Enforcement, Litigation, and Compliance Conference

For the Drug, Device, Food, and Tobacco Industries

Conference Agenda

We are going virtual! To promote optimal interaction between attendees, the conference will include ample audience participation and opportunities to connect with your peers between sessions.

Agenda Subject to Change | All Times are Eastern Time

Top Trends and Cases in FDA and DOJ Criminal Enforcement

4:35–5:30 PM

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.

Hannah R. Bornstein, Partner, Nixon Peabody LLP

William F. Gould, Partner, Holland & Knight LLP

Steven A. Johnson, Vice President – Compliance & Legal Affairs, Zogenix, Inc.

Shannon Pedersen, Trial Attorney, Consumer Protection Branch, Department of Justice

Closing Remarks and Adjournment

5:30 PM

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