President Joe Biden on Friday announced he would nominate Robert Califf, a former FDA commissioner and professor at Duke University School of Medicine, to once again serve as FDA commissioner.

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Who is Robert Califf?

Califf, a cardiologist, previously served as FDA commissioner for less than a year at the end of President Barack Obama's second term. He was confirmed as commissioner by the Senate in an 89-4 vote in February 2016.

During his time as FDA commissioner, Califf made moves to fight the opioid epidemic, including requiring "black box" warnings regarding the dangers of mixing opioids and benzodiazepines.

Califf also sought to allow drugmakers to advertise off-label uses for products approved by FDA, something not currently permitted, the New York Times reports. However, according to the Times, the proposal was blocked by others within the Obama administration.

Recently, Califf has served as a senior adviser to Verily Life Sciences and previously served as vice chancellor for clinical and translational health at Duke University. Califf is still an adjunct professor of medicine at Duke and at Stanford University and also serves on the corporate board of biopharmaceutical company Cytokinetics.

In a statement, President Biden said Califf is "one of the most experienced clinical trialists in the country, and has the experience to lead the [FDA] during a critical time in our nation's fight to put an end to the coronavirus pandemic." Biden added that he is "confident" that Califf "will ensure that the FDA continues its science and data drive[n] decision-making."

Califf in a statement said he's honored to be nominated "at a critical time for our county," adding, "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 Senate Health, Education, Labor, and Pensions (HELP) committee said it will schedule a hearing on Califf's nomination "as soon as possible." However, according to Stacy Cline Amin, co-leader of FDA's regulatory and compliance practice at Morrison & Foerster and former chief counsel to the HELP committee, Califf's nomination is unlikely to receive a vote by the end of the year.

Reaction

Califf's nomination drew praise from many health experts and lawmakers, but also criticism from some who are skeptical of his ties to the pharmaceutical industry.

Harlan Krumholz, a cardiologist at Yale School of Medicine, said he believes Califf "would be terrific" as FDA commissioner. "It is critically important to have a commissioner who can step in and knows the job and knows how to make policy decisions," Krumholz said.

Similarly, Aaron Kesselheim, a professor of medicine at Harvard Medical School, said Califf "is a good choice." Kesselheim added, "Califf certainly spent the vast majority of his early career working on clinical trials … and understands the value of rigorous data."

Sen. Patty Murray (D-Wash.), chair of the HELP committee, also expressed support for Califf. "Califf has led the agency before, and was confirmed last time around in a strong, bipartisan vote," Murray said. "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."

House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) also praised the nomination, saying Califf "is a proven leader who will bring a wealth of knowledge and expertise upon his return to the agency."

However, some experts and lawmakers expressed concerns about Califf's ties to the pharmaceutical industry.

"Califf has a long history of extensive financial ties to Big Pharma, most significantly through pharmaceutical industry funding of the Duke Clinical Research Institute," Michael Carome, director of Public Citizen's Health Research Group, said. "We need someone to tilt in the opposite direction and be more pro-public health and less pro-regulated industry."

Similarly, Sen. Maggie Hassan (D-N.H.) expressed concerns about Califf's ties to the pharmaceutical industry. Given the opioid epidemic, Hassan said FDA needs a commissioner "that acts independently from the pharmaceutical industry, makes decisions based on the science, and puts the health and safety of Americans first."

Hassan said she'll "thoroughly review" Califf's record and did not indicate whether she'd vote against him.

Sen. Richard Blumenthal (D-Conn.) said he has the same "grave reservations" regarding Califf as he did when he previously voted against Califf's nomination in 2016. "I expect I would oppose him," Blumenthal said.

Sen. Joe Manchin (D-W.Va.) also voted against Califf in 2016 and said he opposes Biden's nomination because of Califf's "significant ties" to the pharmaceutical industry.

"I urge the administration to nominate an FDA commissioner that understands the gravity of the prescription drug epidemic and the role of the FDA in fighting back against the greed of the pharmaceutical industry," Manchin said. (Stolberg/Kaplan, New York Times, 11/12; McGinley, Washington Post, 11/12; Perrone/Miller, Associated Press, 11/12; Fernandez/Reed, Axios, 11/15; Firth, MedPage Today, 11/12; Sullivan, The Hill, 11/12)