FDA veteran and outspoken expert Unger retires as the agency finds itself at a crossroads

The FDA is losing a top official as the search for a new commissioner drags on. Ellis Unger, M.D., a cardiologist who led the agency’s Office of Drug Evaluation I, is retiring after 25 years at the agency. 

Unger is retiring for “personal reasons” and not in response to the FDA’s controversial approval of Biogen’s Alzheimer’s disease drug, Aduhelm (aducanumab), he told Stat, which first reported his retirement Thursday. 

His departure follows the exits of three doctors who served on the advisory committee that recommended the FDA reject Biogen’s controversial Alzheimer’s drug. Joel Perlmutter, M.D., David Knopman, M.D., and Aaron Kesselheim, M.D., all quit the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee within days of Aduhelm’s approval. 

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Unger led the Office of Drug Evaluation I from 2012 to 2020, a part of the agency’s Center for Drug Evaluation and Research (CDER) that reviewed drugs for various conditions. He then became the head of the FDA’s Office of Cardiology, Hematology, Endocrinology and Nephrology as part of a reorganization that grouped its division by therapeutic area. 

Though Unger was not directly involved in the FDA’s review of Aduhelm, he is known for speaking out against other controversial decisions. 

In 2016, the FDA approved Sarepta Therapeutics’ Exondys 51 under the accelerated pathway, going against an advisory committee’s recommendation to reject the drug. Aduhelm met the same fate in June this year, though the advisory committee vote was not as close as that for Exondys 51. 

In redacted documents released along with the approval, Unger, among others, expressed concerns about the small study and its lack of clear efficacy. Janet Woodcock, M.D., then the head of CDER and now acting commissioner of the FDA, pushed for the drug’s approval. 

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Woodcock has been the FDA’s temporary chief for more than six months, and a global pandemic is not a great time for the agency to be without a permanent leader. 

Six former FDA commissioners banded together in March to urge President Joe Biden to appoint a full-time leader, noting vaccine, drug and testing issues related to the pandemic as well as the need to implement new tobacco regulations. The ex-commissioners did not endorse any one candidate in their letter to the White House, but they did praise Woodcock, who led CDER from 1994 to 2005 and from 2008 until January 2021.