Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -44

Accepted - Volume 1

Comment Record
Commentor Dr. Russell Van Dyke Date/Time 2002-07-02 12:48:18
Organization Tulane University School of Medicine
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 and the BPCA are both necessary to ensure that drugs and biologics are made available to children in a timely manner. Because of known differences in drug metabolism and safety profiles, drugs to be used in children must be studied in children.
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? All components of the 1998 Pediatric Rule should be preserved and implemented.
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? Approprite pediatric formulatins are essential for children and must be required.
5. General Comments I care for HIV-infected children. Thus, I experienced the delay in availability of effective antiretroviral therapy for children when thesew therapies first became available. This should never happen again. New therapies need to be studied in childern so they can benefit from them. The Pediatric Rule and the BPCA are essential.

EC -44