A New Era of Unprecedented Change – FDA Watch
Shelly and Wayne chat with Nancy Myers, CEO of Catalyst Healthcare Consulting, Inc., and former Special Assistant and Senior Strategic Advisor in FDA’s Office of the Commissioner, and Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli. Together, they discuss what companies should be doing now amid changes at FDA, including the recent confirmation of Dr. Marty Makary as the agency’s new commissioner; the potential effect of the agency’s consolidation of backroom functions such as IT and HR; what it means for FDA to lose such leaders as Drs. Peter Marks and Patrizia Cavazzoni; the impact of staffing reductions on inspections; and much more.
This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.
About Our Guests
Nancy Myers
Nancy Myers, JD, CEO of Catalyst Healthcare Consulting, Inc., is a Washington-based attorney with deep expertise in health care law and regulation, policy development and government relations. She has been closely involved in cutting edge drug, biotechnology and medtech regulatory issues from a range of vantage points over the past two and a half decades.
Myers advises clients from the board room, to executive leadership teams, to regulatory affairs groups on regulatory and health policy matters, ranging from crisis management to long-term strategy development.
At FDA, she served in a number of roles, most recently as special assistant and senior strategic advisor in FDA’s Office of the Commissioner. Within the private sector, she served as special counsel for science policy for the Pharmaceutical Research and Manufacturers of America (PhRMA), vice presidential-level political healthcare analyst for Lehman Brothers, reimbursement counsel and director of government affairs for the Biotechnology Industry Organization (BIO), senior lobbyist for the Blue Cross Blue Shield Association/BCBS of NJ, and a stint on Capitol Hill.
Stuart Pape
Stuart Pape is a Senior Partner and Food and Drug Chair at Polsinelli. He consults clients on regulations imposed by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and similar health and safety regulatory bodies worldwide.
Stuart regularly appears before the FDA, USDA, Consumer Product Safety Commission, U.S. Customs and Border Protection, Federal Trade Commission, numerous other federal and state regulatory bodies, and the Congress of the United States. Stuart serves clients across the U.S. and around the world in many capacities. Previously, he served in various positions in the Office of the Chief of Counsel at the FDA, including as Associate Chief Counsel for food. He also served as executive assistant to FDA Commissioner Donald Kennedy.
FDA Watch Podcast 