Two from the queue that held up this week — both, as it happens, pointed at the same problem the regulator is now policing with software.
The agentic MLR reviewer Veeva bought rather than built
What it is: A tool — Veeva Falcon MLR, the agentic review platform Veeva announced on 23 June after acquiring Copli, the company that pioneered it (veeva.com).
Why it’s worth your time: This is a step beyond the pre-checks we’ve covered before. Where the earlier Quick Check Agent flagged issues for a human to weigh, Falcon is pitched as running the review itself — checking promotional and medical materials against the approved label and local regulations — and Veeva is putting a number on it: the potential to remove 70 per cent or more of manual MLR labour within five years. Whether or not that figure lands, the direction is the thing to register. If your review cycle is your bottleneck — and for most teams it is — the vendor that already owns your content stack now intends to automate the slowest part of it. Better understood before it turns up in a release note.
How to use it:
If you’re on PromoMats, get on the 9 July webinar Veeva is running to show it, and treat it as competitive intelligence whether or not you ever buy.
Pressure-test the 70 per cent claim against your own mix: an agent will do most for high-volume, low-variation assets and least for the nuanced, claim-heavy pieces where the judgement actually lives.
Decide now, on paper, what a human reviewer still signs even when the agent comes back clean — before the efficiency case decides it for you.
Watch out for: “Agentic” review automates the checking, not the accountability. A clean Falcon pass is not regulatory clearance, and the named reviewer is still the named reviewer. Treat the labour saving as real and the sign-off as non-negotiable.
A fair-balance pre-check you can run before the file leaves your desk
What it is: A prompt routine — a self-audit you run on your own draft that sets benefit against risk before it goes anywhere near review.
Why it’s worth your time: With the FDA now using AI to screen ads for exactly this failure (see From the Floor), the cheapest insurance is to read your own copy the way the regulator’s tool will. Generative drafts skew efficacy-heavy and quietly under-weight safety language; a structured pass catches the imbalance while it’s still yours to fix. Run against a near-final piece this week, it surfaced an ISI that had drifted below the fold and a benefit claim with no risk in the same eyeline — both things a reviewer would have bounced.
How to use it:
Paste the draft and ask, in one instruction: “List every efficacy or benefit claim and every risk or safety statement in two columns. Flag any benefit without an adjacent risk, and any place the safety information is less prominent than the claim it qualifies.”
Ask it to rank the three weakest fair-balance moments and explain why — not to rewrite them. You want the diagnosis; the rewrite stays yours.
Keep the rule in front of it: the current FDA/FTC line is that risk must carry equal prominence to benefit, in the piece itself, not behind a “see more” or a linked page (improvado.io).
Watch out for: This finds imbalance; it does not certify balance. A model that helped write the copy is not a neutral judge of it, and a clean self-check is a reason to submit with confidence — never a reason to skip MLR.
One to watch your vendor build; one to run yourself before Friday.
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