EMA Chided Over Lack of Transparency in Pediatric Trials Waiver Process

The EU Ombudsman June 4 criticized the European Medicines Agency’s (EMA) lack of transparency and guidelines for deciding when to require drugmakers to carry out pediatric clinical trials.

Ombudsman P. Nikiforos Diamandouros said the EMA was within its authority when it asked for a trial of candesartan to treat heart failure in children, but did not require similar studies of losartan and valsartan. However, the agency failed to ensure adequate transparency of its process and reasons for the decisions, Diamandouros said. “Systematic changes are needed to avoid similar maladministration in the future.”

The case stems from an October 2009 complaint brought by the makers of candesartan, after the EMA granted product-specific waivers to the manufacturers of losartan and valsartan allowing them not to conduct pediatric heart failure studies. The agency’s Pediatric Committee denied a similar request for candesartan in 2007. The waivers were filed as part of a pediatric investigation plan (PIP) mandated by the 2006 Pediatric Regulation.

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