Overview
FDA Enforcement Actions
We regularly guide clients through the full range of Food and Drug Administration (FDA) regulatory enforcement activity from early-stage advisory actions to formal proceedings with significant operational and commercial consequences. Our work includes counseling clients on responses to FDA inspection reports (483s) and Warning Letters and helping clients navigate withdrawals of product approvals, recalls, import alerts, and denial of export certificates. We represent clients in civil money penalty hearings and clinical investigator disqualification proceedings as well as in formal Department of Justice-led enforcement actions – including product seizures, injunctions and consent decrees, and criminal investigations and prosecutions.
Investigations
We counsel life sciences companies facing both internal and government investigations involving alleged FDA regulatory violations and related theories of criminal and civil liability. On the internal side, our work spans the full lifecycle of an investigation – from initial assessment of triggering events such as audit findings, whistleblower complaints, or due diligence discoveries, through root cause analysis, remediation planning and, where appropriate, voluntary self-disclosure to regulators. On the government side, we defend clients in False Claims Act investigations; Department of Justice, Office of Inspector General, and FDA Office of Criminal Investigations inquiries; and all manner of enforcement action predicated on underlying regulatory noncompliance. Throughout, we help clients assess exposure, engage strategically with regulators and enforcement authorities, and position themselves for the most favorable resolution.
Litigation
We represent clients in judicial challenges to FDA and other federal agency actions, including Administrative Procedure Act proceedings, challenges to product approval and exclusivity determinations, and disputes arising under the Hatch-Waxman framework. These matters frequently present complex scientific and legal questions that can significantly impact our clients’ business operations and product portfolios. We also have extensive experience defending clients against competitor-initiated litigation, including Lanham Act claims, product exclusivity challenges, and other disputes at the intersection of regulatory law and commercial competition. In addition, we represent clients in consumer class action litigation arising from allegations related to FDA-regulated products.
