# Fair Balance

> Fair balance is the FDA/OPDP requirement that pharmaceutical promotion present risk information with prominence and readability comparable to benefit claims — efficacy and safety in honest proportion.

> **Fair balance** is the US regulatory requirement that promotional material present a drug's risks with prominence, readability, and depth comparable to its benefit claims. It is an FDA/OPDP construct: a piece that trumpets efficacy in headline type while whispering risks in footnotes fails fair balance regardless of the accuracy of either.

In practice, fair balance review examines *proportion and placement*: does risk information travel with the benefit claims it balances (not just in an appendix)? Is type size, contrast, and position comparable? Does the safety presentation match the claim's strength — a superiority claim demands more balancing than a mechanism statement? The [ISI](/glossary/important-safety-information/) block and full prescribing information are the standard vehicles.

Fair balance is a US concept; UK/EU material instead anchors to consistency with the [SmPC](/glossary/smpc/) and the ABPI Code's requirements for prescribing information. Cross-market teams should treat "fair balance" findings and "SmPC consistency" findings as cousins, not the same rule — see [MLR vs Copy Approval](/resources/mlr-vs-copy-approval/) for the full translation.

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Source: https://medcom.claims/glossary/fair-balance/ · Updated 2026-07-13 · © Mantir, Inc.