While I do not believe the deal was contingent on Duke beating St. John’s yesterday and giving Coach K his 1000th win, Duke did give something up. Dr. Robert Califf was appointed FDA Deputy Commissioner for Medical Products and Tobacco. As such, Dr. Califf will oversee 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. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.” “Dr. Califf is currently serving as Vice Chancellor of Clinical and Translational Research at Duke University.
Management at the top of the FDA food chain always brings some new learning for the existing staff. Dr. Califf has extensive clinical background, has led many clinical studies, has worked on issues related to medication errors and is a cardiologist by training. One interesting tidbit is his extensive leadership in the field of translational research – a new one on me – which is, according to the press release, “key to ensuring that advances in science translate into medical care”… which is good for FDA (I think) as perhaps it will translate into increasing FDA requirements when they translate into an improvement in safety and efficacy evaluation and not just another requirement.
As the Center for Drug Evaluation and Research is under his purview, it will be interesting to see how his influence impacts the drug review and approval process. It will also be interesting to see what impact he may have on the generic drug program. We will keep track of these and other questions as his tenure begins, after late February.
The full FDA press release can be found here.