Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -65

Accepted - Volume 3

Comment Record
Commentor Dr. Jennifer Plumb Date/Time 2002-07-07 16:00:27
Organization American Academy of Pediatrics
Category Health Professional

Comments for FDA General
5. General Comments The Pediatric Rule is essential for the following reasons: The Pediatric Rule ensures that children are no longer a therapeutic afterthought by the pharmaceutical industry. 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. The Pediatric Rule includes biological products. The BPCA provides incentives to the pharmaceutical industry to study drugs but does not address biological products. Significant portions of therapeutics used in children are biological products. Without the Pediatric Rule there is no mechanism to ensure that pediatric studies are conducted on these important medications. The Pediatric Rule captures drugs and age populations that the Best Pharmaceuticals for Children Act cannot. The BPCA incentive of additional market exclusivity can only be applied once during the life cycle of a drug. When FDA requests pediatric studies under BPCA, all potential pediatric uses must be anticipated in the request. This request cannot be expanded later if additional studies are needed in very young children or newborns or if a new use is discovered for a drug. Once studies have been completed and the incentive has been granted, there is no obligation on the part of participating companies to generate additional pediatric data. The Pediatric Rule may be invoked in instances where pediatric information is essential but the BPCA is no longer available. The Pediatric Rule is ongoing the Best Pharmaceuticals for Children Act is time-limited. The BPCA sunsets in 2007. If it is not renewed, history suggests that the industry may not see it within their scope or financial best interest to continue to do pediatric drug studies. The Pediatric Rule will allow pediatric studies to continue. The Pediatric Rule is mandatory the Best Pharmaceuticals for Children Act is voluntary. Because BPCA is voluntary, not all sponsors are interested in complying with the terms. The Pediatric Rule applies to all drugs and biologicals whose intended use in pediatrics is the same as adults, thus ensuring appropriate pediatric information.

EC -65