Robert Califf

U.S. President Joe Biden nominated Dr. Robert Califf as commissioner of the Food and Drug Administration. (Photo: CVCTforum/cc)

Senate Urged to Reject Biden's 'Poor Choice' for FDA Chief Over Ties to Big Pharma

Critics argue that Dr. Robert Califf, who previously led the agency, is a "blatantly damaging pick."

Ignoring concerns about the influence of Big Pharma, U.S. President Joe Biden on Friday nominated former Food and Drug Administration Commissioner Dr. Robert Califf to reclaim the post--which he held during the Obama administration, when Biden was vice president.

"The Senate... must reject Califf's nomination and demand that Biden nominate an individual who has been dedicated to advancing public health."

While the president, in a statement, pointed out that his nominee has "nearly four decades of experience as a doctor, researcher, leader, and public servant," calls for the Senate to block Califf's confirmation started stacking up Friday morning even before the White House's official announcement, in response to reporting from multiple news outlets.

"Califf must not be allowed to again pass through the revolving door between the FDA and regulated industries," declared Dr. Michael Carome, director of Public Citizen's Health Research Group.

"The Senate therefore must reject Califf's nomination and demand that Biden 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," he said.

Echoing a warning he issued last month amid speculation that Biden would pick Califf, Carome highlighted some of the 70-year-old cardiologist and professor's career history:

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. From 2006 to 2015, he served as a board member and consultant for Faculty Connection, a company that provided a wide array of services to the pharmaceutical, biotechnology, and medical device industries.

During just the few years before his previous stint as FDA commissioner, Califf reported receiving personal fees for consulting from at least 19 major pharmaceutical manufacturers, including Amgen, GlaxoSmithKline, Johnson & Johnson, Novartis, and Pfizer.

After exiting the FDA, Califf revived his lucrative ties with FDA-regulated pharmaceutical companies, receiving consulting fees totaling tens of thousands of dollars from AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Eli Lilly, Merck Sharp & Dohme, and Sanofi. And in February 2018, he was appointed to the board of directors of the biopharmaceutical company Cytokinetics.

Then-President Barack Obama chose Califf to lead the FDA in September 2015 and the Senate confirmed his nomination the following February in an 89-4 vote. Carome said Friday that "Califf was a poor choice for FDA commissioner when he was nominated by Obama in 2015 and he remains a poor choice today."

Diana Zuckerman, president of the nonprofit National Center for Health Research, toldThe New York Times in anticipation of Biden's announcement that "it is surprising that the White House has seemed really tone-deaf on conflicts of interest and very close ties to the industry."

"Califf was not originally the White House's top pick," Politico reported Friday. "He emerged as Biden's choice in recent weeks after the administration had vetted or spoken to roughly a dozen other people about the job, according to a person familiar with the selection process."

As Politico detailed ahead of the announcement:

As early as last winter's presidential transition, the administration had considered nominating longtime regulator and acting Commissioner Janet Woodcock to the role. But her candidacy stalled in the face of Democratic opposition over her track record on opioids and a more recent decision to green-light a controversial Alzheimer's drug.

Biden officials spent the next several months seeking a nominee who had both the requisite FDA experience and was also considered a rising star in the field, the person familiar with the selection process said.

But some of those the administration considered were not interested in running the agency; others were ruled out over their industry ties or other financial entanglements, the person said. Among those that Biden's team looked at were Biotechnology Innovation Organization CEO Michelle McMurry-Heath and Dana-Farber Cancer Institute President Laurie Glimcher.

While Biden's move on Friday came just weeks before a legal deadline for nominating someone to the post, Califf could have trouble securing the support of key members of the evenly divided Senate, including Sens. Richard Blumenthal (D-Conn.), Joe Manchin (D-W.Va.), Ed Markey (D-Mass.), and Bernie Sanders (I-Vt.).

Manchin swiftly released a statement opposing the nomination Friday, saying it "takes us backwards not forward" given Califf's ties to Big Pharma and "makes no sense as the opioid epidemic continues to wreak havoc on families across this country with no end in sight."

In a statement to The Washington Post last month, Blumenthal similarly said that "I would have very grave reservations about this nomination--many of the same reservations I expressed when I voted against Dr. Califf's confirmation in 2016."

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