FDA Civil and Criminal Investigations and Enforcement: Trends and Best Practices

Over the last few years, the Justice Department and Food and Drug Administration have stepped up civil and criminal investigations and enforcement of violations of the Federal Food, Drug, and Cosmetic Act. This more active enforcement environment has spanned a wide variety of activities that FDA regulates, including food, medical product manufacturing quality, clinical trials, promotion, and post-market commitments.

In this webinar, we discussed how companies should operate in this environment. We outlined compliance and enforcement trends, including the FDA's points of emphasis and its escalation process. We then discussed civil investigations and enforcement actions, including their interface with regulatory enforcement. We also reviewed criminal investigations and enforcement, including the Park doctrine, tips for conducting internal investigations, and privilege and work product.