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Feb 02, 2015
 |  BioCentury  |  Politics, Policy & Law

Dr. Califf goes to Washington

Why Duke's Robert Califf could meet high expectations as FDA deputy commissioner

FDA has had three deputy commissioners during the Obama administration;each was expected to play a major role in shaping the agency, and none of them lived up to expectations. Last week's announcement that Robert Califf has been named deputy commissioner for medical products and tobacco raises even higher expectations, and based on his career and reputation, it seems likely that this time those expectations will be met.

Califf, who has taken a leave of absence from his position as vice chancellor of clinical and translational research at Duke University School of Medicine, is stepping into a position where policy is intertwined with politics, and where success requires managing complex relationships within FDA, with the federal bureaucracy, and with the White House and Congress (see "Success Without Succession?" page 5).

When he joins FDA late this month, Califf will bring deep experience in a wide variety of policy areas that are critically important for biomedical innovation. He has decades of experience leading high-impact cardiology trials, and has had leadership roles in national initiatives to advance translational medicine, revamp and modernize clinical trials, and integrate genomics into medical practice.

It isn't possible to predict how he will respond to specific challenges as an FDA employee, but hundreds of peer-reviewed papers and numerous public statements provide insights into how he has thought about, and acted on, key policy issues prior to obtaining a government ID card.

Although he hasn't been active in partisan politics, Califf, a registered Democrat, has participated in several contentious scientific and medical battles, including debates over the safety of Vioxx rofecoxib and Avandia rosiglitazone. He has consistently pushed against taking shortcuts or making decisions on the basis of insufficient or misleading evidence.

He has also led large, complex trials that were designed to produce robust evidence, worked to improve methods for collecting and evaluating data, and championed efforts to put more data in the public domain.

Califf has served on and presented to FDA advisory committees, and was a member of the FDA Science Board's subcommittee on science and technology, which wrote "FDA Science and Mission at Risk," an influential study published in 2007. The subcommittee members put FDA under a microscope - and they didn't like what they saw. The report's analysis and its recommendations have guided FDA Commissioner Margaret Hamburg's efforts to build the agency's scientific capacity and invest in regulatory science in and outside of government.

Califf also has observed and participated in decision-making in biopharma companies. He has interacted with dozens of companies as an investigator, a consultant or a paid speaker. After his move to FDA was announced, Portola Pharmaceuticals Inc. reported Califf had resigned his board seat (see "Well Connected," page 3).

More, better evidence

Examples of Califf's impact on public health and drug development can be found in the sagas of the cholesterol-lowering drug Zetia ezetimibe and the COX-2 inhibitor Vioxx from Merck...

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