Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -55

Accepted - Volume 3

Comment Record
Commentor Dr. Philip Walson Date/Time 2002-07-05 09:16:53
Organization Cincinnati Children's Hospital
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? The FDA must be given more staff and support to investigate every product. Devices and biologics must be expanded/included.
3. What provisions, if any, of the BPCA could apply to biological products regulated under section 351 of the PHSA? All of them could, as could devices.
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? They should either be required or if impossible to formulate a commercially viable formulation, the sponsors should be required to provide whatever formulation information they do have such as what doesn't work or what works only in small batches, or what works but produces a bad tasting or bad smelling formulation. Many reasons for not being able to develop a commercial formulation (eg. inability to 'scale up' or short shelf life) are NOT impediments to widespread use using local resources.
5. General Comments Both the BPCA and the Pediatric Rule are needed to allow children to even approach parity with their parents and grandparents in having access to the fruits of modern pharmaceutical research. Both have been effective in disputing all prior reasons to not develop pediatric drugs.

EC -55