sometimes the prescriptions, the amount, the dosage that had been used was too much, sometimes not enough.

The facts are these. As we all know, children are not just miniature adults. You can't just take the weight and just reduce the dosage. Kids react differently. That is why it is so important to have the testing done. Yet when Senator Chris Dodd and I first started on this cause, 5 or 6 years ago, 80 percent of the drugs that came on the market had never been tested for children at all.

It has been over a year now since this Senate passed and the President signed into law the Best Pharmaceuticals for Children Act. The Best Act was a bill that followed the Better Pharmaceuticals for Children Act, which we passed a few years before that. That law, the Best Pharmaceuticals for Children Act, was part of the solution, just part of the solution to address the problem of getting medicines tested for use by children.

That law provides, as its predecessor bill did, a 6-month patent extension to pharmaceutical companies in exchange for the testing of medicines in children. That was a voluntary law and it has worked pretty well. For as long as the bill has been law--its predecessor was law--the Food and Drug Administration reported success in ensuring that more medicines are tested for use in children. With this economic incentive by this Best Pharmaceutical and Better Pharmaceutical bill in place, companies are seeing the value of studying their drugs in children and are applying for the patent extension, and children are benefiting.

But the Best Pharmaceuticals incentive cannot work alone. It was never intended to work alone to ensure that medicines for children are properly tested for their use. In order to ensure that no medicines needed to treat children, including vaccines or other biologics, would go untested, the FDA, in 1997, proposed what is known as the Pediatric Rule, a companion rule. The Pediatric Rule allowed the FDA to require that drugs deemed important for children be tested for their safety, for their effectiveness, and that they be properly, then, labeled for children.

Unfortunately--and this is what brings us to the Senate floor tonight to consider this bill--the Pediatric Rule came under legal challenge and was, in fact, overturned in court in October 2002, last year, by a district court. That court ruled that the FDA lacked the statutory authority to require pediatric studies.

What the court said was it was incumbent upon Congress to fix it. That is why we are here tonight. This was a troubling step backward for children's health, considering that today 75 percent of the medicines on the market still, even with the Better Pharmaceutical bill and the Best Pharmaceutical bill, still 75 percent of the medicines on the market today are not tested and labeled for pediatric use.

Without the Pediatric Rule in place, without the necessary authority provided to the FDA, new medicines and biologics coming onto the market are not required to be tested for use in kids. Since that court decision on October 17, 2002, the FDA has indicated that over 300 medicines either have applications pending or incomplete studies pending, and that unless the Pediatric Rule stays in place these will all be lost. Many more, hundreds more will be lost in the future. Pediatricians will not know how to prescribe these drugs in the future or whether to prescribe them at all.

That is why Senator Clinton, Senator Dodd, and myself introduced the bill that we hope to pass tonight. It is a bill that would codify a significant piece of the Pediatric Rule to assure that it stays in place and ensures that children will remain on safe footing when it comes to the testing of the medications that they use.

Furthermore, we need to keep the Pediatric Rule in place right now because the Pediatric Rule and incentives work together to ensure that drugs are tested for use in children.

The Best Pharmaceuticals for Children Act, as I said already, was never intended to be a substitute for the rule but, rather, to reinforce and work with the rule. For example, the Pediatric Rule may be invoked in instances where pediatric information is essential but the patent exclusivity incentive is no longer available.

The Pediatric Rule also applies to biologics, whereas the Best Pharmaceutical bill does not. A significant portion of therapeutics used in children, including many cancer treatments or biological products--by that, of course, we mean products that include a live agent. Because the Best Pharmaceutical law does not apply to biologics, the Pediatric Rule is the only way to ensure proper and effective pediatric labeling.

Finally, the Best Pharmaceutical Act is voluntary. For any number of reasons, including insufficient sales, a manufacturer simply may choose to

not conduct the necessary testing to receive additional exclusivity under the ``Best'' law, and when that happens and the drug is not tested for kids, children are the losers. But just because a drug manufacturer chooses not to study the drug in children does not mean that the drug is not critical to the proper care of your children and my children or grandchildren. Without the Pediatric Rule that is in front of us today, there is no way to guarantee that a drug that is used in the pediatric population is tested for children's use.

With the establishment of the Pediatric Rule and the financial incentives of the Best Pharmaceutical law, which will go with this, there has been a dramatic increase in the number of studies that have been undertaken. Let me quote from the Government's Response to Plaintiff's Notice of Reauthorization of FDA Modernization Act. This is the document the Government filed to defend the lawsuit against the rule.

These two options--Best Pharmaceuticals for Children Act

and the Pediatric Rule--have resulted in a number of drugs

being labeled for use in pediatric applications. As of March

31, 2001, 94 applications containing complete or partial

pediatric use and information have been submitted to the

agency. Of these 94 applications, 45 are attributable to the

statutory exclusivity provision. FDA attributes 48 of the 94

applications to the authority of the pediatric rule alone.

So you can see how the two must work together, how important the rule is. Our legislation is a step toward assuring this progress that we have made so far will not erode. Our bill, as amended, provides that the FDA may only impose the pediatric study requirement for already- marketed drugs when the pediatric exclusivity incentive provisions fail to yield necessary pediatric information. This means that for already- marketed drugs, drugs that the FDA has already approved and are already on the drugstore shelf, before FDA can require a company to study the drug for use in children, the incentive provisions of the Best Pharmaceuticals law have to be used first. So the drug manufacturer has to choose to use the incentive provisions first, before FDA can invoke the pediatric study requirement.

Our bill also preserves the waiver and deferral process so that drug companies can get waivers or deferrals for a range of legitimate reasons. Waivers are a simple concept.

Drugs, such as those used to treat Alzheimer's disease--those drugs that would not be used in children at all--obviously should not be tested for use in children. Those drug manufacturers would be allowed to waive the pediatric drug study requirement.

Deferrals are similar. For drug manufacturers who require additional time to complete the drug study or need to get additional information in the adult population before beginning to study the drug in children can, in consultation with the FDA, defer the pediatric drug studies until a later date.

Again, I am very pleased that my colleagues have agreed to pass our bill. It is a vital step toward ensuring that children are no longer a therapeutic afterthought.

Our bill puts children on a level playing field with adults for the first time.

Before I yield the floor, I would like to take this opportunity to thank the many people who have worked diligently to draft this bill and to help get it passed. I would like to thank Majority Leader Frist and Senators Clinton, Dodd, Gregg, Kennedy, and Murray for their leadership on this issue. Without their support, this bill would not be a reality.

I would also like to thank Abby Kral of my staff for her dedication and hard work on this issue--she spent an unbelievable amount of time on it--as well as Christina Ho from Senator Clinton's Staff, Ben Berwick with Senator Dodd, Vince Ventimiglia with Senator Gregg's Staff, and David Dorsey with Senator Kennedy.

Finally, I would like to recognize two groups that provided my staff and the staff of the HELP Committee with invaluable comments and insights--the American Academy of Pediatrics and the Elizabeth Glaser Pediatric AIDS Foundation.

Thank you all for your efforts and commitment to protecting our children's health and safety.

Mr. President, I ask unanimous consent that the committee amendment be agreed to, the Gregg amendment be agreed to, that the bill, as amended, be read a third time and passed, the motion to reconsider be laid upon the table, and that any statements and colloquies relating to the bill be printed in the Record.

Mr. President, I rise today to talk about a very important subject--one that affects parents, doctors, hospitals, nurses and our children each and every day. The subject that I am talking about is the safety and efficacy of the medicines that doctors give our children when they are sick.

Nearly six years ago, I was astonished to learn that close to 80 percent of drugs on the market were not tested for use in children-- yet, doctors were prescribing these drugs to our children. Doctors had no choice but to prescribe these drugs for children if they thought the medicines would be helpful. And, sometimes the medicines did help-- sometimes a child's pain was relieved, or a child would be able to breathe easier or digest food better because of the medicines the doctors prescribed them. But, even when the drugs do work, an anxious feeling remains among doctors and parents about whether these medicines are safe for children. How are doctors and parents to know for certain which medicines will work if they haven't been tested for safety and efficacy in children?

There are many examples, of situations where drugs have been misprescribed for children because doctors simply weren't aware of the effects these drugs would have on kids. For example, the drug, Neurontin, which is used to treat chronic pain, was given to children without being properly tested, and doctors eventually learned they were under-dosing children by 50 percent. That means children were suffering from pain because they were being under-dosed. They weren't being given the proper dose of medication to relieve their pain.

Another drug, Lithium, which has been prescribed to treat bipolar disorder since 1940 was never tested for long-term use in children until just a few months ago. This is an example of a drug that doctors have been prescribing ``off-label'' for years, and only now we are finally getting some evidence of its effect in children. According to doctors, the testing of Lithium revealed important information because children who suffer from bipolar disorder cycle between mania and depression quicker than adults, and they can even have signs of both at the same time. Unlike adults, they don't have periods of normalcy. Doctors now know that Lithium can be used to treat bipolar disorder in children.

Doctors have taken a chance in prescribing medicines for children. Doctors tell parents to cut a pill in half or in quarters so it can be given to a child. Doctors use the best information they have to determine how much or what kind of medicines to give a child. That is all they can do when the medicines children need have not been tested for their use.

Doctors and pediatricians should not be left to guess how much medicine our children should receive. And, parents shouldn't have to feel anxious or question whether the half a pill that's been ground up and put in applesauce will still be effective in treating their child-- or whether it's even safe for their child to take.

It's been over a year now since the Senate passed and the President signed into law the Best Pharmaceuticals for Children's Act. As many of my colleagues know, that law has been part of a solution--but just a part of a solution--to address the problem I just mentioned. The law provides a six-month patent extension to pharmaceutical companies in exchange for the testing of medicines in children. And, for as long as the bill has been law, the Food and Drug Administration is reporting its success in ensuring that more medicines are tested for use in children. With the incentive provided by Best Pharmaceuticals, companies are seeing the value of studying their drugs in children and are applying for the patent extension.

But, the Best Pharmaceuticals incentive cannot work alone to ensure that medicines in children do not go untested. The incentive in the Best Act was never intended to work alone. When the Best Act became law, there was already a rule on the books that helped ensure that no medicine used to treat children, including vaccines or other biologics, would go untested. Back in 1997, the Food and Drug Administration proposed what is known today as the Pediatric Rule. The Pediatric Rule allowed FDA to require that the drugs the agency felt are important for children are safe, effective, and properly labeled for children.

Unfortunately, the Pediatric Rule has come under legal challenge, with a District Court ruling just a few months ago stating that FDA lacked the statutory authority to require pediatric studies. This was a troubling step backward for children's health--a troubling step at a time when 75 percent of the medicines on the market still aren't tested and labeled for pediatric use. We've made some improvements from the 80 percent of medicines on the market, but 75 percent is still too much. Without the Pediatric Rule, new medicines and biologics coming onto the market are not required to be tested for use in children. Congress needs to make sure that the FDA continues to have every tool--that includes the market incentives and the pediatric rule--available to them to ensure that drugs for children are tested for safety and efficacy and that they are labeled properly.

Everyday that a drug manufacturer chooses not to participate in the incentive program, the number of medicines

that go untested for use in children increases. Everyday that we don't have the Pediatric Rule, we sacrifice our children's safety. Medicines that are used by children should be tested for safety and efficacy. That is why Senators Clinton, Gregg, Dodd, and Kennedy and I are introducing a bill today--the Pediatric Research Equity Act--that would ensure that the Pediatric Rule continues to work alongside the Best Act, so that children will remain on safe footing when it comes to the testing of the medications they use.

Congress needs to make sure the Pediatric Rule stays in place, because right now, the Pediatric Rule and the Best Act incentive work together to ensure that drugs are tested for use in children. As I said already, the Best Act was never intended to substitute the rule, but rather to reinforce and work with the rule. For example, the Pediatric Rule may be invoked in instances where pediatric information is essential, but the patent exclusivity is no longer available.

The Pediatric Rule also applies to biologics, whereas the Best Pharmaceuticals does not. A significant portion of therapeutics used in children, including many cancer treatments, are biological products (products that include a live agent). Because Best Pharmaceuticals does not apply to biologics, the Pediatric Rule is the only way to ensure pediatric labeling.

Finally, the Best Pharmaceuticals is voluntary. For any number of reasons, including insufficient sales, a manufacturer may choose not to conduct the testing necessary to receive additional exclusivity under the Best Act. But, just because a drug manufacturer chooses not to study the drug in children does not mean that drug is not critical to the proper treatment of our children. Without the Pediatric Rule, there is no way to guarantee that a drug that is used in the pediatric population is tested for children's use.

With the establishment of the Pediatric Rule and the financial incentives of the Best Pharmaceuticals law, there has been a dramatic increase in the number of studies that have been undertaken. Let me quote from the Government's Response to Plaintiff's Notice of Reauthorization of FDA Modernization Act. This is the document that the government filed to defend the lawsuit against the Rule: ``These two options [the Best Pharmaceuticals for Children Act and the Pediatric Rule] have resulted in a number of drugs being labeled for use in pediatric populations. As of March 31, 2002, 94 applications containing complete or partial pediatric use information had been submitted to the agency. Of these 94 applications, 45 are attributable to the statutory exclusivity provisions. FDA attributes 48 of the 94 applications to the authority of the pediatric rule alone.''

The bill that my colleagues and I are introducing today would help maintain that progress--not erode it. Our bill would provide the FDA with the authority it needs to ensure that the medicines children take are studied for safety and efficacy. And, our bill would give FDA this authority in a way so that it does not conflict with the incentives provided in the Best Pharmaceuticals Act.

Our bill would preserve the waiver and deferral process, so that drug companies can get waivers or deferrals for a range of legitimate reasons. Drug companies could get a waiver or deferral of studies for safety or ethical concerns. A drug company could get a waiver or deferral if the pediatric testing would interfere with the drug's availability for adults.

Ultimately, though, our bill would help make certain that children are no longer a therapeutic afterthought by ensuring that all new drugs are studied for pediatric use at the time a drug comes to market. This would put children on a level playing field with adults for the first time. Our children deserve no less, and I encourage my colleagues to join in support of this legislation.

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

Mr. President, I rise to introduce, with my good friends Senator Hatch, Senator Mikulski and Senator Durbin, the Federal Prosecutors' Retirement Benefit Equity Act of 2003. This bill would correct an inequity that exists under current law, whereby Federal prosecutors receive substantially less favorable retirement benefits than other nearly all other people involved in the Federal criminal justice system. The bill would increase the retirement benefits given to Assistant United States Attorneys by including them as ``law enforcement officers'', LEOs, under the Federal Employees' Retirement System and the Civil Service Retirement System. The bill would also allow the Attorney General to designate other attorneys employed by the Department of Justice who act primarily as criminal prosecutors as LEO's for purposes of receiving these retirement benefits.

The primary reason for granting enhanced retirement benefits to LEOs is the often dangerous work of law enforcement. Currently, Assistant United States Attorneys, AUSAs, and other Federal prosecutors are not eligible for these enhanced benefits, which are enjoyed by the vast majority of other employees in the criminal justice system. This exclusion is unjustified. The relevant provisions of the United States Code dealing with retirement benefits define an LEO as an employee whose duties are, ``primarily the investigation, apprehension, or detention'' of individuals suspected or convicted of violating federal law. See 5 U.S.C. Sec. Sec. 8331(20) & 8401(17). AUSAs and other federal prosecutors participate in planning investigations, interviewing witnesses both inside and outside of the office setting, debriefing defendants, obtaining warrants, negotiating plea agreements and representing the government at trials and sentencings, all of which fall within the definition of the duties performed by law enforcement officers. Indeed, once a defendant is brought to into the criminal justice system, the person with whom they have the most face-to-face contact, and often in an extremely confrontational environment, is the Federal prosecutor.

Although prosecutors do not personally execute arrests, searches and other physically dangerous activities, LEO status is accorded to many criminal justice employees who do not perform such tasks, such as pretrial services officers and probation officers and accountants, cooks and secretaries of the Bureau of Prisons. Moreover, because they are often the most conspicuous representatives of the government in the criminal justice system, Federal prosecutors are natural targets for threats of reprisals by vengeful criminals. Indeed, there are numerous incidents in which assaults and serious death threats have been made against federal prosecutors, sometimes resulting in significant disruption of their personal and family lives.

Only recently a veteran Federal prosecutor in the Western District of Washington was murdered in his home, and, although the crime remains unsolved, based upon the facts of the case the authorities have referred to the crime as a hit. In addition, I have received many other accounts from Federal prosecutors regarding specific threats to which they and their families have been subjected because of the performance of their duties. Federal prosecutors have written to me that they have been forced to relocate themselves and their families due to death threats; that they have been assaulted; that they and their families have been followed by members of criminal organizations; that have been forced to install security systems at their homes and to change their routes to and from the office to protect their safety and the safety of their families.

As our fight against terrorism continues, Federal prosecutors arel on the front lines once again as the symbols of our criminal justice system, and unfortunately therefore the targets of those who seek its downfall. Among other tasks, the Attorney General has designated AUSA's to play a major role working with police and Federal agents in each judicial district's Anti-Terrorism Task Force. One Federal prosecutor wrote to me stating that shortly after his name was in the local news as heading his district's Anti-Terrorism Task Force and he had spoken to his family about taking suitable precautions, that his young son came into his bedroom one night holding a hockey stick for protection asking about their safety. Thus, Federal prosecutors and their families will deal more than ever with a level of stress and danger that justifies their being treated as LEOs.

Another example of the danger facing Federal prosecutors appeared in the USA Today earlier this month. That article, which I ask unanimous consent to make part of the Congressional Record, reports that United States Attorney's will also be asked to play an advisory role in potential hostilities with Iraq. If there was ever an illustration of the importance of granting Federal prosecutors equal retirement status as their other law enforcement partners, this is it.

Enhanced retirement benefits are also justified by the Federal Government's need for experienced prosecutors to bring ever more sophisticated cases under increasingly complex Federal criminal laws. In recent years, we have seen the growth of complex Federal prosecutions to combat the threats posed by organized crime, drug cartels, terrorist groups and other sophisticated criminals. The prosecution of such difficult cases is best handled by experienced prosecutors. It is therefore in the public interest to provide reasonable financial incentives for talented, experienced prosecutors to remain in government service.

This bill would make Assistant United States Attorneys and other Federal prosecutors designated by the Attorney General eligible for immediate, unreduced retirement benefits at age 50 with 20 years of service. For example, prosecutors who are covered by the Civil Service Retirement System would receive 50 percent of the average of their three highest years' salary. At

the same time, it would exempt prosecutors from the mandatory retirement provisions that require other law enforcement officers to retire at age 57. Because the loss of physical strength and agility does not adversely affect a person's ability to function as a prosecutor, there is no reason to mandate early retirement.

Two important features of this bill will contain its costs. First, the bill provides that incumbent Federal prosecutors are themselves responsible for making up the difference in individual contributions owed to the Civil Service Retirement and Disability Fund for their prior service. An incumbent has the choice of making up this difference either by making a payment up front or by accepting a reduction in retirement benefits. Second, government contributions for the prior service of incumbents are made ratably over a ten-year period under this bill. Thus, payments for prior government contributions are spread out to lessen the financial impact. These two provisions will insure that the cost of the bill is kept well within reason.

This bill enjoys broad, grass roots support. When Senator Hatch and I introduced this same bill in the last Congress, I received literally hundreds of letters supporting this bill, sent from over 40 states, District of Columbia and Puerto Rico. The bill also enjoys support in the law enforcement community. The National Association of Assistant United States Attorneys, the Federal Criminal Investigators Association, and the Southern States Police Benevolent Association have all wrote me to voice support for the inclusion of AUSAs in the definition of an LEO. I tried, with Senator Hatch, to include this measure in our Department of Justice Authorization legislation in the last Congress, but the House would not agree to its inclusion in the conference report. I hope that we can work together in both houses to enact the bill in this Congress.

In addition, I know that other Senators, including Senator Mikulski, are considering additional measures to expand these same retirement benefits to other Federal employees who perform law enforcement functions, including IRS employees whose primary duty is to collect delinquent taxes. I cosponsored such a measure in the last Congress, and I continue to support and commend her leadership in bringing these matters to the forefront.

For all of these reasons, I am pleased to introduce this legislation with Senators Hatch, Mikulski and Durbin, and I urge its swift enactment into law.

I ask unanimous consent that the text of the bill be printed in the Record along with the sectional analysis and the newspaper article to which I referred.