Words by Jade Williams
Two major health agencies on opposite sides of the Atlantic are undergoing leadership changes, with the resignations of the FDA’s Vinay Prasad and NICE’s Dr Sam Roberts.
Vinay Prasad, Head, FDA’s Center for Biologics Evaluation and Research, has stepped down following a string of controversial regulatory decisions that drew attention from across the board.
Only appointed in May 2025, Prasad replaced Peter Marks, who was ousted after clashing with the new Health Secretary Robert F. Kennedy Jr on several issues related to vaccine policy, vaccine safety and the FDA’s overall approach to regulation. In contrast, Prasad held a similar stance to Kennedy Jr. on vaccines and COVID-19.
One move that drew particular scrutiny was Prasad’s decision to restrict a gene therapy for Duchenne Muscular Dystrophy from Sarepta Therapeutics. Following three patient deaths, the agency ordered the pause of all limb-girdle muscular dystrophy gene therapy trials and requested Sarepta to halt shipments.
After initially resisting, Sarepta reversed course following a 36% stock price plunge. The FDA later lifted its recommendation to pause shipments for ambulatory patients after determining the third reported death was unrelated to the therapy.
Dr George Tidmarsh has been named acting Center for Biologics Evaluation and Research Director, just a week after being appointed to lead the FDA’s Center for Drug Evaluation and Research. It is not clear who will take up the post permanently yet.
Across the pond, Dr Sam Roberts, CEO, NICE, has announced she will also step down. Planning to leave by the end of 2025, the decision will enable her to “support her children through a difficult time”, according to a statement from NICE. It notes that recruitment for her successor has begun.
Roberts, who succeeded Professor Gillian Leng, was praised by Sharmila Nebhrajani, Chair, NICE. “Under her transformational leadership, NICE has become a more forward looking, collaborative and responsive organisation, whilst staying true to its mission of helping the NHS to get the best care to patients fast, at good value to the taxpayer,” she expressed in a press release.
Roberts’ achievements include a 25% increase in drug assessment speed, new procedures for high-severity disease evaluations and a rapid appraisal framework for digital health tools and AI.
The CEO will continue to lead NICE through the initial implementation of the NHS 10-Year Plan, which seeks to expand the agency’s authority to accelerate access to new technologies and align regulatory pathways with the MHRA.
