Marty Makary on Slow, Bureaucratic Drug Review: warns against

Dr. Marty Makary warned that the FDA’s drug review timelines were too slow, and he pushed Warp-Speed-style urgency — the rationale behind the National Priority Voucher program (targeting 1–2 month decisions) and the agency-wide AI deployment for review triage and safety-signal detection.

Makary’s stated reasoning is that slow review delays life-saving treatments and that faster review, aided by AI and priority pathways, serves patients without abandoning scientific standards.

The for/against dimension matters here: critics, including the biotech industry group BIO and a Health Affairs analysis, countered that speed was sacrificing rigor and that many of his claimed reforms were largely performative — that they advanced little past announcements. This page carries both his position and the sourced criticism.

This page chronicles a stated position of the person above. It is not medical advice and not the site's own conclusion.