Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -11

Accepted - Volume 1

Comment Record
Commentor Dr. Charles Maas Date/Time 2002-06-28 00:17:38
Organization Amer Acad of Pediatrics
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? None. Any changes would weaken the rule and be to the detriment of America's 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? The Pediatric Rule should mirror the scope of the PBCA and aply to all labeled and potential indications as well as new indications.
3. What provisions, if any, of the BPCA could apply to biological products regulated under section 351 of the PHSA? It is essential that the Pediatric Rule remain in place because it is the only mechanism that ensures that biological products wil be studied and available for children.
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? Appropriate formulations are an essential component of providing medications for the pediatric population. It is a requisite for studies in infants and younger children to develop age appropriate formulations, if necessary.
5. General Comments Thank you for the consideration of these comments.

EC -11