On September 16, life sciences partner Joy Liu spoke at FDLI’s Advertising & Promotion Conference, held in Washington, D.C. Ms. Liu participated in a panel discussion entitled “Trends and Priorities in Enforcement – U.S. Department of Health and Human Services (HHS) and States.” The panel focused on recent settlements, corporate integrity agreements and whistleblower rule changes, and provided updates on other issues. Other panelists included Douglas Brown, partner at Rumberger Kirk & Caldwell; Mary Riordan, senior counsel to the inspector general, Department of HHS; and Kirke Weaver, managing counsel at Merck & Co.
Additionally, Ms. Liu organized and spoke on a panel at AdvaMed’s MedTech conference, which took place in Washington, D.C. on September 23-25. Ms. Liu’s presentation, “Enforcement Trends: It’s Not Just About Off-Label Anymore,” focused on new, device-specific enforcement theories. The panel also discussed issues and matters that the FDA refers to the DOJ, what kind of conduct is attractive to the DOJ when deciding to investigate a company, and what companies can do to avoid and respond to enforcement actions. Jill Furman, deputy director, consumer protection branch, U.S. Department of Justice; Paul Kaufman, chief, civil health care fraud, U.S. Attorney’s Office, EDNY; and Kelsey Schaefer, associate chief counsel for enforcement, FDA, office of chief counsel, participated as panelists.
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