The letters went out last autumn, and there were more of them than at any point in nearly a quarter of a century. The FDA spent the back half of 2025 sending pharmaceutical companies its highest volume of advertising enforcement in almost 25 years — thousands of warning letters, around a hundred cease-and-desist notices (natlawreview.com) — and said something in the announcement I haven’t been able to put down since. It is now using AI to surveil drug advertising proactively. Not waiting for a complaint. Reading the page itself.
I keep turning that over because of what sits on the other side of it. The same class of model the agency is pointing at our copy is the one increasingly drafting it. And we know how that model behaves when left alone with a claim: it writes the efficacy beautifully and treats the risk language as something to be got through. Trained on years of marketing, it produces benefit-heavy copy, and if it is optimising for anything it learns that the safety information is the part nobody reads — so it trims it, softens it, moves it down the page (improvado.io). Fair balance is precisely the thing the machine is worst at, because fair balance is a judgement about proportion, not a sentence it can complete.
So here is the shape of the year. The instrument that writes the overstatement and the instrument that catches it are converging on the same architecture. One side drafts the imbalance; the other reads for it. And in the middle is a medical writer who, on a tight Friday, is tempted to let the first machine do more and check the result less.
The line I’d put on the wall is the one the FDA has held for decades and restated without blinking: the company is responsible for the promotional material, regardless of how it was made. There is no AI lane in the regulation, no allowance for “the tool drafted it.” The model is not a co-author you can name in your defence. Accountability did not move an inch when the drafting got faster — it still ends with a human signature, and now that signature is being read back by something that doesn’t get tired at four o’clock.
I don’t take this as a reason to keep AI away from promotional copy. I take it as the clearest argument yet for where our value actually sits. If the regulator has automated the first pass of review, then the fair-balance judgement — the proportion, the placement, the risk carried in the same breath as the benefit — stops being the boring bit at the end of the job. It is the bit the machines on both sides are worst at, which makes it unmistakably ours.
The writers who get nervous about this are the ones who have quietly let the safety information become the thing they do last and fastest. The ones who’ll be fine are the ones who already treat it as the thing they do most carefully. The audit was always coming. It just arrived as software, and it reads every line.
— Ned
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Source links:
FDA’s AI-powered crackdown on alleged deceptive drug promotions: https://natlawreview.com/article/fdas-ai-powered-crackdown-alleged-deceptive-drug-promotions
Pharma ad compliance 2026 — fair balance and ISI: https://improvado.io/blog/pharma-ad-compliance-fda-ftc-fair-balance-and-isi-requirements
AI-generated pharma content and FDA responsibility principle: https://blog.madebyxds.com/ai-generated-pharma-content-fda-compliance-2026