Senate Confirms Califf as FDA Commissioner

By Pat Anson, Editor

The U.S. Senate has overwhelmingly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration after months of controversy over his ties to the pharmaceutical industry and criticism of the agency’s regulation of opioid pain medication.

The vote was 89-4 for Califf, a cardiologist and medical researcher at Duke University, who pledged earlier this month to use tougher language in warning labels for extended release opioids and to prioritize development of non-opioid alternatives for pain. Califf also endorsed the CDC’s controversial opioid prescribing guidelines, even though some of the FDA’s own experts believe the guidelines lack scientific evidence.

"If addiction to opioids and misuse of opioids is the enemy, then we underestimated the tenacity of the enemy," Califf told The Associated Press after his nomination was confirmed. "We've got to adjust."

Califf was pressured into changing the FDA’s opioid policies after his nomination was held up by Democratic presidential candidate Sen. Bernie Sanders of Vermont, and Sens. Joe Manchin of West Virginia (D) and Ed Markey of Massachusetts (D).



Manchin, Markey, Sen. Richard Blumenthal of Connecticut (D) and Sen. Kelly Ayotte of New Hampshire (R) voted against the nomination. Sanders was on the campaign trail and did not vote on the nomination.

"FDA stands for Food and Drug Administration, but over the last 20 years it really stands for ‘fostering drug addiction,' " Markey said in a speech on the Senate floor.

Both Markey and Manchin have vowed to “change the culture” at FDA to combat what they call a “pandemic” of opioid abuse and overdoses.

“I just think he’s the wrong person at this time of need for the position that we need to shake it up,” said Manchin. "The FDA needs new leadership, new focus and a new culture."

Califf founded Duke University’s Clinical Research Institute, which primarily works with and is funded by pharmaceutical companies. He listed over a dozen drug makers in a conflict-of-interest disclosure for a recent article he wrote in the New England Journal of Medicine.

“Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine.  He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public,” said Dr. Stephen Ostroff, the FDA’s chief scientist, who has served as acting head of the agency for the past year.