10th Annual Pharmaceutical and Medical Device Webinar Series | Part Six: Evolution of Off-Label Theory and Enforcement

Maya P. Florence

On April 8, Skadden presented the sixth and final session of our “Pharmaceutical and Medical Device Webinar Series”: “Evolution of Off-Label Theory and Enforcement.” Skadden speakers included Washington, D.C. litigation head Jennifer Bragg and life sciences and health care partner John Bentivoglio, as well as Boston life sciences and health care partner Maya Florence. The panelists examined the evolution of the Department of Justice’s off-label enforcement strategy, relevant U.S. Food and Drug Administration guidance and developments, and how companies should tailor their promotional review and compliance controls to address these evolving approaches.