Newly Confirmed FDA Chief Robert Califf Now Must Tackle a Series of Controversial Issues


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The Senate narrowly confirmed Dr. Robert Califf to be commissioner of the Food and Drug Administration on Tuesday afternoon, capping a fraught nomination process for President Joe Biden’s pick to lead the agency, which has been without a permanent head for more than a year.

Califf, who previously led the FDA in 2016 and 2017, faced criticism from both the left and the right over his ties to the pharmaceutical industry, his response to the opioid epidemic during his previous tenure at the agency, and the FDA’s handling of regulations around medication abortion pills. The final vote Tuesday was 50-46 in Califf’s favor. Six Republican Senators voted for and five Democrats voted against confirming the new head of the agency responsible for reviewing new COVID-19 vaccines and treatments, prescription and over-the-counter drugs, and medical devices and therapies.
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The close vote highlights how health care issues overseen by the FDA have become increasingly politicized in recent years. When Califf, a cardiologist and clinical trial expert, led the agency near the end of President Barack Obama’s second term, the Senate confirmed him with a vote of 89-4.

Califf’s confirmation this week comes at a particularly critical time for the FDA, as it considers a number of high-profile topics, including COVID-19 vaccines for children under 5 years old, whether e-cigarettes should be banned due to their appeal to teens, and the controversy over its approval of the divisive Alzheimer’s drug Aduhelm.

Califf has also said he will conduct a comprehensive review of opioids.

Democratic Sen. Patty Murray, who chairs the Senate Committee on Health, Education, Labor and Pensions, said Califf is “a trusted hand” as the nation faces a “critical moment.”

A tight vote

While the FDA manages issues that affect large swaths of the U.S. health care system and economy, the close confirmation vote is unusual, experts say. Califf earned both support and…

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Source : time


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