Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -59

Accepted - Volume 3

Comment Record
Commentor Dr. Charles Hemenway Date/Time 2002-07-05 13:54:05
Organization Dr. Charles Hemenway
Category Health Professional

Comments for FDA General
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. Lack of pediatric formulations renders some drugs impossible to administer despite efficacy in children. In my opinion, it is unethical to exclude children from the potential benefits of a drug that is otherwise approved for use and that has been demonstrated to be safe and effective in children.
5. General Comments The Pediatric Rule that requires testing in children must be kept in place. Abundant data indicate that the pharmacology of therapeutic drugs sometimes differs substantially in children and adults. Without testing, children are subject to a risk that cannot easily be justified. It is difficult to imagine why the current Pediatric Rule is being questioned given the responsibilty of the FDA to ensure that drugs approved for use in the United States are safe. Children represent a large and important segement of the U.S. population and must be protected by the FDA.

EC -59