ISSUE: Section 3037 of the 21st Century Cures Act amends FDAMA Section 114 to provide greater flexibility in how drug companies communicate economic information to health plans, but what the legal and practical implications of the change are unclear. Peter Neumann will moderate and provide an overview of the history of FDAMA-114 and the scope of recent changes. Coleen Klasmeier will disentangle the text of Section 3037 of the Cures Act and provide a legal perspective. Bryan Johnstone will address potential implications of the changes from the pharmaceutical industry perspective, and Susan Cantrell will provide the managed care perspective. OVERVIEW: Until recently, Section 114 of the Food and Drug Modernization Act of 1997 (FDAMA 114) regulated promotion of health economic information from drug companies to health plans, but was often criticized because of its vague wording and the lack of guidance from FDA about what constituted “competent and reliable scientific evidence.” A provision in the 21st Century Cures Act (Section 3037, “Health care economic information”) amends these rules to provide greater flexibility for drug companies to engage with health plans about the potential value of their products. The Section leaves the “competent and reliable scientific evidence standard” in place but makes several key changes. Section 3037 may offer the potential for more and better communication between drug companies and health plans, but it also raises numerous questions about the interpretation of the rule and its implications for the use of economic information in developing drug policy and coverage decisions.