Pediatric Disincentive? Implications Of US Pricing Bill
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.
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Lilly’s view of the impact of the pending US drug pricing reform legislation is that it will require rethinking of all its small molecule development programs. That may sound extreme, but it is a logical response to the incentives in the bill. Does that mean the end of the generic drug era?
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.
The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.