The Senate voted Tuesday to confirm Robert M. Califf as commissioner of the Food and Drug Administration, overcoming vocal opposition from West Virginia Sen. Joe Manchin III and other Democrats who said President Biden’s pick was too cozy with the pharmaceutical industry.
A handful of supportive Republicans offset the objecting Democrats to put Dr. Califf over the finish line, 50-46, in the evenly divided chamber and fill a critical post during the pandemic.
Mr. Biden left the FDA without a permanent chief for over a year despite its central role in approving vaccines, treatments and tests for COVID-19.
Dr. Califf had previously run the agency for a year under President Obama, but faced headwinds after Mr. Biden asked him to return.
Some Republicans accused Dr. Califf of ignoring dangers from chemical abortions during his previous stint at the FDA, while Democrats said he wasn’t the right man to take on the powerful drug industry and control the opioid epidemic after he worked closely with drugmakers at Duke University’s clinical trials center and as a consultant for pharmaceutical companies.
“Consider what you are doing, consider your families and your constituents, and vote against Robert Califf,” Mr. Manchin, whose state has been devastated by the opioid crisis, said before the vote.
The opposition made Tuesday’s roll call a much tighter squeeze than Dr. Califf‘s 89-4 confirmation vote in 2016.
Dr. Califf‘s job at the FDA won’t be much easier.
The agency is battling its share of turmoil during the pandemic, including uncertain messaging on booster shots last year and, most recently, a sudden reversal of plans to streamline the process for getting shots into the arms of young children.
The FDA was supposed to convene a panel of outside advisers Tuesday to discuss Pfizer-BioNTech’s vaccine for children up to the age of 4 but regulators postponed the session, saying it would be better to wait for trial data on a third dose.
“This is a critical agency right now,” said former FDA Commissioner Mark McClellan in a webinar hosted this month by Duke University. “While the staff there is working really hard, it does make a difference having someone in charge.”
Dr. McClellan described Dr. Califf as an effective clinician and “an expert on medical evidence and things like vaccine safety and effectiveness of treatments.”
“It’s what the agency needs right now,” he said.
Dr. Califf previously served as FDA commissioner from February 2016 to January 2017. He later served as an adviser at Verily, a life sciences branch of Alphabet, Inc., the parent company of Google.
The FDA has operated under an acting commissioner, Janet Woodcock, for over a year.
“Three hundred and ninety-one days. No matter how effective and successful an acting commissioner can be, and we’ve been blessed with Janet Woodcock’s leadership, the full backing of a presidential nomination and confirmation by the United States Senate carry a weight that allows a confirmed commissioner to push forward necessary, meaningful change and leadership within a federal agency,” said Sen. Richard Burr of North Carolina, the senior Republican on the Senate Health Committee who backed Mr. Biden’s pick Tuesday.
He described Dr. Califf as an extremely qualified scientist who will help bring the pandemic to an end.
“He’s the leader we need today, but also for the future,” Mr. Burr said.
Mr. Burr was among several Republicans who supported Dr. Califf‘s nomination, providing enough votes to overcome opposition from a handful of Democrats who pointed to the proliferation of painkiller pills in their states.
“I have serious concerns about the FDA‘s role in fueling this crisis through its handling of opioid approvals and labeling, including during Dr. Califf‘s time at the agency. I voted against his nomination because it does not appear that things would be different under his leadership,” said Sen. Maggie Hassan, a New Hampshire Democrat who is running for reelection this year.
The Susan B. Anthony List, a pro-life organization, condemned the vote because it believes Dr. Califf will go along with the Biden administration’s decision to broaden access to mail-order abortion drugs.
“We’re deeply disappointed in the result of today’s vote. Robert Califf‘s confirmation to lead the FDA paves the way for permanent authorization of mail-order abortion drugs, at a dire cost to women’s health and safety and the lives of countless unborn children,” said SBA List President Marjorie Dannenfelser. “We urge our allies in the states and Congress to take swift action to stop the flow of these dangerous drugs to post offices and pharmacies across America.”
Others prepared a lengthy to-do list for the new commissioner.
“As Chairman of the Subcommittee on Economic and Consumer Policy, I have prioritized the health and safety of all Americans, and it is my sincere hope that Dr. Califf shares this commitment to protect future generations as commissioner,” said Rep. Raja Krishnamoorthi, a senior Democrat on the House Oversight Committee. “In this new capacity, his role will be more important than ever to ensure the FDA sets forth critical policies on a wide array of health issues, including addressing youth e-cigarette use and addiction and lead and other toxic heavy metals in baby food.”