Senate narrowly confirms Robert Califf to lead FDA

Senate narrowly confirms Robert Califf to lead FDA

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The Senate on Tuesday narrowly voted to confirm former FDA commissioner Robert Califf to once again lead the agency.


What You Need To Know

  • The Senate voted 50-46 to confirm former FDA commissioner Robert Califf to once again lead the agency; he was confirmed in an 89-4 vote to lead the FDA in 2016
  • The crucial agency was without a permanent leader for more than a year, during which the COVID-19 pandemic raged across the country
  • Califf becomes the first FDA commissioner since the 1940s to return for a second stint leading the agency
  • A handful of Republicans joined the majority of Democrats to confirm Califf; Some Democrats voted against his confirmation, criticizing Califf’s ties to the pharmaceutical industry and blaming him for spikes in opioid deaths

The crucial agency was without a permanent leader for more than a year, during which the COVID-19 pandemic raged across the country. Califf becomes the first FDA commissioner since the 1940s to return for a second stint leading the agency.

The final vote was 50-46, with a number of Democrats crossing the aisle to oppose his nomination with most Republicans, and a handful of GOP lawmakers voting with Democrats to confirm. South Dakota Sen. Mike Rounds changed his vote to “present” to pair with New Mexico Sen. Ben Ray Luján, who is recovering from a stroke but would have voted in favor of Califf’s confirmation.

The narrow vote Tuesday was a far cry from his 89-4 confirmation vote in 2016.

“I’ve been one of the FDA’s toughest critics over the years,” Sen. Richard Burr, R-N.C., said on the Senate floor on Tuesday in support of Califf. “However, I’m critical because I believe in the agency’s mission. The FDA has an opportunity to be forever changed for the better, but it needs effective leadership to get there.”

Other Republicans who voted in favor of Califf included Maine Sen. Susan Collins, Missouri Sen. Roy Blunt, Alaska Sen. Lisa Murkowski and Utah Sen. Mitt Romney, who previously supported Califf’s confirmation in 2016.

Sens. Bernie Sanders, I-Vt., Richard Blumenthal, D-Conn., Ed Markey, D-Mass., and Joe Manchin, D-W.Va voted against Califf’s confirmation. Some Democrats criticized Califf’s ties to the pharmaceutical industry and blame him for spikes in opioid deaths.

“I will vote no on Dr. Califf’s nomination, and I have never been more profoundly confident of a vote I’m going to cast than I am right now,” Manchin said Monday ahead of a procedural vote, urging his fellow lawmakers to “send a message to this administration, to our President, that we need a new direction at the FDA.”

Manchin, Markey and Blumenthal opposed his confirmation in 2016.  

“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 added. “Nothing that Dr. Califf has said or done has led me to believe he will operate the FDA any differently than he did during his previous tenure.”

A cardiologist and clinical trial specialist, Califf served as FDA commissioner for the last 11 months of President Barack Obama’s second term. Before that, he spent one year as the agency’s No. 2 official after more than 35 years as a researcher at Duke University, where he helped design studies for many of the world’s biggest drugmakers.

Since leaving the government, he has worked as a policy adviser to tech giant Google, in addition to his ongoing work at the Duke Clinical Research Institute.

Califf will oversee decisions on COVID-19 vaccines and treatments along with a raft of other issues, including the regulation of electronic cigarettes and effectiveness standards for prescription drugs. 

The Associated Press contributed to this report.

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