Acting Commissioner Sharfstein Starts Agency Overhaul

Sharfstein takes pre-emptive action on pistachio safety, asks agency staffers to submit short-term ideas for improving FDA.

Before his first week on the job was over, acting FDA Commissioner Josh Sharfstein made decisive moves on two fronts, stepping up regulation and addressing the agency's internal culture.

Neither initiative will surprise his former colleagues, who know both moves are in character for the acting head of the agency. Both moves presage more rapid change to come at the beleaguered FDA.

Sharfstein, named principal deputy commissioner by the Obama administration, started work as acting commissioner March 30. That appointment allows the administration to set its agenda in motion with one of its key players in place while it awaits the confirmation of Commissioner-nominee Peggy Hamburg.

On April 6, under Sharfstein's direction, FDA expanded the recall of pistachio products manufactured by Terra Bella, Calif.-based Setton Farms that were potentially contaminated with salmonella (¹ (Also see "More Salmonella Problems Point To Holes In Food GMPs" - Pink Sheet, 6 Apr, 2009.), p. 11).

The notice expanded an earlier recall of selected lots to include all lots of Setton's "roasted in-shell pistachios, roasted shelled pistachios, and raw shelled pistachios from the 2008 crop that are not subsequently roasted prior to retail sale."

FDA also advised other firms downstream in the supply chain not to serve or sell pistachios unless they could determine they were not supplied by Setton.

The response reflects a few hallmarks of the 39-year-old acting/deputy commissioner's style.

This was a more aggressive, pre-emptive safety action than FDA's step-by-step recall over the past several months of peanut products linked to the Peanut Corporation of America, which knowingly shipped potentially contaminated product into the supply chain.

In internal communications his first week on the job, Sharfstein "made it clear that the new administration wants to move food safety to a new level," according to an FDA spokesperson.

Sharfstein encouraged FDA staffers to work together and swiftly in carrying out the recall process for pistachios.

Input And Expectations

In the meantime, Sharfstein is looking inward at the agency. So far, his approach to rebuilding an institution that has suffered a crumbling reputation and weakened morale appears to combine inclusiveness and high expectations.

He reached out to the agency in an April 6 all-hands memo, inviting staff to provide him with ideas for improving the agency.

He told staffers he would be developing "short-term ideas for the agency" for discussion with the incoming commissioner and asked that they submit to him by e-mail their ideas - in 200 words or less -by April 10.

Sharfstein also often reached out to staff and encouraged their input while working as Baltimore Commissioner of Health, according to the city's current acting health commissioner, Olivia Farrow.

As a boss, Sharfstein "brings out the best in his staff," she said. "He makes us think on another level what we could be doing and what we could be doing better ... not in any aggressive way, but talking things through and looking at the science behind things and understanding the data and really thinking outside the box to help the public's health."

Sharfstein appears to be setting high expectations for hard work, both from himself and staff.

A spokesman for Baltimore Mayor Sheila Dixon's office said Sharfstein was one of the only cabinet members who made himself available by e-mail before 5 a.m. and after midnight.

Further, he noted the public health team Sharfstein built. "He has this really creative mind and he brings people along who are creative and who want to move agendas forward," he said.

At FDA, Sharfstein has made it clear he wants staff to act more quickly, and to shorten the timeline on activities like the pistachio recall, the agency spokesman said.

Sharfstein has asked that "key players" involved in crucial issues make themselves available "whenever, to address that issue."

Sharfstein has spoken directly to FDA inspectors on the ground about greater availability, according to one staffer. "We have been told to have our phones on at all times and make sure we check the Blackberries," he said.

[Editor's note: An expanded profile of the acting commissioner will appear in the April 13 issue of ² 'The Pink Sheet.' For more information call 1-800-332-2181.]

-Katie Stevenson ([email protected])