FDA Has the Wrong Mission. That’s Why It Fails. (opens in new tab)

Congress introduced legislation this month allowing seriously ill patients to access select treatments their physicians would prescribe - without FDA approval. That would mark a fundamental departure from the FDA's total control over every prescription drug in America. That stranglehold is the efficacy mandate - the FDA's requirement to certify that drugs work before any patient can access them, a federal override of the physician-patient relationship. Six center directors, two commissioners,...