U.S. Senate Nears Final Vote on Califf’s FDA Nomination

UPDATE: The Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration, in a final vote of 89 to 4 on Wednesday.

Dr. Robert Califf, President Obama’s nominee to head the U.S. Food and Drug Administration, faced a procedural vote Monday afternoon, in which Califf won the support of Senate, in a vote of 80 to 6. He will now move on to a final confirmation vote, and his Senate opponents will lose leverage to block his nomination.

At least 60 votes were needed to move forward. According to Senate rules, senators can continue to debate Califf’s nomination for up to 30 hours before a final vote.

Several senators — including Sen. Bernie Sanders of Vermont, who is running for the Democratic presidential nomination; Edward Markey of Massachusetts; and Joe Manchin of West Virginia — oppose Califf’s nomination, citing concerns about his close ties to the pharmaceutical industry and the FDA’s response to the opioid epidemic, which they’ve said has not been ‘strong enough.’ Sanders, however, did not leave the campaign trail to register his vote.

“We can’t filibuster, but we are going to use up all of the 30 hours to make our case as to why we feel that Dr. Califf is not the right person to lead the FDA,” said Manchin’s spokesperson Jonathan Kott, in a STAT article.

Califf joined the FDA as a deputy commissioner in February 2015, after having worked at Duke University as a cardiologist, where he led a clinical research center that received a large share of its funding from the pharmaceutical industry. Califf, however, testified that the center’s scientific results were reached independently.

Califf led the clinical trial, known as ROCKET-AF, which serves as the backbone for the approval of rivaroxaban (Xarelto). Currently, there are questions about the validity of the trial’s data, specifically a portable device used to gain approval that appears to have been defective.

Sen. Lamar Alexander of Tennessee showed his support for Califf: “[He’s] the right person for the job. We need a leader who can manage a large and complex organization, not just on big policies that make headlines but on day-to-day matters.”

Senators Manchin and Markey said Califf is a “good man,” but that his work as a consultant for large drug companies makes him a poor fit, especially in light of the opioid epidemic. “Enough is enough,” Markey said. “This whole culture has to change.”