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FDA’s New Playbook: Lots of Media Announcements but Not Much Rulemaking
The agency has announced vaccine limits, drug review changes and food dye actions through op-eds and posts, drawing little legal pushback so far.
Under federal law, the FDA is supposed to avoid major policy announcements in informal settings, but Drug Administration Commissioner Marty Makary has increasingly unveiled changes in op-eds and television interviews, bypassing the Federal Register.
Relying on an 'understanding' with companies, Robert Kennedy unveiled a plan to 'phase out' synthetic food dyes rather than pursuing formal scientific regulatory documents or public comment periods.
Yale University public health expert Susan Mayne argued the administration has yet to produce scientific documentation, while former vaccine panel lead Kathryn Edwards warned that bypassing advisory panels reduces transparency.
Industry pushback remains minimal, as experts suggest companies fear jeopardizing product licensing, though an unnamed drugmaker recently challenged the FDA's legal authority to release confidential drug rejection letters.
Former FDA chief counsel Dan Troy warned that policies not enshrined in law can be easily undone by future administrations, though signs suggest some companies may raise objections with more than two years remaining under Trump.
In one of his first major announcements as U.S. Secretary of Health, Robert F. Kennedy Jr. convened a press conference to present a plan to “slow down” synthetic food dyes.