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