Understanding the Scope of FDA Enforcement Authority and Actions
Perham Gorji
Partner
DLA Piper LLP (US)
- Enforcement overview—identifying the players and their positions
- Investigations, enforcement, litigation, and defenses
- Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions
- Unpacking two recent SCOTUS decisions impacting FDA enforcement authority:
- Civil monetary penalties (SEC v Jarksey)
- Injunctions (Starbucks Corp. v McKinney)
- Exploring FDA compliance and enforcement mechanisms
- For cause inspections vs. routine inspections and communication with the FDA during inspections
- EIRs, Form FDA 483 observations, Untitled Letters, and Warning letters related to inspections
- Examining enforcement actions related to digital advertising and social media
- The use of influencers for direct-to-consumer advertisements (e.g., the Untitled Letter to AbbVie Inc. regarding its UBRELVY commercial, featuring tennis-star Serena Williams)