Monday , March 27 2023
Senate Panel OKs Califf Nomination for F.D.A. Chief

Senate Panel OKs Califf Nomination for F.D.A. Chief

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

Republicans asked how he would handle rules around medications to induce abortion, which had been relaxed during the pandemic after years of tight restrictions. Two days after the hearing, the F.D.A. — under Dr. Janet Woodcock, the interim commissioner — announced that 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, a Republican committee member from Alabama, said in a statement that the recent decision informed his committee vote. “I believe Dr. Califf will continue to advance this administration’s pro-abortion agenda, and I cannot support his nomination,” he said.

Senator Mike Braun, a Republican from Indiana, also said he opposed the nomination over abortion policies and opioid concerns. “Under his leadership in 2016, the F.D.A. expanded access to the dangerous chemical abortion 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 a 89-to-4 Senate vote to lead the F.D.A. during the last year of the Obama administration. If confirmed again, he will face key decisions on tobacco control as he tries to balance e-cigarettes as a tool to help some quit smoking without creating a new generation of users. Scrutiny around accelerated approvals of drugs will be heightened, given the current debate over the agency’s approval of the controversial Alzheimer’s drug Aduhelm.

After Senator Sanders denounced Dr. Califf’s ties to pharmaceutical firms, which include consulting fees and stock ownership amounting to as much as $8 million, the nominee told the Senate panel in mid-December that he would comply with ethics rules set by the F.D.A. 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 on the F.D.A.’s failure to update the labeling of opioid medications. Dr. Califf said the agency would continue to review the evidence coming in.

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