Joshua Oyster and Beth Weinman Present at Food and Drug Law Institute Enforcement Conference

December 9, 2022

Life sciences regulatory & compliance partner Joshua Oyster and counsel Beth Weinman presented at the Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference in Washington, D.C. on December 7—8, 2022.

Joshua spoke on the December 7th panel “FDA’s Recent Medical Device Recalls and Enforcement, Use of Section 518 Authority, and How to Best Prepare.” Speakers discussed how stakeholders should prepare for recall decisions and related communications, which often require balancing of various internal and external perspectives to comply with legal and regulatory requirements.

Beth presented on the December 8th panel “DOJ, FDA, and Compliance in Criminal Violations of the FDCA (Oh My!).” The panel focused on the implications of the establishment by the U.S. Department of Justice’s Consumer Protection Branch of a group of attorneys dedicated to monitoring compliance with commitments made as part of Deferred Prosecution Agreements and Non-Prosecution Agreements including for cases based on allegations of underlying Federal Food, Drug, and Cosmetic Act violations.

In particular, Beth and the panelists discussed the nature of the commitments DOJ would be looking for in these agreements, and the roles of DOJ and FDA in making determinations about when those agreements have been breached, thus leading to further criminal enforcement. They also examined potential concerns that this new arrangement might lead to mixed messages for industry and criminal enforcement for activities more appropriately addressed using FDA’s civil and regulatory enforcement tools.