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# Harvard’s Kesselheim is 3rd FDA Advisor to Resign
- URL: https://www.fdaweb.com/harvards-kesselheim-is-3rd-fda-advisor-to-resign/
- Published: 2021-06-11T12:00:00.000Z
- Updated: 2026-09-14T17:02:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149521

A third advisory committee member — Harvard medical school professor **Aaron Kesselheim** — has resigned in the wake of FDA’s 6/7 decision to grant accelerated approval for Biogen’s Alzheimer’s therapy. Earlier this week, Mayo Clinic (Rochester, MN) professor **David Knopman** and Washington University School of Medicine professor **Joel Perlmutter** also turned in their resignations from the agency’s Peripheral and Central Nervous System Drugs Advisory Committee due to irregularities with the panel process.  

Kesselheim, who has been on the panel since 2015, called the Biogen decision “probably the worst drug approval decision in recent U.S. history.” He was also critical of the agency’s 2016 accelerated approval ([see story](http://fdaweb.com/login.php?sa=v&aid=D5136852&cate=&stid=%241%24ol4.RK1.%24NQooczq.WXSnNm0IJydLg%2F&ref=fdaweb.com)) of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen). In eteplirsen’s approval, CDER director **Janet Woodcock** overrode reviewers’ concerns and the same advisory committee’s recommendation that Sarepta did not provide substantial evidence from adequate and well controlled studies that eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit in patients with DMD.