The Senate on Tuesday confirmed Robert Califf as FDA commissioner in a 50-46 vote, with four Democrats and Sen. Bernie Sanders (I-Vt.) voting against and six Republicans voting in favor, marking the closest vote for FDA commissioner in the agency's 115-year history.

Background

Califf, a cardiologist, previously served as FDA commissioner for less than a year at the end of President Barack Obama's second term. He was confirmed as commissioner by the Senate in an 89-4 vote in February 2016.

During his time as FDA commissioner, Califf prioritized fighting the opioid epidemic, including by requiring "black box" warnings regarding the dangers of mixing opioids and benzodiazepines.

Califf also sought to allow drugmakers to advertise off-label uses for products approved by FDA, something not currently permitted. However, the proposal was blocked by others within the Obama administration.

Recently, Califf has served as a senior adviser to Verily Life Sciences and previously served as vice chancellor for clinical and translational health at Duke University. Califf also served on the corporate board of biopharmaceutical company Cytokinetics.

When President Biden announced he would nominate Califf to once again serve as commissioner, the news drew praise from many health experts and lawmakers, but also criticism from some who are skeptical of his pharmaceutical industry ties.

During his Senate confirmation hearing in December, Califf was questioned by Sanders regarding his relationship to the pharmaceutical industry. Sanders noted that nine out of the last 10 FDA commissioners later worked for or served on the board of directors within the pharmaceutical industry.

"Unfortunately, Dr. Califf, you are not the exception to that rule," Sanders said. "What kind of comfort can you give to the American people when you have been so closely tied to the pharmaceutical industry yourself?" he added.

"I'm totally with you," Califf responded. "The price of pharmaceuticals is way too high in this country."

Califf also faced questions from Sen. Maggie Hassan (D-N.H.) and Ben Ray Luján (D-N.M.) over how the FDA has addressed the opioid epidemic.

Hassan criticized the agency for failing to change policies related to opioids and called for an overhaul of opioid medication labeling, while Luján expressed concern over the approval of Zohydro by FDA in 2013, which was approved despite objection from FDA's advisory committee.

"Something's got to change," Luján said. "And I'm hoping, doctor, that you can be that person."

Califf promised that he would begin a "comprehensive review" of FDA's opioid policies if confirmed, and added that he would look at ways to address the epidemic, including a change to how opioids are labeled. "If I'm confirmed, I'm going to take a very aggressive approach on this," he said.

Senate narrowly confirms Califf as commissioner

Prior to the vote, Sen. Joe Manchin (D-W.Va.) expressed his concern regarding Califf's nomination.

On Friday, Manchin called on President Biden to withdraw Califf's nomination in an opinion essay, noting that while Califf promised to address the opioid epidemic as commissioner, FDA approved five new opioids between 2016 and 2017 when Califf was last commissioner.

Sen. Edward Markey (D-Mass.) also said before the vote that FDA has become the "country's biggest pill pusher" and that Califf didn't do much to address that issue when he was commissioner.

"There was no real commitment to reforming the FDA or to learning from the mistakes that enabled this public health crisis," Markey said.

Sen. Steve Daines (R-Mont.) stated before the vote that he opposed Califf's nomination, criticizing the role Califf played in changes to abortion medication.

"Dr. Califf has refused to distance himself from the FDA decision to abandon vulnerable pregnant women to the reckless and predatory actions of the abortion industry," Daines said.

Ultimately the Senate voted 50-46 to confirm Califf with bipartisan support. Hassan, Manchin, Markey, and Sen. Richard Blumenthal (D-Conn.) were the only Democrats to vote against Califf, as did Sanders.

Meanwhile, Sens. Roy Blunt (R-Mo.), Richard Burr (R-N.C.), Susan Collins (R-Maine), Lisa Murkowski (R-Alaska), Mitt Romney (R-Utah), and Patrick Toomey (R-Pa.) were the only Republicans to vote in favor.

Califf's confirmation marks the closest commissioner vote in the history of FDA and the closest since Scott Gottlieb was confirmed in a 57-42 vote in 2017.

Califf is expected to be sworn in this week, the New York Times reports, and Janet Woodcock, who is serving as acting commissioner, said in a statement that she will remain a principal deputy at FDA. (McGinley/Roubein, Washington Post, 2/15; Jewett/Cochrane, New York Times, 2/15; Florko, STAT News, 2/15; Perrone/Freking, Associated Press, 2/15; Alonso-Zaldivar/Perrone, Associated Press, 12/14/21; Jewett, New York Times, 12/14/21; Gardner et al., Politico, 12/14/21)