Senate Panel OKs Califf Nomination for F.D.A. Chief
A split committee vote revealed concerns about the opioid epidemic and abortion policies, foreshadowing a likely close vote on confirmation by the full Senate.,
A split committee vote revealed concerns about the opioid epidemic and abortion policies, foreshadowing a likely close vote on confirmation by the full Senate.
A divided Senate committee on Thursday advanced the nomination of Dr. Robert Califf to become commissioner of the Food and Drug Administration to the full Senate, with some Democrats citing concerns over the nominee’s commitment to combating the opioid epidemic.
The committee’s vote of 13 to 8 suggests that the full Senate vote will be close. A date for the Senate’s vote on confirmation has not been set.
Four Republican members of the Senate Committee on Health, Education, Labor and Pensions, including Senator Richard Burr of North Carolina, voted in favor of Dr. Califf’s nomination. Senator Burr, the ranking Republican member, noted that the commissioner’s role was one of the “most significant public health positions in the federal government” and that the agency had been without a Senate-confirmed leader for nearly a year. He urged other Republicans to support Dr. Califf, citing his “unparalleled experience” and willingness to support innovation in the medical field. G.O.P. committee members who voted against him mostly cited concerns about abortion policies.
Senator Bernie Sanders, independent of Vermont, and Senators Maggie Hassan of New Hampshire and Edward Markey of Massachusetts, both Democrats, indicated they planned to vote against confirming Dr. Califf for the post. They are all from New England states hard-hit by opioids, though Senator Sanders also criticized Dr. Califf’s journey through the “revolving door” from the F.D.A. to private industry.
Senator Joe Manchin, Democrat of West Virginia, a state which was particularly devastated by overdose deaths, has condemned Dr. Califf’s track record on opioids without directly saying how he will vote. His staff did not respond immediately to a request for comment.
If confirmed, Dr. Califf would lead an agency that had been under intense scrutinyduring the pandemic, as it weighed the safety of coronavirus vaccines and treatments, and reviewed dozens of masks and tests.
Most recently, the agency has been criticizedfor what some consider the sluggish approval of rapid at-home tests, which has led to shortages as the Omicron variant has caused a spike in infections, and as demand has soared for tests for schoolchildren and workers. The agency said that it had concerns about the tests’ sensitivity but not the overall accuracy.
High-risk patients who test positive for Covid-19 are also facing severe shortages of medications that are effective against the variant — even as the agency remains the gatekeeper to therapies and diagnostics that could help.
On Dec. 14, Dr. Califf appeared before the Senate committee, answering questions about the pandemic, the opioid crisis and other topics.
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.
“The evidence has been here for a long time,” she responded. “It’s the evidence of thousands of people, hundreds of thousands of people, dying in this country.”
Senator Markey of Massachusetts, who is not on the committee that voted on Thursday, also issued a statement citing opioid policy failures and saying he would vote against Dr. Califf. The F.D.A. “repeatedly rubber-stamped new prescription opioids,” and “acted too slowly to remove them from the market or place restrictions on their labels,” he said.
Senator Markey said he was dissatisfied after meeting with Dr. Califf late last year, noting that he “did not commit to the decisive and comprehensive action necessary” to regulate opioids.