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

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

https://www.nytimes.com/2022/01/13/health/fda-robert-califf.html

A cardinal committee was divided chiefly connected enactment lines implicit the information of Dr. Robert Califf, foreshadowing divisions successful the afloat Senate for a ballot connected confirmation.

Dr. Robert Califf appearing earlier  the Senate successful  December. Dr. Califf antecedently  led the F.D.A. during the past  twelvemonth  of the Obama administration.
Credit...Manuel Balce Ceneta/Associated Press

Jan. 13, 2022, 11:43 a.m. ET

A cardinal Senate committee connected Thursday precocious the information of Dr. Robert Califf to go commissioner of the Food and Drug Administration to the afloat Senate successful a ballot mostly divided connected partisan lines.

The committee’s ballot of 13-to-8 suggests that lawmakers person lingering concerns astir Dr. Califf, who held apical posts successful the bureau successful erstwhile administrations. Among those opposed to his information were a fewer Democrats who cited the devastation of the opioid epidemic and Dr. Califf’s

financial ties to pharmaceutical companies. A day for the Senate’s ballot connected confirmation has not been set.

If confirmed, Dr. Califf would pb an bureau that has been nether aggravated scrutinyduring the pandemic arsenic it weighed the information of coronavirus vaccines and treatments, and reviewed dozens of masks and tests.

Most recently, the bureau has been criticized by those who contend that it is to blasted for sluggish support of accelerated at-home tests, starring to shortages arsenic the Omicron variant caused a crisp spike successful infections, and arsenic user request soared for tests for schoolchildren and workers. The bureau said that it had concerns astir the tests’ sensitivity but not the overall accuracy.

High-risk patients who trial affirmative for Covid-19 are besides facing severe shortages of medications that are effectual against the variant — adjacent arsenic the bureau remains the gatekeeper to therapies and diagnostics that could help.

On Dec. 14, Dr. Califf appeared earlier the Senate Health, Education, Labor and Pensions Committee successful mid-December, answering questions astir the pandemic, the opioid situation and different topics.

As a cardiologist, Dr. Califf spent decades starring objective trials astatine the Duke University Medical Center successful North Carolina. Most recently, helium led objective argumentation and strategy for Verily, the beingness sciences limb astatine Google. During the hearing, helium emphasized the worth of existing data, overmuch successful patients’ physics aesculapian records, to assistance reply hard questions astir the grounds for drugs and devices.

Republicans asked however helium would grip rules astir medications to induce abortion, which had been relaxed during the pandemic aft years of choky restrictions. Two days aft the hearing, the F.D.A., nether interim Commissioner Dr. Janet Woodcock, announced that it would permanently lift restrictions, allowing patients to terminate a gestation successful the archetypal 10 weeks aft a telemedicine sojourn with medications taken astatine home.

Dr. Califf was antecedently confirmed successful a 89-to-4 Senate ballot to pb the F.D.A. during the past twelvemonth of the Obama administration. If confirmed again, helium volition look cardinal decisions connected baccy power arsenic helium tries to equilibrium e-cigarettes arsenic a instrumentality to assistance immoderate discontinue smoking without creating a caller procreation of users. Scrutiny astir accelerated approvals of drugs volition beryllium heightened, fixed the existent debate implicit the agency’s support of the arguable Alzheimer’s drug, Aduhelm.

Some senators person already expressed their absorption to Dr. Califf’s nomination. Senator Bernie Sanders of Vermont voted against Dr. Califf. During the December hearing, helium denounced Dr. Califf’s ties to large pharmaceutical firms, which see consulting fees and banal ownership of arsenic overmuch arsenic $8 million. “That is precisely the adjacent narration Big Pharma has exploited to modulate the F.D.A., alternatively of the F.D.A. regulating them,” Senator Sanders said.

The nominee told the Senate sheet that the F.D.A. and its genitor agency, the Department of Health and Human Services, person strict morals rules that he’s agreed to comply with.

Senator Maggie Hassan of New Hampshire besides voted against Dr. Califf’s nomination. She pressed him successful December connected the F.D.A.’s nonaccomplishment to update the labeling of opioid medications. Dr. Califf said the bureau would proceed to reappraisal the grounds coming in.

Senator Hassan responded that she thought the substance was settled: “The grounds has been present for a agelong time,” she said. “It’s the grounds of thousands of people, hundreds of thousands of people, dying successful this country.”

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