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FDA Memorandum Outlines Significant Overhaul of Inspection and Compliance Processes

Jonathan Berman
Colleen Heisey
Mark Mansour
Christopher M. Mikson
Emily K. Strunk
Jones Day - Washington Office

February 24, 2014

Previously published on February 2014

In an internal memorandum to FDA leadership, Commissioner Margaret Hamburg "chart[s] the course for modifying Agency functions and processes to improve communication and collaboration and to clarify roles and responsibilities and decision rights across all Agency components."

The memo acknowledges the feedback Dr. Hamburg received during the evaluation that FDA's responsibilities are rapidly changing, and in light of this, the agency must move to a "distinct commodity-based" and "vertically integrated" regulatory scheme. Such changes will require time and reorganization. The commodity-based, vertically integrated regulatory programs mirror the areas of responsibility covered by the various Centers and continue to move the agency away from a regional approach that has previously dominated the agency's inspection regime.

The memo goes on to discuss specialization with regard to inspection and compliance functions, training, agency work planning, compliance policy and enforcement strategy, imports, laboratory optimizations, and de-layering management and review levels to facilitate timely and appropriate actions and enhance accountability. Finally, the Commissioner lists a dozen "next steps" that seek to further clarify and expand on the identified implementation decisions.


The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.

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