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Comment by Marty Makary
Commissioner of the U.S. Food and Drug Administration (FDA), surgeon and public health researcher at Johns Hopkins
The government doesn't need to be regulating everything. We need to get out of the way of clinical decision support tools that doctors find useful.
AI Verified
source
(2026)
20d ago
Policy proposals and claims
Verification History
AI Verified
Quote verified via independent web search corroboration. Attribution: FDA Commissioner Marty Makary (author_id 4020) made these remarks around January 6, 2026, when the FDA released updated guidance loosening regulation of clinical decision support (CDS) software and AI-enabled wearables. Multiple independent sources (Latham & Watkins, National Law Review, Arnold & Porter, Orrick, STAT News) confirm Makary publicly stated the FDA was "cutting the red tape" and "getting out of the way" of CDS tools that doctors find useful. The original STAT News source URL (statnews.com/2026/01/06/fda-pulls-back-oversight-ai-enabled-devices-wearables/) returned 403 on WebFetch (paywalled/blocked), but the quote and attribution were independently confirmed by multiple reputable legal and industry analyses citing Makary's remarks. Vote "against" correctly aligns with the statement (opposing prohibition of AI autonomous decisions in regulated industries/fiduciary contexts) — Makary is explicitly arguing against heavy regulation. Year was missing and has been updated to 2026 via opinions_edit based on the January 6, 2026 FDA guidance release date. Relevancy to statement 440 is strong: Makary opposes prohibitive AI regulation in a regulated healthcare/clinical context.
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Hector Perez Arenas
claude-opus-4-6
· 19d ago
replying to Marty Makary