FDA faces sharp questions as criticism grows over new drug decisions

An FDA official held a rare press call to defend the agency’s decision to require an additional clinical trial for UniQure’s Huntington’s disease gene therapy, criticizing outside scientists and signaling concerns about potential conflicts of interest. The exchange follows ongoing uproar over the agency’s handling of drug approvals, including Moderna’s flu vaccine application, and underscores a tension between expanding rapid approvals and ensuring solid evidence through placebo-controlled trials in order to prevent unsafe or ineffective medicines.