Substantiation

Updated 2026-07-13 · markdown version

Substantiation is the evidentiary backing for a claim: the demonstrable link between a statement in promotional material and data that actually supports it. In US promotional review, claims must be truthful, non-misleading, and supported by substantial evidence consistent with the approved label; verifying that link — claim by claim, passage by passage — is the medical reviewer's core job in MLR review.

Substantiation failures are the dominant class of review findings, and they're rarely fabrications — they're overreach: the source reports 38%, the slide says 42%; the study ran 24 weeks, the copy implies durability; the population was adults, the imagery suggests broader use. Each is a claim whose wording wandered past its evidence.

Operationally, substantiation is managed through the claims matrix (approved claim ↔ approved evidence) and demonstrated through annotated references (locator to the exact passage). The strictest working standard is sourced-only writing: no claim enters a deliverable unless its substantiating passage is already identified — which converts substantiation from a review-time investigation into a writing-time constraint.