In recent weeks, policymakers have turned up the heat on the FDA. First, Congressman Bart Stupak (D-MI) sent Dr. Andrew C. von Eschenbach a Valentine by demanding his resignation on February 14. Less than a week later, Congresswoman Rosa DeLauro (D-Conn) likened the management of the FDA to the Keystone Cops. Congressman John Dingell (D-MI) was one of the members to raise concerns and demand answers about the Pfizer Jarvick ads for Lipitor, notable at a time and after a year when FDA’s DDMAC sent out fewer warning letters than ever. And also this month, hearings were scheduled by the House Subcommittee on Oversight and Investigations hearing titled “Ketek Clinical Study Fraud: What Did Aventis Know?”
And that is just February! All in all, not a good month for the agency or for the industry it regulates. Each of these issues reflects on the FDA’s judgment, leadership, character, abilities and direction. In short, the FDA is in the stew. The response from the FDA?
If you go to the FDA Web site, and look at the compilation of speeches by its leaders, you will see only two from 2007, none in 2008. Only one of those two speeches was by Dr. von Eschenbach.
I’ve stated many times on this page, the need for the FDA to exercise at least some basic crisis communications efforts and for Dr. von Eschenbach to lay out some strategy and vision, but sadly, no such effort has been forthcoming. The result is that foes of the FDA and political opportunists, to be fair, are able to shape the debate almost exclusively.
Imagine if either Senator Barack Obama or Senator Hillary Clinton sat silently by while their opponent characterized their record, accomplishments, character and competence. The public would not vote for that silent candidate. FDA leadership may not believe that they are running for office. They are mistaken. They are running for an office called public confidence. And right now, as for the past few years, the agency is losing that essential race.
The FDA is drifting. That drift has set the stage, at least in part, for a massive overhaul and reform of the FDA by Congress. Perhaps that is a good thing, perhaps not.
Presumably there is not much time left to the tenure of Dr. von Eschenbach and one can easily imagine that whatever happens in November, his days as Commissioner are few. His legacy should be focused on getting the agency as far out of drift as possible to leave some hope of restoring the FDA’s once golden image, rather than letting Congress do the job for him.