Senate committee approves Califf's appointment as FDA chief

A key Senate committee brought forward the appointment of Dr. Robert Califf as the full Senate commissioner of the Food and Drug Adminis...

A key Senate committee brought forward the appointment of Dr. Robert Califf as the full Senate commissioner of the Food and Drug Administration on Thursday in a vote widely divided along partisan lines.

The 13-8 committee vote suggests lawmakers have lingering concerns about Dr Califf, who has held the agency’s most senior positions in previous administrations. Among those opposed to his appointment were a few Democrats who cited the devastation of the opioid epidemic and Dr. Califf’s financial ties to drug companies. A date for the Senate vote on confirmation has not been set.

If confirmed, Dr Califf would lead an agency that has come under scrutiny during the pandemic as it weighs the safety of coronavirus vaccines and treatments, and examines dozens of masks and tests.

More recently, the agency has come under fire from those who argue it is to blame for the slow approval of rapid home tests, leading to shortages as the Omicron variant has caused a surge in infections and demand for the drugs. consumers for tests for schoolchildren. and workers. The agency said it was concerned about the test sensitivity corn not the whole precision.

High-risk patients who test positive for Covid-19 also face severe shortages drugs effective against the variant – although the agency remains the gatekeeper to therapies and diagnoses that may help.

On December 14, Dr. Califf appeared before the Senate Committee on Health, Education, Work and Pensions in mid-December, to answer questions on the pandemic, the opioid crisis and other topics.

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 for Verily, the life sciences arm of Google. During the hearing, he underscored the value of existing data, much of it in electronic patient medical records, in helping answer difficult questions about drug and device evidence.

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

Dr. Califf had already been confirmed by 89 votes to 4 in the Senate to lead the FDA during the last year of the Obama administration. If reconfirmed, he will have to make key tobacco control decisions as he tries to balance e-cigarettes as a tool to help some quit smoking without creating a new generation of users. . Monitoring of expedited drug approvals will be strengthened, given the current debate on the agency’s approval of the controversial Alzheimer’s drug, Aduhelm.

Some senators have already expressed their opposition to the appointment of Dr. Califf. Senator Bernie Sanders of Vermont voted against Dr. Califf. At the December hearing, he denounced Dr. Califf’s links with major pharmaceutical companies, including consultation fees and shareholding of up to $ 8 million. “This is exactly the close relationship that Big Pharma has exploited to regulate the FDA, rather than the FDA to regulate them,” said Senator Sanders.

The candidate told the Senate panel that the FDA and its parent agency, the Department of Health and Human Services, have strict ethical standards that he is committed to abide by.

Senator Maggie Hassan of New Hampshire also voted against Dr Califf’s appointment. She urged him in December of the FDA’s failure to update the labeling of opioid drugs. Dr Califf said the agency would continue to review the evidence received.

Senator Hassan replied that she thought the matter was settled: “The evidence has been there for a long time,” she said. “This is proof that thousands of people, hundreds of thousands of people are dying in this country.”

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Newsrust - US Top News: Senate committee approves Califf's appointment as FDA chief
Senate committee approves Califf's appointment as FDA chief
Newsrust - US Top News
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