Who Should Own MLR Review? Roles, Accountability, and the Cross-Functional Model

"Who owns MLR review?" sounds like a question with an org-chart answer. It is not. Ask ten pharmaceutical companies and you will get a tangle of medical directors, medical-information leads, regulatory reviewers, compliance officers, and the occasional outsourced firm, and that ambiguity is itself a source of friction. When nobody is quite sure who owns a decision, decisions get re-made.

It helps to separate two questions that teams constantly blur: who does the work of reviewing, and who is accountable for the outcome. They are not the same, and the data answers them differently. (If you want the basics of the process first, start with what MLR review is.)

Who actually does the review

Each promotional piece is reviewed by the three functions, medical, legal, and regulatory, each watching for a different kind of risk. But the more revealing question is who, inside medical affairs, actually carries the medical review. In a 2024 promotional-review benchmark from Canopy, the answer split:

Medical director: 44%
Medical information: 23%
A dedicated promotional-review function: 15%
The rest fell to contractors, outsourced firms, and "other"

For nearly half of companies, then, the medical review lands on a senior physician who has plenty else to do, and it is not a small slice of their week. In a separate poll of MLR professionals, about two thirds of medical directors said they spend between 10% and 30% of their total time on MLR-related work. Promotional review is, for some of the most expensive people in the building, a part-time job they were never trained for.

Who should be accountable

Doing the work and owning the outcome are different things, and here practitioners are clearer. Asked who should hold primary accountability for compliance in the MLR process, a majority chose shared, cross-functional ownership:

A cross-functional team with shared accountability: 52%
A dedicated compliance officer or department: 19%
Senior medical leadership alone: 11%
The person who does the final sign-off: 6%
It varies by what is being reviewed: 11%

The cross-functional model wins because MLR genuinely is cross-functional: no single person holds medical, legal, and regulatory judgment at once. But shared accountability has a failure mode worth naming. When everyone owns it, it is easy for no one to, and the disagreements that drive extra review rounds are often the sound of shared ownership without shared judgment.

The practices that make shared ownership work

Shared accountability is not the same as a free-for-all. The teams that run it well tend to follow a few rules:

Keep medical and regulatory as separate voices. They watch for different things and track different requirement sets, and blending them into one role makes the work harder to manage, not easier. The most experienced reviewers resist the urge to collapse the functions.
Use more than one reviewer. A common pattern is a small panel rather than a single gatekeeper, so a sign-off is a shared judgment, not one person's risk tolerance.
Protect senior bandwidth deliberately. Routing routine medical review to a brand's medical-information lead, and reserving the medical director for the pieces that truly need them, keeps the most expensive reviewer out of every single job without lowering the bar.
Know whose model you are in. Accountability is structured differently across regions: where the US leans on a shared committee, the UK and European codes vest final responsibility in a single named signatory. If you operate across markets, do not assume one model maps onto the other.

The training gap underneath it all

There is an uncomfortable foundation under all of this: many reviewers were handed the responsibility without ever being trained for it. In the Canopy data, 38% of companies provided no role-specific training for promotional review. Clear accountability assumes competence, and you cannot really hold someone to a standard they were never taught. If you are formalizing ownership, formalizing training belongs in the same conversation.

Accountability in the AI era

AI adds a new wrinkle to an old question. If an AI-assisted piece causes a compliance breach, who is responsible? Asked exactly that, MLR professionals were clear that the machine does not absorb the blame:

The human who performed the final review: 39%
The whole team: 31%
Not sure: 21%
The department head: 6%
The AI vendor: 3%

Almost nobody pointed at the tool. The principle that emerges is the one experienced reviewers keep repeating: keep a human in the driver's seat. AI can make the accountable reviewer faster and the submission cleaner, but it does not, and should not, take the accountability with it. Any tool you adopt should sharpen a human's judgment, not stand in for it.

Where ownership is heading

The drift is away from "whoever is free absorbs it." Asked which model they expect to run in the next year or two, MLR professionals leaned toward more deliberate structures: 39% expected a hybrid of internal and external resources, and 30% a centralized, dedicated internal team, well ahead of simply keeping the current ad-hoc setup. The direction of travel is clearer ownership, paired with tools that make the accountable people faster.

That last part matters, because clear accountability does not, on its own, fix a slow process. Even the best-defined cross-functional team drowns if every submission arrives un-linked and un-anchored, forcing reviewers to reconstruct evidence instead of verifying it. This is where PharmaText.ai fits: by making sure every claim reaches review already tied to its source, it lets the accountable reviewers spend their scarce time on judgment rather than forensics.

Sources: role-ownership and training figures from a 2024 promotional-review benchmark by Canopy; accountability, time-allocation, and future-model polling from a 2024 industry webinar by Impatient Health.