Person
Previous FDA commissioner who resigned in May, leaving unfinished work on ultraprocessed foods, antidepressants, COVID-19 shots and flavored e-cigarettes.
Rep. Jake Auchincloss (D-Mass.) plans a bill modelled on Australia's faster early-phase clinical trial regime, he said at the STAT Summit. He wants the US to answer China's biotech rise by speeding domestic research.
Reality
Three former FDA chiefs said DOGE's 3,500 job cuts and a larger exodus under Marty Makary cost the agency institutional knowledge. Ned Sharpless said companies he works with now meet more junior reviewers.
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DEA proposed in July to temporarily place 7-OH above a potency threshold in Schedule I, and nearly 36,000 public comments came in by Sept. 10. Experts agree kratom needs guardrails but split on where the line belongs.
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The FDA said in May it would not act against some unauthorized flavored vapes whose applications are pending. Reynolds American is now testing, in a suburban Ohio retail aisle, what that forbearance is worth.
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Heidi Overton would arrive at the FDA from the White House Domestic Policy Council, with a political record rather than a regulatory one. Plan submissions for priorities set from outside the building.
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