Newly Confirmed FDA Chief Robert Califf Now Must Tackle a Series of Controversial Issues

The Senate narrowly confirmed Dr. Robert Califf to be commissioner of the Food and Drug Administration on Tuesday afternoon, capping a fraught nomination process for President Joe Biden’s pick to lead the agency, which has been without a permanent head for more than a year.

Califf, who previously led the FDA in 2016 and 2017, faced criticism from both the left and the right over his ties to the pharmaceutical industry, his response to the opioid epidemic during his previous tenure at the agency, and the FDA’s handling of regulations around medication abortion pills. The final vote Tuesday was 50-46 in Califf’s favor. Six Republican Senators voted for and five Democrats voted against confirming the new head of the agency responsible for reviewing new COVID-19 vaccines and treatments, prescription and over-the-counter drugs, and medical devices and therapies.

The close vote highlights how health care issues overseen by the FDA have become increasingly politicized in recent years. When Califf, a cardiologist and clinical trial expert, led the agency near the end of President Barack Obama’s second term, the Senate confirmed him with a vote of 89-4.

Califf’s confirmation this week comes at a particularly critical time for the FDA, as it considers a number of high-profile topics, including COVID-19 vaccines for children under 5 years old, whether e-cigarettes should be banned due to their appeal to teens, and the controversy over its approval of the divisive Alzheimer’s drug Aduhelm.

Califf has also said he will conduct a comprehensive review of opioids.

Democratic Sen. Patty Murray, who chairs the Senate Committee on Health, Education, Labor and Pensions, said Califf is “a trusted hand” as the nation faces a “critical moment.”

A tight vote

While the FDA manages issues that affect large swaths of the U.S. health care system and economy, the close confirmation vote is unusual, experts say. Califf earned both support and criticism—nearly in equal measures—for his previous service in the same role. Some saw his experience as an advantage, while others argued that he’d fumbled the ball while last in the top seat.

“The wise Dr. Maya Angelou famously said, ‘When someone shows you who they are, believe them,’’ said Sen. Joe Manchin of West Virginia on the floor on Monday. “Well, Dr. Califf has shown us who he is, and he has shown a complete lack of interest in actually making the difficult decisions that we need the leader of the FDA to make.”

Manchin, who also voted against Califf in 2016, was a leading opponent of Califf’s confirmation. As recently as Friday, he called for Biden to withdraw the nomination in an op-ed co-authored with Republican Sen. Mike Braun of Indiana, and continued to encourage his colleagues to vote no this week. During the final vote Tuesday, he said he had “never been more profoundly confident” in a vote than he was in opposing Califf.

Anti-abortion groups also opposed Califf to lead the FDA because the agency has relaxed some regulations around medication abortion in recent years. Susan B. Anthony List, which opposes abortion, raised concerns about the FDA loosening restrictions on the abortion pills in 2016 when Califf was previously at the agency, and then stepped up its advocacy after the agency announced in December that people could receive the pills by mail. The group said it would score Califf’s nomination on its “pro-life scorecard” and urged conservative lawmakers not to support Califf.

Califf comes after Dr. Stephen Hahn, the commissioner under former President Donald Trump, was criticized for not pushing back enough when Trump promoted unproven COVID-19 treatments such as hydroxychloroquine. After Hahn left last January, Dr. Janet Woodcock, a longtime drug regulator, has served as acting director of the FDA. Many expected the Biden Administration to prioritize the choice of a new FDA chief, but it waited until close to its legal deadline in mid-November to nominate Califf.

Califf spent much of his career at Duke University, where he was a professor and founding director of the Duke Clinical Research Institute. Since heading the FDA, and he worked as an advisor to Verily Life Sciences and Google Health. He has a strong understanding of the clinical trial process, but critics have raised concerns about his close relationships to the drug industry.

Enough Republican support to cross the line

Six Republicans ultimately voted to confirm Califf: Senators Richard Burr of North Carolina, Roy Blunt of Missouri, Lisa Murkowski of Alaska, Susan Collins of Maine, Mitt Romney of Utah and Pat Toomey of Pennsylvania. “I urge my colleagues to support Dr. Califf’s nomination because he will provide the leadership needed to promote today’s biomedical advancements and help to pave the way for tomorrow’s innovation,” Burr said on Tuesday.

Ahead of the vote, the White House rallied support for Califf, emphasizing the steps he took to assuage lawmakers’ concerns. “It is critically important to have confirmed leadership at the FDA in the midst of a pandemic,” Karine Jean-Pierre, the White House deputy press secretary, told reporters on Monday. As of Monday, he met with or was scheduled to meet with 47 Senators, among the highest numbers for any of Biden’s nominees.

Other Democratic supporters touted Califf’s previous experience, arguing that he will be able to hit the ground running once confirmed. “Dr. Califf’s previous service in this role,” said Murray, “his career as one of the Nation’s leading research scientists, give him the experience to take on this challenge.”