[Congressional Record (Bound Edition), Volume 147 (2001), Part 15]
[House]
[Page 21252]
[From the U.S. 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 speak on a bill that will be 
coming to the floor soon. H.R. 2887 is commonly called the pediatric 
exclusivity bill. This was a good bill. It was passed and implemented 
back in 1997. It had a 5-year sunset, so it is necessary for Congress 
to reauthorize the pediatric exclusivity bill.
  Pediatric exclusivity simply says this: If a drug company that 
currently has a drug on the market will do an exclusive study for young 
people, those 18 or under, we will grant to them a patent extension for 
6 years.
  It is amazing, but as drug companies put forth drugs, they were not 
required to see what the effect would be on young people. Thus, we 
created the pediatric exclusivity bill to make sure an opportunity was 
provided to have studies done to make sure the proper dosage, the 
amount and the type of drug, would be beneficial to young people, those 
under 18 years of age. Just for agreeing to do a study that the FDA 
wants for young people, a drug company can get its patent extended. 
That is of great benefit to the drug company, of course, because they 
hold the patent and make money off the drug, and this bill is now due 
to be reauthorized.
  As we move through this bill in our Subcommittee on Health of the 
Committee on Energy and Commerce, there are a number of improvements we 
would like to see made with the bill. While there have been a number of 
improvements made already, there is still one part of the bill that 
troubles me, and hopefully, I will be able to offer an amendment to 
correct this inequity in the bill. What my amendment would say is that 
if we provide a pediatric exclusivity, before that patent extension is 
provided, the drug company must make the necessary label changes on a 
product that has been studied.
  In fact, I would like to quote the FDA's report to the Congress dated 
January of this year. It says, and I quote, ``The ultimate goal of 
encouraging pediatric studies is to provide needed dosing and safety 
information to the physicians in product labeling.'' To paraphrase, and 
I want to emphasize, ``The goal of pediatric exclusivity is the 
labeling.'' It is the labeling where we find out how much to give, the 
safety information, and who should be given it. That is why I must 
offer my amendment when this bill comes to the floor. My amendment 
would tie the grant of exclusivity to the necessary labeling changes.
  There have been 33 drugs approved for pediatric exclusivity, but only 
20 of them have made the needed changes on the label. How would a 
doctor, a parent, or a patient who is under 18 know what is the right 
dosage or if this drug is safe for them without this information? 
Currently, the exclusivity period is given only for conducting studies. 
For the safety of our children, for our health care system, this must 
and should be changed.
  Take, for example, one of the drugs that has been granted pediatric 
exclusivity, Eli Lilly's drug Prozac. The benefit to the public, 
specifically parents, patients and pediatricians, is zero, because the 
manufacturer has yet to place any information in the public record 
regarding the pediatric dosing or other data relating to the drug's 
safety in juvenile populations. Just for doing a study, for doing very 
little to aid our understanding of the operation of this antidepressant 
drug, they are allowed to have the pediatric exclusivity, to make the 
money, but not without giving us full disclosure of the needed safety 
information. That information on Prozac is never given to doctors, 
parents and patients on how it affects young people.
  Sadly, physicians and parents have no way of knowing what the results 
of the study were on Prozac regarding the myriad of presumed uses of 
Prozac in young people. Unless Eli Lilly elects to tell us, we do not 
know what testing occurred, in what specific age groups, what dosage, 
or what reactions. Pediatricians, parents, and patients have no 
information; they are literally left in the dark.
  When the current bill comes to the floor, it will only require that 
manufacturers in the future will be required to label their products 
after the results are known. But that knowledge will not be given until 
11 months after the product is on the market. That gives them 11 months 
to negotiate with the FDA in a secret proceeding, unless the FDA is 
prepared to declare a product misbrand, and the FDA has been reluctant 
to do so.
  Under my labeling amendment, which I hope to bring to the floor, 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 the doctors, the patients, 
and the parents with the results of this study and the information they 
need to make it available.

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