A key Senate committee on Thursday advanced the nomination of Dr. Robert Califf to become commissioner of the Food and Drug Administration to the full Senate in a vote largely divided on partisan lines.The committee’s vote of 13-to-8 suggests that lawmakers have lingering concerns about Dr. Califf, who held top posts in the agency in previous administrations. Among those opposed to his nomination were a few Democrats who cited the devastation of the opioid epidemic and Dr. Califf’s financial ties to pharmaceutical companies. A date for the Senate’s vote on confirmation has not been set.If confirmed, Dr. Califf would lead an agency that has been under intense scrutiny during 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 criticized by those who contend that it is to blame for sluggish approval of rapid at-home tests, leading to shortages as the Omicron variant caused a sharp spike in infections, and as consumer demand 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 Health, Education, Labor and Pensions Committee in mid-December, 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 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 interim Commissioner Dr. Janet Woodcock, 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.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.Some senators have already expressed their opposition to Dr. Califf’s nomination. Senator Bernie Sanders of Vermont voted against Dr. Califf. During the December hearing, he denounced Dr. Califf’s ties to major pharmaceutical firms, which include consulting fees and stock ownership of as much as $8 million. “That is exactly the close relationship Big Pharma has exploited to regulate the F.D.A., instead of the F.D.A. regulating them,” Senator Sanders said.The nominee told the Senate panel that the F.D.A. and its parent agency, the Department of Health and Human Services, have strict ethics rules that he’s agreed to comply with.Senator Maggie Hassan of New Hampshire also voted against Dr. Califf’s nomination. She 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.Senator Hassan responded that she thought the matter was settled: “The evidence has been here for a long time,” she said. “It’s the evidence of thousands of people, hundreds of thousands of people, dying in this country.”By: Christina Jewett
Title: Senate Panel OKs Califf Nomination for F.D.A. Chief
Sourced From: www.nytimes.com/2022/01/13/health/fda-robert-califf.html
Published Date: Thu, 13 Jan 2022 17:11:00 +0000
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