The departure of Principal Deputy Commissioner Joshua Sharfstein provides FDA an opportunity to take stock of its relationship with the new Congress and to re-evaluate its own organizational structure.

Sharfstein’s decision to leave the agency on Jan. 7 to head up the Maryland Department of Health and Mental Hygiene will deprive House Republicans of a key target – and one with strong, Democratic ties – for criticism over FDA actions.

The vacancy created in the number two post, in conjunction with other personnel changes that have marked the start of 2011, gives Commissioner Margaret Hamburg a chance to re-evaluate and restructure job functions and positions, while also presumably having a far greater say in selecting her top lieutenant than she did in 2009.

Joshua Sharfstein

Hamburg’s decision to tap John Taylor, an agency veteran and currently counselor to the commissioner, to temporarily fill the principal deputy commissioner post for the next 60 days could aid the agency’s relationship with House GOP investigators. It also could provide an impetus to reshape the number two slot into one more focused on day-to-day operations, rather than the more policy-oriented role pursued by Sharfstein (Also see "FDA Counselor Taylor Is Acting Deputy As Hamburg Mulls Reorganization" - Pink Sheet, 5 January, 2011.).

Different Backgrounds, Different Dynamic

The dissimilarity between Sharfstein and Taylor’s backgrounds could lead to a different dynamic between the agency and Congress, particularly now that Republicans control the House.

Like Hamburg, Sharfstein came from the public health world, working as Baltimore City’s health commissioner before moving to FDA. This background served him particularly well in his early dealings with Congress, explaining the agency’s response to the H1N1 influenza outbreak in Spring 2009 (Also see "Vaccine For Swine Flu Faces Multiple Decision Points By Government" - Pink Sheet, 4 May, 2009.).

However, Sharfstein also found himself on the hot seat during a House Oversight and Government Reform Committee hearing in September on the plethora of Johnson & Johnson over-the-counter product recalls. Sharfstein conceded the agency should have asked more questions about the company’s alleged “phantom recall” of some Motrin products (Also see "J&J, FDA Share Blame On Motrin "Phantom Recall"" - Pink Sheet, 30 September, 2010.).

The same committee also has begun an inquiry into the operations of FDA’s Puerto Rico district office (Also see "House Oversight Panel's Investigation Of FDA Puerto Rico Office Previews Focus On Agency Operations Under GOP" - Pink Sheet, 9 November, 2010.).

Scrutiny is expected to become far more intense in 2011. House Oversight and Government Reform Committee Chairman Darrell Issa, R-Calif., already has cited FDA recalls as one of a half dozen areas targeted for immediate investigation by his panel.

Sharfstein’s political ties to California liberal Henry Waxman would have done him no favors in the new GOP-controlled House.

Sharfstein’s political credentials would have done him and the agency no favors in the new House. A former health policy aide to current Energy and Commerce Ranking Member Henry Waxman, D-Calif., Sharfstein undoubtedly would have faced withering questioning from House Republicans.

Taylor Offers In-House And Industry Experience

In contrast, Taylor might face less hostility.

Taylor began his career at FDA in 1991 as an attorney in the Office of Chief Counsel. Five years later he became a senior advisor for regulatory policy within the Office of Commissioner. His subsequent roles included special assistant to the associate commissioner for regulatory affairs, acting director of the Center for Drug Evaluation and Research’s Office of Compliance, director of the Office of Enforcement and associate commissioner for regulatory affairs.

John Taylor

After working at FDA for 14 years, he spent the next four on the industry side – first as divisional VP for federal government affairs at Abbott, and then executive VP for health at the Biotechnology Industry Organization – before returning to the agency in 2009.

Prevision Policy LLC’s Cole Werble, an EBI contributor, pointed out that Taylor’s tenure at the agency spanned Democratic and Republican administrations. His experience working with former FDA Commissioner Mark McClellan and BIO President and CEO (and former Republican congressman) Jim Greenwood gives him the type of GOP backing that would suggest a more civil reception on Capitol Hill, Werble observed.

Furthermore, Taylor’s agency background makes him the perfect spokesman for FDA’s enforcement and compliance activities, a popular subject of lawmaker scrutiny given the J&J recalls and the recently enacted food safety legislation, which provides new inspectional oversight and product recall authorities.

As counselor to the commissioner, he has been tasked with leading development and oversight of FDA’s emergency and crisis management activities. As recent incidents involving H1N1 influenza, contaminated heparin and food-borne illness have demonstrated, Congress is fond of convening hearings on FDA’s response to public health crises, and Taylor would presumably play a key role in the agency’s briefing to lawmakers.

Looking beyond his initial 60-day stint, Taylor could be well-positioned to assume the job permanently, particularly if Hamburg reshapes the position to one focusing on the regulatory and enforcement elements of FDA’s work, as opposed to those involving medical policy. Or, Hamburg could restructure the position into one overseeing the agency’s day-to-day operations, conceivably another role for which Taylor would fit the bill.

Unusual Partnership

From the beginning, the partnership between Hamburg and Sharfstein was an unusual one.

Sharfstein was named to the principal deputy post by President Obama and served as acting commissioner for two months in 2009 while Hamburg awaited confirmation. The administration’s unusual joint selection of a commissioner and principal deputy commissioner was viewed as a compromise between Sharfstein’s and Hamburg’s respective political backers, Waxman and Sen. Ted Kennedy, D-Mass.

Hamburg and Sharfstein had not previously worked together, and during her Senate confirmation hearing Hamburg tried to tamp down as “quite misleading” reports that she would focus on food and tobacco, while Sharfstein would concentrate on medical product regulation (Also see "FDA’s Hamburg And Sharfstein: A Chain of Command, Not Division Of Power" - Pink Sheet, 11 May, 2009.).

In a Jan. 5 memo, Hamburg commended Sharfstein’s work in leading the FDA transition for the Obama Administration and the agency’s Transparency Initiative. “He has brought intelligence, energy and his signature sense of humor to everything he has done,” Hamburg said, adding Sharfstein “will be greatly missed at FDA.”

FDA Restructuring Possible

Hamburg also used the memo to discuss other recent personnel changes. Among these are the retirement of Deputy Commissioner for Administration Russell Abbott and the appointment of Curtis Coy to fill Abbott’s role on an acting basis. Coy is on detail from HHS, where he most recently served as deputy assistant secretary for the Administration for Children and Families.

The personnel changes have provided an opportunity for rethinking, and possibly redefining, the agency’s leadership structure.

Commissioner Hamburg is using the opportunity provided by various personnel transitions to “review certain functions and positions.”

“In light of these many transitions, I would like to take this opportunity to consult with senior FDA leaders and review certain functions and positions,” Hamburg said. “My top priority is advancing FDA’s public health mission, and I want to ensure all our resources – from our programs to our key staff positions – are as efficient and well-organized as possible.”

Any reshuffling would be the second of Hamburg’s tenure; she initially reorganized the Office of the Commissioner in 2009, realigning four deputy-level offices to streamline common functions and strengthen science and food safety ([A#00710340001]).

Unfinished Business On Transparency

As for Sharfstein, he leaves an active and aggressive, though in some respects unfinished, legacy.

His influence on FDA was felt two years before he joined the agency. As Baltimore City health commissioner, he led a group of pediatricians in petitioning FDA in 2007 to amend labeling for OTC cough/cold products to state that they should not be used in children under six years old.

Although the OTC industry voluntarily relabeled its cough/cold products against use in children under four years old in 2008, FDA has been working to revise the OTC cough/cold product monograph. The agency said Sharfstein has been recused from proceedings involving the rulemaking since joining the agency.

During his approximately 21-month tenure, he has been a lead voice on dietary supplement enforcement. He also commissioned FDA’s 2009 re-examination of a controversial medical device clearance decision. The subsequent report on ReGen Biologics' Menaflex knee repair device outlined broader problems with the 510(k) clearance program itself, and was among the catalysts for the large-scale review of the 510(k) program currently underway.

However, it was his leading role in the Transparency Initiative that may leave the most lasting impression on the agency’s functions.

Sharfstein said he learned early in his FDA tenure that the agency needs to be transparent in its actions and the supporting rationale if it wants the public to understand them Also see "From Beginning To End, FDA Transparency Weighed On Sharfstein’s Mind" - Pink Sheet, 10 January, 2011.).

He helped implement the agency-wide performance tracking management program FDA TRACK and has been holding regular briefings with individual offices under the program. FDA said senior agency staff will take Sharfstein’s place at these briefings.

He also chaired the transparency task force that in May released a host of draft recommendations to make information publicly available, including disclosure of “complete response” and refuse-to-file letters (Also see "FDA Transparency Initiative: Disclosure Rules Could Expand, Then Be Harmonized" - Pink Sheet, 24 May, 2010.). FDA said it is reviewing comments received in response to the draft recommendations and analyzing legal and resource issues.

On Jan. 6, his penultimate day at the agency, he led a press call announcing release of the third phase of the task force’s work, encompassing 19 "action items" and five proposals for improving transparency to regulated industry (Also see "Where's Your Application? FDA May Soon Have An App For That" - Pink Sheet, 6 January, 2011.). Hamburg and her new, evolving leadership team will now be tasked with completing work under the transparency endeavor.

“Incredible Opportunity” For Sharfstein

In an interview with “The Pink Sheet,” Sharfstein said the Maryland health secretary’s post was “an incredible opportunity” that allows him to return to his public health roots and also be involved in implementing health care reform at the state level. He said he leaves behind an agency that is on a positive trajectory.

“When I started at FDA there were articles being written about whether the agency was a failed agency. I think I’m definitively appreciative of the fact that FDA has taken a number of steps that I really believe has improved its credibility,” he said, citing the transparency program and more vigorous public warnings to prevent foodborne illness.

“I don’t really leave with regrets,” he said. “I think FDA is on a trajectory where a lot of great things will happen. I think the commissioner has a terrific set of agendas and they will continue to bear fruit.”

When asked whether he would be interested in returning to the agency some day, perhaps in the role of commissioner, he responded: “Who knows what will happen? I have a tremendous respect for FDA and the people there.”

By Sue Sutter

FDA’s Congressional Relations, Internal Structure May Change With Sharfstein’s Departure

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