The FDA’s vaccine chief, Vinay Prasad, is leaving his post at the end of April, according to the FDA commissioner. CIDRAP has the news.
Prasad was responsible for pulling the “review process from Moderna’s new mRNA flu vaccine, then [reversing] course, leading to confusion and public statements from Moderna’s CEO.”
He has also endured a public fight with UniQure, the “maker of a new gene therapy for Huntington’s disease. The company said last week [that] the FDA was demanding a new trial of its gene therapy, and that the trial would require some participants get a sham surgery, which they called unethical.”
Prasad also made “several chaotic moves at the FDA, at times announcing changes that make the FDA review process faster, and at other times issuing new warnings and onerous study requirements for some drugs and vaccines, which slowed the process.” His most notable change is the “FDA’s two-to-one policy, which says drugmakers are now required to show one well controlled clinical trial for new drug approvals instead of two.”
