ISI (Important Safety Information)

Updated 2026-07-13 · markdown version

Important Safety Information (ISI) is the standardized block of key risk content — boxed warnings, contraindications, warnings and precautions, common adverse events — that accompanies US pharmaceutical promotional material. It is the primary vehicle for satisfying fair balance: the benefit claims in the piece are counterweighted by the ISI's risk presentation.

MLR review checks the ISI three ways: content (does it reflect the current approved label — a label update instantly stales every deliverable's ISI), placement (does it travel with the claims: scrolling ISI on websites, facing-page ISI in print, persistent ISI in e-details), and prominence (type size and contrast comparable to the promotion). "ISI buried below the fold" is a classic OPDP citation.

For writers, the operational rule is pairing: claims and their required safety context should be managed together, so a claim can't be reused in a new deliverable without dragging its safety obligations along. Claims-matrix rows that record the required pairing make this mechanical rather than remembered.