Fair Balance

Updated 2026-07-13 · markdown version

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 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 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 for the full translation.