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Sharfstein: US FDA Incentives Not Broke, But Fix Them

 
• By Derrick Gingery

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.

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Former FDA Principal Deputy Commissioner Joshua Sharfstein said exclusivity awards should be proportionate with their cost to the health care system. • Source: Shutterstock

A former US FDA principal deputy commissioner is calling for reforms to accelerated approval, orphan drug exclusivity and other incentives to improve their effectiveness and ensure sponsor rewards are balanced with their costs to the health care system.

Joshua Sharfstein, who served as the US Food and Drug Administration's second in command from 2009 to 2011 under Commissioner...

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