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Biden nominates Robert Califf as FDA commissioner

The key position has been one of the few that has remained unfilled more than nine months into Biden’s presidency
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WASHINGTON — President Joe Biden nominated Robert Califf to head the Food and Drug Administration, a long-awaited nominee to run an agency key to combating the Covid pandemic, according to people familiar with the process.

Califf, a cardiologist at Duke University who has worked with Google parent company Alphabet, briefly served as FDA commissioner at the end of the Obama administration. He also worked at the agency as deputy commissioner overseeing medical and tobacco products.

"Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic," Biden said Friday in a statement. "As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA."

Biden waited until the final possible moments to make the nomination — under the federal Vacancies Act the acting commissioner Janet Woodcock would no longer be able to serve in the temporary role as of Monday unless Biden put forward a nominee.

With Democrats holding a razor thin margin in the Senate, Califf could face a difficult nomination process where members could raise a range of issues from his involvement in the private sector to wider issues around drug safety and ties between the FDA and the companies it regulates. Republicans have stalled a number of Biden's nominees across a range of agencies from ambassadors to the Defense Department.

Califf had wide bipartisan support during the Obama administration where he was confirmed by the Senate with a vote of 89 to 4.

Sen. Joe Manchin, D-W. Va., has already announced opposition to Califf, citing his ties to the pharmaceutical industry and a need for a change in culture at the FDA as a result of the opioid epidemic.

"I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic," Manchin said in a statement Friday. "Instead, Dr. Califf's nomination and his significant ties to the pharmaceutical industry take us backwards now forward."

While at the FDA, Califf was among top officials there who in 2016 called for a plan to reassess the agency’s approach to opioid medications, saying at the time that “we are determined to help defeat this epidemic through a science-based and continuously evolving approach."

Biden called on the Senate to act quickly and said he is confident Califf would be confirmed.

"Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment," Biden said.

As a researcher, Califf's work has mostly focused on better ways to treat heart disease and improve how experimental medicines are studied.

“I am honored to be nominated by President Biden for this position at a critical time for our country," Califf said in a statement. "There's a lot of work to do, and if confirmed I look forward to rejoining the great team at the FDA to help in their inspiring mission to serve the public.

The FDA has played a central role in Biden’s response to the pandemic with its oversight of vaccines, tests and treatments. Public health officials have said the uncertainty about who would fill the post has led to instability at the agency.

Among the pressing issues before the FDA are whether to approve new antiviral drugs to treat Covid from Merck and Pfizer and if booster shots of Pfizer’s vaccine should be cleared for use in all adults.

The agency has taken heat over the last year for the length of time it took to give final approval to the Covid vaccines and a controversial approval of an Alzheimer’s drug.