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US Senate Confirms Califf as FDA Commissioner

16.02.2022 - The US Food and Drug Administration (FDA) finally has a new commissioner, after 391 days of interim leadership. In a narrow vote of 50 to 46 on Feb. 15, the Senate confirmed Robert Califf to the top job, which has been vacant since January 2021.

Former president Donald Trump’s last commissioner, Stephen Hahn, resigned after Trump lost the 2020 election to Joe Biden. Hahn later hired on with Flagship Pioneering, the venture capital firm that launched Covid-19 vaccine maker Moderna.

Under Biden, the agency appointed Janet Woodcock to lead it in a transitional role. She was first expected to be tapped for the permanent position but fell out of favor after the FDA’s highly controversial decision to approve Biogen’s Alzheimer’s treatment Audhelm.

Several senators from Biden’s Democratic Party voted against Califf on grounds he was too close to the pharmaceutical industry; however, in an unusual move for today’s divided Congress, six opposition Republican senators crossed the aisle and voted for him.

Other Republicans opposed him because of his earlier support for abortifacients and for what some perceived as his inaction on the burgeoning opioids crisis when he served as former president Barack Obama’s FDA chief. The agency approved five new opioids in 2016 and 2017, while Califf was on the job.

At his first nomination for the commissioner’s position in 2016, the now 70-year-old cardiologist enjoyed strong support from both parties. He was confirmed by a vote of 89 to 4, with strong support on sides of the aisle. In the gap between past and future stints with the FDA, Califf was a senior adviser for Verily, a research organization devoted to the life sciences, as well as Google Health.

The new commissioner spent most of his active career at Duke University School of Medicine in the US state of North Carolina, where he founded the Duke Clinical Research Institute, one of the world’s largest academic clinical trial operations.

Author: Dede Williams, Freelance Journalist