Biden Seeks to Return Califf as FDA Chief

Kerry Dooley Young

Disclosures

November 12, 2021

President Joe Biden on Friday said he will nominate Robert Califf, MD, to return as the top US regulator of drugs and medical devices, selecting a cardiologist with extensive experience in clinical trials.

Califf served as the commissioner of the Food and Drug Administration (FDA) in the Obama administration, leading the agency from February 2016 to January 2017. Califf's critics include Sen Joe Manchin III (D-WV), who on Friday tweeted a statement objecting to Califf due to his past work with pharmaceutical companies. Manchin also was among the naysayers in the Senate's 89-4 vote in 2016 to confirm Califf as FDA commissioner.

But Sen Patty Murray (D-WA), who leads the Senate's health committee, on Friday noted how Califf had received "strong bipartisan" support on his first Senate confirmation vote.

"We are fighting a historic pandemic, and the expert scientists at the FDA who are working hard to help get us through this crisis deserve a Senate-confirmed leader to support and direct their work," Murray said in a statement.

The FDA has been led so far during the Biden administration by Janet Woodcock, MD, an experienced agency official who serves as acting director. The FDA's controversial approval of aducanumab (Aduhelm, Biogen) for Alzheimer disease fueled opposition to Woodcock, who already had been criticized for the agency's response to the opioid crisis.

In her statement on Califf, Murray said she looks forward to "working with him to see our nation through this pandemic and to tackle other critical challenges like the ongoing opioid crisis, rising youth tobacco use, high drug prices, health inequities, and more."

In contrast, Manchin said in a Friday statement that the choice of Califf "takes us backward," in terms of creating an FDA better equipped to stand up to drug makers.

The consumer watchdog group Public Citizen raised similar objections in a Friday statement.

"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," said Michael Carome, MD, director of Public Citizen's Health Research Group.

At a 2015 hearing on Califf's first nomination as FDA commissioner, Murray also noted that while other recent FDA leaders had come from the public health sector, Califf had partnered "extensively" with drug makers during his career as an active researcher. She asked him to explain how he could then regulate these companies as FDA chief "without any undue influence."

In response to Murray, Califf noted that much of the research in which he had participated had been funded by the National Institutes of Health. In cases where companies funded this work, there were "ironclad" contracts in place that guaranteed the independent right to publish the findings, Califf said.

"We are running the trial and we publish the papers with input from the companies, but they have absolutely no right to change what we say. We have the final right of publication," Califf said.

"So, yes, industry funds the trial," Califf added. "They need to have their products evaluated. We have an independent voice, guaranteed by contract. I believe you'll find that 100% of the studies that I've been involved in have been published so that they're in the public record for people to view."

Califf has been an advocate for efforts to make results of clinical trials public. In a May viewpoint in JAMA Internal Medicine, Califf argued that neither the FDA nor the National Institutes of Health had used its existing leverage fully to compel reporting of data, with the result that "thousands of trials are out of compliance" with federal rules on reporting.

Califf has been part of more than 1200 peer-reviewed publications, according to the White House's Friday statement about Biden's intention to nominate him as FDA commissioner.

Califf is also a professor of medicine at the Duke University School of Medicine, where he founded the Duke Clinical Research Institute, the White House said. And Califf works as head of clinical policy at Verily Life Sciences, a research organization.

Supporting Califf as the FDA nominee on Friday were the Pharmaceutical Research and Manufacturers of America and the Association of American Medical Colleges.

Also backing Califf was the American Heart Association (AHA). In a statement, Nancy Brown, chief executive of the AHA, said Califf had been a lead author of the group's 2020 call to action for addressing inequities in rural health. Califf also aided AHA's efforts to "address the social determinants of health and the barriers to achieving health equity for all communities — urban, suburban, and rural," Brown said.

Kerry Dooley Young is a freelance journalist based in Washington, DC. She is the core topic leader on patient safety issues for the Association of Health Care Journalists. Young earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the FDA for Bloomberg. Follow her on Twitter:  @kdooleyyoung

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