Senate confirms Califf as FDA commissioner

The Senate confirmed Robert M. Califf, MD, as FDA commissioner on Feb. 24, placing the cardiologist atop the agency in the final year of President Barack Obama’s second term.

The Senate voted 89-4 in favor of Califf, who was nominated for the position on Sept. 15, 2015.

“Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine,” Stephen Ostroff, MD, the FDA’s acting commissioner, said in a news release. “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.”

A Senate panel approved Califf’s appointment on Jan. 12, but Senators Bernie Sanders (I-Vt.), Edward Markey (D-Mass.) and others placed a hold on the appointment. Sanders expressed concerns with Califf’s ties to the pharmaceutical industry, while Markey said he wanted changes to the FDA’s approval process for opioid painkillers.

Before joining the FDA in February 2015, Califf was the vice chancellor of clinical and translational research at Duke University. He is also the founder of the Duke Clinical Research Institute, the world’s largest academic research organization.

“Dr. Califf is an acclaimed leader in the cardiovascular community who brings impressive medical knowledge, clinical research experience and leadership capabilities to the FDA,” American College of Cardiology President Kim Allan Williams Sr., MD, said in a news release. “He has made important contributions to the field of medicine and has the vision required to lead the FDA in its efforts to promote and protect public health. Dr. Califf is the right person to lead the FDA, and the American College of Cardiology congratulates him on his confirmation as the new FDA commissioner.”

Markey was among the four Senators who voted against Califf. He said in a news release that he would continue fighting to have the FDA convene advisory committees for opioid approvals.

“We will not solve the prescription drug crisis with an FDA that operates with business as usual and continues to turns its back on external experts,” he said. “The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive opioid painkillers without limits, without supervision and without consequence. The FDA needs to welcome outside expert advice and must convene expert advisory committees for all opioid approval decisions.”