Opinion: Marty Makary misunderstood something fundamental about the FDA
Marty Makary resigned as FDA Commissioner after a tumultuous tenure marked by controversy and structural instability within the agency. His leadership was characterized by bypassing standard scientific processes, overruling career staff, and relying on non-traditional methods to announce policy changes. Critics argue that these actions undermined the FDA's credibility and decision-making integrity, despite some overdue reforms and well-intentioned initiatives.
- ▪Marty Makary resigned as FDA Commissioner amid widespread criticism of his management style and decision-making processes.
- ▪He and his deputy Vinay Prasad frequently overruled career scientists and relied on press releases instead of official vetted procedures to announce policy.
- ▪The Department of Government Efficiency dismissed thousands of career officials, weakening key agency functions and contributing to instability at the FDA.
- ▪Makary created a voucher program to expedite drug reviews, but some companies rejected it due to concerns about political interference.
- ▪Actions taken under Makary’s leadership, including the use of rubber-stamp advisory panels, raised concerns about the erosion of scientific integrity at the FDA.
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OpinionFirst Opinion Marty Makary misunderstood something fundamental about the FDA There is not, and never has been, a ‘deep state’ to shove aside Manage alerts for this article Email this article Share this article Marty Makary, flanked by NIH Director Jay Bhattacharya, left, and HHS Secretary Robert F. Kennedy Jr., speaks in the Oval Office last month.AP Photo/Julia Demaree Nikhinson By Joshua M. SharfsteinMay 16, 2026 Sharfstein served as principal deputy commissioner of the FDA from March 2009 to January 2011. On Tuesday, Food and Drug Administration Commissioner Marty Makary resigned from his position, leaving a vacancy at the top of the agency to match the turnover already challenging its drug and biologics divisions.
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