|Dr. Robert Califf|
In move that was generally expected, Dr. Robert Califf is now officially in line to take over as commissioner of the FDA after being nominated by the president on Tuesday.
When former FDA Commissioner Margaret Hamburg brought him on board in February, a month before her own departure, he was presumed to be in line for the job. He has twice before been vetted for the position, by the last President Bush and then by President Obama before he selected Hamburg.
Unless he decides to bring in his own team to run things, those with manufacturing responsibilities might expect little change, assuming Califf gets through the partisan political process that has blocked other Obama nominees. For manufacturers, Janet Woodcock has laid out a clear path with her push for drugmakers to establish a "culture of quality" and her creation of the Office of Pharmaceutical Quality.
A cardiologist, Califf has been serving as FDA Deputy Commissioner for Medical Products and Tobacco. But he is very experienced and well known in the pharmaceutical industry, having conducted a lot of clinical research as the founding director of in-house CRO Duke Clinical Research Institute. Before joining the FDA, he was on several company boards and is on the record as believing in collaboration between regulators and industry for effective drug development. He told Time magazine earlier this year that the FDA's role includes both "regulating an industry and creating the conditions where the industry can thrive."
If approved by the Senate, one of the most pressing issues on his plate is the potential approval of the 21st Century Cures Act. Since it would speed drug approvals, it has implications for those in manufacturing by shortening the drug development to commercial production process.
- here's the White House release