FDA scored a major star in the pharmaceutical world and maybe its next commissioner with the hiring of Robert Califf to oversee its medical product and tobacco operations.

Califf will become deputy commissioner for medical products and tobacco and manage the centers for drugs, biologics, devices and tobacco products, as well as the Office of Special Medical Programs in the Office of the Commissioner.

A cardiologist and distinguished researcher, Califf is director of Duke University’s Translational Medicine Institute and vice chancellor for Clinical and Translational Research.

Califf also has served on FDA’s Cardiovascular and Renal Drugs Advisory Committee and Science Board Subcommittee on Science and Technology and is active with the Institute of Medicine.

Robert Califf

Source: Duke Photography

In addition, he has been instrumental in pushing clinical trial reform efforts ([A#14121203003]) and worked closely on the NIH Health Care Systems Research Collaboratory, which was created to improve how trials are conducted Also see "FDA Scales Back Near-Term Goals For Sentinel Postmarket Data Network" - Pink Sheet, 15 January, 2014..

Rachel Sherman, former director of the CDER Office of Medical Policy and now principal at the consultancy Greenleaf Health, said there are few people as well qualified as Califf for the deputy commissioner for medical products and tobacco position.

Sherman, who co-chaired the agency’s clinical trial transformation initiative with Califf, said in an interview that he has the leadership and scientific acumen and understands agency and outside perspectives, which will be a huge asset.

Califf also likely will fit well with Commissioner Margaret Hamburg’s regulatory science initiative, which looks to expand and improve FDA research efforts so its staff can keep up with the latest technology.

Hamburg said in a Jan. 26 announcement of the hiring, “Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we’ve made in medical product development and regulation over the last few years.”

Hamburg made regulatory science among her top priorities for the agency early in her tenure Also see "FDA Has Regulatory Science Plan; Now It Needs Funding" - Pink Sheet, 6 October, 2010..

Hamburg’s Successor?

Califf will join the agency in late February, FDA said in the statement. He did not respond to a request for comment.

In the position, Califf will report directly to Hamburg and “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,” the agency said in the statement.

But much of the initial reaction to the announcement centered on Califf’s potential to replace Hamburg, if and/or when she decides to leave the agency.

Scott Gottlieb, a resident fellow at the American Enterprise Institute and former FDA deputy commissioner for medical and scientific affairs, said Califf was a “smart pick” and has been set up to be the next commissioner when Hamburg leaves.

Gottlieb said Califf would be “well-received across the political spectrum” should the administration decide to promote him to commissioner.

Nancy Myers, president of Catalyst Healthcare Consulting and former FDA staffer, also suggested Califf’s hire may have been about agency succession planning.

Califf had been thought of as one of the candidates for FDA commissioner when the Obama Administration took office in 2009 Also see "Duke’s Califf Bows Out Of FDA Search; Quest Moves To Baltimore, New York" - Pink Sheet, 18 February, 2009..

While Califf may be a strong candidate, selection of the next commissioner also will require political considerations, even though FDA likes to be thought of as a science-based agency and above politics.

There has been no indication that Hamburg is planning to leave FDA. But it appears now that the official watch may be under way.

A Long Vacant Position

Hamburg announced the deputy commissioner for medical products and tobacco position in 2011 as part of a reorganization that created management directorates between the medical product centers and commissioner’s office to better coordinate activities Also see "FDA Reorganization Adds "Directorate" Layer, But Sharpens Agency's Focus" - Pink Sheet, 18 July, 2011..

Stephen Spielberg was the first to hold the position. He said in an email that Califf is an “outstanding choice” and “can help advance regulatory science at a time of ever more complex and exciting new medical products.”

Spielberg joined FDA in 2011, but left in 2013 because of a family medical issue Also see "Spielberg’s Replacement At FDA Also Will Have Strong Industry Ties" - Pink Sheet, 23 January, 2013..

Leona Brenner-Gati took over on an acting basis, but resigned after only a few months. Her departure sparked a House committee investigation Also see "FDA’s Potential Black Hole: House Investigates Departure Of Acting Head Of Medical Products Office" - Pink Sheet, 15 May, 2013..

FDA issued a formal notice to find another candidate in July 2013, but it has been vacant for more than 18 months Also see "FDA Ready To Hire New Deputy Commissioner For Medical Products And Tobacco" - Pink Sheet, 16 August, 2013..

An Outside Hire

Califf becomes the latest hire in an agency-wide effort to bring in senior managers from industry and academia.

FDA would like some new leaders to come from outside the agency in part to add new perspective and ideas.

Richard Moscicki, deputy CDER director for science operations, who came to the agency from Genzyme Corp., said FDA also needs leadership candidates in part because a number of key leaders are expected to retire in the coming years ([A#00140324010]).

It has been hindered in part because of salary and other issues that plague the federal hiring system.

Califf has some ties to industry along with his academic career. Shortly after FDA announced his hiring, Portola Pharmaceuticals Inc. announced he had retired from its board of directors, where he had served since 2012.

Spielberg worked at Children’s Mercy Hospital in Kansas City, as well as Merck & Co. Inc. and Johnson & Johnson, prior to joining FDA. Brenner-Gati also spent many years at J&J and Sandoz Inc. prior to moving to the agency.

Gregory Geba was hired in 2012 to become director of the Office of Generic Drugs after spending several years at a number of drug companies. But he left after less than a year on the job.

FDA veteran Kathleen Uhl took over on an acting basis and recently was named the permanent director ([A#14150115001]).

FDA Lands Duke’s Califf As Top Deputy, Potential Next Commissioner

More from United States

More from North America