Califf, who was deputy commissioner for medical products and tobacco, was nominated as FDA commissioner by President Barack Obama in mid-September. No significant opposition was expected for his confirmation hearing on Tuesday, as the Senate voted 89-4 in favor of his appointment.
Stephen Ostroff, the FDA’s chief scientist, has served as acting commissioner since the end of last March upon the resignation of Margaret Hamburg.
“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,” Ostroff said. “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.”
Key issues before the FDA include speeding the pace of getting new drugs to market, including streamlining the clinical trial process, as well as navigating the arrival of biosimilars, stronger oversight of electronic cigarettes and new food safety measures.
A cardiologist and clinical researcher, the 64-year-old Califf has had a distinguished academic career, mostly at Duke University from 1982 through 2015, where he served as director of the university’s cardiac care unit. He also founded Duke’s clinical research institute in 2006 and has been involved with many professional organizations, including committees of the Institute of Medicine of the National Academies.
“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,” Sylvia Burwell, secretary of the U.S. Department of Health and Human Services, said on Wednesday. “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.”
The opioid painkillers issue was the catalyst for the four votes against Califf by Sens. Edward Markey (D., Mass.), Joe Manchin (D., W.V.), Richard Blumenthal (D., Conn.) and Kelly Ayotte (R., N.H.), who called on the FDA to take more action on rising prescription drug and heroin abuse.
“The FDA is supposed to be our nation’s pharmacist, but right now it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” Markey said. “We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers that are the cause of this deadly scourge of opioid addiction and overdoses. The FDA must begin by agreeing to convene advisory committees for all opioid approval decisions.”