The road ahead for Biden’s FDA nominee Robert Califf

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It’s taken nearly 10 months for President Biden to be nominated for the role of permanent FDA commissioner — former FDA chief Robert Calif. — and it’s unlikely his confirmation will be complete before the end of 2021.

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why it matters: The agency has been without a Senate-approved commissioner for nearly a year, all while playing a central role in the response to the ongoing COVID pandemic.

selection The former commissioner’s post came after the White House fired several former candidates, including Acting Commissioner Janet Woodcock, who faced stiff opposition over his pharmaceutical ties, New York Times report,

  • A Health and Human Services official told Nerdshala that Woodcock plans to remain in his position as the nomination process is underway.
  • Before Biden’s announcement on Friday, today would be her last day she was able to oversee the agency as acting commissioner under the Vacancies Act.

What will happen next: An aide on the committee said the Senate Aid Committee expects a hearing on his nomination “as soon as possible.”

  • But she’s unlikely to get a floor vote until the end of the year, said Stacey Kline Amin, who co-leads the FDA Regulatory and Compliance practice at Morrison & Foster and was the help committee’s chief counsel during Calif.’s final nomination.
  • The committee may not feel that much time pressure because [Woodcock] Doing a good job and generally well liked,” Amin told Nerdshala.

what to watch: Calif was confirmed in 2016 by an 89-4 vote, but he will still face some questions over his ties to the pharmaceutical industry. Democratic Sens. Joe Manchin, Ed Markey and Richard Blumenthal, who last voted against Calif, all reiterated their concerns on Friday.

  • He was the founding director of the Duke Clinical Research Institute, where he worked closely with pharmaceutical companies and received consulting fees prior to his first term as FDA commissioner. Most recently, he has served as a senior advisor to Verily and Google Health.
  • “The public is asking whether they can trust the FDA to ensure that the benefits outweigh the risks of Alzheimer’s drugs, cancer treatments, and implanted devices,” said Diana Zuckerman, president of the National Center for Health Research, a non-profit. -biased non-profit think tank, told Nerdshala.
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Bottom-line: “It has been a really tough time for the agency. The staff are working round the clock. They are exhausted,” Amin said. “I think it’s good that they chose a nominee who has experience with the agency. It will be a smooth transition, likely. I think it’s important for the staff there.”


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