Sharfstein Leaving FDA: What Does It Mean? Consider the Source

The news that FDA Deputy Commissioner Joshua Sharfstein is leaving the agency broke late yesterday, via a tweet by CQ HealthBeat. If you are wondering what it means for FDA, we suggest you consider the source.

Symbolically, we love the irony of a big FDA story breaking on social media, even as industry is growing increasingly impatient for formal guidance from the agency on the ground rules on engaging in social media based marketing.

Recall that Sharfstein's tenure began with a series of letters sent to biopharma companies citing sponsored links on Google. Those letters were in the works before Sharfstein joined FDA, but that nuance didn't much matter to marketing organizations who saw the warnings as setting up social media regulation as a defining issue for his tenure at FDA.

So it does seem appropriate that the end of Sharfstein's stint at FDA was announced on Twitter.

But more important, though, is who broke the story: Congressional Quarterly. That suggests that the place to start in thinking about the implications of Sharfstein's departure is on Capitol Hill.

Sharfstein's appointment as Maryland's Secretary of Health will be formally announced tomorrow, the very day that the new Republican Congress convenes.

The announcement will be made by Democratic Governor Martin O'Malley, who previously made Sharfstein Baltimore city health commissioner in 2006, when O'Malley was mayor.

But Sharfstein's public health background is less important here than his political background. He once served on the staff of Democratic Rep. Henry Waxman and also worked for Public Citizen. It was those Democratic bona fides that catapulted him into consideration for the commissioner post in the first place--and that also scared the heck out of plenty of industry folks who worried about a sharp change in direction at FDA.

It also made him a tempting target for score-settling in the new Congress, which has declared its intention to make oversight of the Obama Administration a key priority. Waxman, in particular, never really saw eye-to-eye with Incoming Oversight and Government Reform Committee Chairman Darryl Issa, who is promising subpoenas galore in 2011.

Call it triangulation if you want, or consider it simply a tactical move to present a lower profile to a hostile Congress, but we see Sharfstein's departure means first and foremost as a change in positioning for FDA facing the incoming Republican majority in the House.

Following Up With Sid Wolfe (Part 2)

Washington is full of interesting connections.

Given how much people jump from job to job in DC, it’s only a bit of an overstatement to say that everybody has worked with everybody at some point in their careers.

So it should come as no surprise, perhaps, that Joshua Sharfstein, the incoming principal deputy commissioner of the Food & Drug Administration, used to work with a prominent policy figure in Washington who happens to be a staunch critic of the pharmaceutical industry.

No, we’re not talking about Rep. Henry Waxman, for whom Sharfstein worked early in his career. This is someone perhaps even less favorable to Big Pharma (if that could be possible): Public Citizen’s Health Research Group director Sidney Wolfe.

Sharfstein worked at Public Citizen as a researcher between April-August 1992—after completing his undergraduate degree from Harvard University and starting medical school. During his five months at Public Citizen, he contributed to a report on the capacity of the U.S. correction system’s ability to care for mentally ill. (One finding: states without adequate inpatient mental health facilities jailed mentally ill patients rather than providing appropriate treatment.)

In an interview, Wolfe recalled Sharfstein's stint at Public Citizen, but was careful not to give him too much praise. When asked of his impressions of the incoming FDA official, Wolfe spoke generally of the “extreme public health experience” of both Sharfstein and FDA commissioner-designate Margaret Hamburg. “I can’t remember the last commissioner with solid public health experience,” Wolfe said. (He discounted David Kessler, who as the former head of a hospital, Wolfe says, did not rise to the same level as health commissioner of a big city.)

After Public Citizen, Sharfstein went into his first year of medical school, and promptly did something rather Wolfeish: he led a student campaign urging his classmates to return free textbooks donated by pharmaceutical companies.

According to a story in the Harvard Crimson, Sharfstein set up a drop-box for students to return two textbooks donated by Sandoz, and wrote a letter to president Timothy Rothwell protesting their distribution. The protest didn’t seem to attract much support: few books were returned, and a few that were returned were stolen from the drop-box.

Wolfe and Sharfstein kept in touch, collaborating on a 1999 petition to then-HHS secretary Donna Shalala against Pfizer’s marketing practices for the antibiotic Zithromax. Wolfe and Sharfstein, who at the time was a pediatrics fellow at Boston Medical Center, accused Pfizer of launching a campaign to convince physicians to prescribe Zithromax over the “effective and inexpensive” antibiotic amoxicillin—against CDC guidelines.

They also testified at the same FDA public hearing in 2008 over the safety of cough and cold medicines; Sharfstein petitioned FDA to relabel the products as not safe and effective for children under six years. At the public meeting, Sharfstein was the opening presenter, and Wolfe spoke during the open public hearing portion of the meeting.

We're not saying that makes them bosom buddies, but it does make for an interesting Washington connection.

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.

Sharfstein Speaks: Is He Headed To Washington?

During a Baltimore City rally for Barack Obama on Saturday, Dan Rodricks, a host for the local National Public Radio station, WYPR, got a coveted interview with a Baltimore official who has been making national headlines.

No, it wasn’t Baltimore City mayor, Sheila Dixon, who was recently indicted for perjury and theft charges (and who, may we add, did not receive a shout-out from president-elect Obama when he addressed the massive crowd).

WYPR spoke to Baltimore City health commissioner Joshua Sharfstein, one of two finalists for the FDA commissioner job. (You can read all about that story in this week’s issue of “The Pink Sheet.”) Sharfstein was at the Obama rally in an official capacity as health commissioner, directing people to warming tents and trying to prevent hypothermia and frostbite.

And while that's certainly a good story, Rodricks also asked Sharfstein whether he would leaving Baltimore to become FDA commissioner. Sharfstein was non-committal (as would be expected), but also expressed his deep admiration for Obama, and the science-based policies that he will support as president.

We’ll let you be the judge on the meaning behind his remarks. Here’s the interview, as transcribed by us from an online recording of Dan’s show, which aired yesterday afternoon:

Dan Rodricks: Are you going to go to work in Washington? Are we going to lose you here in Baltimore?

Joshua Sharfstein: I’m fully expecting to be health commissioner of Baltimore. It’s a great job, and lots to do this year.

Rodricks: OK, because there have been all these stories in the press about Joshua Sharfstein and the Food and Drug Administration.

Sharfstein: I know, my mom sends them all to me.

Rodricks: But you’re going to be around here for a while?

Sharfstein: That’s what I totally expect.

Rodricks: What do you expect from Barack Obama….Are you expecting generally more progressive ideas coming out of the White House?

Sharfstein: Absolutely. The first thing he said is that he wants to base health policy on the science. That’s a huge shift from what we’ve had. When you look at the science, you look at what things have worked, those are the kinds of things that we’re trying to do in Baltimore. I think we can expect some support for that, because we’ve got evidence for what we are doing. ...

Rodricks: Have you felt this way before about a president?

Sharfstein: I’ve never experienced anything like this. It’s been terrific. I’ve had a chance to work on the transition some, and that’s been great. From the moment—I just remember Iowa and everything, it’s just been so exciting.

Photo credit: Reuters/Jason Reed

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.