[Congressional Record (Bound Edition), Volume 147 (2001), Part 16]
[Extensions of Remarks]
[Page 22584]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 BEST PHARMACEUTICALS FOR CHILDREN ACT

                                 ______
                                 

                               speech of

                        HON. ALBERT RUSSELL WYNN

                              of maryland

                    in the house of representatives

                       Tuesday, November 13, 2001

  Mr. WYNN. Mr. Speaker, I rise today in strong support of the ``Best 
Pharmaceuticals for Children Act of 2001'', a bill I am proud to 
cosponsor.
  Mr. Speaker, most pharmaceuticals have not been tested and labeled 
for pediatric safety and use. We've heard it time and time again, 
children are not small adults. With that in mind, why would we cut an 
adult dosage of medication in half and assume it's appropriate for 
treating a child's condition? It isn't, and that is why this 
legislation is so important.
  This legislation re-authorizes a program that has proven to be the 
most effective way to generate studies of medications in children. 
Before the law was passed, 80 percent of drugs given to children had 
been tested only on adults. Since then, 60 studies have been conducted 
to assess the safety and effectiveness of medicines used in children, 
and another 400 are under way. Physicians who prescribe medications for 
children, and parents who administer them, now have more information 
about appropriate dosages, as well as, the side effects of medications 
in the pediatric population. It has truly been a remarkable achievement 
for children's health.
  As part of the authorization of these ``pediatric exclusivity'' 
provisions, FDA was required to submit a report to Congress describing 
the results of the program and commenting on its success. FDA's report, 
submitted in January, stated that an unprecedented number of pediatric 
studies had been conducted and crucially important new pediatric labels 
were improving medical care for children.
  According to a GAO study, ``as of April 1, 2001, 28 drugs had been 
granted marketing exclusivity extensions, and research results have 
provided new and useful information about how drugs work in children, 
which have been incorporated into labels for 18 drugs.'' This 
information, previously unavailable to parents and doctors, includes 
new information about dosing, important new safety considerations, 
extension of dosing, safety, and efficacy data to younger patients, 
along with development of age-appropriate formulations.
  Because Congress was uncertain as to whether this program would be 
successful, it chose to ``sunset'' the provisions at the end of 
calendar year 2001. It is now time to re-authorize this highly 
successful program, to ensure that its accomplishments continue and 
that pediatric studies and labeling for many more drug products will be 
achieved. The 6-month period of exclusivity assures priority of 
pediatric studies, and helps to justify establishing infrastructure 
necessary for doing pediatric studies. The exclusivity has been the 
primary driver in building capacity and expertise in pediatric drug 
development. The ability of a pediatric research program to pursue 
unique pediatric illnesses, and pediatric-predominant diseases is 
dependent on such R&D resource allocations.
  As a proud cosponsor of H.R. 2887, I encourage all of my colleagues 
to follow Representative Eshoo's leadership in supporting the 
continuation of this successful research program.

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