Presenters: Dulce Foster and Robert Klepinski, Fredrikson & Byron, P.A.
Why hospitals and physicians should care about the FDA laws you thought were just for manufacturers.
Regulators, prosecutors, whistleblowers and legislators have begun expanding their enforcement efforts against illegal, off-label promotion of drugs and devices under the Food, Drug and Cosmetics Act. While in the past FDA compliance was a concern only for drug and device manufacturers, investigations into illegal off-label promotion practices are focusing more and more on healthcare providers. We will provide a brief summary of the law on off-label promotion, and discuss how recent enforcement challenges in this area are affecting hospitals and physicians.
