FDA Hires World-Renowned Cardiologist to Oversee Medical and Regulatory Policy

Regulatory NewsRegulatory News
| 26 January 2015 | By Alexander Gaffney, RAC

One of the world's top cardiologists is set to join the US Food and Drug Administration (FDA) next month to oversee four of its largest regulatory divisions, FDA Commissioner Margaret Hamburg has announced.

In a 26 January 2014 announcement, Hamburg said FDA had appointed Robert Califf as deputy commissioner for Medical Products and Tobacco.

Califf is a familiar figure to many within the life sciences field. He is currently the director of the Duke Translational Medicine Institute (DTMI), and founded the Duke Clinical Research Institute (DCRI), the largest academic research organization in the world and a frequent collaborator with FDA.

In a statement, Hamburg called Califf a recognized leader in the field of translational research and cardiovascular medicine, and noted his prior involvement on an FDA advisory committee and his involvement in several groundbreaking reports published by the Institute of Medicine (IOM).

In addition, Califf is one of the most-cited medical authors in the world "with more than 1,200 peer-reviewed publications," Hamburg noted.

At FDA, however, Califf will take over a position that has had a tumultuous history.


The Office of Medical Products and Tobacco (OMPT) is a relatively new office at FDA, having been created in July 2011. 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).

Since OMPT's creation, however, it has struggled to retain leadership. In January 2013, OMPT's first-ever deputy commissioner, Stephen Spielberg, announced he would step down due to an unspecified "family medical issue." At the time, FDA announced Spielberg would be succeeded by Leona Brenner-Gati on an acting basis.

However, just five months later Brenner-Gati announced that she, too, would be leaving FDA.

Since then, FDA has not had a permanent leader for OMPT.

New Leadership

With Califf, FDA aims to change that—and in a big way.

In a statement, Hamburg said Califf will "play a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities and will manage cross-cutting clinical, scientific and regulatory initiatives in several key areas for the agency, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system."

For a job that requires a keen understanding of a wide array of public health issues and translational science, FDA appears to have found an extraordinarily qualified individual. Their challenge, if history is any guidepost, will be in keeping him for any length of time.

Califf is set to join FDA in "late February," Hamburg said in a statement.


FDA Statement


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