FDA Enforcement Actions
Our attorneys have a wealth of experience in designing and carrying out plans to address potential FDA enforcement actions. We regularly advise clients on enforcement matters ranging from advisory actions such as FDA Warning Letters to formal actions such as withdrawals of product approvals, product seizures, injunctions and consent decrees, recalls, import alerts, denial of export certificates, civil money penalty hearings, clinical investigator disqualification hearings, and criminal prosecutions.
We are frequently engaged to protect the interests of our clients by bringing legal actions directly against the FDA and other federal and state government agencies. In many cases, these legal actions involve complex scientific and legal challenges to government decisions that can impact our clients’ business or their products. These situations also entail strategic decisions about timing and access to the administrative records that govern federal agency determinations.