FDA Announces Agency Restructuring: A Change For The Better?

FDA Announces Agency Restructuring: A Change For The Better?

Columbia, MD (July 19th, 2011)

FDAImports.com has obtained a copy of some very recent email correspondence sent by U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg to her employees announcing her decision to restructure the agency’s top management tier. Although she cites increased growth in agency responsibilities, technological and scientific trends, globalization, and agency administration demands, it appears more like she is creating an additional layer of management between herself and career FDA managers. For instance, Center Directors who used to report to the Commissioner now will report to Deputy Commissioners (who we affectionately dubbed “Overlords”). Dr. Hamburg cited four major areas of (political) management changes:

1. Dr. Steven Spielberg, Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City, will become the Deputy Commissioner for Medical Products and Tobacco. It looks like FDA is about to Put On Its Heart Light and try to snuff out big tobacco altogether; merging its regulatory oversight with medical products.

2. Deborah Autor, now Director of CDER’s Office of Compliance, will take on the role of Deputy Commissioner for Global Regulatory Operations and Policy. If Deb is given the power to do what is necessary to actually fix the broken import and international operations at FDA (and she makes headway in 20% of the issues) she will indeed earn our new title for her of FDA “Global Regulatory Overlord”.

3. Mike Taylor will lead the implementation of the Food Safety Modernization Act in the Office of Foods. Most people in the food industries governed by HACCP already know the risks associated with seafood and juice – and so do FDA, the states and most foreign countries. But what are the risks associated with, say, black fungus? Or, bamboo shoots? And what about the fact that much of the international/foreign aspects of FSMA cannot even be implemented as written because it assumes wrongly that international trade in food is Bi-Lateral? There will be some serious growing pains, but I suspect Mr. Taylor will be back at GWU before much of this gets going.

4. Establishment of a new Office of Operations, headed by a Chief Operating Officer (position yet to be filled) to oversee administration, human resources, facilities, information technology, finance, and support. This one is particularly troubling. This is an administrative overseer of administrative overseers – from the “department of redundancy department.” Most people do not know this, but when FDA allocates resources for an investigator to do some task, it burns 1.9 hours for every 1.0 hour of work actually done. The 1.0 hour of work done is accounted for (by the investigator) – the 0.9? That is consumed by the top third of the agency in things like overseeing administration, human resources, facilities, IT, finance and support – and it is never accounted for except in large (really large) aggregate numbers. Try to do that on your taxes this year when you report expenses and see what happens.

“Where did you want your chair, sir? Facing the iceberg?”

This is a timeless story, retold again. Adding management layers to protect a political appointee from career FDA managers will not usher forth a faster, more flexible and efficient FDA. While for the short term we might expect a shower of sparks and smoke as the agency attempts to implement a major internal restructuring of titanic proportions, in the long run FDA will turn into the iceberg itself: large, lumbering, inflexible, and mostly hidden from view.

Benjamin L. England is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Currently he is founder and CEO of FDAImports.com, LLC, a firm of consultants and affiliated attorneys practicing at the intersections of complex administrative law and regulations that impact international traders in highly regulated commodities.

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