Obama’s former FDA chief Califf is the lead agency’s precursor (1)

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Robert Calif, who headed the United States Food and Drug Administration under President Barack Obama, rose to the top of the rankings to lead the agency again, according to people familiar with the matter.

Although a decision is not final, Califf is now the frontrunner, said the people, who asked not to be identified because nothing has been announced. Calif, who is currently Head of Clinical Strategy and Policy for Alphabet Inc.’s Verily and Google Health units, would replace Acting FDA Commissioner Janet Woodcock, if confirmed by the Senate.

The FDA has been without a permanent chief since the start of the Biden administration, even as the agency made a series of very important decisions related to the response to the US pandemic. This week, an advisory group is assessing whether to support booster shots for people who have received Moderna Inc. and Johnson & Johnson Covid-19 vaccines, just weeks after the FDA cleared a similar additional dose for people having received the Pfizer Inc.-BioNTech Coup SE.

Obtaining clearance for the booster doses has been a priority for the White House since the country was gripped by a wave of new infections fueled by a delta variant over the summer. Amid fears that the protection offered by licensed vaccines may wane, Biden has vowed to make booster available – a promise that some observers have said has outstripped science.

A cardiologist who graduated from Duke University School of Medicine, Califf served as the FDA’s deputy commissioner for medical products and tobacco from 2015 to 2016 before leading the agency in its own right. As commissioner, he pushed the agency to catch up with the rapidly changing tobacco industry, where the electronic cigarette market was booming. The FDA just this week for the first time approved a vaping-type product for sales in the United States, claiming it would have a public health benefit.

Without a candidate, Woodcock would not be eligible for the post of Acting Commissioner beyond mid-November, but may continue to serve if a candidate is in place by then. The White House excluded Woodcock earlier in the midst of opposition on Capitol Hill, privately concluding that she would not be the candidate, but stopping to say so publicly. The White House hailed Woodcock’s leadership as acting commissioner.

The perception that politics played a role in the recall authorization process led two of the FDA’s top vaccine experts to say they would be stepping down this year. Any new commissioner will likely have to address similar concerns among agency base employees.

The controversy has sued the FDA on other fronts. The approval earlier this year of Biogen Inc.’s Alzheimer’s drug Aduhelm over objections from agency advisers caught the attention of lawmakers, along with an investigation by an HHS inspector general into contacts between the company and FDA employees.

The long wait for a permanent commissioner to be appointed has puzzled some observers of the agency.

“This has been the most secretive process we have ever seen, and also in a most confusing sense, since the FDA has been in the forefront of the news all year and has not named anyone to. such an important position, ”said Wayne Pines, a former associate commissioner of the FDA.

(Updates with additional information on Califf in the sixth paragraph)

–With the help of Fiona rutherford.

To contact journalists on this story:
Josh wingrove in Washington at [email protected];
Nancy cook in Washington at [email protected]

To contact the editors responsible for this story:
Crayton Harrison to [email protected]

Timothy annett

© 2021 Bloomberg LP All rights reserved. Used with permission.


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