US Senate Confirms Dr. Robert M. Califf as FDA Commissioner

February 24, 2016—The US Senate voted to confirm President Obama’s nominee, Robert M. Califf, MD, to lead the Food and Drug Administration (FDA). Senators voted 89-4 on Dr. Califf's nomination.

In a statement released by the FDA, Stephen Ostroff, MD, who has served as Acting Commissioner of the agency since April 2015, commented, “Today the US Senate voted in support of the confirmation of Dr. Robert Califf to be Commissioner of [the] US Food and Drug Administration. Dr. Califf has demonstrated a long and deep commitment to advancing public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine. He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public, across the many areas we regulate—and I am confident that our public health and scientific contributions will further grow under his exceptional leadership.”

In January 2015, then-FDA Commissioner Margaret A. Hamburg, MD, announced Dr. Califf’s appointment as FDA deputy commissioner for medical products and tobacco. Shortly thereafter, Dr. Hamburg announced that she would be leaving the FDA after a 6-year tenure as Commissioner.

The FDA noted that Dr. Califf is a recognized global leader in cardiology, clinical research, and medical economics. Before joining the FDA, he served as Vice Chancellor of Clinical and Translational Research at Duke University in Durham, North Carolina.

As FDA Deputy Commissioner, Dr. Califf provided executive leadership to 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. Additionally, he provided oversight to the Office of Special Medical Programs in the Office of the Commissioner.

The FDA stated that other prominent roles during Dr. Califf’s tenure at Duke included Director of the Duke Translational Medicine Institute and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. Before serving as Director of the Duke Translational Medicine Institute, he was the founding Director of the Duke Clinical Research Institute, the world’s largest academic research organization. 

The Institute for Scientific Information recognized Dr. Califf as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.

In a statement from the US Department of Health and Human Services, Secretary Sylvia M. Burwell, commented, “I commend the Senate for their bipartisan vote today and am pleased that President Obama’s nominee, Dr. Robert Califf, will become the commissioner of the FDA. Dr. Califf is the right person with the right experience to build on the FDA’s unsurpassed record of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market. I look forward to working with Dr. Califf to ensure the FDA can carry out every aspect of its critical mission; from ensuring the safety and effectiveness of the medical products we use, to protecting the nation’s food supply and implementing its oversight of tobacco products, to furthering our efforts to combat opioid abuse. Dr. Califf's life in medicine and research has positively impacted the lives of many Americans, and as the new head of the FDA, he will be able to improve the lives of many more.”

Secretary Burwell continued, “I would also like to express my sincere appreciation to Dr. Steve Ostroff for serving as acting commissioner. He has provided important leadership and a steady hand as the FDA has continued its important work. I am grateful for his willingness to serve and look forward to continuing our work together through the remainder of the administration.”