New Drug and Device Approval: What Is Sufficient Evidence?

Growing pressure to expedite drug and device approvals through pathways like accelerated approval creates risks of premature market entry for products later found ineffective or harmful, as illustrated by cases like the Wingspan stent where a larger trial revealed increased stroke and death rates. While expedited access is appropriate for seriously ill patients with no alternatives, the FDA must maintain robust evidentiary standards as its default position, since Type I approval errors are unusually resistant to correction once products reach the market.