[Congressional Record Volume 143, Number 74 (Tuesday, June 3, 1997)]
[Extensions of Remarks]
[Page E1093]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                BETTER PHARMACEUTICALS FOR CHILDREN ACT

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                          HON. HENRY A. WAXMAN

                             of california

                    in the house of representatives

                         Tuesday, June 3, 1997

  Mr. WAXMAN. Mr. Speaker, I rise today to join my colleague, Jim 
Greenwood, in sponsoring H.R. 1727, the Better Pharmaceuticals for 
Children Act. I support this bill because it focuses on a serious but 
little known problem in our children's health care, and can provide 
some additional tools to address it.
  While dramatic progress has been made in the treatment and cure of 
diseases and chronic illnesses, it cannot be said today that our 
children have fully benefited from this innovation. As increasingly 
sophisticated medicines are developed, the knowledge needed to 
optimally treat children with these medicines has not kept pace. In 
crucial ways, our understanding of how to use these drugs for children 
is simply inadequate.
  According to the American Academy of Pediatrics and the Food and Drug 
Administration [FDA] only a minority of prescription drugs in the 
United States with potential pediatric uses are actually labeled for 
use by children. Since 1962, 80 percent of all drugs have been approved 
for adult use with an explicit disclaimer that they are not approved 
for use by children. This is because the research necessary to prove 
the safety and efficacy of these pediatrics uses is not being done, 
either before or after the drugs are marketed. Despite widespread 
recognition in Government, industry, and academia of this problem, 
little progress has been made to correct it.
  I firmly believe that the FDA has been remiss in not taking action to 
conclusively remedy this situation. The agency has statutory authority 
to encourage and require the performance of pediatric clinical studies. 
It should exercise that authority and take every possible step to 
ensure that new drugs with potential pediatric uses are approved on the 
basis of data demonstrating safety and efficacy in both adults and 
children. The Government's failure to act in this manner is 
unacceptable and we pay for such a failure in our children's health.
  It is also imperative to recognize that prescription drug 
manufacturers already have significant incentives to pursue research, 
development, and regulatory approval in the form of patent protection 
and other forms of market exclusivity. Much of the responsibility for 
the absence of adequate pediatric drug information today can be laid at 
their feet.
  However, I recognize that limited additional incentives may be 
appropriate in some instances to promote pediatric drug research, such 
as for some drugs which are currently marketed. It is my hope, however, 
that such incentives are only necessary in supplementing the FDA's use 
of existing statutory authority to ensure that adequate information is 
available about pediatric drug uses.
  H.R. 1727 would help improve and increase the information available 
about pediatric drug uses by providing additional market exclusivity as 
an incentive to prescription drug manufacturers in limited situations. 
Under the bill, the Secretary of Health and Human Services would 
determine whether a new drug might provide health benefits for 
pediatric populations, and have the authority to request that pediatric 
studies be conducted by the manufacturer to establish these benefits. 
Upon completion of these studies and their acceptance by the Secretary, 
the manufacturer would be granted an additional 6 months of market 
exclusivity.
  I am sure that many parents would be disturbed to learn that, when 
their infants and children receive a prescription medicine, there may 
not be clinical studies establishing the safety and efficacy of that 
treatment in children. In conjunction with independent and decisive 
steps by the Food and Drug Administration [FDA], I believe the Congress 
can change this situation for the better. H.R. 1727 can help do that, 
and that is why I am cosponsoring it today.

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