Robert Califf, FDA

Five Years Later, Califf Nomination Still Controversial

By MedTech Intelligence Staff
Robert Califf, FDA

President Biden intends to nominate former FDA Commissioner Robert Califf, M.D. as agency head, and the same opposition voiced during his previous nomination remains.

Last week President Biden announced his intent to nominate former FDA Commissioner Robert Califf, M.D. to once again lead the agency. Califf had a very brief stint (less than a year) in the position during the Obama administration. His confirmation (89-4 vote) in 2016 was met with opposition, as opponents took issue with his ties to the pharmaceutical industry. Five years later, the same opposition remains. Democratic Senators Joe Manchin III, Richard Blumenthal, and Ed Markey voted against Califf in 2016, and they voiced the same concern over the recent announcement.

“Dr. Califf’s nomination makes no sense as the opioid epidemic continues to wreak havoc on families across this country with no end in sight. 2020 was the deadliest year on record for drug related overdose deaths with 1,386 West Virginians and nearly 95,000 Americans dying from a drug related overdose. I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic. Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward. His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction,” said Manchin in a statement. “I could not support Dr. Califf’s nomination in 2016 and I cannot support it now. I urge the Administration to nominate an FDA Commissioner that understands the gravity of the prescription drug epidemic and the role of the FDA in fighting back against the greed of the pharmaceutical industry. Championing the needs of our nation’s public health must be their number one priority.”

Meanwhile, President Biden finds Califf’s experience to be especially useful in the face of the pandemic: “As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA,” stated President Biden in a White House press release. “I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making. Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment.”

Medtech industry association AdvaMed also praised the nomination of Califf. ““On behalf of the medtech industry, I congratulate Dr. Califf on his nomination to again lead FDA. His prior experience as FDA Commissioner will be invaluable as he oversees the global gold standard for medical device safety and effectiveness,” said AdvaMed CEO Scott Whitaker in an association press release. “If confirmed by the Senate, Dr. Califf will be tasked with protecting and promoting the public health, as well as the crucial role of innovation in improving patient care, and we look forward to working closely with him to meet these goals on behalf of the patients we serve. We also want to thank Dr. Janet Woodcock for her steadfast leadership as acting commissioner during this historic pandemic.”

The Senate must vote on the confirmation of Califf, who is currently a professor of medicine at Duke University School of Medicine.

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