MedPage Today - After Long Wait, Biden Taps Robert Califf to Again Lead the FDA

Shannon Firth | November 12, 2021

The White House tapped cardiologist Robert Califf, MD, to once again head the FDA.

In a statement formally announcing his decision, President Biden praised Califf's clinical research expertise and leadership skills, and said he is the right person to lead the agency and the country out of the COVID-19 pandemic.

"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," he said.

Califf will ensure that "science and data drive decision-making" at the agency, Biden added. He also recalled the "strong bipartisan support" that the cardiologist received from the Senate in 2016, when Califf first served as FDA Commissioner under the Obama administration, and urged lawmakers to swiftly confirm him.

Califf is a professor at the Duke University School of Medicine in Durham, North Carolina, and previously served as vice chancellor of the school. He also founded the Duke Clinical Research Institute, and oversees clinical policy at Verily Life Sciences.

From 2016 to 2017, Califf served as commissioner after being confirmed by the Senate in a vote of 89-4.

HHS Secretary Xavier Becerra congratulated Califf in a press release, stating that he "knows the job and is ready for the challenge."

Becerra also acknowledged Janet Woodcock, MD, who has been serving as the acting commissioner, for her "instrumental" contributions to the agency during a difficult period. "We will continue to be on solid footing because of her continued leadership and focus on strengthening FDA and supporting its workforce," he said.

'A Poor Choice'

Not everyone was pleased with the news. Some Democratic lawmakers, including Joe Manchin (D-W.Va.), were quick to make their disappointment with Califf's nomination known.

"Dr. Califf's nomination makes no sense as the opioid epidemic continues to wreak havoc on families across this country with no end in sight," said Manchin in a statement he shared on Twitter.

"I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic. Instead, Dr. Califf's nomination and his significant ties to the pharmaceutical industry take us backwards not forward. ... I could not support Dr. Califf's nomination in 2016 and I cannot support it now," he continued.

In October, Sen. Richard Blumenthal (D-Conn.) said that if Califf were to be nominated, "I expect I would oppose him," according to Bloomberg Government.

Sen. Maggie Hassan (D-N.H.) also expressed reservations over Califf's ties to the pharmaceutical industry. Given the continuing substance misuse epidemic, Hassan called for "an FDA Commissioner that acts independently from the pharmaceutical industry, makes decisions based on the science, and puts the health and safety of Americans first."

"I have been deeply troubled by some of the FDA's past decisions -- especially as it relates to the approving and labeling of opioid-based medications -- and the FDA has yet to make clear what it is doing to learn from its actions," she noted in a statement.

Hassan added that she would "thoroughly review" Califf's record, but stopped short of saying she would vote against him.

Public Citizen, a consumer advocacy group, immediately panned Biden's choice, arguing that Califf would put the pharmaceutical industry's interests ahead of the public's.

In a statement, Michael Carome, MD, director of Public Citizen's Health Research Group, recalled the consulting fees Califf received from more than 19 pharmaceutical companies before serving as FDA commissioner the first time, as well as "the tens of thousands of dollars" he received from drug and device companies afterwards.

"Califf was a poor choice for FDA commissioner when he was nominated by Obama in 2015 and he remains a poor choice today," he added.

'A Proven Leader'

Others, however, appeared happy about the nomination.

Sen. Patty Murray (D-Wash.) stressed the need for a Senate-confirmed leader to oversee and support scientists during an "historic pandemic" in a press statement.

"Dr. Califf has led the Agency before, and was confirmed last time around in a strong, bipartisan vote. I look 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," she said.

Califf's nomination also spurred accolades from research advocates, including Ellen Sigal, PhD, chair and founder of Friends of Cancer Research. "Dr. Califf's commitment to science, dedication to research, and fierce advocacy for patients unequivocally makes him the right leader at this critical time," she said in a statement. "There are few individuals better positioned to continue to build confidence in the agency, ensure science-based regulatory standards, and build a strong foundation for the future."

Among those rumored to have been considered for the role of FDA commissioner was Michelle McMurry-Heath, MD, PhD, CEO of Biotechnology Innovation Organization, as well as Woodcock, whose term as acting commissioner is slated to end November 15. However, White House officials, speaking anonymously, confirmed in August that it was unlikely that Woodcock would be given the opportunity.

https://www.medpagetoday.com/publichealthpolicy/fdageneral/95632