TUESDAY, Feb. 15, 2022 (HealthDay News) — In a tight vote, the U.S. Senate on Tuesday confirmed Robert Califf, M.D., to once again head the U.S. Food and Drug Administration, ending the agency’s year-long stretch without a permanent leader.

Six Republicans crossed over to support Califf in the Senate’s 50-46 vote, while five Democrats opposed him. One senator voted present. Califf, a cardiologist and medical researcher, briefly served as FDA commissioner toward the end of President Barack Obama’s administration. During the last year of the Obama administration, Califf had been confirmed in an 89-to-4 Senate vote to become FDA commissioner, The New York Times reported.

Califf’s nomination was nearly derailed by opposition from multiple directions. Some Democrats decried the FDA role in the opioid epidemic under Califf’s prior tenure, while some Republicans opposed his nomination because the agency had eased access to abortion medication while he was last in charge, The Times reported.

Califf will now take over an agency that has been under the spotlight during the COVID-19 pandemic as it dealt with decisions about vaccines, treatments, tests, and masks. The agency has been criticized for sluggish approval of rapid at-home tests, leading to test shortages as the omicron variant raged across the country and consumer demand soared for tests for schoolchildren and workers, The Times said. Meanwhile, high-risk COVID-19 patients are facing shortages of treatments that can help battle omicron — even as the FDA remains the gatekeeper to therapies and diagnostics that could help.

Other major challenges facing the FDA are new electronic cigarette rules and accelerated approval of drugs, an issue triggered by the agency’s approval of the controversial, pricey new drug for Alzheimer disease, Aduhelm.

The New York Times Article

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