The Food and Drug Administration has installed Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER), the unit responsible for regulating vaccines and other biological products for human use, according to a Department of Health and Human Services official.
Szarama, who joined the FDA late last year, previously served as deputy director under Vinay Prasad, whom she now replaces. Before her FDA appointment, she held roles at the Centers for Medicare and Medicaid Services and the National Institutes of Health. Her new role places her in charge of evaluating the safety, effectiveness, and availability of a wide range of biologics, including vaccines, blood products, and gene therapies.
Prasad's tenure at CBER was notably rocky. He was appointed after former director Peter Marks departed amid clashes with HHS Secretary Robert F. Kennedy Jr. Prasad's own time in the role was marked by political controversy. MAGA influencer Laura Loomer publicly attacked him over past comments praising Senator Bernie Sanders and criticizing President Trump. Soon after, Prasad left the FDA, only to be reinstated quickly. At the time, HHS stated that “neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration.”
The revolving door at CBER underscores broader tensions within the Trump administration's health agencies. The appointment of Fox News contributor Nicole Saphier as Surgeon General pick earlier this year signaled a preference for media-savvy loyalists, while the acting CDC chief recently blocked a COVID vaccine study, sparking a political firestorm. These moves have raised questions about the independence of scientific oversight in public health agencies.
Prasad's brief return to CBER did little to stabilize the unit. His departure now leaves Szarama to navigate the agency's vaccine and biologics portfolio amid ongoing scrutiny from both political factions. The FDA has faced criticism for its handling of vaccine approvals and safety monitoring, particularly as the administration pushes for rapid development of new vaccines and treatments.
Szarama's background in both CMS and NIH suggests a focus on regulatory efficiency and public health outcomes. However, her appointment as acting director, rather than permanent, hints at continued uncertainty at the top of the FDA's biologics division. Political observers note that the position has become a flashpoint in the broader battle over vaccine policy and federal health authority.
The Hill first reported the confirmation of Szarama's appointment, which was initially disclosed by Politico. As acting director, Szarama will oversee a unit that has been at the center of controversies over vaccine mandates, emergency use authorizations, and the balance between safety and speed in product approvals.
