Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -30

Accepted - Volume 1

Comment Record
Commentor Dr. Lynn Manfred Date/Time 2002-06-30 16:54:40
Organization UMassMemorial Health Care
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? Hard for me to say.... but I think that you might want to require that all drugs be tested starting with the teeens and working down as the safety is shown.
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? for drugs still under patent, they shold still apply and they should be fined if they don't try to test on kids. The off patent ones are harder as they don;t have much financial backing. I would think that if more than a certian number of units are sold in the USA per year that the manufacturer could still be required to test
3. What provisions, if any, of the BPCA could apply to biological products regulated under section 351 of the PHSA? ?
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... kids have no real advocates and we must stand up for them and require this..
5. General Comments PLEASE support our children and those who care forthem!!! require that medicines be tested on children and not just tried one on one.

EC -30