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Robert Califf shakes hands with Sen. Bill Cassidy (R-La.) before his nomination hearing before the Senate Health, Education, Labor and Pensions Committee in 2015. Photo: Win McNamee/Getty Images

It's taken about 10 months for President Biden to name a nominee for the role of permanent FDA commissioner — former FDA chief Robert Califf — and it's unlikely his confirmation will be complete before the end of 2021.

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.

The selection of the former commissioner came after the White House dropped several prior candidates, including acting commissioner Janet Woodcock, who faced strong opposition over her pharmaceutical ties, the New York Times reports.

  • Woodcock plans to remain in her position as the nomination process plays out, a Health and Human Services official tells Axios.
  • Prior to Biden's announcement on Friday, today would have marked her last day she was able to oversee the agency as acting commissioner under to the Vacancies Act.

What's next: The Senate HELP Committee expects schedule a hearing on his nomination "as soon as possible," a committee aide said.

  • But he's unlikely to get a floor vote by the end of the year, said Stacy Cline Amin, who co-leads the FDA Regulatory & Compliance practice at Morrison & Foerster and was chief counsel for the HELP committee during Califf's last nomination.
  • The committee may not feel as much time pressure because [Woodcock] is doing a good job and is generally well-liked," Amin told Axios.

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

  • He was the founding director of the Duke Clinical Research Institute, where he worked closely with drug companies and received consulting fees prior to his first stint as FDA commissioner. More recently, he's served as a senior adviser for Verily and Google Health.
  • "The public has been asking if they can trust the FDA to ensure that the benefits outweigh the risks for Alzheimer's drugs, cancer treatments, and implanted devices," Diana Zuckerman, president of the National Center for Health Research, a non-partisan non-profit think tank, told Axios.

The bottom line: "This time has been really really hard for the agency. The staff is working around the clock. They are exhausted," Amin said. "I think it's good they chose a nominee who has experience with the agency. It will be a smooth transition, likely. I think that's important for the workforce there."

Go deeper

Updated 2 hours ago - Health

The next big bottleneck in the global vaccination effort

Illustration: Rae Cook/Axios

The world still needs more coronavirus vaccines, but an additional bottleneck has emerged in many low-income countries: They need help getting shots in arms.

Why it matters: Increasing vaccination rates across the world is both a humanitarian necessity and the best way to prevent dangerous new variants from emerging, but it increasingly requires complex problem-solving.

Updated 3 hours ago - Health

COVID-19 Omicron variant cases identified in Europe, U.K.

People wearing masks walk in London on Nov. 25. Photo: Li Ying/Xinhua via Getty Images

Health officials in the United Kingdom, Italy and Germany announced on Saturday that they've detected the first known cases of the new COVID-19 Omicron variant.

Why it matters: The discoveries come as the world scrambles to respond to concerns over the new variant, discovered in South Africa earlier this week.

Black Friday in-store shopping up from 2020 but trails pre-pandemic levels

Shoppers carry their purchases during Black Friday shopping at Fashion Outlets of Chicago in Rosemont of Greater Chicago Area, Illinois on Nov. 26, 2021. Photo: Joel Lerner/Xinhua via Getty Images

More shoppers flocked to stores on Black Friday this year compared to last, but online shopping was lower than expected, according to data from Friday.

Driving the news: Online shopping was on the lower end of what was expected, largely because people had been ringing up their shopping carts earlier in the year in an effort to skirt potential supply chain issues, according to the Adobe Digital Economy Index.