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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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‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.