Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -68

Accepted - Volume 3

Comment Record
Commentor Dr. Victor Braren Date/Time 2002-07-08 08:59:35
Organization Mid-South Urology PC
Category Health Professional

Comments for FDA General
5. General Comments Food and Drug Administration Dockets Management Branch (HFA-305) Docket Number: 02N-0152 5630 Fishers Lane - Room 1061 Rockville, MD 20652 Dear Sirs/Madams: I write in support of the continuation of the so-called Pediatric Rule. It is absolutely imperative that we support pediatric studies of new drugs. As a pediatric urologist who cares for children every day, I welcome the opportunity to comment on the relationship between the 1998 Pediatric Rule and the Best Pharmaceuticals for Children Act (P.L. 107-109). Securing safe and appropriate drugs for use by children has had a long and laborious history. Significant progress toward pediatric drug studies and labeling has been made over the last five years. You are well-versed in the dual approach to obtaining essential pediatric data. In March 2002 the FDA proposed suspension of the Pediatric Rule. While this proposal was reversed, this action indicates that children are at risk of losing the ground we have fought so hard to secure for them. The Pediatric Rule ensures that children are no longer a therapeutic afterthought by the pharmaceutical industry. It is an essential and successful tool in ensuring that children have the quality and quantity of drugs they need. All new drugs must be studied for pediatric use at the time a drug comes to market unless the FDA grants a waiver. This makes medications for children a certainty, not an option and puts children on a level playing field with adults for the first time. I believe that all components of the 1998 Pediatric Rule must be preserved. It is a comprehensive approach to securing pediatric studies. The FDA has not yet invoked all the provisions of the Pediatric Rule; however, together they establish a safety net for children to ensure that appropriate drugs are available for their use. You have received from the AAP comments and recommendations in response to questions and issues raised in the Federal Register notice soliciting public comments. I will not further remark on those except to strongly support them. Please do the right thing. Thank you, Victor Braren, MD, FACS, FAAP Mid-South Pediatric Urology PC Meharry & Vanderbilt Medical Schools 329 Twenty-first Av N Nashville, TN 37203

EC -68