Rep. Bart Stupak, the influential Michigan Democrat known so well to pharma, is lobbying President-elect Barack Obama for a wholesale change in FDA leadership. A frequent critic of the agency, Stupak maintains in a letter to Obama that the FDA's top officials are "too close with the industries they regulate." He wants the president-elect to sweep the ranks clean with a "complete change" in management.
The letter appears to be a response, at least in part, to some Democratic support for CDER chief Janet Woodcock as an interim FDA commissioner. Industry types are also backing Woodcock as either interim or permanent FDA chief, the Wall Street Journal reports.
As you know, the FDA has been criticized from all sides over the past couple of years, as withdrawals of popular meds (such as Vioxx)and safety recalls (such as this year's heparin debacle) tarnished the agency's reputation. Few now argue that the FDA doesn't need widespread reform. And Woodcock herself has drawn criticism not only from Stupak, but also from Rep. Joe Barton, a Texas Republican, who alleged that she failed to disclose some meetings with industry reps.
With Commissioner Andy von Eschenbach expected to resign soon, Obama and his team will need to make some decisions soon, too. The WSJ suggests that appointing an interim commissioner would give Obama more time to choose a permanent leader. But given the speed with which Obama has been filling in the blanks on his appointment sheet, he doesn't seem likely to stall with this one.