As a cardiologist, Dr. Califf led clinical trials at Duke University Medical Center in North Carolina for decades. Most recently, he led clinical policy and strategy for Verily, the life sciences division of Google’s parent company Alphabet. At the hearing, he emphasized the value of existing data, much in patient electronic health records, to help answer difficult questions about the evidence for drugs and devices.
Republicans asked how he would deal with rules around abortion-inducing drugs, which had been relaxed during the pandemic after years of strict restrictions. Two days after the hearing, the FDA – led by Dr. Janet Woodcock, the interim commissioner – said it would permanently lift restrictions, allowing patients to terminate a pregnancy in the first 10 weeks after a telemedicine visit with medications taken at home.
Senator Tommy Tuberville, an Alabama Republican committee member, said in a statement that the recent decision informed his committee’s vote. “I believe that Dr. Califf will continue to advance this administration’s pro-abortion agenda, and I cannot support his nomination,” he said.
Senator Mike Braun, an Indiana Republican, also said he opposed the nomination because of abortion policies and concerns about opioids. “Under his leadership in 2016, the FDA expanded access to the dangerous chemical abortion drug mifepristone and failed to take action to turn the tide of the opioid crisis plaguing our country,” he said in a statement.
dr. Califf was previously confirmed in an 89-to-4 Senate vote to lead the FDA during the final year of the Obama administration. If reaffirmed, he will have to make important tobacco control decisions as he tries to balance e-cigarettes as a tool to help some quit smoking without creating a new generation of users. The oversight of accelerated drug approval will be stepped up, given the current debate over the agency’s approval of the controversial Alzheimer’s drug Aduhelm.
After Senator Sanders removes the tapes of Dr. Califf had exposed himself to drug companies, including consulting fees and stock ownership of as much as $8 million, the nominee told the Senate panel in mid-December that he would abide by ethical rules set by the FDA and its parent company, the Department of Health and Human Services.
New Hampshire Senator Hassan also voted against the nomination of Dr. Califf. She had pressured him in December for failing to update the labeling of opioid drugs by the FDA. dr. Califf said the agency would continue to review the incoming evidence.