In February, the Senate overwhelmingly voted to confirm the new commissioner of the FDA, Robert Califf. Califf was nominated by President Obama in September of 2015 for the position. Over the past few months, the nomination was contested for a variety of reasons before finally satisfying the Senate review.
The Office of the Commissioner provides the agency with management and direction. The commissioner focuses the agency and allocates resources to further the public health initiatives. Since 1907, there have been just over 20 commissioners. Most serve about five years, although some have served for more than a decade. The office is a political appointment, however, it is not usually as partisan as other positions.
Introducing Dr. Califf
Dr. Robert Califf is a cardiologist and researcher. Prior to joining the FDA last year, he had spent decades working as an administrator and researcher at Duke University. He is an internationally recognized expert in the fields of cardiovascular medicine, healthcare quality, research in health outcomes, and clinical research. He’s led numerous clinical trials that have had significant impact on the medical community, and has published more than a thousand articles in peer-reviewed publications.
Beginning in February 2015, he was the Deputy Commissioner for Medical Products and Tobacco. During his brief stint in this capacity he worked with a variety of programs and initiatives in fields such as precision medicine, orphan drugs, combination products, and pediatric therapeutics.
As the head of the FDA, he has already made it clear that this is a new era for the agency. New priorities include addressing the opioid epidemic, recruiting and retaining industry leaders, incorporating new data streams, differentiate trials for targeted therapies, cancer treatment, and exploring the role of genetics and genomics as they relate to drug therapies.
It is clear the new head of the FDA is going to be making some major changes in the way the nation researches, introduces, and prescribes drugs. While the practical impacts won’t be felt immediately, the FDA seems to be working towards becoming more relevant and interactive with the medical community. The direction and changes thus far seem to be quite positive, and they are definitely worth keeping up with what comes next.