Senate panel approves Califf’s nomination as FDA chief

As a cardiologist, Dr. Califf has spent decades leading clinical trials at Duke University Medical Center in North Carolina. Most recently, he led clinical policy and strategy at Verily, the life sciences arm of Alphabet, Google’s parent company. During the hearing, he highlighted the value of existing data, much of it in patients’ electronic medical records, to help answer difficult questions about drug and device evidence.

Republicans asked how he would handle rules on abortion drugs, which had been relaxed during the pandemic after years of tight restrictions. Two days after the hearing, the FDA – under the direction of Dr. Janet Woodcock, the acting commissioner – announced that it would permanently lift the restrictions, allowing patients to terminate a pregnancy within the first 10 weeks after a visit to telemedicine with medicines taken at home.

Sen. Tommy Tuberville, a Republican committee member from Alabama, said in a statement that the recent decision informed his committee’s vote. “I believe Dr. Califf will continue to push this administration’s pro-abortion agenda, and I cannot support his nomination,” he said.

Sen. Mike Braun, a Republican from Indiana, also said he opposed the nomination because of abortion policies and opioid issues. “Under his leadership in 2016, the FDA expanded access to the dangerous abortive chemical drug mifepristone and failed to take action to stem the tide of the opioid crisis ravaging our country,” he said in a statement.

Dr. Califf was previously confirmed in an 89-4 Senate vote to lead the FDA in the final year of the Obama administration. If reconfirmed, it will face key tobacco control decisions as it attempts to balance e-cigarettes as a tool to help some quit smoking without creating a new generation of users. Monitoring of fast-track drug approvals will be stepped up, given the ongoing debate over the agency’s approval of the controversial Alzheimer’s drug Aduhelm.

After Senator Sanders exposed Dr. Califf’s ties to pharmaceutical companies, which include consulting fees and $8 million in stock ownership, the candidate told the Senate panel in mid-December that it would abide by ethics rules established by the FDA and its parent agency, the Department of Health and Human Services.

Senator Hassan of New Hampshire also voted against Dr. Califf’s nomination. She had pressed him in December about the FDA’s failure to update the labeling of opioid drugs. Dr Califf said the agency would continue to review future evidence.

Comments are closed.