The White House announced on Tuesday that it was going to nominate Duke University cardiologist Rob Califf to serve as the next Commissioner of the FDA. The nomination had been widely expected since his appointment in January as the FDA Deputy Commissioner for Medical Products and Tobacco.
Before going to the FDA Califf had most recently been the vice chancellor of clinical and translational research at Duke University. As I have previously reported, 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.
Califf is widely recognized as one of the most influential cardiologists in the world and a leading authority on clinical trial design and drug regulation. Some observers have been critical of Califf for his ties to industry and because DCRI relies largely on industry funding. Others have lavished praise on Califf for his leadership and sharp intelligence.
In 2009 there was widespread speculation that Califf was under consideration for the top position of FDA commissioner. Margaret Hamburg was eventually nominated for the job. If the nomination is successful Califf will succeed acting commissioner Stephen Ostroff.
The Wall Street Journal reported that Califf is expected to gain Senate confirmation. “Unless they’re looking for a reason to slow this down to score points, he should get relatively quick approval,” according to one federal official quoted.
Rob Califf speaking last month at the European Society of Cardiology meeting in London