Off-Label Promotion Defense and Pharmaceutical Fraud Consulting
Independent reads on clinical evidence integrity, regulatory exposure, and FDA compliance for pharmaceutical legal affairs and compliance departments.
Modern pharmaceutical enforcement actions frequently target off-label marketing, medical science liaison (MSL) activities, and scientific study integrity. Defending these claims requires a precise clinical evaluation of actual standard of care practices, coupled with a deep understanding of billing intent structures under federal enforcement frameworks.
Dr Sonny Saggar MD provides specialized clinical and regulatory consulting for legal counsel and compliance officers navigating pharmaceutical litigation and internal investigations.
The credential: Oxford and Barts. 25 years emergency medicine. Published scholar with twelve papers on healthcare enforcement, administrative law post-Loper Bright, digital health standards, and open medical coding systems. Direct experience navigating federal healthcare enforcement as both defendant and scholar.
Initiate Conflict CheckEngagement Areas
Off-Label Promotion Defense
Clinical context auditing of scientific presentation transcripts, marketing materials, and MSL communications to evaluate off-label promotion allegations.
Clinical Evidence Integrity Review
Forensic clinical analysis of dataset endpoints, trial protocols, and medical literature assertions in preparation for litigation defense audits.
FDA Enforcement Risk Assessment
Pre-litigation compliance review mapping how local standard of care patterns align with current federal enforcement guidelines.
Fee Structure
- Document Review & Consultation From $400 / hr
- Scientific Audits & Reports From $4,500
- CLE Presentations & Seminars From $3,000
Scholarly Authority
Direct academic back-references to peer-distributed SSRN research series relevant to pharmaceutical compliance and regulatory enforcement:
Analyzes how federal agencies have lowered the intent standard in regulatory audits, turning administrative compliance errors into potential enforcement targets.
A deep dive into regulatory compliance audits, illustrating how administrative mistakes are transformed into high-stakes liabilities for healthcare entities.