US Senate voting Tuesday on FDA commissioner; Manchin speaks against nominee

CHARLESTON, W.Va. — The U.S. Senate will vote Tuesday on confirming Dr. Robert Califf as Food and Drug Administration commissioner following a procedural vote a day prior advancing the nomination.

The Senate on Monday voted 49-45 to move the nomination forward. Sen. Joe Manchin, D-W.Va., was one of four Democrats who joined most Republicans in voting against ending debate.

Califf served as FDA commissioner under President Barack Obama in the administration’s final year; the Senate confirmed the first nomination 89-4. He was a deputy commissioner with the agency from February 2015 to February 2016.

His prior experience also includes serving as a professor of medicine and vice chancellor for clinical and translational research at Duke University — his alma mater — and leading the Duke Translational Medicine Institute and the Duke Clinical Research Institute.

Dr. Robert Califf (File)

President Joe Biden cited Califf’s clinical trial background as a factor in the selection. The president last November stressed the importance of such expertise as the federal government continues its response to the coronavirus pandemic.

Manchin and other Democrats have raised concerns regarding Califf because of his ties to the pharmaceutical industry and the FDA’s handling of the opioid epidemic under Califf’s leadership. Manchin voted against confirming Califf in 2016.

“Let’s not beat around the bush,” Manchin said Monday on the Senate floor. “Dr. Califf bears a great deal of responsibility for these deaths. We have a luxury with this nomination that we’re not usually granted because Dr. Califf has already served as the FDA commissioner. We have insight into how he will lead the agency.”

According to the U.S. Centers for Disease Control and Prevention, there were around 100,000 drug overdose deaths in the United States between April 2020 and April 2021. Opioid-related overdose deaths between the years rose from 56,064 to 75,673. The agency has reported significant increases in overdoses deaths involving synthetic opioids like fentanyl since 2013.

“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,” Manchin said.

During his remarks, Manchin spoke about the death of a West Virginia University alumna; Lauren Cole of Morgantown died in July 2020 from a fentanyl overdose. Cole was pursuing a master’s degree in social work before a relapse.

“Dr. Califf’s nomination is an insult to Lauren’s memory and the millions of families who have lost a loved one at the hands of this epidemic, and I cannot for the life of me understand why this administration is so committed to asking each of us in the Senate to reconfirm a person who had the opportunity to make a difference, but [showed] us who he really was,” the senator said. “Do not expect a different outcome if he is given another opportunity to lead the FDA. That won’t happen.”

Califf has asked the acting commissioner, Dr. Janet Woodcock, to stay with the agency. Manchin previously criticized the Biden administration’s selection of Woodcock, referencing her leadership of the Center for Drug Evaluation and Research during the FDA’s review and approval of OxyContin.

“Dr. Woodcock bears more responsibility for the opioid epidemic in our country than any other person at the FDA,” Manchin argued Monday.

Democratic Sens. Richard Blumenthal of Connecticut, Maggie Hassan of New Hampshire, and Ed Markey of Massachusetts joined Manchin in voting against advancing the nomination.

Sen. Shelley Moore Capito, R-W.Va., did not vote; she announced last Thursday she tested positive for the coronavirus. The Senate does not allow voting by proxy.

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