A prominent official from the U.S. Food and Drug Administration responsible for vaccines and biotechnology treatments will resign from the agency following numerous decisions that triggered apprehensions within the sector.
Vinay Prasad, head of the Center for Biologics Evaluation and Research, is set to depart the FDA at the end of April, as confirmed by an agency spokesperson on Friday. This marks his second exit from the role: He had briefly stepped down in July after facing backlash regarding his regulatory choices, only to return two weeks later in August.
In a message posted on X, FDA Commissioner Marty Makary stated that a successor will be appointed before Prasad resumes his position next month at the University of California San Francisco, where he taught prior to joining the FDA last year. Makary noted that Prasad “achieved a significant amount” during his time at the agency.
Prasad’s resignation follows escalating criticism of the FDA from the biotech and pharmaceutical sectors and former health officials. Over the past year, the agency has rejected or advised against the approval requests for at least eight drugs, according to RTW Investments, after disputing the data that the companies supplied to support their bids. The FDA also initially declined to examine Moderna’s flu vaccine before later changing its decision.
All these companies have accused the FDA of altering previously established guidance regarding the evidence they could use to support their applications, igniting concerns within the industry that an unpredictable regulatory environment could hinder the advancement of medications for challenging diseases.
A former FDA staff member who spoke with CNBC on the condition of anonymity to discuss the matter candidly described the reversals as the most detrimental type of regulatory unpredictability, noting that companies report being informed one thing, only to encounter a different reality.
In a statement earlier Friday, an FDA spokesperson asserted that there was “no regulatory unpredictability,” emphasizing that the agency “makes decisions based on the evidence, but does not guarantee outcomes.” The spokesperson indicated that the FDA is “conducting thorough, independent assessments and is not merely rubber-stamping approvals.”
The latest controversy emerged after the FDA discouraged UniQure from seeking expedited approval for its experimental treatment for Huntington’s disease.
The agency, which has seen staff reductions and restructuring under Health and Human Services Secretary Robert F. Kennedy Jr., has encountered broader criticism regarding its drug and vaccine approval process. Observers are concerned that the agency may impede the development of new therapies and jeopardize patient safety.
The Wall Street Journal previously reported on Prasad’s imminent departure.
