Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior counsel, neurology & immunology at EMD Serono, and Morgan Lewis partner Scott Memmott, who highlighted specific compliance risk areas for healthcare professionals (HCPs), as well as permissible interactions with pharmaceutical and medical device manufacturers and contracting/risk mitigation best practices.
If you were still recovering from the Thanksgiving holiday and weren’t able to catch the live program, we have you covered with some key takeaways.
Our speakers provided an initial overview of the legal sources from which these compliance risk areas are derived, including the Anti-Kickback Statute; the False Claims Act; the Federal Food, Drug, and Cosmetic Act; the Physician Payments Sunshine Act; and state law transparency reporting, gift ban, and other compliance requirements. For further discussion of these risk areas, view our program.
Although these compliance risks exist, there are still a number of ways that industry and HCPs can interact appropriately as long as the proper safeguards are maintained. The program highlighted various generally acceptable lower risk interactions that were categorized into three general types: medical and scientific, training and education, and commercial. The presenters also discussed potentially problematic...
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