[Congressional Record (Bound Edition), Volume 147 (2001), Part 16]
[Extensions of Remarks]
[Pages 22940-22941]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 BEST PHARMACEUTICALS FOR CHILDREN ACT

                                 ______
                                 

                               speech of

                        HON. BENJAMIN A. GILMAN

                              of new york

                    in the house of representatives

                       Tuesday, November 13, 2001

  Mr. GILMAN. Mr. Speaker, I rise today in strong support of H.R. 2887, 
the Best Pharmaceuticals for Children Act. I urge my colleagues to join 
in supporting this important measure.

[[Page 22941]]

  This legislation reauthorizes the pediatric exclusivity provision 
provided for in the Food and Drug Administration Modernization Act of 
1997, which expires at the end of this calendar year. This legislation 
reauthorizes the provision through fiscal year 2007.
  The bill directs the Secretary of HHS to create an annual list of 
approved drugs for which: (1) There is an approved or pending new drug 
application and (2) additional pediatric safety and effectiveness 
studies are needed. It further instructs the Secretary to award 
contracts to entities that have the appropriate experience for 
conducting clinical trials of such drugs.
  The legislation also amends the Federal Food, Drug, and Cosmetic Act 
to: (1) Eliminate the user fee waiver for pediatric supplements to a 
human drug application; (2) provide priority status for pediatric 
supplements; (3) include neonates within the definition of pediatric 
studies; (4) provide for dissemination of pediatric supplement 
information; and (5) set forth requirements for the additional six-
month exclusivity period for new or already-marketed pediatric drugs. 
Additionally, it amends title IV of the Public Health Service Act to 
direct the Secretary to establish the Foundation for Pediatric Research 
to support research on drugs lacking exclusivity for which pediatric 
studies are needed.
  Finally, the bill directs the Secretary to: (1) Establish an Office 
of Pediatric Therapeutics within the Office of the Commissioner of Food 
and Drugs, which shall coordinate all FDA pediatric activities; and (2) 
contract with the Institute of Medicine to review federal regulations, 
reports, and support for research involving children, with particular 
attention to issues of compensation, informed consent, and risk/
benefits assessments in terms of research versus therapeutic treatment.
  Mr. Speaker, the pediatric exclusivity provision that was established 
in the FDA Modernization Act of 1997 has been overwhelmingly successful 
in generating clinical studies for the pediatric population in its 5 
years of existence. According to the FDA, in the 6 years prior to the 
enactment of this provision, there were a total of six studies on the 
pediatric population at the request of the FDA, the 4 years since 
enactment have seen 197 requests to conduct more than 400 studies.
  These studies are an invaluable tool in determining the safety and 
efficacy of newly approved drugs on the pediatric population. With the 
large number of drugs being approved each year, it is imperative that 
we have a working knowledge of the effects these medicines will have on 
our children's health and well-being. This bill will advance this 
purpose, and for that I urge my colleagues to support its adoption.

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