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 was the previous FDA chief in 2016 and 2017. He faced both left- and right-leaning criticism over the way he handled it. The pharmaceutical industry has tiesHis response to the Opioid epidemic during his previous tenure at the agency, and the FDA’s handling of regulations around Pregnancy medication pills. The final vote Tuesday was 50-46 in Califf’s favor. Six Republican Senators voted to confirm the appointment of the executive director of the agency, which is responsible for reviewing COVID-19 new vaccines and treatment, prescription drugs and other medical devices as well as therapies. Five Democrats opposed it.
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This close vote shows how FDA has become more politicized over health care matters 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 said that he’d conduct a thorough review of the 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

Although the FDA handles issues that have an impact on large parts of the U.S. economy and health care system, close votes for confirmation are unusual according to experts. 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. He called for Biden’s withdrawal in an editorial he wrote with Republican Sen. Mike Braun from Indiana and continued encouraging his colleagues not to vote 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.

Because the FDA has eased some restrictions on medication abortion over the years, anti-abortion organizations also opposed Califf’s appointment to head it. Susan B. Anthony List is an anti-abortion group that raised concerns in 2016. This was when Califf was at FDA. The FDA then announced in December that they would allow people to receive abortion pills via mail. According to the group, it was would score Califf’s nomination on its “pro-life scorecard” and urged conservative lawmakers not to support Califf.

Califf was created after former president Donald Trump’s commissioner, Dr. Stephen Hahn failed to push back sufficiently when he promoted COVID-19 unproven treatments like hydroxychloroquine. Janet Woodcock is a veteran drug regulator who was appointed acting director for the FDA after Hahn resigned last January. The Biden Administration was expected to prioritise the selection of an FDA chief. However, it held off until mid-November when the deadline expired. Califf nominated.

Califf was an active member of Duke University’s faculty and the founding director of its Duke Clinical Research Institute. He was an advisor for Verily Life Sciences, Google Health and FDA. Although he has an excellent understanding of clinical trials, critics raised questions about his close ties to the pharmaceutical industry.

Not enough Republican support to allow us to cross the finish line

Six Republicans supported Califf’s confirmation: Sens. Richard Burr (North Carolina), Roy Blunt (Missouri), Lisa Murkowski of Alaska and Susan Collins of Maine. Mitt Romney (Utah) was also present. “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. At the time of this writing 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.”


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