January 26th, 2015
Califf to Leave Duke to Become FDA Deputy Commissioner
The FDA announced today that Duke University cardiologist Robert Califf will be the next FDA Deputy Commissioner for Medical Products and Tobacco. The agency said that Califf will be responsible for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.”
Califf replaces Steven Spielberg, who resigned last week due to an unspecified “family medical issue.” Califf will be the third person to hold the position, which was created by FDA commissioner Margaret Hamburg as “part of a broader set of changes” emerging from an FDA reorganization, according to FDA maven Alexander Gaffney.
Califf is now the vice chancellor of clinical and translational research at Duke University, where he has held a number of leadership positions. Califf initially gained national attention in the 1980s as one of the pioneers of clinical trials involving thrombolysis for acute myocardial infarction, which at the time was one of the hottest areas of medicine. Along with co-principal investigator Eric Topol, Califf led the TAMI group, which eventually evolved into the first GUSTO study, an enormously influential trial at the time. The trial helped struggling Genentech establish one of the first major biotechnology drugs, tPA (alteplase). The GUSTO trial also led directly to Califf’s founding of the Duke Clinical Research Institute (DCRI), which is the world’s largest academic research organization, employing over 1,000 people. Most recently Califf was in the limelight as a co-principal investigator of the IMPROVE-IT trial.
In 2009 there was widespread speculation that Califf was under consideration for the top position of FDA commissioner. Some are now speculating that Commissioner Hamburg may be seeking to put Califf in position to possibly take over her job when she retires.
- FDA announcement
- David Kroll in Forbes
- Wall Street Journal
- Regulatory Affairs Professionals Society