[Congressional Record Volume 145, Number 74 (Thursday, May 20, 1999)]
[Senate]
[Pages S5756-S5757]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DeWINE (for himself, Mr. Kennedy, and Mr. Bond):
  S. 1091. A bill to amend the Public Health Service Act to provide for 
the establishment of a pediatric research initiative; to the Committee 
on Health, Education, Labor, and Pensions.


             the pediatric research initiative act of 1999

  Mr. DeWINE. Mr. President, today I rise to introduce legislation that 
will increase our nation's investment in pediatric research.
  Despite the medical breakthroughs that have been made by health 
researchers in recent years, it is obvious that health care research is 
under funded. I have joined with many senators to express support for 
doubling the budget at HIH for biomedical research. I will continue to 
fight for this increased funding so that NIH can expand its research 
efforts. An increase in funding is especially needed to improve our 
knowledge about illnesses and conditions affecting children.
  Children under age 12 represent 30 percent of the population--and 
yet, NIH devotes less than 12 percent of its budget to their needs. 
There has been a growing consensus that children's health deserves more 
attention from the research community.
  The bill I am introducing today would help us begin to remedy the 
need for stronger investment in children's health research. I thank 
Senator Bond for joining with me in sponsoring this important 
legislation. This bill would authorize the Pediatric Research 
Initiative within the Office of the Director of National Institutes of 
Health (NIH) to encourage, coordinate, support, develop, and recognize 
pediatric research.
  The bill would authorize $50 million annually for the next three 
years. During the last three years, I worked with my colleagues to fund 
this important Initiative and as a result, it received $5 million in 
fiscal year (FY) 1997, $38.5 million in FY 1998, and at least $38.5 
million in FY 1999. I look forward to working with my colleagues again 
to continue on the path toward reaching the necessary funding level.
  Under this bill, the Initiative would provide $45 million over the 
next three years to encourage new initiatives and promising areas of 
pediatric research. It would also promote greater coordination in 
children's health research. Today, there are some 20 Institutes and 
Centers and Offices within NIH that do something in the way of 
pediatrics. In my view, we need to bring some level of coordination and 
focus to these efforts.
  In developing this Initiative, I have made sure that it would give 
the Director of NIH as much discretion as possible. The money has to be 
spent on outside research, so that the dollars flow out to the private 
sector--but it can go toward basic research or clinical research.
  This bill does not create any new Office, Center, or Institute. I 
would simply authorize funding for more research and better research 
coordination for children--not infrastructure.
  In addition to authorizing the Initiative, the legislation would 
authorize new funding, through the National Institutes of Child Health 
and Human Development (NICHD), for pediatric research training grants 
to provide a major increase in support for training additional 
pediatric research scientists. We need to strengthen our national 
investment in pediatric research training.
  The supply of pediatrician scientists needs to increase if we are to 
fulfill the new NIH policies that require the participation of children 
in NIH-funded clinical trials and the new Food and Drug Administration 
(FDA) policies that require the testing of drugs for use by children 
before they can receive FDA approval.
  The number of pediatricians training to become subspecialists--the 
potential supply of future pediatrician scientists--is declining. The 
number of medical school pediatric departments that receive significant 
NIH research training grant support is limited--fewer than half receive 
any NIH research training grants. Many pediatricians in training have 
little or no exposure to research.
  Together, the Pediatric Research Initiative and the pediatric 
research training grants are crucial investments in our country's 
future--and will produce great returns. If we focus on improving health 
care for our children, we'll set the stage for them becoming healthy 
adults.
  This important legislation has the support of the pediatric research 
community in children's hopsitals and university pediatric departments 
all over the country, including the National Association of Children's 
Hospitals, Association of Medical School Pediatric Department Chairmen, 
American Pediatric Society, and Society for Pediatric Research, as well 
as the Juvenile Diabetes Foundation International, March of Dimes, 
Association of Ohio Children's Hospitals, and many more
  I urge my colleagues to support this investment in our children and 
cosponsor this bill. I ask unanimous consent that the text of my 
legislation be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1091

       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 ``Pediatric Research 
     Initiative Act of 1999''.

     SEC. 2. FINDINGS.

       Congress finds that--
       (1) innovations in health care, deriving from scientific 
     investigation of the highest quality, offer substantial 
     benefits to the well-being of children and savings in health 
     care costs;
       (2) findings in pediatric research not only promote and 
     maintain health throughout a child's lifespan, but also 
     contribute significantly to new insights and discoveries that 
     will aid in the prevention and treatment of illnesses and 
     conditions among adults;
       (3) the rapidly expanding knowledge base in biology and 
     medicine is offering greater opportunities than ever for 
     pediatric physician-scientists and basic researchers to 
     harness this knowledge to the benefit of children and 
     society;
       (4) the relatively smaller number of children compared as 
     to adults and the relative rarity of many of their diseases 
     and conditions has resulted in comparatively fewer resources 
     being devoted to pediatric research and a lesser focus on 
     children's needs;
       (5) substantially more of the support for children's health 
     research is provided through the Federal Government than is 
     the case for adults because of these market forces;
       (6) a new commitment to invest in children's research today 
     will make a real difference for children tomorrow;
       (7) the commitment to invest in children's research should 
     include not only added investment that is devoted to 
     pediatric research but should also focus on ensuring the 
     existence of a future supply of pediatric physician-
     scientists;
       (8) the supply of pediatric physician-scientists is 
     threatened by market demands which provide little room for 
     support for research training for new pediatric physician-
     scientists;
       (9) over 60 percent of the pediatric departments in the 
     United States have no National Institutes of Health training 
     grant support; and
       (10) improvements in the level of training grant support is 
     essential to ensuring the existence of future generations of 
     pediatric clinical investigators who are responsible for 
     moving research discoveries from the laboratories to the 
     patients, and who are therefore critical to clinical 
     research.

     SEC. 3. ESTABLISHMENT OF A PEDIATRIC RESEARCH INITIATIVE.

       Part A of title IV of the Public Health Service Act (42 
     U.S.C. 281 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 404F. PEDIATRIC RESEARCH INITIATIVE.

       ``(a) Establishment.--The Secretary shall establish within 
     the Office of the Director of NIH a Pediatric Research 
     Initiative (referred to in this section as the `Initiative'). 
     The Initiative shall be headed by the Director of NIH.
       ``(b) Purpose.--The purpose of the Initiative is to provide 
     funds to enable the Director of NIH to encourage--
       ``(1) increased support for pediatric biomedical research 
     within the National Institutes of Health to ensure that the 
     expanding opportunities for advancement in scientific 
     investigations and care for children are realized;
       ``(2) enhanced collaborative efforts among the Institutes 
     to support multidisciplinary research in the areas that the 
     Director deems most promising; and
       ``(3) the development of adequate pediatric clinical trials 
     and pediatric use information to promote the safer and more 
     effective use of prescription drugs in the pediatric 
     population.
       ``(c) Duties.--In carrying out subsection (b), the Director 
     of NIH shall--
       ``(1) consult with the Institute of Child Health and Human 
     Development and the other Institutes, in considering their 
     requests for new or expanded pediatric research efforts, and 
     consult with other advisors as the Director determines 
     appropriate;

[[Page S5757]]

       ``(2) have broad discretion in the allocation of any 
     Initiative assistance among the Institutes, among types of 
     grants, and between basic and clinical research so long as 
     the--
       ``(A) assistance is directly related to the illnesses and 
     conditions of children; and
       ``(B) assistance is extramural in nature; and
       ``(3) be responsible for the oversight of any newly 
     appropriated Initiative funds and annually report to Congress 
     and the public on the extent of the total extramural support 
     for pediatric research across the NIH, including the specific 
     support and research awards allocated through the Initiative.
       ``(d) Authorization.--To carry out this section, there is 
     authorized to be appropriated in the aggregate, $50,000,000 
     for each of the fiscal years 2000 through 2002.
       ``(e) Transfer of Funds.--The Director of NIH may transfer 
     amounts appropriated under this section to any of the 
     Institutes for a fiscal year to carry out the purposes of the 
     Initiative under this section.''.

     SEC. 4. INVESTMENT IN TOMORROW'S PEDIATRIC RESEARCHERS.

       Subpart 7 of part C of title IV of the Public Health 
     Service Act (42 U.S.C. 285g et seq.) is amended by adding at 
     the end the following:

     ``SEC. 452E. INVESTMENT IN TOMORROW'S PEDIATRIC RESEARCHERS.

       ``(a) In General.--The Secretary shall make available 
     within the National Institute of Child Health and Human 
     Development enhanced support for extramural activities 
     relating to the training and career development of pediatric 
     researchers.
       ``(b) Purpose.--The purpose of support provided under 
     subsection (a) shall be to ensure the future supply of 
     researchers dedicated to the care and research needs of 
     children by providing for--
       ``(1) an increase in the number and size of institutional 
     training grants to medical school pediatric departments and 
     children's hospitals; and
       ``(2) an increase in the number of career development 
     awards for pediatricians building careers in pediatric basic 
     and clinical research.
       ``(c) Authorization.--To carry out this section, there is 
     authorized to be appropriated, $10,000,000 for fiscal year 
     2000, $15,000,000 for fiscal year 2001, and $20,000,000 for 
     fiscal year 2002.''.
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