The Journal. The FDA Boss on the Agency’s MAHA Makeover
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Aug 5, 2025 
Dr. Marty Makary, the new head of the FDA and a former professor and surgeon, discusses his ambitious plans to reform the agency. He highlights how the FDA has been influenced by Big Food and Big Pharma. Key topics include the rise of ultra-processed foods linked to childhood obesity, the need for clearer vaccine regulations amidst rising measles cases, and the integration of AI in speeding up drug approvals. Makary emphasizes a transparent approach to rebuild trust in public health initiatives.
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FDA's Industry Capture and Reform
- The FDA has been 'captured' by the industries it regulates at times, compromising independence.
- Marty Makary is restoring scientific independence by removing pharma members from FDA expert panels.
Streamline Drug Approvals
- Streamline drug approval by cutting unnecessary steps like routine animal testing.
- Enhance communication with drug developers to save up to a year in review times.
AI Accelerates FDA Reviews
- Use AI tools like ELSA to speed up scientific reviews, cutting days to minutes.
- Reviewers should understand AI's limits but embrace its benefits to modernize FDA work.