Regulatory Focus™ > News Articles > Spielberg, Overseer of Top FDA Centers, to Step Down in February

Spielberg, Overseer of Top FDA Centers, to Step Down in February

Posted 22 January 2013 | By Alexander Gaffney, RAC

Steven Spielberg, one of the US Food and Drug Administration's (FDA) top regulatory officials, will be resigning from his post in a little more than two weeks due to an unspecified "family medical issue," FDA announced in a staff email on 22 January 2013.

Spielberg was a relatively new addition to FDA, having worked mainly as an academic researcher and in industry before joining FDA in July 2011 to head up the new Medical Products and Tobacco division of FDA. At the time, FDA Commissioner Margaret Hamburg said Spielberg's appointment was part of a broader set of changes meant to address "several key challenges," including the size of the agency, the evolution of regulatory science and the globalization of regulated products.

As part of that change, many of the agency's centers, super-offices and offices were organized under what Hamburg called "directorates. Of the four offices created, two-the Office of Medical Products and Tobacco (OMPT) and the Office of Global Regulatory Operations and Policy (OGROP)-remain central to the oversight of healthcare product regulations.

The former office was Spielberg's, and it oversees the Centers for Devices and Radiological Health (CDRH), Drug Evaluation and Research (CDER), Biologics Evaluation and Research (CBER) as well as the relatively new Center for Tobacco Products (CTP). Veterinary foods and medicines are overseen by a separate directorate, the Office of Foods and Veterinary Medicines.

A New Office Gets Its Second Leader

Now, just a year and a half into its existence, OMPT is finding itself in the uncomfortable position of transferring leadership. In an email sent to staff on 22 January 2013, Hamburg thanked Spielberg for his service, calling him a "key member of [the] senior management team]" and a "terrific spokesperson for the Agency."

"He has been an important partner in helping the agency toward a more integrated approach to medical product evaluation across the Directorate, in working together with Center leadership to address the rapid changes in human biology and therapeutic interventions, and in helping optimize FDA's approach to evolving areas such as personalized medicine," Hamburg added.

Stepping in to fill the void will be Leona Brenner-Gati, MD, currently associate commissioner at the agency and another long-time employee of industry before joining FDA. Brenner-Gati worked for Johnson & Johnson for 17 years in a number of senior positions, as well as Sandoz Pharmaceuticals, FDA said in its statement.

She will assume the title of Acting Deputy Commissioner for Medical Products and Tobacco until a permanent replacement-potentially her-is found.

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