With more than 20 years of federal service, including nearly a decade as the Deputy Chief Counsel for Litigation at the US Food and Drug Administration (FDA) and a dozen years combined as a Department of Justice (DOJ), Consumer Protection Branch (CPB) trial attorney and Assistant U.S. Attorney, Perham Gorji has extensive litigation experience and a deep understanding of the FDA's regulatory goals and methods of enforcement.
With his unique level and breadth of experience at FDA and DOJ, Perham has the judgment and skills necessary to guide clients through significant litigation and investigations and manage the reputation risks they present. In addition to overseeing a firm's response to an enforcement action, his administrative and regulatory experience at the FDA enables him to help clients properly respond to and resolve warning letters, import alerts, and other regulatory actions. Perham is able to advise clients as they navigate the FDA inspection process, including product application inspections, routine inspections, for cause inspections and supervision inspections pursuant to an FDA consent decree or other government compliance agreements, and clients benefit from his insider's understanding of the factors that inform agency decisions to move matters from the regulatory inspection phase, to warning letters and/or enforcement.
Perham's work has involved the full gamut of FDA regulated medical products, and he has the experience and skills necessary to evaluate these product offerings and manufacturing processes for compliance with the statutes and regulations that govern them. He is able to assist clients to establish and maintain robust compliance programs and attain a long-term culture of adhering to the US Department of Health and Human Services (HHS) and FDA regulatory requirements.
Perham's practice focuses on the following areas central to legal disputes, compliance, and transactional matters, and engagement with federal regulatory agencies:
• FDA/DOJ civil enforcement litigation, related investigations, and criminal prosecutions
• Challenges to FDA agency action: e.g., application denials, product classification, clinical holds, rulemaking
• Agency citizen petition process and comments on proposed rulemaking and guidance
• Product liability litigation concerning FDA-regulated products
• Competitor litigation
• FDA Inspectional Violations (Form 483) or Warning Letter responses
• Recalls and marketing withdrawals
• Product and Manufacturing Quality
• Labeling & Disclosures, Advertising & Promotion
• Government Compliance Agreements and Orders: DOJ; FDA; FTC; HHS, OIG
• Compliance Program Development: FDA; HHS; FTC; CPSC
• Risk Assessment
• Distribution, Licensing, and Supply Agreements
• Clinical Trial Agreements
• DOJ's Voluntary Self-Disclosure Program
