EU Pediatric Drug Rule Produces Mixed Results, Report Says

October 30, 2017

An EU regulation meant to boost pediatric drug development has led to more medicines for children since it was adopted, although actual use of new products has not increased at the same pace, a European Commission report said.

The regulation requires sponsors to agree to a plan for pediatric research into a drug early in the development stage, or risk denial of the approval for all uses, including adult indications. Companies that comply with the regulation can receive rewards in the form of extended marketing exclusivity.

Why actual use of the drugs has not increased is unclear. The discordance may be due to delays in approval of coverage of the new products by different national health agencies, which would reduce their availability. Or, physicians may be too accustomed to write off-label prescriptions of adult drugs in modified dosages for children, the report said.

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