The Senate confirmed Dr. Robert Califf 50-46 as Food and Drug Administration commissioner on Tuesday, over objections to his pharmaceutical industry ties and concerns he would not act aggressively enough to stem the opioid epidemic.
Califf is a prominent cardiologist with extensive clinical research experience who served as FDA commissioner during President Barack Obama’s final year in office. President Joe Biden has said Califf will bring a steady hand to the FDA as the drug regulator faces urgent decisions on Covid vaccines, therapeutics and testing to fight the pandemic.
Califf’s confirmation comes more than a year after Biden took office. Dr. Janet Woodcock, a three-decade agency veteran, served as acting commissioner last year while the FDA gradually lowered the eligibility age for Pfizer’s vaccine, authorized booster shots and approved two major antiviral drugs to treat Covid patients.
Though the White House reportedly considered Woodcock for the permanent role, she faced opposition on Capitol Hill. Woodcock led the FDA’s Center for Drug Evaluation and Research when prescription opioids, including OxyContin, were approved in the 1990s.
In a December letter to the Senate health committee, six former FDA chiefs said the year-long absence of a confirmed commissioner had complicated the drug regulator’s ability to fulfill its mandate. They endorsed Califf as someone with the experience to immediately play an effective leadership role in a time of crisis.
“Confirming Dr. Califf is critical not only for moving beyond the Covid-19 emergency, but also to help meet FDA’s many other major regulatory responsibilities where Senate confirmed leadership is essential for the nation’s wellbeing,” wrote Drs. Scott Gottlieb, Stephen Hahn and four other former commissioners.
However, Califf’s nomination was not without controversy, with opposition coming from several members of Biden’s own party. Sen. Bernie Sanders, I-Vt., has criticized Califf for owning millions of dollars in pharmaceutical stock, accusing him of participating in a revolving door between industry and the FDA.
Califf is as a senior advisor for Google Health and Verily, the life science arm of Alphabet. He received a salary of $2.7 million and up to $5 million in stock at Verily, according to an ethics disclosure form. Califf serves on the board of directors at Centessa Pharmaceuticals and the biopharmaceutical company Cytokinetics. He has up to $5 million in unvested stock options at Centessa and owns hundreds of thousands of dollars in Cytokinetics stock. Califf also has stock in Amgen, Gilead Sciences and Bristol-Meyers Squibb.
Califf has said he will resign from Verily, Centessa and Cytokinetics upon confirmation and divest his pharmaceutical stock holdings within 90 days.
Sens. Joe Manchin, D-W.Va., and Maggie Hassan, D-N.H., opposed Califf’s nomination over his previous leadership of the the FDA during the opioid crisis. Overdose deaths from all opioids increased 12% to more than 47,000 during Califf’s tenure as commissioner from 2016 to 2017, while fatalities specifically from prescription opioids remained high with more than 17,000 people succumbing to overdoses, according to the Centers for Disease Control and Prevention.
Manchin last week called on Biden to withdraw Califf’s nomination, arguing that he had “failed to address this crisis in any meaningful way” and would not bring the change needed at the FDA to address opioids, which have hit West Virginia particularly hard.
“We need new, dedicated leadership that understands the gravity of the drug epidemic and will fight back against the greed of the pharmaceutical industry,” Manchin wrote with Sen. Mike Braun, R-Ind., in an op-ed published in USA Today. In a statement last month, Hassan said “it does not appear that things would be different” under Califf’s leadership.
While serving as FDA deputy commissioner for medical products, Califf announced a review of the drug regulator’s opioid policy. However, Manchin criticized Califf for the FDA approval of three new opioid drugs during his tenure as the agency’s commissioner.
During his nomination hearing, Califf acknowledged FDA’s failure when it approved OxyContin in 1995 without long-term studies or an assessment of the drug’s addictiveness. He said the FDA should aggressively look at relabeling opioids to warn they are not intended for long-term use.
“I think we need to learn from all that’s happened over the last several decades with us and reassess where we are today,” Califf said. “Because whatever we’ve done up until now, it’s not enough. It’s going to take all hands on deck and specifically, the FDA needs to redouble its efforts on prescriber education.”
A record number of Americans, more than 68,000, died of opioid overdoses in 2020, according to the CDC data. More than 500,000 Americans have died of opioid overdoses since 1999, according to the data.
Lawmakers also pressed Califf about his stance on the FDA’s fast-track approval process for drugs that have potential to help patients with serious conditions who have few other treatment options. Woodcock faced backlash over the accelerated approval of Biogen’s Alzheimer’s drug, aduhelm, in June after a report revealed that company executives met with FDA officials outside official channels. The acting commissioner requested an inspector general investigation into the approval of Biogen’s Alzheimer’s drug.
Sen. Ron Wyden, D-Ore., told Califf in a letter earlier this month that some companies have taken advantage of the fast-track process while the FDA has shied away from wielding its authority to punish those who abuse the process. Califf, in his response letter, said he will work with Congress to close gaps in accountability.
During his nomination hearing, Califf said the American people want earlier access to drugs that can potentially treat life-threatening illnesses. However, he acknowledged the fast-track process inherently comes with uncertainty, and the FDA needs to do better at tracking the performance of drugs that are approved early.
“We got to have a better system to evaluate these products as they’re used on the market,” Califf told the Senate health committee in December.