A turbulent week for the staff of the US Food and Drug Administration (FDA) has affected yet another of the agency's top staff members, with Commissioner Margaret Hamburg announcing Friday that the Acting Deputy Commissioner of Medical Products and Tobacco, Leona Brenner-Gati, will be leaving the agency effective immediately.

Background

The Office of Medical Products and Tobacco (OMPT) is one of the newest offices at FDA, created in July 2011 under the initial tutelage of then-Deputy Commissioner Stephen Spielberg. In an announcement at the time of OMPT's creation, Hamburg said that the office was meant to address "Several key challenges" at the agency, including the size of FDA, its increasingly global focus, and the continuing evolution of regulatory science and its use in regulating 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 (GO)-remain central to the oversight of healthcare product regulations.

GO is basically in charge of all regulatory operations and inspections in the agency-"the field" of FDA-while OMPT looks over FDA's major centers like the Center for Drug Evaluation and Research (CDER), Devices and Radiological Health (CDRH), and Biologics Research and Evaluation (CBER).

Now, in the span of a single week, Hamburg has announced that the leaders of both of those new offices will be leaving. On 30 April 2013, Hamburg sent a message to FDA staff indicating that Deborah Autor, a highly-respected veteran of the agency, would be leaving to take a new position at Mylan Pharmaceuticals. Autor will depart the agency-and her 4,400-staff at GO-on 1 June 2013.

Another Departure

But the second departure is perhaps more unexpected than that of Autor, because it comes just two months after Brenner-Gati took the helm of OMPT after Spielberg left the agency, citing unspecified family medical issues.

Brenner-Gati joined FDA in September 2012 after a 17-year career with Johnson & Johnson as associate commissioner, and was promoted to her new position in February 2013.

Hamburg's statement to staff on 3 May 2013 indicates that Brenner-Gati is leaving the agency immediately-a relatively unusual occurrence. Hamburg cited "unexpected personal circumstances" for the departure, but did not elaborate.

The Commissioner said that Brenner-Gati had "played a key leadership role in many critical ongoing initiatives," including the integration of new regulatory approaches between centers and enhancing relationships between FDA stakeholders.

No replacement for position of Acting Deputy Commissioner has yet been named.

Full Email:

Dear FDA Colleagues,

I regret to inform you that Dr. Leona Brenner-Gati, Acting Deputy Commissioner of Medical Products and Tobacco, will be leaving the Agency on May 3, 2013, due to unexpected personal circumstances.

Since joining FDA in September 2012 as the Associate Commissioner of Medical Products and Tobacco, Dr. Brenner-Gati has played a key leadership role in many critical ongoing initiatives. These include implementation of the OMPT Directorate; better enabling integrative regulatory approaches across drugs, biologics, diagnostics, devices, and tobacco products; fostering collaboration, alignment, and process optimization across OMPT Centers and Offices, with other Directorates, and with the Office of the Commissioner; enhancing FDA relationships with sister agencies, foundations, institutes, research and patient advocacy groups; establishing new fellowship programs; and championing regulatory science.

After a long and distinguished career in the private healthcare sector and academic medicine, Dr. Brenner-Gati brought to the Agency invaluable experience with innovation in science, technology, medicine and healthcare; excellent leadership and management expertise; and personal attributes, including her collaborative spirit, drive, and interpersonal skills, that will be sorely missed.  Please join me in thanking Dr. Brenner-Gati for her contributions to FDA and in wishing her all the best in her future endeavors.

Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs