Advertising and Promotion Regulatory Affairs Conference

Advertising and promotion issues continue to arise in a wide range of legal contexts, from civil litigation brought by injured plaintiffs to state and local authorities acting under general consumer protection statutes and nuisance principles and a variety of civil and criminal investigations and settlement agreements arising under the False Claims Act. At the same time, the Food and Drug Administration’s implementation of the advertising and promotion provisions of the Federal Food, Drug, and Cosmetic Act has continued to develop in response to First Amendment pressures and other shifts in the external environment. This session will identify and summarize key developments in the law affecting manufacturer communications, with a focus on characterizing the enforcement and litigation risks confronting regulated entities. Our focus will include practical risk mitigation techniques and effective tools to remain up-to-date as the legal landscape continues to shift in this important area of manufacturer activity.