[Congressional Record Volume 146, Number 84 (Wednesday, June 28, 2000)]
[Senate]
[Pages S6021-S6025]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD (for himself and Mr. DeWine):
  S. 2809. A bill to protect the health and welfare of children 
involved in research; to the Committee on Health, Education, Labor, and 
Pensions.


                   children's research protection act

  Mr. DODD. Mr. President, I rise today with my colleague from Ohio, 
Senator DeWine, to introduce important legislation to enhance the 
safety

[[Page S6022]]

of our children. The Children's Research Protection Act will strengthen 
protections for children participating in research and also increase 
the number researchers expert in pediatric pharmacology.
  Three years ago, Senator DeWine and I were successful in enacting 
legislation to reverse a troubling statistic--the fact that only 20 
percent of drugs on the market have been tested specifically for their 
safety and efficacy in children. Our legislation, The Better 
Pharmaceuticals for Children Act, for the first time provided a 
incentive for drug companies to test their products for use with 
children. The results of that legislation have been overwhelming. In 
the 2 years since this initiative was started, drug manufacturers have 
launched more than 300 new pediatric studies of 127 drugs. In contrast, 
in the 5 years prior to enactment of our legislation, the industry 
conducted only 11 pediatric safety studies for drugs already on the 
market--11 studies in five years versus over 300 in just 2 years. The 
most immediate consequence of this surge in the industry's interest in 
testing their products in children is the rapid increase in the number 
of children being signed up to participate in research studies--more 
than 18,000 children will eventually be needed just for the 300 trials 
that have been proposed so far.
  While we're thrilled with the success of our legislation, it has 
forced us to take a hard look at the adequacy of the safety protections 
for children participating in research. All experimental treatments, by 
their very nature, contain some risk. Research involving children is no 
exception. Yet, despite the risks, each year thousands of parents agree 
to allow their children to participate in a clinical trial, either in 
hopes of improving their own health or the health of other children. In 
doing so, they place their trust in the expertise and ethics of the 
researchers and in strong oversight by the federal government. The vast 
majority of the time that trust is well-founded. But recent isolated 
incidents involving children harmed during clinical trials, as well as 
increasing concerns about the adequacy of federal oversight for 
clinical trials, generally point to the need to proactively address the 
issue of the safety of children in research.
  It is that need to be proactive that has led Senator DeWine and I to 
introduce the Children's Research Protection Act. This legislation will 
address critical safety issues in children's research by:
  (1) Requiring the Secretary of Health and Human Services (HHS) to 
review the current regulations for the protection of children 
participating in research and to clarify and update them to ensure the 
highest standards of safety.
  Requiring that all HHS funded and regulated research comply with 
these strengthened federal protections. (Currently research overseen by 
the Food and Drug Administration, but funded by private pharmaceutical 
companies, is not required to comply with the additional children's 
protections, although many pharmaceutical companies do so voluntarily.)
  (3) Requiring the 15 federal agencies that don't currently have 
special guidelines for children's research to develop them within 12 
months.
  (4) Asking the Secretary of HHS to review the adequacy of the IRB 
(Institutional Review Board) process for protecting children in 
clinical trials and to report to Congress within 6 months on the 
question of whether we should have a national board(s) to review 
adverse events arising out of research on children.
  (5) Increasing the number of researchers that are experts in 
conducting drug research with children by providing grants for 
fellowship training and creating a loan repayment program for pediatric 
drug researchers. Only 20 physicians complete clinical pharmacology 
speciality training programs each year--of these, only 2 or fewer 
specialize in pediatric pharmacology.
  We still have a long way to go to make sure that children are not an 
afterthought when it comes to drug research, but we can start by making 
sure that when they volunteer to help other children by participating 
in research, their safety is paramount. This measure prescribes a 
strong dose of safety for our children. It provides critically 
important safeguards and protections when it comes to pediatric 
medicine testing, allowing us to increase our knowledge of children's 
medication without increasing the danger to children.
  I am pleased to join Senator DeWine in this effort and I look forward 
to working with my colleague to pass this legislation.
  I ask unanimous consent that the attached letters and a copy of the 
bill be printed in the Record.
  There being no objection, the materials were ordered to be printed in 
the Record, as follows:

                                S. 2809

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Children's Research 
     Protection Act''.

     SEC. 2. FINDINGS, PURPOSES, AND DEFINITION.

       (a) Findings.--Congress makes the following findings:
       (1) Children are the future of the Nation and the 
     preservation and improvement of child health is in the 
     national interest.
       (2) The preservation and improvement of child health may 
     require the use of pharmaceutical products.
       (3) Currently only 1 out of 5 drugs on the market in the 
     United States have been approved for use by children. The 
     enactment of the provisions of the Food and Drug 
     Administration Modernization Act (Public Law 105-115) 
     relating to pediatric studies of drugs, however, is expected 
     to increase the pediatric testing of pharmaceuticals and thus 
     to increase the numbers of children involved in research.
       (4) Children are a vulnerable population and thus need 
     additional protections for their involvement in research 
     relative to adults. Yet, current Federal guidelines for the 
     protection of children involved in research have not been 
     updated since 1981, do not currently apply to Food and Drug 
     Administration-regulated research that is not Federally 
     funded, and have not been adopted by all Federal agencies 
     that conduct research involving children.
       (5) Currently, in the United States, there is a shortage of 
     pharmacologists trained to address the unique aspects of 
     developing therapies for children. There are fewer than 200 
     academic-based clinical pharmacologists in the United States, 
     of which 20 percent or fewer are pediatricians. Currently, 
     only 20 physicians complete clinical pharmacology specialty 
     training programs each year, and of these, only 2 or fewer 
     specialize in pediatric pharmacology.
       (b) Purposes.--It is the purpose of this Act to--
       (1) ensure the adequate and appropriate protection of 
     children involved in research by--
       (A) reviewing and updating as needed the Federal 
     regulations that provide additional protections for children 
     participating in research as contained in subpart D of part 
     45 of title 46, Code of Federal Regulations;
       (B) extending such subpart D to all research regulated by 
     the Secretary of Health and Human Services; and
       (C) requiring that all Federal agencies adopt regulations 
     for additional protections for children involved in research 
     that is conducted, supported, or regulated by the Federal 
     Government; and
       (2) ensure that an adequate number of pediatric clinical 
     pharmacologists are trained and retained, in order to meet 
     the increased demand for expertise in this area created by 
     the pediatric studies provisions of the Food and Drug 
     Administration Modernization Act (Public law 105-115), so 
     that all children have access to medications that have been 
     adequately and properly tested on children.
       (c) Definition.--In this Act, the term ``pediatric clinical 
     pharmacologist'' means an individual--
       (1) who is board certified in pediatrics; and
       (2) who has additional formal training and expertise in 
     human pharmacology.

     SEC. 3. REVIEW OF REGULATIONS.

       (a) Review.--By not later than 6 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall have conducted a review of the regulations 
     under subpart D of part 45 of title 46, Code of Federal 
     Regulations, considered any modifications necessary to ensure 
     the adequate and appropriate protection of children 
     participating in research, and report the findings of the 
     Secretary back to Congress.
       (b) Areas of Review.--In conducting the review under 
     subsection (a), the Secretary of Health and Human Services 
     shall consider--
       (1) the appropriateness of the regulations for children of 
     differing ages and maturity levels, including legal status;
       (2) the definition of ``minimal risk'' and the manner in 
     which such definition varies for a healthy child as compared 
     to a child with an illness;
       (3) the definitions of ``assent'' and ``permission'' for 
     child clinical research participants and their parents or 
     guardians and of ``adequate provisions'' for soliciting 
     assent or permission in research as such definitions relate 
     to the process of obtaining the informed consent of children 
     participating in research and the parents or guardians of 
     such children;
       (4) the definitions of ``direct benefit to the individual 
     subjects'' and ``generalizable

[[Page S6023]]

     knowledge about the subject's disorder or condition'';
       (5) whether or not payment (financial or otherwise) may be 
     provided to a child or his or her parent or guardian for the 
     participation of the child in research, and if so, the amount 
     and type given;
       (6) the expectations of child research participants and 
     their parent or guardian for the direct benefits of the 
     child's research involvement;
       (7) safeguards for research involving children conducted in 
     emergency situations with a waiver of informed assent;
       (8) parent and child notification in instances in which the 
     regulations have not been complied with;
       (9) compliance with the regulations in effect on the date 
     of enactment of this Act, the monitoring of such compliance, 
     and enforcement actions for violations of such regulations; 
     and
       (10) the appropriateness of current practices for 
     recruiting children for participation in research.
       (c) Consultation.--In conducting the review under 
     subsection (a), the Secretary of Health and Human Services 
     shall consult broadly with experts in the field, including 
     pediatric pharmacologists, pediatricians, bioethics experts, 
     clinical investigators, institutional review boards, industry 
     experts, and children who have participated in research 
     studies and the parents or guardians of such children.
       (d) Consideration of Additional Provisions.--In conducting 
     the review under subsection (a), the Secretary of Health and 
     Human Services shall consider and, not later than 6 months 
     after the date of enactment of this Act, report back to 
     Congress concerning--
       (1) whether the Secretary should establish national data 
     and safety monitoring boards to review adverse events 
     associated with research involving children; and
       (2) whether the institutional review board oversight of 
     clinical trials involving children is adequate to protect the 
     children.

     SEC. 4. REQUIREMENT FOR ADDITIONAL PROTECTIONS FOR CHILDREN 
                   INVOLVED IN RESEARCH.

       (a) In General.--Notwithstanding any other provision of 
     law, not later than 6 months after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     require that all research involving children that is 
     conducted, supported, or regulated by the Department of 
     Health and Human Services be in compliance with subpart D of 
     part 45 of title 46, Code of Federal Regulations.
       ``(b) Other Federal Agencies.--Not later than 12 months 
     after the date of enactment of this Act, all Federal agencies 
     shall have promulgated regulations to provide additional 
     protections for children involved in research.

     SEC. 5. GRANTS FOR PEDIATRIC PHARMACOLOGY.

       (a) In General.--The Secretary of Health and Human Services 
     shall award grants to qualified academic research 
     institutions and research networks with the appropriate 
     expertise to provide training in pediatric clinical 
     pharmacology, such as the Pediatric Pharmacology Research 
     Units of the National Institute of Child Health and Human 
     Development, and the Research Units of the National Institute 
     of Mental Health, to enable such entities to provide 
     fellowship training to individuals who hold an M.D. in order 
     to ensure the specialized training of pediatric clinical 
     pharmacologists.
       (b) Amount of Grant.--In awarding grants under subsection 
     (a), the Secretary of Health and Human Services shall ensure 
     that each grantee receive adequate amounts under the grant to 
     enable the grantee to fund at least 1 fellow each year for a 
     3-year period, at a total of $100,000 per fellowship per 
     year.
       (c) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each fiscal 
     year.

     SEC. 6. LOAN REPAYMENT PROGRAM REGARDING CLINICAL 
                   RESEARCHERS.

       Part G of title IV of the Public Health Service Act is 
     amended by inserting after section 487E (42 U.S.C. 288-5) the 
     following:

     ``SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING PEDIATRIC 
                   PHARMACOLOGY.

       ``(a) In General.--The Secretary, acting through the 
     Director of the National Institutes of Health, shall 
     establish a program to enter into contracts with qualified 
     individuals who hold an M.D. under which such individuals 
     agree to undergo training in, and practice, pediatric 
     pharmacology, in consideration of the Federal Government 
     agreeing to repay, for each year of service as a pediatric 
     pharmacologist, not more than $35,000 of the principal and 
     interest of the educational loans of such individuals.
       ``(b) Application of Provisions.--The provisions of 
     sections 338B, 338C, and 338E shall, except as inconsistent 
     with subsection (a) of this section, apply to the program 
     established under subsection (a) to the same extent and in 
     the same manner as such provisions apply to the National 
     Health Service Corps Loan Repayment Program established in 
     subpart III of part D of title III.
       ``(c) Funding.--
       ``(1) Authorization of appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each fiscal 
     year.
       ``(2) Availability.--Amounts appropriated for carrying out 
     this section shall remain available until the expiration of 
     the second fiscal year beginning after the fiscal year for 
     which the amounts were made available.''.

     SEC. 7. EFFECTIVE DATE.

       The provisions of sections 5 and 6 shall take effect on the 
     date that is 6 months after the date of enactment of this 
     Act.
                                  ____

                                                      May 1, 2000.
       Dear Senator Dodd, I am addressing you today in support of 
     proposed senate bill, AAC: ``Children's Research Protection 
     Act'' ``. . . that will protect the health and welfare of 
     children involved in research.'' Additionally, this bill will 
     serve to ascertain whether specific guidelines should be 
     included in the Code of Federal Regulations for conducting 
     research with other vulnerable members of our society.
       As a long time advocate and provider of services for 
     persons with disabilities, families and children, my ongoing 
     research of the informed consent process as it relates to 
     clinical trials dates back to 1979. At that time, I focused 
     on some very complex issues of conducting medical research 
     with children who had mental retardation and were being 
     placed under state care.
       We are a wealthy and powerful nation and I believe that our 
     children are our greatest treasure. They deserve the highest 
     ethical standards that we can provide in all areas of their 
     lives including medical research and health. With the passage 
     of the Food and Drug Administration Modernization Act, we 
     have widened the field of pediatric clinical research, as 
     should be the case since until this time it has been 
     seriously lacking attention. Due to this surge in new 
     research, it is the opportune time to review federal 
     regulations that provide guidelines for clinical trials. We 
     need to close gaps and better define protections so that our 
     children will be offered the safest environment possible 
     during research efforts. Furthermore, the parents and 
     guardians of our children need to have every advantage and 
     possible opportunity afforded them so they can more fully 
     understand the experimental nature of any research before 
     giving consent.
       I am particularly excited that there are provisions in this 
     bill to help increase the number of pediatric clinical 
     pharmacologists and clinical investigators. This action will 
     strengthen the quality of research and treatment prescribed 
     for children.
       In closing, this bill helps reach a goal of optimal health 
     therapy for our children. As always, I appreciate the hard 
     work and time that has been expended to bring this issue 
     forward for legislative action. Thank you.
           Sincerely,
     Sheila S. Mulvey.
                                  ____

                                                      May 1, 2000.
       To Whom It May Concern: My name is David Krol and I am a 
     pediatrician in New Haven, Connecticut and a recent graduate 
     of pediatric residency training. I am writing in support of 
     the Children's Research Protection Act. As both a practicing 
     pediatrican and a child health researcher I am very 
     interested in studies that can improve the lives of children. 
     These studies, however, need to keep in mind the unique 
     biology of children as well as the developmental needs of 
     those who would participate in these studies. Children are 
     most definitely a unique population and require protections 
     in the research environment that are adequate, appropriate, 
     and different from adults. I am pleased to see that the 
     Children's Research and Protection Act addresses these 
     issues.
       In addition, as a recent graduate from medical school with 
     a debt burden hovering near $90,000, I am very aware of the 
     difficult decision that many medical school graduates face in 
     choosing a specialty. It can be a very difficult decision to 
     pursue further training and postpone the reduction of the 
     significant debt many of us face. Those who pursue pediatric 
     subspecialty training, including pediatric pharmacologists, 
     are no exception to this fact. I am very happy to see that 
     the Children's Research Protection Act provides both funding 
     for pediatric pharmacology positions and loan repayment for 
     those who would choose to further their education in such an 
     important and rewarding specialty. I hope we can extend this 
     opportunity to all who pursue pediatric subspecialty 
     training. Pediatric research requires not only experts in 
     pediatric pharmacology but also in the specific diseases that 
     need to be researched.
       It is with great pleasure that I write this letter in 
     support of the Children's Research Protection Act. I ask for 
     your support concerning this important issue in child health.
           Sincerely,
     David M. Krol, MD.
                                  ____



                               American Academy of Pediatrics,

                                                      May 1, 2000.
     Hon. Christopher Dodd,
     U.S. Senate,
     Washington, DC.
     Hon. Mike DeWine,
     U.S. Senate,
     Washington, DC.
       Dear Senators Dodd and DeWine: The American Academy of 
     Pediatrics, representing 55,000 pediatricians throughout the 
     United States, is pleased to support the Children's Research 
     Protection Act. This legislation provides appropriate and 
     needed requirements for the inclusion of children in any 
     research conducted, supported, or regulated by the U.S. 
     Department of Health and Human Services.
       Protection of children in all research settings is an 
     imperative. Under your strong

[[Page S6024]]

     leadership, important advances are being made in therapeutic 
     research for children through the Food and Drug 
     Administration Modernization Act (FDAMA). As a result of 
     FDAMA, the increase in the number of new clinical trials 
     involving pediatric patients is unprecedented. The Children's 
     Research Protection Act balances the need to continue and 
     encourage more and better clinical trials involving children 
     while at the same time ensuring that children are protected 
     by requiring that all research be in compliance with subpart 
     D of part 45 of title 46, Code of Federal Regulations.
       This legislation also recognizes the importance of 
     increasing the number of pediatric clinical researchers 
     through the grant and loan repayment provisions. We strongly 
     believe that this kind of greater support is needed for all 
     pediatric research scientists. Still, we recognize that this 
     legislation specifically addresses FDAMA's significant 
     increase on the need for additional pediatric clinical 
     pharmacologists to conduct pediatric drug studies. The grant 
     program and loan repayment provisions of this bill are 
     important incentives to securing greater numbers of well-
     trained experts of pediatric clinical pharmacology, and can 
     hopefully be used as models for promoting a broader scope of 
     pediatric research.
       Throughout the years, you have been a strong and successful 
     advocate for children and their needs and the American 
     Academy of Pediatrics is grateful to you. The Children's 
     Research Protection Act will be an advance for children. We 
     offer our assistance as this bill moves through the Congress.
           Sincerely,
                                         Donald E. Cook, MD, FAAP,
     President.
                                  ____

                                       Pharmaceutical Research and


                                     Manufacturers of America,

                                    Washington, DC, June 26, 2000.
     Hon. Mike DeWine,
     U.S. Senate,
     Washington, DC.
     Hon. Christopher J. Dodd,
     U.S. Senate,
     Washington, DC.
       Dear Senators DeWine and Dodd: The Pharmaceutical Research 
     and Manufacturers of America (PhRMA) is pleased to offer its 
     support for The Children's Research Protection Act. This 
     piece of legislation addresses several key gaps towards the 
     successful implementation of Section 111 of the Food and Drug 
     Modernization Act of 1997 (FDAMA). This particular section of 
     FDAMA has had an enormous impact on the investigation of 
     important medicines in children. There has been a remarkable 
     increase in the number of medicines being studied by 
     pharmaceutical companies. The pharmaceutical industry has 
     proposed pediatric studies on 177 medicines and the FDA has 
     issued 145 written requests for studies as of May 1, 2000. In 
     the short time since its inception, the legislation has 
     fundamentally changed our approach to the study of medicines 
     in children and holds enormous promise for improved treatment 
     of sick children.
       Several issues have become apparent as we have embarked on 
     this new era of clinical investigation. There is clearly a 
     shortage of experienced pediatric clinical pharmacologists, 
     and those active in the field are generally quite senior. 
     There is thus a need for training the next generation of 
     investigators. If children are to receive the benefits of the 
     new medicines now under development, and of the exciting 
     therapies of the future, we will need highly qualified 
     pediatric investigators, knowledgeable in the safe, ethical, 
     and efficient study of medicines in children. The NICHD 
     Pediatric Pharmacology Research Unit network has been 
     instrumental in doing excellent studies in this area, and is 
     an exemplary training ground for young pediatric 
     investigators. It is vital that pediatric clinical 
     investigation be performed by our best physician/scientists, 
     in centers fully equipped to ensure a positive environment 
     for children who participate in studies, and to ensure that 
     all studies are done with the very highest standards of 
     clinical investigation and clinical care.
       It is also crucial, as the number of patients studied is 
     expanding, to re-emphasize the ethical standards for 
     conducting studies in children. The FDA has held meetings of 
     its Pediatric Pharmacology Subcommittee, and one issue of 
     concern was that the DHHS Guidelines in investigation of 
     vulnerable subjects, 45 CRF 46, Subpart D does not cover all 
     of the studies or investigative centers where studies of 
     medicines under FDAMA might be done. It is clear that it is 
     in the interest of children, and of the clinical 
     investigative process, that the provision be reviewed and 
     that all studies of medicines in children be covered under 
     this provision.
       To assure career paths for the new trainees in pediatric 
     clinical pharmacology, renewal of Section 111 of FDAMA is 
     particularly important since it assures continued pediatric 
     clinical investigation of new medicines. These two 
     legislative initiatives will have a major impact on the 
     future of the health of our children.
           Sincerely,
     Stephen P. Spielberg, MD, Ph.D.,
     Vice President, Pediatric Drug Development, Janssen Research 
     Foundation, Chair, Pediatric Task Force, PhRMA.
     Alan Goldhammer, Ph.D.,
       Associate Vice President, US Regulatory Affairs PhRMA.
                                  ____

                                     American Society for Clinical


                                Pharmacology and Therapeutics,

                                     Alexandria, VA, May 16, 2000.
     Hon. Christopher Dodd,
     U.S. Senate,
     Washington, DC.
       Dear Senator Dodd: The American Society for Clinical 
     Pharmacology and Therapeutics is pleased to express support 
     of the Children's Research Protection Act. Our society is the 
     largest academic society of clinical pharmacologists in the 
     United States and consists of member scientists, clinicians 
     and researchers from the academic, regulatory and industry 
     sectors including physicians, PhDs and PharmDs. We endorse 
     the great need for this legislation as a means of improving 
     the care of children by improving medications available to 
     them and by increasing the effective use of medicines that 
     are already on the market for children. In addition, we 
     believe that the provisions of this legislation will 
     ultimately lead to a reduced incidence of side effects and 
     the rate of medication errors in children.
       There are only two pediatric clinical pharmacology training 
     programs in this country, and it is estimated that the number 
     of practicing pediatric clinical pharmacologists may be as 
     few as 20. Consequently, it is little wonder that 80% of the 
     drugs already on the market have yet to be approved for use 
     in children. We must expand the cadre of well-trained 
     pediatric clinical pharmacologists who can focus their 
     scientific and clinical skills on assuring that children have 
     access to the same therapies readily available to adult 
     patients. Further, special studies are required regarding the 
     proper dosage and safe use of medications in children. The 
     ASCPT applauds your recognition of these needs, and we 
     believe that your bill includes the means to these ends: a 
     program to increase the number of funded pediatric clinical 
     pharmacology fellowships and a loan repayment program to 
     attract physicians to careers in clinical pharmacology will 
     improve the health of children through the safe use of 
     available medications.
       Thank you for your leadership on children's health care, 
     and please add the American Society for Clinical Pharmacology 
     and Therapeutics to the list of organizations endorsing the 
     Children's Research Protection Act.
           Yours sincerely,
                                         Raymond L. Woosley, M.D.,
     President.
                                  ____

                                           National Association of


                                         Children's Hospitals,

                                      Alexandria, VA, May 9, 2000.
     Hon. Christopher Dodd,
     U.S. Senate,
     Washington, DC.
     Hon. Mike DeWine,
     U.S. Senate, Washington, DC.
       Dear Senators Dodd and DeWine. On behalf of the National 
     Association of Children's Hospitals (N.A.C.H.), an 
     organization representing more than 100 freestanding 
     children's hospitals and pediatric departments of major 
     medical centers, I am writing to support the ``Children's 
     Research Protection Act.'' This legislation represents an 
     important step in assuring that children enrolled in 
     federally supported and/or regulated research receive 
     important protections for their safety and well-being when 
     participating as research subjects.
       Children's hospitals are major centers for pediatric 
     clinical research--research supported by the federal 
     government, as well as private industry. The biomedical 
     research efforts undertaken by children's hospitals recognize 
     that ``children are not little adults'' and that their unique 
     needs must be taken into account when developing and 
     monitoring research protocols to address pediatric diseases 
     and conditions. With the relatively recent adoption of the 
     Food and Drug Administration Modernization Act (FDAMA), the 
     number of children enrolled in pediatric clinical trials is 
     rising. Therefore, it is especially important that a 
     consistent set of additional protections for children 
     participating in research, such as those included within 
     subpart D of part 45 of title 46, Code of Federal Regulations 
     (i.e. the ``common rule''), be reviewed and extended to all 
     federally conducted, supported, or regulated clinical 
     research.
       The ``Children's Research Protection Act'' also establishes 
     a grant program and loan repayment provision to help address 
     the expected shortage of pediatric clinical pharmacologists 
     and clinical investigators trained to develop therapies for 
     children. This is especially important given the increased 
     demand for expertise in this area created by the pediatric 
     studies provisions of FDAMA. In addition, we are hopeful that 
     such a model of grant and loan repayment can eventually be 
     replicated to provide added incentives to increase the 
     overall pediatric research workforce, such as is proposed in 
     Sen. Bond's ``Healthy Kids 2000 Act.''
       N.A.C.H. applauds your efforts for introducing this 
     important piece of legislation. Please feel free to contact 
     me if I can be of further assistance as this bill moves 
     through Congress.
           Sincerely,
                                            Lawrence A. McAndrews.

  Mr. DeWINE. Mr. President, I rise today to join my friend and 
colleague from Connecticut, Senator Dodd, in introducing the Children's 
Research Protection Act. This bill is a logical and

[[Page S6025]]

necessary follow-up to the Better Pharmaceuticals for Children Act, 
which Senator Dodd and I got passed and enacted into law in 1997 as 
part of the FDA Modernization Act. This law created incentives for drug 
manufacturers for use by children. Since the law has been in place, 
more children than ever before are participating in clinical trials for 
drug testing.
  Mr. President, it is imperative that we test drugs for children--on 
children. There are several reasons that such testing is necessary. 
Children have different physical make-ups from adults, which means they 
metabolize drugs differently. They likely need different doses and 
different amounts of time between doses for medications to be safe and 
effective. Also, because the same disease can manifest itself very 
differently in children and adults, we need to thoroughly test the 
drugs that we are using for children to treat the same illness.
  As I noted already, since our Better Pharmaceuticals Act was enacted, 
we have seen a rapid increase in the number of children being enrolled 
in clinical trials. More than 18,000 children will be needed just for 
the 300 studies that have been proposed so far. Research has been 
completed and exclusivity granted on 22 drugs that were previously used 
for children without safety information, and more than 300 pediatric 
studies of 127 products are currently underway. Of those 22 drugs for 
which studies have been completed, eight drugs have already been re-
labeled to reflect, the new pediatric safety information.
  In contrast, in the five years prior to enactment of our Better 
Pharmaceuticals Act, only 11 studies to gather additional pediatric 
safety information about drugs already on the market were conducted--
that's 11 studies in five years versus over 125 in just two years since 
this legislation was enacted. The increase in pediatric studies is good 
news for children and parents and is certainly a welcome improvement at 
a time when only one in five drugs currently on the market in the 
United States has been approved for use by children.
  While we want to encourage better drug testing for children, we also 
need to ensure that strong federal protections are in place to protect 
children who participate in such research. Tragically, there are parts 
of the current law that do not protect children who participate in HHS 
federally-regulated research, unless it is also federally funded 
research. These federal protections for children also have not been 
updated since 1981, and have not been adopted by all of the federal 
agents that conduct research involving children.
  That's why the Children's Research Protection Act we are introducing 
would require the Secretary of Health and Human Services (HHS) to 
review the current regulations governing the protection of children 
participating in research and update them to ensure that the strongest 
federal protections exist for such children.
  Now, only HHS federally funded and federally regulated research has 
to comply with certain protections for children.
  Our bill also would extend research protections for children to all 
research regulated by the Secretary of HHS, even if it is not federally 
funded.
  Furthermore, our bill would require that all other federal agencies 
that conduct, support, or regulate research involving children must 
adopt regulations to provide greater protections for those children.
  Finally, our bill would address the shortage of pediatric clinical 
pharmacologists whose specialized expertise is essential in performing 
pediatric studies, because the bill would authorize grants to ensure 
that an adequate number of pediatric clinical pharmacologists and 
clinical investigators are trained and retained to meet the increased 
demand for expertise created by the Better Pharmaceuticals law. There 
are fewer than 200 academic-based clinical pharmacologists in the 
United States, of whom 20 percent are pediatricians. Moreover, the bill 
would authorize the Secretary of HHS to enter into loan repayment 
contracts with doctors who agree to train and practice in pediatric 
pharmacology.
  Mr. President, it is very important that we pass our legislation this 
year. While we have successfully encouraged better drug testing for 
children through the incentives in the ``Better Pharmaceuticals for 
Children Act,'' we must take the next step and ensure that strong 
federal protections are in place to protect the children who 
participate in such research.
  The children who are participating in clinical trials are medical 
pioneers. They will help to ensure that drugs used for children will be 
proven to be safe and appropriate for use in children. At the very 
least, we should make certain that strong federal safeguards exist to 
ensure their safety as they participate in these trials.
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