# OPDP (Office of Prescription Drug Promotion)

> OPDP is the FDA office that regulates prescription-drug promotion in the US — receiving Form 2253 submissions and enforcing truthful, balanced promotion through untitled and warning letters.

> **OPDP** — the FDA's Office of Prescription Drug Promotion, within CDER — is the US regulator of prescription-drug promotion. It receives promotional materials filed on [Form 2253](/glossary/fda-form-2253/), monitors marketplace promotion, and enforces the requirements that promotion be truthful, non-misleading, consistent with approved labeling, and fairly balanced — chiefly through **untitled letters** and **warning letters**.

OPDP letters are the concrete risk MLR review exists to prevent. Recurring citation themes are stable across years: unsupported superiority or efficacy claims (substantiation failures), minimized or omitted risk information ([fair balance](/glossary/fair-balance/) failures), broadened indications, and misleading presentations of data. A letter triggers corrective action — pulling material, sometimes corrective advertising — and reputational cost with the agency that outlasts the specific piece.

For writers and reviewers, OPDP is the "audience of last resort" heuristic: material is written for clinicians but reviewed as if OPDP reads it too — because via the 2253 pipeline and marketplace surveillance, it does.

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