Gov't advisor calls on FDA to boost clinical trials of drugs in kids

U.S. regulators have overseen improvements in the way drugs are tested in children, but the FDA could do more to make pharma companies conduct safety tests on the long-term effects of meds in kids, according to a new Institutes of Medicine (IOM) report.

Done at the request of the FDA, the report highlights the importance of studying the safety and impact of drugs in children, whose developing systems can react differently to treatments than adults. The U.S. has made progress in studying the safety of meds in kids since two federal laws were passed that resulted in new requirements and incentives for drugmakers to carry out pediatric studies, MedPage Today reports.

"Still, studies involving children continue to be limited, especially in certain areas such as medications' use in newborns and long-term safety and effectiveness in children," the IOM said this week. The group has suggested that Congress and the FDA could turn up the pressure on companies to do "long-term pediatric studies of possible safety risks." It also recommended giving the FDA the flexibility to level sanctions "for unreasonably delayed studies."

- check out the IOM's release
- read more in MedPage Today's article
- find the full IOM report here

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