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Biden Taps Califf to Return as FDA Commissioner

23.11.2021 - US president Joe Biden has nominated Robert M. Califf to return to the job he once held as commissioner of the Food and Drug Administration (FDA). In a statement, Biden – who had been criticized for not naming a new FDA chief sooner, said Califf “has the experience and expertise to lead FDA during a critical time in our nation’s fight to put an end to the coronavirus pandemic.”

The 70-year-old well connected cardiologist and researcher who held the job during the final year of the Obama administration must still be confirmed by the US Congress. If he succeeds, he will replace Janet Woodcock, who has been acting commissioner since Biden’s inauguration last January.

The last FDA commissioner appointed by former president Donald Trump in December 2019, Stephen Hahn, resigned just days before Biden took office. Woodcock was long expected have the job in her pocket, but tripped over her decision to recommend approval of  Biogen’s Alzheimer’s drug Audhelm, despite the agency’s advisory panel turning thumbs down on it  due to its high price and unclear efficacy.

Because of her Audhelm decision, some critics accused Woodcock as being too close to the pharma industry and having bungled the country’s opioid crisis, which is still having repercussions. Among the critics was Joe Manchin, the influential conservative Democratic Senator from West Virginia, who said Woodcock in her previous job of ……bungled the opioid crisis, which is still having repercusssions.  Manchin, who has multiple coal assets currently in trust  himself has been criticized for being too close to the coal industry.

Califf currently is a senior adviser for Verily, a research organization devoted to the life sciences, as well as Google Health. He 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.

Commenting on the nomination, some FDA watchers said they thought Califf, an expert on clinical trials and other types of health data, would be better than Woodcock at pressing for better evidence in assessing drugs and devices and could be more adept at improving the US testing system, which has been criticized as “cumbersome.”

Along with Manchin, more liberal political figures such as Connecticut senator Richard Blumenthal and the nonprofit Public Citizen’s Health Research Group said they thought the FDA needed fresh leadership and direction and that Califf’s long-standing links to pharma sector make him the wrong candidate.

But Califf is seen as having not only strong times to pharma but also to health advocacy group Campaign for Tobacco-Free Kids – which called the cardiologist “a strong tobacco-control advocate. Biden’s nominee has also won the support of Democratic senator Patty Murray of Washington state, who chairs the Senate Committee on Health, Education, Labor and Pensions, which will consider his nomination.

Author: Dede Williams, Freelance Journalist

FDA

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