Vinay Prasad, an oncologist and critic of fast-track approvals, has been named director of the FDA's Center for Biologics and Research (CBER), replacing Peter Marks, who resigned after nine years.[1][2][6] Prasad criticized Marks for being too pro-pharmaceutical, including his decision to approve Sarepta Therapeutics' Elevidys treatment for Duchenne muscular dystrophy, even after the death of a 16-year-old patient.[1][2] His appointment caused shares of more than a dozen gene and cell therapy companies to drop by double-digit percentages[1][5][6]. Analysts on Wall Street described this change as unexpected and bringing uncertainty to the field of rare diseases[1]. Prasad is skeptical of the use of surrogates in clinical trials and prefers randomized controlled trials with hard clinical outcomes[4][5][7]. During the pandemic, he criticized vaccination mandates and public health measures[2][6]. The rare disease community, drug manufacturers and investors express frustration with his approach[10].