Enforcement matters are a top priority for FDA and other government agencies. As such, they are a top priority for our practice as well. Our substantial government experience includes representation of clients in FDA, HHS, Office of Inspector General (OIG), Department of Defense (DoD) and Department of Justice (DOJ) investigations and enforcement actions.
We have an established track record of closely working with clients facing FDA enforcement actions. We coordinate closely with clients to effectively communicate to FDA headquarters and district offices the clients’ understanding of the agency’s compliance concerns. When appropriate, we counsel clients in developing corrective and preventative action plans. If litigation ensues, we vigorously defend the client. Indeed, our firm litigated the only Consent Decree in which FDA lifted the application hold on pending product applications.
Reflecting the geographic and practice diversity of our firm, Sidley lawyers handle the full range of litigation matters in which the food and drug regulation is an element. Lawyers in our Food, Drug and Medical Device practice serve in interdisciplinary teams advising clients in False Claims Act litigation arising under the Federal Food, Drug and Cosmetic Act (FDCA). Our regulatory lawyers work closely with our products liability team in analyzing FDCA issues and devising the most effective defense strategies. We have also served as expert witnesses for defendants in enforcement actions on technical issues of FDA regulation. Finally, our vibrant Hatch-Waxman practice, involving lawyers from our IP and FDA practices, demonstrates our commitment to working for clients on the full range of FDCA litigation matters they might face.