Did you know that only one-third of prescribed pediatric drugs have been studied or labeled for pediatric use? The Best Pharmaceuticals
for Children Act (BPCA) was enacted in 2002 to improve this statistic by providing companies with six months of additional
marketing exclusivity if they conduct pediatric trials. The Government Accountability Office recently issued a report that
examined data from studies conducted between 2002 and 2005 for drugs specified by the US Food and Drug Administration under
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.
Although these points may be warranted, Congress should consider the larger picture. Renewing BPCA and PREA will keep us on
the path toward helping drug manufacturers produce safe and reliable medications for children.
Angie Drakulich is the managing editor of Pharmaceutical Technology, email@example.com