On February 3, 2014, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg issued a memorandum detailing dramatic changes to FDA’s inspection and compliance activities. Among the changes identified in the memorandum, FDA will shift from the current region-based inspection and compliance system to a product-based system. Under this approach, investigators and compliance officers will specialize according to commodity. FDA will also ‘de-layer’ its management and review levels associated with inspections and enforcement to shorten review time and enhance accountability.
Deputy Commissioner for Global Regulatory Operations & Policy Howard Sklamberg noted in a recent National Association of State Department of Agriculture meeting that the changes will result in “a unified food and feed program,” allowing the Agency to “have seamless conversations within FDA.” Further, FDA’s “workforce will be specialized, much more than it is today,” where “[t]here will be folks in [FDA] whose only job will be food safety.” “I think they’re the most fundamental changes at FDA in memory — in decades.”
A detailed analysis of Commissioner Hamburg’s memorandum is provided in our client alert, available here. Michael Best & Friedrich LLP can provide clients with a detailed analysis of what these changes will mean for regulated industry.