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What Kind of FDA Commissioner Will Margaret Hamburg Be?

As everyone here knows, the long history of FDA Commissioners has been an oscillation between those who have taken an essentially collaborative approach minimizing confrontation with industry, and those who have been, let's say, more skeptical from the start. ("Skeptical" is not the same as "adversarial," although there have been a few--very few--of those as well.)

Over the last few administrations, conciliation and collaboration have certainly won the day. The mostly "acting" Commissioners during the Bush 2 administration, and even the acting ones, were about as far from adversarial as it is possible to be. But the history goes back longer. Jane Henney, Commissioner during the end of the Clinton administration, also took a generally light-handed approach, and it was her mission to do so. Clinton-Gore believed that only through such a policy would companies do the kind of self-regulation upon which we ultimately depend. The rash of withdrawals from the "class of '97"--and especially the Rezulin saga--raised questions about that thinking. But it certainly did not change.

Hamburg and Sharfstein seem to be ready for some bold steps, but their style is not to make much noise about it. That's probably a good thing. The fact that they (especially Hamburg) have such bipartisan support, and the support of industry as well, could be interpreted in a variety of ways. At the least, it seems likely that virtually everybody now knows what every study has said: FDA as it has been functioning at least since the mid-90s (and, some would say, for much longer) is barely afloat. The former deregulators (Gingrich, et. al.) who are now the preemptors seem certainly to have accepted that sinking FDA entirely--close as they came--is not the future. And "deregulation" is not a winning philosophy in the midst of recent economic history.

So it is an unusual collection of mariners who have gotten on board whatever in FDA is above waterline. Whether they will be able to get it to sail, and work as anything resembling a crew, remain to be seen.