[Congressional Record (Bound Edition), Volume 147 (2001), Part 20]
[Extensions of Remarks]
[Page 28007]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 BEST PHARMACEUTICALS FOR CHILDREN ACT

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                               speech of

                            HON. BART STUPAK

                              of michigan

                    in the house of representatives

                       Tuesday, December 18, 2001

  Mr. STUPAK. Mr. Speaker, I rise tonight to urge Members to vote 
against the pediatric exclusivity bill, S. 1789. It is the product of a 
flawed negotiating process, a flawed legislative process, and a flawed 
regulatory process which was instituted back in 1997.
  First approved in 1997, pediatric exclusivity granted drug companies 
an extra six-month extension on their patent if they would conduct a 
study to determine what the effects were on young people. The FDA sends 
a written request for a pediatric study to the drug company. Upon 
completion of the study, FDA grants a six month extension of the patent 
monopoly--the ``pediatric exclusivity''--which the drug companies then 
use as a marketing tool to promote and increase the drug's sales.
  What I find horrifying is the grant of exclusivity takes place after 
the drug company does its study but before anyone knows what is 
included in the results of the study. Nothing is said to the general 
public--which includes parents and pediatricians--or prescribing 
physicians about the safety, effectiveness, or dosage requirements. 
Under S. 1789, there is no requirement to change the labeling on the 
drug to reflect the changes that may be needed when the drug is 
dispensed to young people. There is no label to tell doctors, patients, 
and their families the proper dosage, or how to dispense or use the 
drug.
  My argument has always been this: before you grant pediatric 
exclusivity to a pharmaceutical company and before this exclusivity is 
then marketed as being FDA approved for pediatric use, shouldn't you at 
least know what is the effect of the drug on young people?
  Under current law--and this bill would extend current law after the 
study is completed, exclusivity is granted, but whether the drug helps 
or hurts young people remains a secret and is not disclosed to the 
doctors, patients, and their families for an average of 9 months. 
Shouldn't this information get out to these people before they ingest 
this medicine?
  I have a chart, which I have used on the floor before. It highlights 
the problems with S. 1789, which does not require labeling changes 
until 11 months after the drug is being used in the pediatric 
population. How many of you would give your child a drug and not know 
whether it helps or harms your child until 11 months later?
  There have been 33 drugs granted pediatric exclusivity. Only 20 have 
been re-labeled to reflect the results of the pediatric study, and even 
those label changes have taken an average of 9 months.
  For 9 months, doctors, patients, and their families have no idea if 
the child is receiving the proper dosage or even if the drug is really 
safe!
  Now why can't doctors, patients, and their families know this 
information before the grant of pediatric exclusivity is given? I was 
not allowed a chance to offer my amendment before the full House. My 
amendment is very simple and very commonsense: before pediatric 
exclusivity is granted, all drugs must be labled especially for 
pediatric use.
  Under other prescription drug patent extension programs, labeling is 
an absolute prerequisite to receiving patent extension. But not 
pediatric exclusivity. Why would we treat our children any differently?
  For the love of me, I cannot understand why the majority does not 
want doctors, patients, and their families to know the effect of drugs 
may have on children!
  What is the proper dosage? What is the efficacy? What is the safety 
level for our children?
  Why do we wait an average of 9 months before we see proper labeling? 
Why must we wait to find out if a child has received the proper dosage?
  Let us defeat this legislation. I urge a no vote.

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