Developments over the past several years have produced momentous changes affecting the research-based pharmaceutical and biotech industries. These include the rise of digital-based health technologies, the utilization of real-world experience (RWE) and real-world data (RWD) in the drug approval process, and dissemination of evolving medical information to an expanding audience. At the same time, regulatory and compliance concerns over industry promotional practices and activities continue.

Government concerns relating to off-label promotion have prompted an increasing number of investigations by FDA as well as state and federal government bodies and agencies such as the Office of Inspector General of the Department of Health and Human Services (OIG), the Department of Justice (DOJ), and various state attorneys general. In turn, these investigations have given rise to significant fines and imposition of rigorous Corporate Integrity Agreement.

This CLE course will provide a detailed overview of the compliance and regulatory issues confronting these industries and the methods being developed and implemented to establish policies and procedures to allow for compliant promotion and proper dissemination of scientific information to the medical and lay communities.