The FDA’s legal choices and the federal court’s response

This session will focus on the FDA’s struggles with the PMTA review process.  Those struggles were first seen with the Agency’s initial scheduling of the PMTA deadline – with a federal court ultimately requiring the Agency to pull the deadline forward by two years.  They have continued with FDA’s review decisions, where the Agency has chosen to institute what appears to be a de facto product standard (i.e., a flavor ban) by simply denying every application for an e-cigarette product in a flavor other than tobacco.  FDA is increasingly encountering setbacks from the federal bench for these PMTA decisions, including most notably in a recent, extremely critical, 5th Circuit en banc decision against the Agency. Brian Yagi will share his views on how the FDA can get the PMTA decision-making process on track and, thereby, increase the chances that regulated harm reduction can make a positive impact on American public health.