Tuesday, January 04, 2011

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.

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