Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -49

Accepted - Volume 1

Comment Record
Commentor Dr. Robert Couch Date/Time 2002-07-03 10:57:27
Organization Vanderbilt University
Category Health Professional

Comments for FDA General
1. What changes to the pediatric rule, if any, would be necessary to integrate the BPCA and the pediatric rule more effectively? The pediatric rule is adequate as it now stands.
2. How would the criteria used by NIH and FDA under section 3 of the BPCA to request studies of already approved drugs relate to the standards promulgated in the pediatric rule and described in 21 CFR 201.23, 314.55, and 601.27 for requiring pediatric labeling for certain drugs and biological products? Which criteria are more appropriate for determining when studies are conducted? The pediatric rule would allow the 6 month exclusive rights to be used at any time, rather than at first release.
4. How does the provision in section 3 of the BPCA providing for a recommendation for a formulation change relate to the pediatric rule provision stating that in certain cases a sponsor may be required to develop a pediatric formulation? Should pediatric formulations be required in certain cases? The sponsor should be required to provide a pediatric formulation, if possible, in all cases.
5. General Comments I have been a pediatrician for 20 years, using hundreds of drugs that have no formal testing in children. I have been very excited by the prospect of learning if what I have seen and been taught about drugs in children is really true (so much of medical history has been disproving strongly-held opinions about the value of certain treatments). I would be really disappointed if careful, organized research on drug treatments in children stops, as I fear it would, because this rule is altered.

EC -49