We still don't know who might take the reins at FDA, but a couple of other key Washington posts appear to be filled. First, there's Sen. Tom Daschle, former Majority Leader, who's been nominated to run HHS (or so sources tell a variety of newspapers, including the Washington Post). And then there's Rep. Henry Waxman's upset takeover of the House Energy and Commerce Committee, which oversees the FDA and the drug and device industries, among many others.
Many see Obama's choice of Daschle as a major signal that, despite our current economic woes, healthcare reform is far from last on the President-elect's to-do list. Daschle is likely to not only take the helm at HHS, but to play a role as White House liaison to Congress on healthcare reform legislation. In fact, that role as top WH adviser on healthcare was key to Daschle's acceptance of the job, sources tell the Post. "Being a Cabinet secretary is a car and driver and you get to go to the head of the line at the airport, unless you're Defense or State," said one Daschle associate. "This was key for Tom to have that White House connection."
What does this mean for the FDA? Probably nothing more than what we already know: that the new HHS secretary will be under major pressure to revitalize the much-maligned agency. But with Daschle focusing on comprehensive healthcare reform, FDA change will be only part of the overall package. We might expect moves toward comparative efficacy in pharma as well as non-pharma treatments--similar to but not exactly like U.K.'s NICE--and a push for the FDA to regulate tobacco. We can also anticipate confirmation-hearing questions about the lobbying Daschle's law firm--and his wife Linda--have done on behalf of various drugmakers.
As for Waxman's ascendance at Energy and Commerce, don't expect the committee to lighten up on drugmakers. Despite the fact that Waxman's getting more attention for the fact that he's greener on energy than his predecessor John Dingell, you in pharma know that like Dingell, he's been an outspoken critic of drug and device makers. A couple of his pet issues have been preemption (he's against it) and off-label marketing restrictions (he's for them).