The provisions in the FDA Safety and Innovation Act (FDASIA) for communicating with FDA about manufacturing issues that could play out in drug shortages or facilitate regulatory surveillance are heightening industry’s focus on the agency’s expectations for proactive communications.
Shedding valuable light on these expectations was a panel of experts that convened earlier in 2014 at an ISPE conference on “proactive compliance” in East Brunswick, New Jersey. A session was held at the conference to take a close look specifically at the issues around the communication component in the proactive compliance equation.
The session featured a comprehensive analysis of the FDA/industry proactive communication process by Covington & Burling Partner Jennifer Zachary, whose insights reflected her six-year service between 2005 and 2011 as an associate chief counsel for enforcement at FDA prior to joining the prominent Washington, D.C.-based law firm. Her role at FDA included providing legal advice to the Office of Regulatory Affairs (ORA) and the district offices on field operations, including reviewing warning letters.
Weighing in during her presentation were three other panelists who also played roles in FDA’s compliance operations: two from Genentech’s global quality group – Stephen Mahoney (Senior Director) and Karen Hirshfield (Senior Compliance Specialist) – and Lachman Consultant Services’ Roy Sturgeon.