The Journal. The FDA Commissioner on Vaccines and Public Trust
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Sep 9, 2025 
Dr. Marty Makary, Commissioner of the FDA, discusses the recent approval of updated COVID-19 vaccines, aimed at rebuilding public trust in health policies. He addresses the agency’s efforts to regulate misleading pharmaceutical ads and announces an upcoming report linking Tylenol use during pregnancy to autism. Makary emphasizes the need for open dialogue and transparency in vaccine communications to counteract the politicization of health issues, advocating for data-driven decisions in public health.
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FDA's Regulatory Role Clarified
- The FDA is a regulator that ensures vaccine makers' claims match their submitted data.
- It does not recommend vaccines or practice medicine; it enforces statutory standards.
Risk‑Stratified Booster Policy
- The FDA adopted a risk‑stratified approach approving the COVID booster only for older or high‑risk people.
- Makary notes much of the world has moved to this model and the risk differs greatly by age and comorbidity.
Back To Gold‑Standard Approval
- Makary says the FDA is returning to 'gold standard' approval: require clinical trial data rather than automatic yearly authorization.
- He notes it's been four years since a clinical trial and wants approvals based on evidence, not blind renewal.