Pfizer Chief Executive Officer Albert Bourla has publicly raised concerns about the leadership of the US Food and Drug Administration’s vaccine and biologics division, citing internal discord and recent regulatory decisions as problematic.

Speaking at a healthcare conference, Bourla said the company “has a problem” with the current director of the agency’s Center for Biologics Evaluation and Research, asserting that he believes the official is not following the recommendations of the agency’s career scientists. The remarks come in the context of recent decisions by the regulator, including an initial refusal to review an mRNA-based flu vaccine from a major competitor—later reversed—which has highlighted broader concerns about regulatory consistency and shifts in vaccine policy under the current U.S. administration.

Despite his criticism of leadership decisions, Bourla emphasised that Pfizer continues to maintain “very productive professional collaborations” with the agency’s career scientists and reiterated the company’s ongoing commitment to investing in vaccine development. He stressed the importance of a stable and science-driven regulatory environment while expressing confidence in the scientific review process provided by experienced staff at the regulator.

The comments underscore growing industry scrutiny of vaccine regulatory pathways in the United States, particularly following several high-profile vaccine review decisions that have drawn attention to internal agency dynamics and policy direction.