Pfizer CEO Criticizes FDA Leadership
In a rare public rebuke, Pfizer's CEO has voiced concerns about the U.S. Food and Drug Administration's vaccine leadership. The move signals potential friction between the pharmaceutical giant and its primary regulator, which could foreshadow future policy or regulatory battles in the sector.
The target of the critique by Pfizer CEO Albert Bourla was specifically Dr. Vinay Prasad, the director of the FDA's Center for Biologics Evaluation and Research (CBER). Speaking at the TD Cowen healthcare conference, Bourla asserted that Prasad is disregarding the recommendations of the agency's career scientists, creating a "problem" for the pharmaceutical giant. This public friction follows the FDA's recent and unusual reversal on Moderna's mRNA flu vaccine application. The agency, in a letter signed by Prasad, initially refused to review the vaccine before changing course a week later, a move that has reportedly unsettled career staff and created uncertainty around vaccine approvals. Dr. Prasad, an oncologist, has been an outspoken critic of U.S. COVID-19 vaccines and mask mandates. He was appointed to lead the powerful CBER last year by FDA Commissioner Marty Makary, who has also publicly criticized COVID-19 policies. Under this new leadership, the FDA has narrowed its approvals for COVID-19 vaccines and is currently reviewing deaths that it suggests may be linked to the shots. This represents a significant policy shift for the agency that oversees the U.S. vaccine market. This is not the first time Prasad's actions have drawn controversy. He briefly left the agency in the previous year following sharp criticism over the FDA's handling of Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, which resulted in the deaths of two teenagers. While criticizing the leadership, Bourla was careful to praise the agency's staff, highlighting Pfizer's "very productive professional collaborations" with career scientists within the vaccine department. Bourla's recent comments align with his increasingly public role in policy debates. In January 2026, he characterized the vaccine views of Health and Human Services Secretary Robert F. Kennedy Jr. as "anti-science" and called for a change in leadership at the department.
