Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications

The rules regarding truthful, non-misleading communications by medical product manufacturers have long been unclear. In recent years, there have been significant developments in the case law, as well as in FDA guidance and DOJ policy, with regard to manufacturer communications about unapproved uses of their medical products. In this Ropes & Gray podcast, life sciences partner Kellie Combs is joined by government enforcement and litigation partners Joan McPhee and Doug Hallward-Driemeier to discuss the most recent developments in this area, relating both to FDA policy development and DOJ enforcement priorities.