The Food and Drug Administration (FDA) is facing significant internal changes and concerns about its future direction, according to a recent opinion piece by a policy analyst and former government official. The author, who has closely followed the agency for years, argues that the FDA’s core values of predictability and expertise are at odds with President Trump’s approach to governance.
“The agency’s history and culture enshrine predictability and expertise as core values. In my opinion, those values are antithetical to Trump’s norm-breaking approach to policymaking,” the author states.
Recent developments have raised questions about the stability of FDA leadership. Commissioner Marty Makary had hoped that appointing Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER) would bring stability, but Pazdur’s sudden retirement has left only three veteran leaders in senior positions at the agency. A BioSpace analysis found that nearly 90% of senior leaders from a year ago are no longer with the FDA, including all from the Office of the Commissioner.
“Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner,” Jef Akst wrote in an editorial published on December 3, 2025.
Concerns have also been raised about political influence in regulatory decisions. According to Bloomberg reporting cited by the author, invitations were extended to two members of Congress to attend a meeting with a product sponsor—an action that was later reversed but prompted worries about possible favoritism or misunderstanding of FDA protocols.
Changes in vaccine policies have also come under scrutiny. Vinay Prasad, Director of the Center for Biologics Evaluation and Research (CBER), announced major proposed changes via email without broad discussion or public notice. The author notes that staff debate was welcomed but there is little evidence it has occurred on other policy shifts. Prasad reportedly suggested that staff who publicly disagreed should resign.
The article further describes how science-based decision-making may be giving way to approaches not grounded in data or expert input. Secretary Kennedy’s personal views on vaccines are said to be influencing Centers for Disease Control and Prevention (CDC) policy rather than scientific reasoning.
“It is now clear that Prasad and Acting CDER Director Tracy Beth Høeg are similarly committed to anti-vaccine policies at the FDA,” according to the opinion piece. Høeg has begun investigating deaths tied to vaccines—a move seen as potentially being used against vaccination efforts despite their benefits.
A new “one pivotal trial policy” is also causing concern among experts who believe it could weaken patient protections by requiring only one clinical trial for drug approval unless otherwise specified by regulators. This represents a shift from previous guidance which allowed flexibility but generally favored more evidence before approval.
The lack of public input, internal discussion, dissent, and reliance on independent expertise is described as eroding long-standing FDA practices intended to ensure sound decision-making. The author warns that ongoing staff turnover threatens institutional memory and could make recruitment difficult if confidence in consumer protection declines.
Editorials published by BioSpace highlight these issues further: “Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative,” wrote Jef Akst on November 13, 2025.
The article concludes with uncertainty about whether current leadership will address these challenges: “The prescription is clear—maximize predictability and rely on expertise—but it is uncertain whether FDA’s leadership will take the medicine.”
