Turmoil, Turnover and Industry Backlash Mark Makary’s Tenure
FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makary’s tenure, according to accounts from agency staff, industry executives and policymakers, raising questions about leadership stability at the nation’s top drug regulator. Makary, initially viewed as a conventional and well-qualified pick backed by bipartisan support, now presides over an agency described by some insiders as beset by management conflicts, leadership turnover and declining staff morale, new reporting by Bloomberg indicates. Several individuals familiar with the situation characterized the current environment as difficult to sustain, warning that another high-profile misstep could jeopardize his position, though no immediate leadership change is planned.
The commissioner and his allies dispute those assessments, pointing to policy initiatives and regulatory actions they say demonstrate progress. These include efforts to limit synthetic food dyes, address misleading advertising and streamline elements of the drug approval process. Administration officials have also defended Makary as aligned with broader White House priorities to modernize the agency, according to Bloomberg.
Makary’s transition from academic physician to head of a more than 16,000-person federal agency has been uneven, according to current and former officials. Critics cite a management style they describe as insular, with tighter control over information flow and reluctance to formalize decisions in writing — claims Makary has rejected, emphasizing transparency and accessibility.
The agency has also experienced significant turnover across senior roles. The FDA’s drug center cycled through multiple leaders in the past year, while prominent officials, including longtime oncology regulator Richard Pazdur, exited leadership positions citing concerns about communication and decision-making processes.
Controversy also surrounded Makary’s former deputy and CBER director Vinay Prasad, whose confrontational approach to regulation and high-profile decisions drew industry backlash. Prasad’s departure has eased some tensions, according to people familiar with the situation. Broader staffing disruptions tied to workforce reductions across the U.S. Department of Health and Human Services have further weighed on morale, even as Makary maintains that staffing levels have since stabilized, Bloomberg reports.
Biopharmaceutical companies have increasingly voiced concern about what they see as inconsistent regulatory decision-making. Firms including Moderna, uniQure and Replimune Group have reported unexpected setbacks in their interactions with the agency, with some executives warning that unpredictability could undermine U.S. leadership in drug innovation.
Tensions have been particularly acute in the rare disease sector, where companies argue that shifting standards and stricter evidentiary expectations have contributed to a decline in approvals. Lawmakers, including senator Ron Johnson (R-WI), have launched inquiries into recent regulatory decisions affecting these therapies, Bloomberg notes. Some companies have escalated disputes beyond FDA, appealing directly to senior administration officials or Congress to challenge regulatory outcomes they view as inconsistent or opaque.
While Makary has emphasized that drug approval decisions reflect the recommendations of FDA scientific review teams, critics point to instances where senior leadership overruled staff conclusions. Public records indicate that agency leadership intervened in certain vaccine-related decisions, fueling concern among some stakeholders about political or managerial influence over scientific review.
Industry groups have also raised concerns about what they describe as overly rigid evidentiary standards — particularly in emerging areas such as gene therapy — arguing that such approaches may delay patient access to treatments for serious conditions, according to Bloomberg.
In response to the turbulence, HHS has reportedly introduced new procedures aimed at improving coordination on policy rollouts and hiring. Makary has increased outreach to industry leaders, lawmakers and former FDA commissioners, including consultations with predecessors such as former commissioner Scott Gottlieb.
The agency is also working to fill key vacancies and implement more structured hiring practices, while elevating internal personnel in policy and food safety roles. Makary has said he is prioritizing recruitment of experienced scientific staff and reinforcing internal review processes. Bloomberg notes that some industry observers say these steps are encouraging but remain cautious about whether they will be sufficient to restore confidence. “The FDA is trying to get better,” said one biotech investor, noting increased engagement with stakeholders. “But there’s still a need to demonstrate consistent execution.”
For now, Makary retains support within parts of the administration, and a leadership change would complicate an already crowded Senate confirmation agenda for other top health positions. Still, the coming months are widely viewed by stakeholders as critical in determining whether the commissioner can stabilize the agency and rebuild trust with both staff and industry.