What Marty Makary Actually Got Done As FDA Commissioner
Marty Makary resigned as FDA Commissioner in May 2026 amid controversy over his opposition to the Trump administration's push to approve fruit-flavored e-cigarettes, which he argued would attract minors. Despite the controversies, the article argues Makary enacted the most significant FDA modernization in decades. Key reforms include reducing drug review times from a year to 1-2 months, increasing generic drug approvals by 20%, deploying artificial intelligence to speed up reviews, issuing new guidance for psychedelics, creating a 'plausible mechanism' pathway for rare disease drugs, and changing estrogen labels. The analysis, written by a colleague who served with Makary on a think tank advisory board, asserts that while individual reforms may be debated, collectively they represent major improvements to the FDA's regulatory approach.
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