Senate confirms Robert Califf as head of FDA

Voting against his confirmation were Sens. Lindsey Graham, R-S.C., said Wednesday in a statement.

Several senators held up the confirmation over concerns ranging from the FDA’s approval and labeling processes to doubts about the candidate’s ties to the drug industry. Dr. Califf joined FDA after 33 years with Duke University School of Medicine and the Duke University Medical Center, most notably vice chancellor of clinical and translational research and, in 2006, founder of the Duke University Clinical Research Institute. He forged close relationships with the pharmaceutical industry that some critics say are too close for comfort.

With only a year left in Obama’s presidency, Califf is tasked with wrapping up the administration’s initiatives at the agency, including unfinished tobacco regulations and food safety and labeling reforms.

With this successful cloture vote, further debate on Califf’s nomination will be limited to 30 hours, likely setting up a potential final vote on Tuesday.

Manchin, Markey, Democratic Sen.

“With 51 Americans dying every day due to an opioid overdose, the FDA now more than ever needs a champion who is committed to changing the way the agency handles opioids.”

“We consume 80 percent of all prescription opioid pills in the world”.

A Senate panel approved Califf’s appointment on January 12, but Senators Bernie Sanders (I-Vt.), Edward Markey (D-Mass.) and others placed a hold on the appointment. Patty Murray of Washington, the top Democrat on the Senate Health Committee.

A vote on the nomination is expected around 11 a.m.

“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.

“It’s a proud day for the DCRI and Duke”, said the executive director of Califf’s former institute, Dr. Eric Peterson, in a statement. “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”. The FDA’s chief scientist, Dr. Stephen Ostroff, is serving as acting head of the agency.

Califf, 64, is a well-regarded cardiologist and researcher who takes the helm at the FDA at a time it is under pressure from lawmakers to speed the approval process for drugs and medical devices and finalize a proposed rule giving it authority to regulate e-cigarettes.

On the pharmaceutical side, the agency is working to approve generic drugs more quickly, as well as figuring out the details of regulating a new class of drugs called biosimilars, which are less expensive versions of biologic drugs.