After Long Delay Senate Confirms Califf for FDA Chief

WASHINGTON — The Senate on Tuesday approved Robert Califf’s nomination to be the new head of the Food and Drug Administration.

The 50-46 vote came just over 12 hours after the chamber cast a decidedly narrow vote to limit debate on his confirmation.

One senator voted present on Tuesday.

Monday night’s 49-45 procedural vote to invoke cloture also provided a window into where both stiff opposition and bipartisan support lay for the native South Carolinian who headed the agency in the final years of the Obama administration.

In the end on Monday night, five Republicans voted for Califf: Send. Roy Blunt, R-Mo., Richard Burr, R-N.C., Susan Collins, R-Maine, Lisa Murkowski, R-Alaska, and Mitt Romney, R-Utah.

But four Democrats broke ranks with their party and the president, voting against Califf’s nomination due to concerns over his ties to the pharmaceutical industry and his handling of the opioid drug crisis.

These were Sens. Richard Blumenthal, D-Conn., Maggie Hassan, D-N.H., Joe Manchin, W.Va., and Ed Markey, D-Mass.

Sen. Bernie Sanders, I-Vt., joined the quartet in their opposition to Califf.

Prior to joining the FDA in January 2015, Califf was the founding director of the Duke Clinical Research Institute at Duke University. There he oversaw more than 1,000 employees and had an annual budget of $320 million, about 50%-60% of which is funded from industry.

During his tenure, Califf led a number of clinical cardiology research studies, health outcomes research, health care quality and translational research, which seeks to ensure that advances in science translate into medical care.

That work led to his being a paid consultant for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline, AstraZeneca and Eli Lilly, according to ProPublica.

As for his alleged complicity in the opioid addiction crisis, much of the fireworks Monday night came from Manchin who, in an angry floor speech, said he felt “extreme disbelief” and “disappointment” over Califf’s pending confirmation, blaming the nominee for the surge in opioid-related deaths over the past five years.

“Since Dr. Califf was confirmed, more than 400,000 Americans and 5,000 West Virginians have died from drug-related overdoses,” Manchin said. “And 2020 was the deadliest year on record for drug-related overdoses.

“Let’s not beat around the bush,” the senator continued. “Dr. Califf bears a great deal of responsibility for these deaths.”

Manchin went on to say the Senate had a luxury with Califf’s nomination that it ordinarily does not enjoy — knowing his track record from his earlier tenure at the agency.

“During Dr. Califf’s previous tenure drug-related overdoses went up. Five years later, they went up again … despite his pledge to overhaul the FDA’s policy during his tenure,” Manchin said. “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. And as if this is not enough, reports have circulated that he intends to keep Dr. Janet Woodcock on board as a senior advisor to the FDA.

“Woodcock bears more responsibility for the opiate epidemic in our country than any other person at the FDA because of her oversight role and the approval of every single one of the opiates that ravage communities like ours in West Virginia.”

Woodcock, currently the acting FDA commissioner, has been running the agency since January 2021.

Among the senators who didn’t cast a vote Monday was Califf’s fellow South Carolinian, Sen. Lindsey Graham, R-S.C.

Califf’s confirmation has been stalled in the Senate since November after opposition arose among both Democrats and Republicans to his nomination. In addition to the concerns cited above, Califf faced scrutiny from conservative Republicans over medication abortion, which was expanded under his prior tenure.

Those same concerns inspired a number of anti-abortion groups to vow to try to block his confirmation.

Califf served as FDA commissioner in the final year of the Obama administration after being confirmed with a rousing bipartisan 89-4 vote.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue.