In Law360, Washington, D.C. Attorneys Examine Guidance on False Claims Act Cooperation Credit for Life Sciences Companies
In a Law360 article published on June 18, life sciences partner Greg Levine, life sciences counsel Beth Weinman, and litigation & enforcement counsel Samantha Barrett Badlam (all of Washington, D.C.) examine the impact for life sciences companies of recent U.S. Department of Justice guidelines on cooperation credit in False Claims Act matters.
The authors explain that while life sciences companies may disagree with the DOJ regarding what kinds of FDA regulatory violations can serve as a basis for false claims violations, the guidance’s focus on proactive disclosure provides a framework to educate the DOJ and frame a company’s narrative in the context of an ongoing investigation. The article reviews the costs and benefits of disclosure and suggests that companies consider when and how to share information disclosed to DOJ with the U.S. Food and Drug Administration.