Paving Way for Pediatric Drug Safety

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 BPCA.

Angie Drakulich

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, adrakulich@advanstar.com.