Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -15

Accepted - Volume 1

Comment Record
Commentor Dr. Katherine Luzuriaga Date/Time 2002-06-28 09:49:37
Organization Pediatrics/University of Massachusetts Medical Sch
Category Academic

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? There is a need for a single, mandatory mechanism that is not time-limited and that applies to all pharmaceutical and biologic products (including vacines). The 1998 Pediatric Rule is a comprehensive approach to securing pediatric studies and must be preserved. BPCA is time-limited, voluntary and subject to continuation by the Congress. In addition, some of the most innovative new therapies are biological products, which are not covered under BPCA. * Noting again that the BPCA is subject to continuation by Congress and that future reauthorization is uncertain, the Pediatric Rule should mirror the scope of the BPCA and apply to all labeled and potential indications as well as new indications.
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? In determining the process of when pediatric studies are conducted, the FDA should rely on the detailed process for requesting pediatric studies of already marketed drugs and securing labeling that is outlined in the BPCA.
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. Failure to require needed formulations for specific age populations negates the intent of the BPCA and the Pediatric Rule.

EC -15