[Congressional Record Volume 147, Number 157 (Wednesday, November 14, 2001)]
[House]
[Page H8166]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       PEDIATRIC EXCLUSIVITY BILL

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Michigan (Mr. Stupak) is recognized for 5 minutes.
  Mr. STUPAK. Mr. Speaker, I rise today to urge Members to vote against 
H.R. 2887, the Pediatric Exclusivity bill, as it will appear on the 
suspension calendar tomorrow. It has a number of controversial 
provisions.
  First approved in 1997, pediatric exclusivity granted the drug 
companies an extension of 6 months under patents if they would provide 
a study to determine if the drug was beneficial to young people. The 
FDA invites drug companies to do a study on what effect the drug may 
have on young people. Upon completion of the study, the FDA then grants 
a pediatric exclusivity to the drug, which the drug companies then use 
as a marketing tool to promote and increase drug sales.
  The grant of pediatric exclusivity takes place after the drug company 
study is completed, without anyone knowing what the study says about 
the safety, the effectiveness, or the dosage requirement for young 
people. There is no requirement to change the labeling on a drug to 
reflect the changes that may be needed when a drug is dispensed to 
young people. There is no label to tell doctors, patients, or their 
families on the proper dosage or on how to dispense or use the drug.

                              {time}  1500

  Before we grant pediatric exclusivity to a drug and before this 
pediatric exclusivity is marketed as approved for pediatric use, we 
should know what is the effect of this drug on young people.
  Under the bill that will be before us tomorrow, H.R. 2887, after a 
study is completed, exclusivity is granted; but the results of the 
study, the results may not be disclosed to the doctors, patients and 
their families for up to 11 months. The physician, the patient and the 
family has a right to know about the drug the patient is about to 
ingest. Why does it take 11 months?
  This chart highlights the problems with pediatric exclusivity. There 
have been 33 drugs granted pediatric exclusivity, and only 20 have been 
relabeled; and it takes an average of 9 months to do that. The average 
time from the granting of pediatric exclusivity is 9 months. For 9 
months, doctors, patients and their families have no idea if the child 
is receiving a proper dosage and if the drug is really safe.
  On this chart, exclusivity granted, and below in parentheses was when 
the label was provided. In Lodine, it took 9 months for them to change 
the label, and after the label was changed, approximately two times a 
lower dose recommended. It should have been cut in half. Nobody knew 
that for 9 months.
  Buspar, if Members take a look at it, 2 months after exclusivity is 
granted, they finally say safety and effectiveness were not established 
in patients 6 to 17 years old. In other words, it did not do anything. 
They are marketing it as a drug to help the patient.
  How about Fluxvoxamine. Again, exclusivity granted January 3, 2000. 
Eight months later the label is changed. It says it may require lower 
dosage, and it gives an age group.
  Propofol, exclusivity is granted August 11, 1999; but they did not 
change the label to let the doctors, patients, and families know until 
18 months later. It says here ``may result in serious bradycardia.'' It 
goes on to say it is not indicated for pediatric ICU sedation, as 
safety has not been established. That is information doctors need to 
know.
  The worse thing is, the incidence of mortality doubles from 4 percent 
to 9 percent. That is information we need to know. Doctors, patients, 
and families should know this information before we grant pediatric 
exclusivity. My amendment would require not just a study but proper 
labeling on the drug before it is granted pediatric exclusivity and 
marketed.
  Pediatric exclusivity is the only time that labeling is not a 
prerequisite to granting a drug approval. Why would we want to endanger 
our children?
  Mr. Speaker, I cannot offer my amendment under the suspension 
calendar. In order to have an opportunity to offer my amendment to 
protect the health and safety of our young people in this country, we 
must defeat the bill under the suspension calendar and send the bill to 
the Committee on Rules where I will be given an opportunity to offer my 
amendment.
  I do not understand why the majority does not want doctors, patients, 
and families to know the effect of the drug, what is the effectiveness 
of the drug, and is the drug safe for our children. Tomorrow I ask 
Members to defeat the bill under suspension so we can bring it back to 
the floor.

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