Unger Unplugged: FDA Needs Accelerated Approval To ‘Take More Chances’ – But Also A Clear Path To Withdrawal

Accelerated Approval was “a stroke of genius,” when it was created 30 years ago, but the Food & Drug Administration still needs an easier path to removing a product from the market when confirmatory trials fail to show benefit, former FDA review manager Ellis Unger said during a recent Everylife Foundation Congressional caucus briefing.

Unger’s participation during Rare Disease Week marked his first public appearance to discuss FDA regulatory policy since leaving the agency last summer. He ended his 25-year career at FDA as director of the Office of Cardiology, Hematology, Endocrinology and Nephrology, and has recently joined the law firm Hyman, Phelps, and McNamara as principal drug regulatory expert