View from the FDLI Annual Conference - Day Two

The Food & Drug Law Institute (FDLI) continued its annual conference on October 7, 2020. The conference set out to explore advanced topics in Food & Drug Law. In this blog series, Perkins Coie reports on the three-day conference and meaningful takeaways for food litigation. Day Two of the 2020 Annual Conference featured significant representation from the FDA. One of the first panels of the day convened former FDA Chief Counsels to discuss, among other things, the agency's regulatory authority and how the FDA was exercising that authority during the COVID-19 pandemic. Later in the day, the Conference featured an address by Steven M. Solomon, Director of the FDA's Center for Veterinary Medicine. Director Solomon reported on its investigation into dilated cardiomyopathy in pets and noted that the agency has learned that "dilated cardiomyopathy is a complex and multi-faceted issue." Separately, Director Solomon noted that the agency is considering which of the temporary regulatory flexibility policies that the Center for Veterinary Medicine issued during the pandemic might become more permanent guidance. Director Solomon particularly highlighted three potential candidates for such treatment, temporary flexibility policies applicable to telemedicine, animal clinical trials, and drug shortages. Regarding food safety, FDA Senior Advisory Sharon L. Mayl participated on a panel specific to the agency's New Era for Smarter Food Safety initiative. Mayl and other panelists discussed ways the agency is encouraging manufacturers to adopt cutting-edge technologies to improve traceability and outbreak response as well as some of the challenges and concerns in the agency's current food safety plans. At several of the panels, including one entitled "FDA in the COVID-19 Era," discussions continued about the agency's efforts to implement its New Era of Food Safety Blueprint (available here), which the agency hopes will enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of a food safety culture. Panelists from industry and government noted that the agency was already examining risk-based approaches to food safety prior to the pandemic as the FDA considered its use of resources prior to the pandemic. For example, panelists discussed whether the increased use of remote, routine food safety inspections during the pandemic might continue. As Day Two drew to a close, the FDLI Annual Conference provided an opportunity to hear from agency officials discussing topics from COVID-19 to food safety. Day three is ahead.