[Congressional Record Volume 147, Number 152 (Tuesday, November 6, 2001)]
[House]
[Page H7727]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 H.R. 2887, PEDIATRIC EXCLUSIVITY BILL

  The SPEAKER pro tempore (Mr. Culberson). Under the Speaker's 
announced policy of January 3, 2001, the gentleman from Michigan (Mr. 
Stupak) is recognized during morning hour debates for 5 minutes.
  Mr. STUPAK. Mr. Speaker, I rise today to speak of a bill that may be 
coming to the floor in the very near future. It is called the H.R. 
2887, the Pediatric Exclusivity bill. It was passed by Congress in 1997 
to encourage drug companies to do studies in how their drugs would 
affect young people, those people under 18. Unfortunately, before this 
bill, drug companies did not necessarily take into consideration a 
drug's effect upon children 18 and younger, so Congress granted them a 
pediatric exclusivity which would allow them to extend their patent for 
another 6 months to do a study.
  Now, when they get done with this study, what happens to the study? 
It goes to the FDA and sits there, but yet the drug company gets the 
extension of the patent.
  From that study, we learned certain things, such as the dosage of 
medicine to be given and symptoms we should look for. What we found, 
since 1997, is that 33 drugs have been granted pediatric exclusivity. 
Of the 33, 20 of them have done label changes. The other 13 have not. 
Why not?
  The problem we are concerned about is why we would grant pediatric 
exclusivity prior to receiving the study. We should wait and not grant 
pediatric exclusivity until after we have the study, we know what the 
dosage recommendation should be, and then the product is labeled for 
pediatric use according to the study. So what we want to see is that 
the grant of pediatric exclusivity is tied into not only a study but 
also the necessary label changes.
  It only makes sense. The doctors, the patients, their families should 
know what was found in those studies and what they need to know to make 
sure that they are administering the drug in a proper way to young 
people.
  The goal of pediatric exclusivity, the FDA has been quoted as saying, 
is the labeling. That is why when the bill comes to the floor we would 
like to offer an amendment which would tie the grant of exclusivity 
necessarily to labeling changes. As I said, there have been 33 
pediatric exclusivity drugs, but only 20 of them have changed their 
labels. What about the last 13?
  Currently, the exclusivity period is given only for doing a study. 
For the safety of our children, for the health care profession, and for 
all families, we should change this. Under our proposed amendment, all 
new drugs must complete the labeling requirement before the product is 
marketed.
  I cannot understand why we allow drug manufacturers to undertake a 
pediatric study, but not provide parents and doctors with the results 
they need to make informed decisions to properly use and dispense the 
drugs. As the FDA says, the goal of pediatric exclusivity is labeling, 
and we cannot lose sight of that.
  We went on the FDA Web site and they listed the drugs with the 
pediatric exclusivity. As seen on this chart, the first one, Lodine, 
Etodolac Lodine, 9 months after the pediatric exclusivity was granted, 
they changed their label. The labeling says it is now appropriate for 
young people 6 to 16, but the dose in younger children is approximately 
two times lower dosage than is recommended for adults.
  Now, would the doctor not want to know that before he gives Lodine, 
since it is used for juvenile rheumatoid arthritis, that the 
recommended dose is two times less than what is given for adults? The 
manufacturer was granted the pediatric exclusivity on December 6, 1999, 
yet the information did not get out to the doctors and patients and 
their families until August.
  Let us take this one right here. BuSpar. It was approved on May 22 
this year for pediatric exclusivity. Two months later the labeling 
change comes out. And what did it find? The safety and effectiveness 
were not established in patients below the age of 18. In this drug 
here, they got the pediatric exclusivity, and 2 months later they had 
to change their label to let people know there really was no advantage. 
In fact, the safety and effectiveness was not established. I think that 
would give a red light to doctors and patients that maybe this drug is 
not doing what it is supposed to be doing.
  This one on the bottom, the Propofol Diprivan. Take a look at it. It 
is for anesthesia. When we take a look at it, it says it may result in 
serious bradycardia. Propoful is not indicated for pediatric ICU 
sedation, as safety has not been established. Now, if I was a medical 
professional, I am sure I would want to know this.
  Why does it take 18 months after the grant of the pediatric 
exclusivity to get the information out to the health care 
professionals?
  If we look closer at this, the incidence of mortality, it is 9 
percent versus 4 percent. So there is twice as much chance of a deadly 
accident occurring with this drug as when it was given in the old form. 
Again, it takes 18 months to get this information out.
  So, again, before we grant pediatric exclusivity to a pharmaceutical 
such as this, should we not have the labeling change so we know what it 
is going to do to the patient, so the doctor knows what dosage he 
should recommend? That is the whole idea behind the labeling amendment. 
That is what we want to see be a part of the exclusivity bill.
  It is a good bill, with good intent, but we have to finish the job. 
Now that we have had it on the books for 4 years, we have seen the 
shortfalls. So let us change the label so everybody is informed about 
the value of these drugs.

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