OPDP Intelligence was founded on the direct experience of a former FDA Division Director within the Office of Prescription Drug Promotion (OPDP), with 15 years inside the agency evaluating and acting on prescription-drug promotional materials.
That experience includes direct oversight of promotional enforcement — the same function that issues the Warning Letters and Untitled Letters this platform's corpus is built from — creating FDA's Bad Ad Program, the agency's national outreach initiative educating healthcare providers on how to identify and report potentially misleading prescription-drug promotion, and expert witness testimony in landmark pharmaceutical promotion cases.
Most tools claiming FDA expertise are built by reading public enforcement letters after the fact. OPDP Intelligence is built by someone who was inside the process that produced them: evaluating benefit-risk presentation, weighing whether a claim crossed the line, and deciding when enforcement was warranted — and who then built the program that trained the field to spot those same issues. That judgment — not a summary of it — is what shapes the platform's Regulatory Principles and Evaluation Gateways.
Direct authorship, not third-party interpretation.
The Regulatory Principles and Evaluation Gateways behind OPDP Intelligence reflect the same judgment that shaped real FDA enforcement decisions — not a reconstruction of it from public documents alone.
Founder background reflects prior FDA employment and enforcement experience. OPDP Intelligence operates independently of FDA and is not affiliated with, endorsed by, or acting on behalf of the agency.
See the framework in action.
Request a demo to see how this experience is encoded into every risk assessment.