MLR review is a marketing cost nobody benchmarks
MLR review exists for good reason. The rounds it adds, and the agency rework around them, rarely get priced or measured like any other cost of that size.
MLR review is one of the largest unpriced costs in pharma and consumer health marketing. Agency scopes rarely account for review rounds, so the cost turns up as slow campaigns and quiet change orders instead of a tracked number. Measure rounds per asset and write them into the agency scope, and the cost becomes manageable without changing a single compliance decision.
Nobody serious argues MLR shouldn't exist. Getting a health claim wrong carries real consequences, for patients and for the company. Every ad, claim, leave-behind, product page and social post has to clear medical, legal and regulatory review before it ships. The question is what that process costs and whether it runs as well as it should.
Why is the cost going up?
Because enforcement went up. On September 9, 2025, the FDA announced a push on direct-to-consumer drug advertising, including plans for rulemaking on the "adequate provision" standard. Its Office of Prescription Drug Promotion issued more than 100 warning and untitled letters that month alone, most of the untitled letters aimed at DTC television. Sidley counted at least nine more OPDP letters by early March 2026, against five in all of 2024. One letter objected not only to a comparative claim but to humor and costume colors that FDA said implied superiority.
The FDA doesn't fine companies for this. As EMARKETER points out, it makes them change or pull the ads, which lands as legal, medical and production work. More review rounds, more conservative reviewers, more assets remade. The cost of MLR rises whether anyone measures it or not.
Does this apply to consumer health?
Yes, at a lighter weight. Prescription brands run medical review tied to approved labeling. The FTC's Health Products Compliance Guidance, issued in December 2022, covers health claims generally and expects competent and reliable scientific evidence, which usually means randomized, controlled human trials. In consumer health reviews we usually see the same pattern as in pharma: more approval steps than the marketing team scoped for, and nobody revisiting the workflow itself.
Where does the money go?
Into rounds nobody priced. Agency scopes get written for strategy, creative and production, not for the number of review rounds an asset will need. When legal flags a claim in round two, or a reviewer asks for a substantiation reference in round three, the agency either absorbs it quietly or bills a change order. Nobody tracks whether four rounds is normal for that asset or a sign the brief was wrong from the start.
The friction is rarely one slow reviewer. It's structural:
- Nobody owns the queue. Assets wait between functions with no one accountable for the handoff.
- Version control lives in email. Reviewers comment on superseded drafts, and the round repeats.
- The platform outran the process. The review system, often Veeva Vault PromoMats, was bought years ago without redesigning the workflow around it.
Veeva is now adding AI agents to PromoMats that check content against brand and compliance rules before it reaches reviewers. Useful, if the claims library and workflow underneath are clean. Bolted onto a broken process, it just produces rework faster.
That is where MLR and procurement overlap. The review platform is one license among many. The agency retainer is priced without an honest number for review cycles. Neither gets audited like a supply contract of the same size.
What should you measure?
| Metric | Why it matters |
|---|---|
| Average review rounds per asset type | The core cost driver; compare year over year |
| Turnaround per round, by function | Shows where the queue stalls |
| Late-stage claim changes | Signals briefs written without claims input |
| Rework billed or absorbed by agencies | The hidden line in your agency costs |
| Assets approved but never used | Review effort spent on content nobody deployed |
What should the agency scope say?
Once you have a baseline, put it in the contract. Name the number of review rounds included per asset type. Make rework caused by agency error the agency's cost, and show rework caused by brief changes as its own line, so marketing can see what its own late changes cost. Ask for hours by job number each month. None of this touches what reviewers decide or the standard they apply.
Where to start this week
Ask two questions. Does anyone know, with a number, how many rounds the average asset takes to clear MLR, and how that compares with a year ago? Does the agency scope treat review cycles as a cost driver, or is rework absorbed by whichever side has less power? If the answer to either is "we don't track that," pull one brand's last quarter of approved assets from the review system and count. Our pharma and consumer health work covers the rest of the commercial vendor stack, and the marketing cost page covers agency scopes generally.
Sources: Hogan Lovells, FDA targets DTC advertising, Sidley, new FDA letter on drug promotion, EMARKETER, pharma TV ads face rising FDA enforcement, Covington, FTC Health Products Compliance Guidance, Veeva, AI agents in PromoMats.
Why does MLR review slow pharma and consumer health marketing?
Every claim and asset needs medical, legal and regulatory sign-off, and agency scopes are rarely written for the number of review rounds. The cost shows up as slower campaigns and quiet change orders instead of a tracked number.
Has FDA enforcement on drug advertising increased?
Yes. After the FDA's September 2025 DTC announcement, its Office of Prescription Drug Promotion issued more than 100 warning and untitled letters that month, and Sidley counted at least nine more by early March 2026.
Does MLR-style review apply to consumer health brands?
Yes, at a lighter weight. The FTC's Health Products Compliance Guidance expects competent and reliable scientific evidence for health claims, so legal and regulatory review still gates what a brand can say.
What should a marketing leader measure first?
Average review rounds per asset type, and whether the agency scope prices review cycles. If neither is tracked, that is usually where the time and money go.
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