Geriatric Exclusivity? Incentives For Research In Elderly Debated At National Academies Workshop
FDA principal deputy commissioner Amy Abernethy and former commissioner Robert Califf point to success of orphan drug and pediatric exclusivity incentives in spurring drug development for neglected populations.
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The ripple effects from the pending drug price reform legislation in the US would include fundamentally changing the math on the incentive to encourage pediatric research on new products.
New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.
Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.