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Robert Califf

U.S. President Joe Biden is reportedly considering reappointing Robert Califf as commissioner of the Food and Drug Administration. (Photo: CVCTforum/cc)

Biden Warned Not to Nominate Robert Califf, 'Recycled FDA Commissioner' Tied to Big Pharma

"Biden must nominate an individual who has been dedicated to advancing public health—one who unquestionably will place the public interest ahead of the interests of FDA-regulated industries."

Jessica Corbett

Critics of Big Pharma's influence on U.S. politics urged President Joe Biden not to nominate former Food and Drug Administration Commissioner Dr. Robert Califf to reclaim his old post following reports Thursday that the move is likely.

"There are plenty of other, highly qualified doctors and leaders who don't bring his corporate ties to this most crucial agency."

Citing numerous unnamed sources, The Washington Post and other outlets reported that "the White House is closing in on" Califf as its pick for the position, which requires Senate confirmation. The professor of cardiology at Duke University School of Medicine declined to comment.

White House Press Secretary Jen Psaki was also evasive, telling reporters Thursday that "I'm not gonna speak to a hypothetical, maybe nomination and people's hypothetical reactions to the hypothetical nomination."

However, Dr. Michael Carome, director of Public Citizen's Health Research Group, was critical of the "recycled FDA commissioner" potentially reclaiming the role. He said in a statement:

The country desperately needs an FDA leader who will reverse the decadeslong trend in which the agency's relationship with the pharmaceutical and medical-device industries has grown dangerously cozier—resulting in regulatory capture of the agency by industry. Califf would not be that leader.

Califf has a long history of extensive financial ties to Big Pharma, most significantly through pharmaceutical industry funding to the Duke Clinical Research Institute, which he founded in 1996.

He also received personal payments from numerous companies including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme, and Sanofi-Aventis—both before and after his last stint as FDA commissioner. And he currently sits on the board of directors of the biopharmaceutical company Cytokinetics.

Rather than choosing Califf, "Biden must nominate an individual who has been dedicated to advancing public health—one who unquestionably will place the public interest ahead of the interests of FDA-regulated industries," Carome asserted.

The Post noted Califf "has advised Google and its spinoff, Verily Life Sciences, since leaving the Obama administration," work that also drew criticism of the potential nominee.

"It would obviously improve Verily's prospects on the markets if everyone knows they have a friend in charge of the agency approving their products," Jeff Hauser, who leads the Revolving Door Project, part of the Center for Economic and Policy Research, told the newspaper. "There are plenty of other, highly qualified doctors and leaders who don't bring his corporate ties to this most crucial agency."

Politico detailed some of the tasks that the next leader of the agency—currently overseen by acting Commissioner Janet Woodcock—will face:

The next FDA commissioner will be charged with shepherding the country to an eventual end to the Covid-19 pandemic, overseeing the scientists vetting vaccines, therapeutics, and tests. Califf also will have to contend with a workforce burned out from the sheer workload and, before that, from attempts by some Trump administration officials to short-circuit the agency's regulatory process for authorizing those interventions.

This fall and winter the agency is poised to make major decisions on Covid-19 vaccines for children and booster shots for adults, along with treatments for the disease—such as Merck's antiviral drug molnupiravir.

The FDA also is navigating sweeping new e-cigarette policies, building a framework for regulating cannabidiol, and vastly broadening its oversight of over-the-counter products.

Califf could face opposition from senators critical of Big Pharma, including Sen. Bernie Sanders (I-Vt.), who opposed his appointment to the FDA under former President Barack Obama.

"At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices," Sanders said six years ago. "Unfortunately, I have come to the conclusion that Dr. Califf is not that person."

"Instead of listening to the demands of the pharmaceutical industry and their 1,400 lobbyists, it is about time that the FDA and Congress started listening to the overwhelming majority of the American people who believe that medicine is too expensive," Sanders added. "It is time for the United States to join the rest of the industrialized world by implementing prescription drug policies that work for everybody, not just the CEOs of the pharmaceutical industry."

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