Vinay Prasad, a key ally of Martin Makary, is leaving the FDA, where he has been the focus of several controversies.[1][2] He served as chief medical and scientific officer and director of the Center for Biologics Evaluation and Research (CBER).[2][3] He has been involved in controversial decisions on the treatment of rare diseases, including the rejection of an application for an mRNA influenza vaccine and the delay or rejection of several cell and gene therapies.[2][4] He instructed CBER staff to consult with him before continuing work on scientific publications or new projects to avoid mistakes and waste of time.[2] His departure came less than three months after his appointment as CBER director and was linked to criticism of a conservative approach to rare disease drugs.[3][4][5] Prasad stated that he was leaving to spend more time with his family.[1]