[Congressional Record (Bound Edition), Volume 147 (2001), Part 20]
[Extensions of Remarks]
[Page 27985]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 BEST PHARMACEUTICALS FOR CHILDREN ACT

                                 ______
                                 

                               speech of

                        HON. SHEILA JACKSON-LEE

                                of texas

                    in the house of representatives

                       Tuesday, December 18, 2001

  Ms. JACKSON-LEE of Texas. Mr. Speaker, I rise in support of S. 1789, 
the Best Pharmaceuticals for Children Act. As Chair of the 
Congressional Children's Caucus, the welfare of children has always 
been a top priority for me. The bill before us today is reauthorizing 
legislation designed to ensure that more medicines are tested for 
children and that useful prescribing and dosing information appears on 
labels.
  Under a 1997 law, pharmaceutical companies that test drugs on 
children at the request of the FDA are given an extra six months of 
exclusive marketing rights. This law was aimed at encouraging drug 
companies to test their products on children so that a pediatrician 
would be able to prescribe appropriate doses for children. As a result 
of this law, we have seen more drugs for children on the market that 
have a label telling how they can be used, and even more basic 
information for pediatricians.
  The difficulty of prescribing medicine for children results from 
various factors: a child's weight and metabolism, the quick 
metamorphosis of a child's body, and a child's inaccurate information 
about how medicines are affecting them.
  A recent six-week study done in Boston found that over that time, 616 
prescriptions written for children contained errors. Of those, 26 
actually harmed children. Of the errors that were caught before the 
medication was administered, 18 could have been fatal. Medication 
errors in hospitals occur three times more often with children than 
with adults. This bill can help prevent such mistakes by prescribing 
adequate testing and proper labeling.
  Mr. Speaker, S. 1789 also requires that the General Accounting Office 
(GAO) study the inclusion of children of ethnic and racial minorities 
in drug studies. Ethnic and racial minorities make up a substantial 
percentage of our population, yet many studies do not reflect the 
multi-cultural and multi-racial fabric of our society.
  Mr. Speaker, S. 1789, which reflects a consensus of the sponsors of 
both the earlier House and Senate passed bills, is a good bill. It is a 
necessary bill--necessary to protect the welfare of our nation's 
children.

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