FDA's Vinay Prasad, controversial CBER chief, to depart
statnews.com • • business
Key Points:
- Vinay Prasad, a controversial FDA official and oncologist, is leaving the agency at the end of April, with no successor named yet, according to FDA Commissioner Marty Makary.
- During his tenure, Prasad oversaw vaccines, gene therapies, and blood products regulation, and played a key role in initiatives like reducing clinical trial requirements and launching a fast drug review program.
- Prasad's leadership at the Center for Biological Evaluation and Research (CBER) has been marked by increased scrutiny of rare disease drugs, rejecting several cell and gene therapies that might have been approved previously, causing concern among patient advocates.
- His management style has been criticized internally, with reports of mistrust and paranoia among staff, and several complaints filed
