Date: December 16, 2020
Time: 4:35 - 5:30 p.m. Eastern
Location: Virtual Event
Nixon Peabody partner Hannah Bornstein will speak on the topic "Top Trends and Cases in FDA and DOJ Criminal Enforcement," at the Food and Drug Law Institute's (FDLI) two-day virtual Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries.
The most powerful of FDA’s enforcement tools, criminal liability is generally thought to be, and often is, reserved for entities exhibiting willful disregard for the laws and regulations enforced by FDA. In the past 18 months, FDA, together with DOJ, has announced the resolution of a number of criminal actions against manufacturers. Some of these involve violations of the FDCA that, as described in the charging documents, do not appear to involve willful misconduct, while others do. Examining these resolutions together offers a timely reminder of the broad reach of FDA’s criminal authority and its willingness to pursue criminal cases where it perceives a significant risk to public health, including in cases that may not reflect the types of willful disregard generally associated with criminal resolutions.
For more information, or to register visit the FDLI website.