FDA Commissioner Update: Announcement Timing Provides Clues

Comments out of the White House that an announcement is imminent on President Obama’s choice for FDA commissioner indicate the pick is someone who has already been thoroughly vetted.

Duke cardiologist Robert Califf and Baltimore Health Commissioner Joshua Sharfstein have been formally interviewed for the job by HHS Secretary-designate Tom Daschle and would appear to be the two most serious names to make the final cut (“The Pink Sheet,” January 19, 2009, p. 3).

It’s understood that Califf has the backing of Senate Health, Education, Labor & Pensions Committee Chairman Ted Kennedy (D-Mass.) while Sharfstein is being vigorously supported by House Energy & Commerce Committee Chairman Henry Waxman (D-Calif.).

“I know the President hopes in the next few days to announce a pick for commissioner at FDA,” Press Secretary Robert Gibbs said during a briefing on January 30 in response to a question regarding tainted peanut butter. To read the thoughts of our OTC friends on an agency review, click here. (For peanut-butter-jelly-time, click here.)

The timing of the announcement makes it less likely that a name to have emerged recently would be under serious consideration for the FDA post unless the individual had already been through an interview with either Daschle or White House personnel officials.

For example, former New York City health commissioner Margaret Hamburg’s name made the rounds of the Washington rumor mill over the last week. While Hamburg was a member of the HHS transition team, is a former high ranking HHS official, and could be considered for any number of health positions, it’s unclear whether she received anything more than a screening interview. To read more about Hamburg, click here.

Former FDA commissioner Jane Henney could be a strong fallback option if the administration feels Sharfstein and Califf don’t meet all of the necessary criteria for the job. Whether Henney ever went beyond the initial screening process, however, is unconfirmed.

Still, the FDA announcement could wait until the tax situation holding up Daschle’s confirmation becomes more lucid and predictable. President Obama told White House reporters he “absolutely” stands behind Daschle’s nomination for HHS Secretary.

In fact, the administration is proceeding as if the confirmation will be a forgone conclusion. Obama’s top FDA advisor in the Senate Dora Hughes is now at the White House working with the health policy group, presumably in the Office of Health Reform. Harvard economist and top Obama advisor during the campaign David Cutler is also moving to Washington to work on the administration’s reform agenda. To read more, click here.

NIH Department of Bioethics Chairman Ezekiel Emanuel is on detail to the Office of Management & Budget working with new health desk head Keith Fontenot on health reform issues. To read more about Fontenot, click here.

Emanuel, author of the health care book “Healthcare Guaranteed,” is the brother of White House Chief of Staff Rahm Emanuel.

FDA Commissioner Update: Califf's Name Emerges But Is Sharfstein the Pick?

We know you've been waiting on the edge of your seat so we thought we'd send you an update. We've heard that Duke researcher Robert Califf and Baltimore Commissioner of Health Joshua Sharfstein have been tapped, at the very least, for interviews. 

In fact, multiple sources say Sharfstein may have been offered the job. But we're not quite ready to confirm that just yet. 

Califf as we understand it has the support of senior FDA officials who would be very happy if he were named FDA Commissioner. Califf knows the folks at the agency quite well. In September 2006, Duke entered into an agreement with FDA to serve as a warehouse for electrocardiograms to serve as tools for drug safety research through the Critical Path Initiative. In addition, he's served on FDA advisory committees. 

As we've said before (click here), if the Administration chose to go with a big name who was less controversial, Califf would fit that description. His ties to the drug industry would be a hindrance in the vetting process, but as we understand it, Duke has among the strictest, most transparent guidelines when it comes to running their clinical trials for drug developers. 

The choice of Sharfstein would indicate the transition knew exactly who they wanted to head the agency from the beginning. Sharfstein is leading the FDA review team for the HHS transition. We'd heard Sharfstein had encountered resistance from different stakeholder factions but clearly he's been able to overcome those concerns. 

To read the likely picks for FDA Chief Counsel and HHS General Counsel, see our previous post here. We'll let you know as soon as we find out more.