Company: ARAC - Applied Research and Analysis Company
The election of Donald Trump in November 2024 prompted great anticipation in the nicotine and tobacco industry among those hoping that the incoming administration would overhaul the beleaguered PMTA process. To many, it seemed that the Reduction In Force orders would force the agency to reduce the evidentiary standards for PMTA applicants, reducing the barriers to market entry and expediting reviews. But instead, and perhaps prompted by the recent SCOTUS ruling in favor of FDA, the authorization of Juul and the denial of Blu suggest that the FDA remains unwavering in its commitment to assess public health benefit on the basis of robust and reliable evidence submitted by applicants.
This session draws on evidence from FDA guidance to industry, Press Releases accompanying recent MDOs and MGOs, the recent SCOTUS ruling and circuit court litigation to explore the integral role of behavioral science in product authorization. The ‘lessons learned’ from triangulating evidence from these sources should inform current and prospective PMTA applicants’ strategy.
