FDA Becomes An Agency Of “Directorates” Under Hamburg’s Reorganization
This article was originally published in The Tan Sheet
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Commissioner Margaret Hamburg’s structural reorganization of FDA leaves the current leadership of the agency’s centers intact, but adds a new layer of management and accountability between the medical product center directors and the commissioner’s office. Hamburg tapped Stephen Spielberg, a former pharmaceutical industry executive and a leader in the field of personalized medicine, to provide “high level coordination and leadership across the centers” for drugs, biologics, medical devices and tobacco products. The reorganization, which FDA outlines in a chart, also creates a new office dedicated to global regulatory operations and policy that will be helmed by Deborah Autor, who currently heads the Center for Drug Evaluation and Research’s compliance office.
“The new organizational alignments more accurately reflect the agency’s responsibilities, subject matter expertise and mandates in an ever more complex world, where products and services do not fit into a single category,” Hamburg said in a July 13 all-hands email announcing the changes. The reorganization will decrease both the size of the immediate office of the commissioner and the number of direct reports to Hamburg. However, the changes appear to reflect and underscore Hamburg’s oft-stated pledge to ensure that the agency is better prepared to keep up with the changes in science and technology and to address the challenges posed by globalization. A Six-Month Review Hamburg’s review of the agency’s organizational structure began more than six months ago with the January departure of then-Principal Deputy Commissioner Joshua Sharfstein (Also see "FDA Congressional Relations, Internal Structure May Change With Sharfstein Exit" - Pink Sheet, 17 Jan, 2011.). The new structure does away with the principal deputy commissioner’s position and creates a more streamlined reporting structure, primarily through cross-cutting “directorates” that reflect the agency’s core functions and responsibilities, Hamburg said. One of the new directorates is the Office of Medical Products and Tobacco, which will oversee the operations of the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Center for Tobacco Products and Office of Special Medical Programs. Serving as head of this directorate, a role akin to a medical products “czar,” will be Spielberg, currently director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City. A pediatrician by training, Spielberg brings a long background in academia and industry, including positions at Merck and Johnson & Johnson. He has some familiarity with FDA and its personnel; he is a current member of the agency’s Science Board and a former member of the Pediatric Advisory Subcommittee. Given his current position at Children’s Mercy, Spielberg is expected to help accelerate FDA's efforts to encourage personalized medicine. His overarching role also seems ideal for addressing issues related to drug-device and drug-diagnostic combinations, a subject on which the agency recently issued a draft guidance ("In Long-Awaited Guidance, FDA Lays Out Approval Path For Drugs And Companion Dxs," ''The Pink Sheet" DAILY July 12, 2011). In his role as deputy commissioner for medical products and tobacco, Spielberg will serve “as both [an] advocate and a support for center directors in their important work for FDA,” Hamburg said. She added that the individual medical product centers “will, of course, remain as discrete management entities under their current expert leadership.” CDER Loses A Compliance Director While the reorganization leaves in place the current directors of the drugs and biologics centers, Janet Woodcock and Karen Midthun, respectively, it will change the top of CDER’s compliance office. Autor, head of CDER’s Office of Compliance for the past five years, has been tapped to oversee a new directorate focused on globalization and regulatory affairs. As deputy commissioner for global regulatory operations and policy, Autor “will provide broad direction and support to the Office of Regulatory Affairs and to the Office of International Programs, with a mandate from me to make response to the challenges of globalization and import safety a top priority in the years to come," Hamburg said. The reorganization means that Associate Commissioner for Regulatory Affairs Dara Corrigan, who previously reported directly to Hamburg, now will report to Autor.
Changes also are in store for agency veteran and Deputy Commissioner Murray Lumpkin, who currently heads the Office of International Programs. Lumpkin will take on a new role as senior advisor and representative for global issues, Hamburg said. "In this role, he will be charged primarily with special projects that draw on his expertise working with counterpart regulatory agencies on issues of global regulatory harmonization, governance and capacity-building." Autor’s move out of CDER comes just weeks after the center’s Office of Compliance was elevated to “super-office” status (Also see "CDER’s Drug Integrity Program Gains Formal Role In Compliance Office Reorg" - Pink Sheet, 13 Jun, 2011.). She has been serving as acting director of the new super-office since early June. Ilisa Bernstein, deputy director for program operations in CDER’s compliance office, will become acting office director upon Autor’s move. Directorates For Foods, Operations The structure over the agency’s food center, and in turn its supplements and cosmetics programs, remains intact, and appears to serve as a model for the rest of the restructuring. The third directorate is the previously established Office of Foods, which oversees the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. Hamburg created the foods office in her first restructuring initiative a few months after she became commissioner in 2009 and appointed Mike Taylor as director (Also see "FDA Reorganization Elevates Scientific And Food Safety Priorities" - Pink Sheet, 24 Aug, 2009.). Taylor, a stalwart for a preventive approach to food safety enforcement, earlier this year noted FDA needs additional funding to fully implement the Food Safety Modernization Act. The agency backs expanding fees imposed on industry, he said at an industry conference (Also see "FDA's Food Safety Reform Needs More Funding – Mike Taylor" - Pink Sheet, 31 Jan, 2011.). Office of Operations: COO Sought The fourth directorate will be a new Office of Operations, to be headed by a chief operating officer. The agency has begun a search to fill the COO role. The new COO "will oversee the agency's administrative functions, such as human resources, facilities, information technology, finance and other activities that provide support to your organizations," Hamburg said. In addition, budget formulation and budget execution functions will be consolidated under a chief financial officer within the operations office. Since the 2009 reorganization, budget-related functions have been handled under the umbrella of the Office of Policy, Planning and Budget, a move that will link more directly budget development with programmatic planning. The current office is headed by acting Deputy Commissioner David Dorsey. With the relocation of budget functions into the Office of Operations, however, Dorsey’s position will revert to its former title of associate commissioner for policy and planning. The Office of the Chief Scientist, headed by Chief Scientist and Deputy Commissioner for Science and Public Health Jesse Goodman, also will function as a directorate. New Responsibilities For John Taylor The Offices of Policy and Planning, Legislation and External Affairs will continue to report directly to the commissioner but also now will report indirectly to John Taylor, counselor to the commissioner. When Sharfstein left the agency Hamburg tapped Taylor to serve as acting principal deputy commissioner for 60 days while she re-examined the agency’s structure. That 60-day stint turned into a six-month term. Under the new framework, Taylor will remain in his role of counselor, a position he has held since 2009, but add responsibility for policy and planning functions, external affairs and legislative affairs. Despite the broad scope of the changes, "for most of the FDA, this organizational alignment will likely not have a significant impact on you or your day-to-day work," Hamburg said. FDA said the reorganization will be implemented over the next few weeks. “Planning for the changes has already begun, though it may take some time for all of the administrative matters to be complete,” the agency said. By Sue Sutter |
