A year of unusually high turnover at the Food and Drug Administration — including multiple resignations in late November and early December — has intensified scrutiny of the agency’s internal operations as senior officials continue to depart. The developments have renewed attention on past public remarks made by senior FDA advisor Vinay Prasad before he joined the agency.
During a 2020 episode of the Plenary Session podcast, Prasad criticized the prior administration’s handling of the COVID-19 pandemic, stating he believed the sitting president at the time was “perhaps the worst president we’ve had in the history of the Republic,” and alleging federal mismanagement “cost hundreds of thousands of lives.”
The comments resurfaced as the FDA experienced extensive leadership changes this year, including the resignations of Center for Drug Evaluation and Research chief George Tidmarsh, longtime vaccine director Peter Marks, and cancer researcher Richard Pazdur.
In addition to internal tensions, external pressure has mounted. On December 9, Susan B. Anthony Pro-Life America called for FDA Commissioner Dr. Marty Makary to be fired, arguing that the FDA had “slow-walked” a comprehensive safety study of mifepristone and criticizing the agency’s recent approval of a new generic version of the drug, according to OSV News.
The White House rejected the call, stating the administration has “the utmost confidence” in Makary and describing the ongoing review as a “Gold Standard Science” process.
The public dispute added to broader scrutiny surrounding the FDA as several senior officials departed key positions in recent weeks.
Pazdur’s retirement was reported on December 5 by CNN, which stated he had raised concerns about personnel changes and the pace of proposed policy shifts after briefly agreeing to lead the FDA’s largest drug division.
Tidmarsh resigned in early November following a lawsuit from Aurinia Pharmaceuticals and an internal review tied to a deleted social media post, Fierce Pharma reported. HHS said Tidmarsh had been placed on administrative leave prior to his resignation due to concerns about personal conduct.
According to data cited by Bloomberg on December 8, roughly ninety percent of senior FDA officials who were at the agency a year ago have since departed. Bloomberg also reported that Prasad briefly left the FDA earlier this year and later returned, and that leadership transitions across multiple divisions have accelerated during Commissioner Marty Makary’s tenure.
Despite the turnover, the White House and HHS have repeatedly reaffirmed their confidence in Makary.
In comments to OSV News, White House spokesman Kush Desai said Makary “is working diligently” on a comprehensive review of mifepristone and that the administration maintains “the utmost confidence” in his leadership. HHS described Makary’s approach as rooted in “gold-standard science and evidence-based reviews.”
Officials have also pointed to policy initiatives under Makary’s leadership, including a review of artificial food additives and a major safety evaluation of infant formula, as work that aligns with current agency priorities. Bloomberg noted Makary received bipartisan support during his Senate confirmation earlier this year.
Industry leaders have expressed concern about regulatory uncertainty linked to the departures.
John Crowley, chief executive of the Biotechnology Innovation Organization, told Bloomberg that the turnover has created unpredictability and said it is “time to right this ship.”
Administration officials maintain that ongoing FDA reviews and policy actions will continue as the agency works through the leadership transitions.
