FDA Biologics Chief Vinay Prasad to Step Down in April
CBER director Vinay Prasad will step down at the end of April, according to HHS. His departure comes on the heels of several recent controversial decisions at the Center and news of an internal investigation into complaints from staff. HHS did not provide additional details about the reason for his upcoming departure or who will lead the biologics center after he leaves.
Prasad, an oncologist who previously built a reputation as an outspoken critic of U.S. drug and vaccine policy, has led CBER since 5/2025. He stepped down from the role in July, with HHS saying at the time that he did not want to become a distraction amid ongoing controversies. He returned to the position just over two weeks later at FDA commissioner Marty Makary’s insistence.
“Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, & the new plausible mechanism framework for ultra rare diseases which we launched last week,” Makary wrote in a post on X. “He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month. We will name a successor before his departure.”
Prasad's tenure at the agency has been marked by a series of high-profile regulatory disputes and controversial product decisions. Most recently, CBER has been engaged in a public dispute with uniQure over its experimental gene therapy for Huntington’s disease. Regulators asked the company to conduct an additional study to support approval, a request uniQure and some patient advocates argued would take too long and place additional burdens on patients with the rare neurological condition. Another incident involved his overruling staff to issue a "refusal-to-file" letter for a Moderna influenza vaccine, which was later reversed. Prasad also faced internal and external scrutiny for an internal memo in which he claimed Covid vaccines were responsible for the deaths of at least 10 children, a claim that critics said relied on unverified and “incomplete information.”
Additionally, Prasad has faced internal complaints that alleged he fostered a "toxic" work environment, which included allegations of verbally berating staff and retaliating against employees who disagreed with his decisions. These incidents have been investigated by outside firm Professional EEO Services. Media reports indicated that career staff felt intimidated, with some attempting to transfer out of the vaccine center. In a memo to staff, Prasad reportedly demanded that employees who disagreed with him should resign, calling internal disputes "unethical" and "illegal".