Defining 'Substantial Efficacy': Post Hoc Analysis OK (When US FDA Does It)

The US Food and Drug Administration's approach to weighing "non-positive" efficacy data against the results from two successful clinical trials for an antidepressant drew protests from some members of its Psychopharmacologic Drugs Advisory Committee on Dec. 1. The development could have implications beyond antidepressant drug development and highlights the potential need for FDA guidance on this issue.