OPDP (Office of Prescription Drug Promotion)

Updated 2026-07-13 · markdown version

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, 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 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.