Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics Comment Number: EC -18
Accepted - Volume 1
Dr. Leonard Feld
Altantic Health System
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?
All new drugs must be studied for pediatric use at the time a drug comes to market unless the FDA grants a waiver. This puts children on a level playing field with adults for the first time.
5. General Comments
It is imperative that pediatric drugs receive appropriate testing. The Lack of clinical studies places the children at increased risk for medication errors and inappropriate treatment. There is no other way to ensure that the pharmaceutical industry avails themselves to drug testing unless there is a financial advantage. At this time the only advantage is an extension of the patent potection. If we want quality care with the lowest incidence of complications, loss of school and work time and the best long-term outcomes, it is vital to maintain this regulation.