Promotional review is a precedent-driven discipline running on inconsistent tools. Reviewers rely on institutional memory, prior enforcement letters they happen to remember, and judgment calls that vary by person and by day.
Risk that could have been caught in creative development instead surfaces in MLR — or after launch, in a Warning Letter. The cost of catching a problem late isn't just rework; it's review cycle time, agency hours, and in the worst case, the enforcement record and reputational fallout that follow.
FDA's enforcement history is public, extensive, and instructive.
But it isn't organized in a way that scales across a portfolio of brands, reviewers, and campaigns — until now.
Not a general model applied to a new domain. A platform built specifically for FDA promotional review.
Grounded in precedent. Structured for defensibility.
OPDP Intelligence is built on a curated corpus of OPDP Warning and Untitled Letters, FDA statutes and regulations, FDA guidance, and judicial precedent — organized through a structured evaluation framework.
The standards promotion is actually judged against
Fair balance, substantiation, adequate risk communication, and avoidance of misleading net impression.
Staged checkpoints, not one score
Materials pass through defined gateways mirroring how promotional review actually works.
Every finding ranked by strength
Direct precedent, analogous precedent, or principle-based reasoning — clearly tiered, never uniform.
Built by someone who ran FDA promotional enforcement — not engineers guessing at it.
The evaluation methodology behind OPDP Intelligence was developed by a former FDA/OPDP Division Director with 15 years of experience inside the agency overseeing promotional enforcement, including creating FDA's Bad Ad Program and expert witness testimony in landmark pharmaceutical promotion cases. The Regulatory Principles and Evaluation Gateways encoded into the platform reflect the same judgment that shaped real FDA enforcement decisions — not a reconstruction of it from public documents alone. Learn more about our founder expertise →
From draft to defensible, before MLR.
A five-stage process that feeds directly into your existing review workflow.
Submit
Materials and context — claims, indication, audience, channel.
Cross-reference
Checked against the curated regulatory corpus.
Evaluate
Structured framework assesses risk through defined gateways.
Explain
Every finding cited to its regulatory or precedent basis.
Remediate
Guidance feeds into your existing MLR and legal review.
Why this isn't generic AI review.
Purpose-built corpus
Not a general-purpose model applied to a new domain.
FDA enforcement judgment
Built on the experience of a former FDA/OPDP Division Director with 15 years of enforcement oversight — and creator of FDA's Bad Ad Program.
Explainable output
Citations, not conclusions.
Structured methodology
Regulatory Principles, Evaluation Gateways, Evidence Weighting.
Consistency at scale
Applied uniformly across reviewers, brands, and campaigns.
Full audit trail
Every assessment traceable, defensible, and reviewable.
Built for every team that touches promotional risk.
Regulatory affairs, legal promotional review, medical affairs, MLR and commercial review committees, promotional agencies, and compliance teams — anyone accountable for what a piece of promotional material says and how it says it.
Find promotional risk before FDA does.
See OPDP Intelligence evaluate a real promotional asset — with full citations and remediation guidance — before it reaches MLR.
OPDP Intelligence does not replace MLR, legal, or regulatory review. Outputs are decision-support tools only. Recommendations are intended to reduce regulatory risk, not guarantee FDA acceptance. Final promotional decisions remain with your organization's internal review process.
No promotional materials required to attend a demo.