As I See It: FDA reorganization

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James G. Dickinson
James G. Dickinson

How much well-meaning revision of the government is actually good for the government—and the public?

A planned reorganization of FDA's “backbone” organization, its 5,000-strong field inspection force, announced by commissioner Margaret Hamburg, has the potential to placate industry critics but at the cost of weakening inspection objectivity and public safety.

Designated the Program Alignment Group (PAG), this initiative may soon confront a thorny philosophical issue with cultural and legal spikes: Could PAG change the FDA inspection paradigm from honest, objective assessments to faster, easier ones?

While some may object that the two conditions shouldn't be seen as mutually exclusive, history is full of cases where the “law of unintended consequences” wreaks havoc. Consider the consequences of the government shutdown, or before it, budget sequestration.

In FDA's case, internal empire builders are using PAG to shift power from far-flung managers beyond the Beltway. PAG consists of the six program center directors and four high-level Washington chiefs—and nobody from the far-flung field offices. To marketing types, this may look like “palace politics,” but it is really another example of Washington dysfunction, with the potential to damage the public's confidence in marketed products.

Strong, timely and objective FDA inspections and emergency responses by experts who aren't directed by headquarters managers with other priorities inside the Beltway historically have provided a kind of good housekeeping shield around marketed products.

That may seem an intangible, even doubtful, benefit, but let it erode and you'll find that it's not.


James G. Dickinson is editor of Dickinson's FDA Webview (fdaweb.com).

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