Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -54

Accepted - Volume 1

Comment Record
Commentor Dr. Elizabeth Jackson Date/Time 2002-07-03 18:30:32
Organization Pediatric Nephrology University of Kentucky
Category Individual

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? I believe that the pediatric rule should be preserved in its entirety.
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? If a company submits a supplemental indication to the FDA, the Pediatric Rule should ensure that appropriate pediatric studies be conducted for that new use.
3. What provisions, if any, of the BPCA could apply to biological products regulated under section 351 of the PHSA? No provision of BPCA applies specifically to biological products since the vast majority of biologics are covered under the Public Health Service Act. The Pediatric Rule is the only mechanism that ensures that biological products will 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? Yes, failure to require needed formulations for specific age populations negates the intent of the BPCA and the Pediatric Rule.
5. General Comments Children are not small adults. Currently we are trying to estimate pediatric doses from adult recommendations or getting information from case reports. I appreciate your efforts to ensure approptiate pediatric drug and biologic product trials.

EC -54