FDA’s deputy commissioner for medical products and tobacco will continue to be filled by someone with a long history in industry, but a short regulatory career.

Commissioner Margaret Hamburg announced in a Jan. 22 memo to staff that Leona Brenner-Gati will become acting deputy commissioner for medical products and tobacco, moving up from the associate commissioner position. Brenner-Gati has been with FDA since Sept. 24, 2012.

Stephen Spielberg, the current deputy commissioner, is leaving the position on Feb. 15 because of a family medical issue, according to the memo. He is returning to Philadelphia and in March will become editor-in-chief of the Drug Information Association’s Therapeutic Innovation and Regulatory Science journal.

The publication is the official DIA journal and was rebranded this month after being known for many years as The Drug Information Journal.

Spielberg joined FDA with a background spent in industry, including clinical and drug development positions at Merck & Co. Inc. and Johnson & Johnson. He also was director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City and spent time in academia.

Hamburg hired Spielberg as part of a reorganization of FDA’s leadership structure that added management directorates between the medical product centers and commissioner’s office. It also included the promotion of Deborah Autor to head a new Office of Global Regulatory Operations and Policy and elimination of the principal deputy commissioner position Also see "FDA Reorganization Adds "Directorate" Layer, But Sharpens Agency's Focus" - Pink Sheet, 18 July, 2011..

Spielberg’s position was created to help coordinate issues that affect multiple medical product centers at FDA, including oversight of orphan products, pediatric therapeutics and combination products.

Hamburg said at the time the commissioner and principal deputy positions were responsible for a number of issues and stretched too thin Also see "FDA's Spielberg To Focus On Cross-Center Collaboration, Hamburg Says" - Pink Sheet, 1 August, 2011..

More Reorganization Coming?

Spielberg’s departure could create an opportunity for Hamburg to reorganize senior agency leadership, but Brenner-Gati’s resume would suggest otherwise.

Brenner-Gati spent much of her career in the private sector, including 17 years with J&J, where she held several senior leadership positions, according to the memo.

And like Spielberg, she also has a product development background, particularly in regenerative medicine. The memo states she founded J&J’s cell therapy for diabetes program and also headed the Sandoz International GMBH Internal Medicine Clinical Research Therapeutic Area, where she helped gain approval for several products.

In addition, she has been secretary of the Alliance for Regenerative Medicine, a Washington D.C. lobbying group Also see "Despite Advances, Regenerative Medicine Faces Funding Crisis" - Scrip, 1 February, 2010..

The fact that the role on an acting basis will be filled by someone with a similar background, instead of a career regulator or academic, indicates Hamburg likes how Spielberg developed the position.

Brenner-Gati’s promotion continues a growing list of recent leadership hires with industry experience. Gregory Geba, a former executive at Sanofi US and several other companies, took over as director of the Office of Generic Drugs in July 2012 Also see "FDA Office Of Generic Drugs Director Has Brand Industry Background" - Pink Sheet, 13 July, 2012..

Geba joined the agency shortly before OGD was elevated to super office status and the launch of the generic drug user fee program in October 2012 Also see "Generic Drugs Gain Status Boost Within CDER" - Pink Sheet, 7 September, 2012..

“A Terrific Spokesperson”

Hamburg praised Spielberg’s efforts as “a terrific spokesperson for the agency” and as an “important partner in helping the agency toward a more integrated approach to medical product evaluation,” according to the memo.

FDA records indicate he regularly met with stakeholders and gave speeches on a wide variety of topics and in a number of countries. He traveled to Japan in November and December 2011 to talk with authorities about potential collaborations and also attended events in England and Italy in 2012, according to the agency calendar of leaders’ meetings.

Hamburg has brought a remarkable degree of stability to the commissioner post following years of vacancy and short-term appointments in the position. But several of her key advisors have had relatively shorter tenures.

Former Principal Deputy Commissioner Josh Sharfstein, who served as acting commissioner before Hamburg was confirmed, left the agency in January 2011 to become the head of the Maryland Department of Health and Mental Hygiene Also see "FDA’s Congressional Relations, Internal Structure May Change With Sharfstein’s Departure" - Pink Sheet, 10 January, 2011..

Former FDA Chief Counsel Ralph Tyler cited personal medical problems as a reason for his departure in August 2011 after 18 months at the agency Also see "Ralph Tyler's Departure As FDA Chief Counsel Leaves Another Chair To Fill" - Pink Sheet, 5 July, 2011.. He joined the law firm Venable LLC in November of that year Also see "FDA Looks Inside For Chief Counsel, Taps Elizabeth Dickinson" - Pink Sheet, 5 March, 2012..

Spielberg’s Replacement At FDA Also Will Have Strong Industry Ties

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