Biden meets with the best FDA candidate | MCU Times

Biden meets with the best FDA candidate

Biden has not yet completed his selection. But the two people with knowledge of the case and a third person familiar with the search process said Biden’s meeting with Califf represents a final step ahead of a formal decision. The White House has spent the last few weeks investigating Califf, who headed the FDA for a year under President Barack Obama.

A cardiologist by training, Califf also spent two years as deputy commissioner for the FDA’s medical products and tobacco office. He worked closely with Biden in the Obama era on the then Vice President’s Cancer Moonshot Initiative and also helped form the FDA’s Oncology Center of Excellence.

Califf has since spent the last many years at the Duke Clinical Research Institute, and in 2019 took a position leading medical strategy and policy at Alphabet, Google’s parent company.

If nominated, Califf would stand in line to run an agency that has been under scrutiny for several months for its role in the Covid-19 vaccination campaign and a broader pandemic response. He would likely face a number of questions during any confirmation hearing on the FDA’s assessment of Pfizer’s application for emergency approval of its Covid-19 vaccine for children aged 5 to 11 years. The agency is convening an advisory committee on Tuesday to discuss the company’s request.

Califf won broad bipartisan support during his first term as commissioner in 2016, winning Senate confirmation by a margin of 89-4.

Still, among his skeptics was Senator Joe Manchin (DW.Va.), who earlier this year was instrumental in marshaling opposition to the potential nomination of acting commissioner Janet Woodcock as permanent chief. Senator Bernie Sanders (I-Vt.) Also questioned Califf’s work with the industry when he was nominated by Obama – such as advising various drug and device manufacturers – but ultimately voted for the nominee.

In recent weeks Proponents of her case have been working to make the actual transcript of this statement available online.

“The bottom line is that Califf cannot immediately rely on acting in the public interest,” Max Moran, research director at the Revolving Door Project, told POLITICO earlier this month. “This is extremely dangerous for any FDA commissioner, but especially in the midst of a pandemic.”

But Califf’s appointment is likely to be hailed by health experts who have been pushing Biden for months to settle for a nominee, considering him an experienced regulator who has already proven his ability to run the FDA.

Industry groups, including the medical device lobby, AdvaMed, have also preventively signaled support for Califf if he is formally nominated.

“Smart choice, if this is where the president lands,” AdvaMed CEO Scott Whitaker told POLITICO. “He is extremely light, has enormous experience as a cardiologist, academic and also as a former commissioner. Should be very good at continuity in operations at the FDA in challenging times. ”

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