According to the report, companies agreed to approximately 80% of FDA written requests to conduct pediatric studies under BPCA. The act also helped usher in labeling changes for nearly 90% of the drugs granted pediatric exclusivity. Although approving these labeling changes took three years in some cases, BPCA has had a positive effect on overall pediatric drug safety in terms of increasing information, trials, and accurate labeling. In fact, in 2006, Trileptal became the 100th FDA-approved drug to include appropriate labeling information about safety, efficacy, dosing, and unique risks for children and teens.
But we shouldn't stop there. At press time, Congress was debating BPCA's reauthorization, along with that of the Pediatric Research Equity Act of 2003 (PREA)—which enables FDA to require pediatric studies whenever a new ingredient, indication, dosage form, dosage regimen or route of administration is proposed for approval. Both acts fall under the pending renewal of the Prescription Drug User Fee Act. Some legislators would like to scale back BPCA's exclusivity period, claiming that companies earn far more during those six months of exlusivity than it costs to carry out a pediatric trial and that exclusivity can block potential generic drugs from entering the market.
Angie Drakulich is the managing editor of Pharmaceutical Technology, [email protected]