Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act | Clinical Pharmacy and Pharmacology | JAMA Pediatrics | JAMA Network

Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act | Clinical Pharmacy and Pharmacology | JAMA Pediatrics | JAMA Network

Data specific to kids is often lacking on drug labels

(JAMA PEDIATRICS)

The FDA has the power to require drug makers to study their products in kids — but those studies aren't often happening in a timely manner, according to a new analysis. Drug makers are often allowed to carry out the studies after the drugs are approved based on data in adults. Researchers looked at what happened with 222 studies that should've been carried out after FDA approvals between 2007 and 2014. Five years after approval, only 27 percent of the studies had been completed. The authors also found that many drug labels still lack important information specific to use in kids. "Stronger policies are needed to ensure the timely availability of pediatric information for most new medicines," they write.