What MLR review is and why it stalls
MLR is the joint review of a material by the Medical, Legal and Regulatory functions before that material circulates. Each function looks at something different: Medical verifies that the claim is supported by the evidence and that the benefit-risk balance is represented honestly; Legal looks at contractual and intellectual property risk; Regulatory compares against approved product information and the local rules of each country.
The process rarely fails for lack of rigour. It fails on sequencing. The material reaches review already laid out, with the agency waiting and the congress date closing in. At that point any substantive medical observation is perceived as a commercial obstacle rather than what it is: the correction of a claim the evidence does not support.
The second failure pattern is the reference. A claim rests on a study that did not measure what the piece implies, or measured it in a different population, or is cited second-hand. Verifying that takes minutes when the reviewer knows the literature of the area and weeks when they do not.
The third is communication between functions. Comments scattered across emails, parallel versions of the same file and decisions nobody documented. Three review rounds where one would have done.
The role of the medical reviewer
The medical reviewer is not a copy editor with a medical degree. The role is to answer three questions with clinical judgement: is the claim true, is the claim supported by the cited source, and does the piece as a whole leave the reader with a faithful impression of the product profile.
That third question is what separates a reviewer with clinical experience from one trained only in documentation. A piece can have every sentence technically correct and still build an impression the evidence does not support, through what it omits, the order in which it presents data, or the visual hierarchy it gives a secondary endpoint.
Thirty years inside the industry and an active clinical practice change the vantage point. I know what question the specialist will ask when the material reaches them, because that question is asked of me in the consulting room. And I know what the commercial team needs to hold the conversation without stepping outside the evidence.
What I review
- Promotional material aimed at healthcare professionals
- Visual aids and field-force support material
- Product monographs and evidence summaries
- Evidence dossiers for access and purchasing committees
- Standard response documents for medical enquiries
- Congress content: posters, symposia and booth material
- Digital content, emails to professionals and professional-network pieces
- Internal training material for representatives and MSLs
In every case the review covers scientific accuracy, reference verification, benefit-risk balance, consistency with approved product information, message clarity and fit to the audience. Comments are delivered traceably, with the source supporting each observation and a concrete wording recommendation, not just a rejection.
How I integrate into an existing MLR workflow
I do not ask the company to change its system. I join as medical reviewer inside the workflow that already exists, whether that is a formal review platform, an internal board or an email process with versioning.
Onboarding takes one alignment session: which therapeutic categories, which approved product information applies in each country, what review precedents exist, who decides when Medical and Commercial disagree, and what counts as a blocking observation versus a recommendation.
From there I work with two rules. The first is to review early: reading the script or draft before layout avoids most rounds. The second is to document the criterion: every substantive decision is written down so the next piece does not relitigate it. After a few months that record of criteria becomes the company's review guide.
Turnaround times
Turnaround is agreed in advance and depends on the type of piece, not on the month's volume. As a usual reference: a short piece or minor update comes back within one to two working days; a full promotional material with reference verification, within three to five working days; a monograph or evidence dossier, within one to two weeks.
Congress batches and launch peaks are planned on their own calendar and booked in advance. When the company works under retainer, fixed monthly hours and a committed response window are assigned.
How it is contracted
Three ways, depending on volume and continuity. Per material, when the need is one-off and the scope is defined. Per batch, for campaigns, congresses or launches with several related pieces. As an assigned medical reviewer, with monthly hours, when the company needs continuous availability and consistency of judgement.
In every case scope is defined before work starts and fees are quoted against that scope. Confidentiality is handled under a signed agreement before any material is received.
