Dr. Vinay Prasad Leaves FDA Amid Controversy

Dr. Vinay Prasad, who recently took on the role as head of the FDA’s Center for Biologics Evaluation and Research, has resigned from his position after less than three months, citing a desire to avoid becoming a distraction to the agency’s work.

According to a spokesperson for the HHS, Prasad made the decision to return to California to be with his family. His departure comes as a surprise and marks the end of a turbulent period overseeing vaccines, gene therapy, and blood product reviews at the FDA.

Controversial Appointment and Swift Actions

Prasad’s appointment to lead CBER in May was met with mixed reactions, with some questioning whether FDA standards would shift under his leadership. During his brief tenure, Prasad worked on implementing stricter guidelines for COVID-19 vaccine approvals and made several contentious decisions, including overruling agency reviewers in granting limited clearances for certain vaccines.

Despite attempts to reassure stakeholders about maintaining regulatory flexibility, Prasad faced criticism from various quarters, including conservative commentators and op-ed writers, who accused him of being too rigid in his decision-making.

Public Standoff and Resignation

Prasad’s time at the FDA was marred by public disputes with biotech companies over drug approvals, particularly in the gene therapy space. The FDA’s rejection of a Duchenne cell therapy and the subsequent standoff with Sarepta over its gene therapy Elevidys further fueled controversy surrounding Prasad’s leadership.

Following pressure from various sources, including Wall Street analysts speculating about political interference, the FDA allowed Sarepta to resume shipments of Elevidys, leading to further speculation about Prasad’s future at the agency.

Ultimately, Prasad’s decision to resign was seen as a move to prevent further distraction and controversy within the FDA, bringing an abrupt end to his eventful tenure at CBER.