December 15, 2008
As I see it
With the FDA flailing and everyone impressing upon the Obama transition team how important their choice for commissioner will be, few acknowledge how impotent this post has become over the years.
This was most recently seen in the complaints, reported nearby, of dissident FDA scientists that the current commissioner, Andrew von Eschenbach, did not address their reports of unqualified managerial interference in their product-review judgments—prompting them to go to Congress instead.
Similar staff rebellions by other scientific employees in the FDA's human and veterinary drug centers have uniformly been ignored by this and previous commissioners. FDA leadership impotence extends beyond commissioners' serial inability to exercise the broad powers of their office to right wrongs within the agency. Commissioners have been consistently unable to protect the FDA from budget cutters, enfeebling the agency to the point where it can't prevent unsafe products from entering the market.
Not since an acting commissioner in the late 1970s—Mark Novitch, later an Upjohn VP—has any commissioner been known to do what private sector CEOs do when customers complain: put things right.
On paper, the commissioner has sweeping discretionary authority, but in practice does little more than sign documents prepared by others, give speeches written by others, present testimony written by others and, in the words of one Washington lawyer, like the British Queen, “reign but not rule.” Whether Obama's choice for commissioner can be any different will be a test of how much change we can believe in.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)