Promotional review before OPDP does it
FDA off-label promotion enforcement actions can exceed $1 billion in fines. Fair balance deficiencies are increasingly targeted by OPDP enforcement. With AI now generating promotional materials at scale, the gap between what's produced and what compliance can review has never been wider.
What Pharma Compliance does
Off-label claim detection
Evaluates promotional content — detailing aids, print ads, digital materials — for off-label claims, implied off-label promotion, and population expansion claims. Every verdict is mapped to FDA-approved indications with specific citation.
Fair balance analysis
Measures the prominence balance between efficacy claims and risk/benefit disclosures, with specific remediation recommendations referencing 21 CFR 202.1(e) requirements. Catches fair balance deficiencies before OPDP sees them.
Evidence verification
Cross-references claimed efficacy statistics against the source clinical trial — primary endpoint, population match, statistical significance. Flags claims that overstate or mischaracterize study results.
Adverse event disclosure checking
Identifies missing or under-emphasized serious adverse events against the FDA label. Returns the specific additions required to meet disclosure requirements, with label citation.
MLR teams, regulatory affairs, and marketing ops
FDA advertising law, OPDP guidance, ICH E6
Implements FDA 21 CFR Part 202 (prescription drug advertising), 21 CFR Part 201 (labeling), OPDP guidance documents (fair balance, DTC, detailing aids, social media), and FTC truth-in-advertising requirements.
21 CFR Part 11 compliant electronic audit records — suitable for OPDP inquiry responses and warning letter defense. ICH E6 R2 Good Clinical Practice alignment for trial evidence verification. SOC 2 Type II certification in progress.
See Pharma Compliance in your MLR workflow
We work with pharmaceutical MLR teams, regulatory affairs, and promotional agencies. Let's talk about your pre-submission screening problem.