Tuesday, January 13, 2009

FDA Commissioner Decision Coming Today?

A decision on the next FDA commissioner (and possibly other positions) could be made today with an announcement coming a little later.

The timing suggests someone less controversial, possibly a former government official, could be the pick in order to get through the minefield that has become the FDA confirmation process unscathed. Many FDA stakeholders have told the transition team that nominating and confirming a permanent head of the agency is of the utmost importance.

Former FDA Commissioner Jane Henney and former Office of Women's Health Director Sue Wood would likely fit that profile, although both do have issues that could raise a few questions. Henney, for example, sits on the boards of multiple health care companies. To read more, click here. Wood worked on a project related to reauthorization of the Prescription Drug User Fee Act in April 2007, which was funded in part by Pfizer. You can read it here. But we think that is not a big deal in the world of conflicts of interest. The timing, and choice of Bill Corr as HHS deputy secretary, would seem to render the possiblity of former commissioner David Kessler as less of a longshot as well. To read about Obama's choice of Corr, click on our previous post here.

On the flipside, it appears that the nomination of Joshua Sharfstein, Baltimore Commissioner of Health and FDA transition team leader, has encountered serious resistance from two factions: career FDA staff and external groups who are nervous about House Energy & Commerce Committee Chairman Henry Waxman micromanaging the agency through a former staffer. That resistance does not bode well for a candidate like Cleveland Clinic cardiologist Steve Nissen, who has been among the most outspoken critics of the agency.

Still, as we understand it, Sharfstein is down but not out.

If a decision is indeed made today followed by an announcement shortly thereafter, it would likely result in a confirmation hearing sometime in February or early March. That would be a very speedy timeline, given the historical trends.

Check back with the In Vivo Blog and The RPM Report for further updates.


Anonymous said...

A lot of what we are seeing today was going on under Henney. Cutbacks in the labs, promotion of aspects of the critical path safety issues and recalls. Reviewers being hounded by criminal investigators for speaking to Congress.

Yes we know who the FDA staff are who wouldn't like anyone from Waxman's office etc.

Former FDA Reviewer

PharmaGuy said...

Are you kidding? Wood would have a major hurtle to get over in confirmation hearings -- she resigned FDA in protest after the delay in switching the morning-after pill over-the-counter.

Obviously, Woods' nomination would send a message to the foes of abortion about where Obama stands on women's rights. This, undoubtedly would be grist for the confirmation mills!

But, it's not just about women's rights and abortion, it's about science vs. politics in control of the FDA and having someone in charge who will "stand up and demand that FDA do its job properly."

Anonymous said...

With regard to CDER, new drug approvals and drug safety the old line like Temple, Woodcock et al really hold the power. They are an entrenched group that are the real obstacles to FDA reform.. The commissioner is just a showpiece.

Anonymous said...

People should know that Susan Wood was on sabatical in London the entire time the Plan B OTC switch application was at FDA. And, the Office of Women's Health has absolutely nothing to do with the review of human drug applications. For her to resign over and continue to speak about the issues surrounding that application are ridiculous as she was 3,500 miles away...