Vinay Prasad will replace Marks as CBER director
Vinay Prasad has worked as a professor of medicine, haematologist/oncologist, and health policy researcher.
Controversial doctor Vinay Prasad, a public health researcher at UCSF known as a critic of US health policy, has been named as director of the FDA's Center for Biologics Evaluation and Research (CBER).
He steps into the shoes vacated by Peter Marks, who resigned from the role a few weeks ago – reportedly before being pushed out – whilst delivering a swipe to Health and Human Services Secretary Robert F Kennedy Jr.
In his resignation letter, Marks wrote: "It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies," adding that "efforts currently being advanced by some on the adverse health effects of vaccination are concerning."
Prasad, who has been pitching for a role in Kennedy's department for some time and at one point was rumoured to be seeking the surgeon general role, fits the mould of other senior health figures in the Trump administration in that he has been a sceptic about the use of COVID-19 vaccines in children, annual boosters, and the emergency authorisation of the shots.
He has been appointed to the FDA as the agency is in the process of considering updates to the annual COVID-19 vaccines and reportedly considering a mandate that all new vaccines undergo placebo-controlled trials – even for well-established diseases.
Before Marks' resignation, Prasad accused the former CBER chief of being "one of the most dangerous, pro-pharma regulators of the 21st century" and claimed on a social media that he could be replaced "with a bobblehead doll that just stamps approval and you would have the same outcome at FDA with lower administrative fees."
FDA Commissioner Martin Makary said on social media that Prasad "brings the kind of scientific rigour, independence, and transparency we need at CBER," adding that his appointment is a "significant step forward" at the agency.
The biotech index on the Nasdaq fell 6% after news of the appointment emerged, in a sign that investors are concerned the sector now faces additional uncertainty.
Shares in Sarepta Therapeutics, which has been singled out for criticism by Prasad over its Duchenne muscular dystrophy therapy Elevidys (delandistrogene moxeparvovec) under Marks' watch, plunged nearly 27%.
Meanwhile, COVID-19 vaccine developer Moderna – which recently said it was deprioritising development of a combination COVID-10 and flu jab as part of a slowdown in new vaccine development – was down 12%.
