John Taylor Temporarily Replaces Sharfstein As FDA's Second-In-Command

John Taylor, counselor to FDA Commissioner Margaret Hamburg, will serve temporarily as second-in-command while Hamburg considers how to reorganize the agency's leadership following Principal Deputy Commissioner Josh Sharfstein's departure.

Sharfstein, who helped Hamburg vastly expand the commissioner's presence across FDA's responsibilities, left the agency Jan. 7 to become Maryland's top public health official.

The move "deprives Dr. Hamburg of an alter ego who she could rely on with confidence … whether it was dietary supplements, performance management or biosimilars," said Steven Grossman, a health policy and public affairs consultant with HPS Group and author of the blog, FDA Matters.

Acting Principal Deputy Commissioner John Taylor

Hamburg said in a Jan. 5 memo that Sharfstein "will be greatly missed," but her "top priority" remains advancing the public health mission that Sharfstein helped revive at the agency. Sharfstein helped launch Hamburg's direction for the agency by serving as acting commissioner for roughly three months prior to her confirmation in June 2009 (Also see "Sharfstein Takes “Acting” Title Literally, Starting FDA Overhaul" - Pink Sheet, 13 Apr, 2009.).

Taylor will fill Sharfstein's role for the next 60 days while Hamburg consults with senior FDA leaders and reviews "certain functions and positions" at the agency, according to the memo.

While Taylor does not have the same public health background as Sharfstein – holding a law degree instead of a medical degree – his long history at FDA gives him an insider's knowledge of the issues the agency faces and areas it regulates.

Taylor's past experience as director of the Office of Enforcement suggests he will perpetuate Sharfstein's hard-line enforcement approach. Taylor also served as associate commissioner for regulatory affairs during the 14 years he worked at FDA before leaving for the private sector in 2005 and then returning to FDA with Hamburg.

Outgoing Principal Deputy Commissioner Josh Sharfstein

Future Structure Is Unclear

Hamburg did not say whether Taylor would remain in Sharfstein's position, or whether FDA permanently will fill the principal deputy commissioner position at all.

"The agency has often operated without a principal deputy. Structurally, the job is not important. However, when the principal deputy has knowledge, insight, experience and the confidence of the commissioner, then it becomes important. This was the case with Dr. Sharfstein. It is also the case for John Taylor," said Grossman.

One reason FDA might spread Sharfstein's responsibilities among multiple deputies is that finding qualified candidates could be difficult considering the post could be eliminated in two years, depending on the results of the 2012 presidential election.

If FDA replaces Sharfstein permanently, the next principal deputy commissioner might put less focus on the supplement and OTC industries.

Sharfstein took a special interest in these industries prior to joining FDA and that translated naturally to his work at the agency, Grossman said.

For example, Sharfstein co-authored the 2007 citizen petition that prompted FDA's review of pediatric cough/cold products. However, he recused himself from the review process once he joined FDA, according to the agency (Also see "FDA Call For Pediatric Cough/Cold Input Signals New Rule Is A Long Way Off" - Pink Sheet, 25 Aug, 2008.).

Likewise, Sharfstein may have taken more interest in dietary supplements than his colleagues among FDA's leadership.

If Sharfstein's replacement is interested in dietary supplements and OTCs, then that "would be much the way it was with Dr. Sharfstein – incidental to his credentials rather than a central part of his credentials," Grossman said.

Finding one person with similar depth of knowledge in all the areas Sharfstein covered may be difficult. If FDA declines to fill Sharfstein's position it would need to divide his duties.

Drawbacks to dividing the responsibility include a less well-defined "face" for FDA.

Successor Criteria

Important qualities FDA likely will look for in Sharfstein's successor include the ability to multi-task in many crisis areas, said Steve Mister, president and CEO of the Council for Responsible Nutrition.

"FDA has jurisdiction over so many products and at any given point there are potential crises in multiple areas," Mister observed.

He added, "There is always a long list of things that absolutely have to get resolved because they affect the public health."

Taylor is no stranger to crisis management. He helps develop and manage FDA's emergency and crisis management policies and programs and oversees FDA's participation in counterterrorism and emergency exercises, according to the agency.

Sharfstein's permanent replacement also must be able to build relationships quickly, reach across the aisle and reach out to industry, Mister said.

FDA's emerging "approach of trying to engage regulated industry and work with them is a good one," and is important because Sharfstein's successor will not have a Democrat-controlled House or Energy and Commerce Committee chairman for backup, Mister said. The replacement must garner industry support by convincing it changes are in the best interest of industry even if they are not easy, he added.

Sharfstein worked with supplement industry trade groups to tighten enforcement against so-called supplements tainted with undeclared pharmaceuticals (Also see "FDA, Trade Groups Team Up To Bolster Enforcement On Tainted Supplements" - Pink Sheet, 20 Dec, 2010.).

As a former industry advocate, Taylor likely has a leg up on establishing a working relationship with industry. His experience as Abbott Laboratories' VP of government affairs for two years and his time as the VP for health at the Biotechnology Industry Organization would influence his understanding of industry needs and motives.

Based on Taylor's past experience, he also likely could play well with Republicans, which would come in handy with the new Congress.

He was the agency's chief counsel under George H.W. Bush's administration and served in enforcement and regulatory affairs positions under George W. Bush's administration. In addition, he worked with former Republican Congressman Jim Greenwood, of Pennsylvania.

Taylor worked at FDA under the Clinton years, too, as FDA's chief counsel.

Whoever permanently fills Sharfstein's role as the agency spokesman on the Hill also must be able to take a pounding.

Sharfstein often was the face of FDA at congressional hearings and whoever replaces him "will likely have to sit on that congressional hot seat a lot this year," Mister said.

He noted House Oversight and Government Reform Committee Chairman Darrell Issa, R-Calif., "is bound to do some investigatory hearings of some of the industries FDA regulates. We have already seen the beginnings of this" with Issa calling FDA to task for the quality control problems at McNeil Consumer Healthcare ("House FDA Investigation Previews Oversight Shift Under GOP" "The Tan Sheet" Nov. 10, 2010).

The impending congressional investigations could have been a factor is Sharfstein's unexpected decision to leave, but if so it likely was not a large one.

Sharfstein told media he was not actively looking for a new job when this opportunity arose, and he was committed to FDA – which included defending it before Congress. Rather, the offer was one he could not refuse.

Sharfstein worked with Maryland Gov. Martin O'Malley before and has a young family in the area.

In the end, "the new opportunity really presented a 'can't refuse' situation for Dr. Sharfstein. It involves enormous responsibility. It gives him the opportunity to turn his attention to a much broader set of public health issues. Given his roots, this must have been enormously appealing." Grossman said.

Other personnel changes

Hamburg also announced several other leadership changes – potentially complicating a reorganization further.

Curtis Coy temporarily will replace Russ Abbott as deputy commissioner for administration. Abbott recently retired after more than 40 years with FDA. Coy comes from the Health and Human Services Department where he most recently served as deputy assistant secretary for administration of children and families.

Segundo Pereira also will join FDA from HHS. He will serve as the acting director of FDA's Equal Employment Opportunity Office in the Office of Administration. Previously he was the deputy assistant secretary for the Office of Diversity Management and EEO at HHS, Hamburg said.

By Elizabeth Crawford