Food industry players across the value chain are frustrated by lingering questions about how to implement sweeping food safety changes that go into effect in little over a year, including fears of some stakeholders “going berserk” with new technology or asking for more than the law requires and before the national deadline.

Recently, the FDA has taken additional actions to clarify and streamline its policies regarding the EA process, including issuing guidance documents on EA, restructuring the FDA web page on EA, launching Project Facilitate (a call and information center to help with EA request submissions), simplifying the application form for single-patient requests so that form completion takes an estimated 45 minutes, and working with the Reagan-Udall Foundation to launch the Expanded Access Navigator website to help patients and physicians more easily locate relevant information about EA.

Jones who was previously an official at the Environmental Protection Agency, was also on the Reagan-Udall Foundation panel that published an evaluation of FDA’s HFP which made recommendations for the reorganization of FDA’s HFP.