FDA reorg puts an industry veteran in charge of drugs

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FDA Commissioner Hamburg named a former Merck and J&J scientist to the new post of deputy commissioner for medical products and tobacco as part of a sweeping reorganization of the agency's management structure.

“The structure of the Office of the Commissioner that I inherited was created in 1970, when the FDA consisted of three centers and a field office,” said Hamburg in an email to staff. “By 2011, we had grown to seven Centers and a Commissioner's Office with more than 1,600 staff.”

The reorg, she said, divides agency programs into “directorates” reflecting core functions and responsibilities and “help tie together programs that share regulatory and scientific foundations.”

Dr. Stephen Spielberg, MD, PhD, a former dean of Dartmouth Medical School and current director of the Center for Personalized Medicine and Therapeutic Innovation at Children's Mercy Hospital in Kansas City, will oversee the Centers for drug, biologics, medical devices and tobacco products, and will also oversee Special Medical programs. Spielberg, who becomes deputy commissioner for medical products and tobacco, spent seven years at J&J, where he headed pediatric clinical trials internationally until 2003, having joined from Merck, where he did research in pharmacogenetics and chaired PhRMA's pediatric task force. He has served on the FDA's scientific advisory board for the past two years.

Dr. Spielberg's appointment could indicate a shift in agency-industry relations, given pharma's strained relationship with the principal deputy commissioner previously in charge of drugs and devices, Joshua Sharfstein, a longtime industry critic who left FDA in January to head up public health for his home state of Maryland.

"It means that the Critical Path Initiative will have a stronger voice in agency policy development," said former FDA associate commissioner for external relations Peter Pitts. "The FDA is very fortunate to have attracted such a high caliber name. It sends an important signal --that Commissioner Hamburg is serious about keeping her Advancing Regulatory Science Initiative at the top of her agenda."

Hamburg also promoted Deborah Autor, director of CDER's Office of Compliance, to another new post, that of Deputy Commissioner for Global Regulatory Operations and Policy, in which role she will establish a second directorate “focused on grappling with the truly global nature of today's world … so that the FDA can move from being a regulator of domestic products to one overseeing a worldwide enterprise.” Dr. Murray Lumpkin, deputy commissioner for international programs and director of the Office of International Programs, becomes senior advisor and representative for global issues, tasked with handling special projects working with counterpart regulatory agencies on global regulatory harmonization and governance.

Mike Taylor will continue to head a third directorate, the Office of Foods, and a fourth directorate will be a new Office of Operations overseeing the agency's administrative functions – HR, facilities, IT, finance – which will be headed by a COO for whom a search has been launched.

In the office of the commissioner, counselor and principal deputy John Taylor will take on the additional duties of overseeing policy and planning, the Office of Legislation and the Office of External Affairs.
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