Senate confirms Biden's FDA pick despite political divisions

The FDA hasn't had a permanent leader in more than a year despite playing a central role in the COVID-19 response effort, reviewing the vaccines, drugs and tests used to fight the pandemic.

The razor-thin vote underscores the increasing political polarization around the health care issues FDA oversees and contrasts with Califf's overwhelming support just six years ago. The Senate previously confirmed him to the job by a vote of 89-4.

Califf now inherits a raft of reviews and decisions pending at the agency, which regulates several multibillion-dollar industries, including prescription and over-the-counter drugs, medical devices, tobacco products and most foods.

Califf's to-do list also includes specific commitments he's made to Senate lawmakers to clinch the job. In particular, he has vowed to quickly launch a comprehensive review of opioid painkillers like OxyContin, which helped trigger the worst drug epidemic in U.S. history after their FDA approval in the 1990s.

Sen. Joe Manchin, D-W.V., urged senators to oppose Califf, saying he bears "a great deal of responsibility" for many of the drug overdose deaths that have occurred in the years since his first stint as FDA commissioner. During his 11-month tenure, Califf added new warning labels to opioids and commissioned outside recommendations on how to tighten regulation of the drugs. But he was replaced by President Donald Trump before implementing any major changes.

"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," said Manchin, whose home state has been ravaged for decades by opioid addiction and overdoses.

The White House long assumed enough Republicans would support Califf to easily overcome any Democratic defections, given his strong support from pharmaceutical companies and patient groups.

But anti-abortion advocates recently launched a campaign to sink his Senate vote, outraged by a recent FDA decision that eased access to abortion pills. Groups including the Susan B. Anthony List threatened to pull support from any Republican senators supporting Califf.

In the end, six Republicans joined with all but five Democrats in voting to confirm Califf. Sen. Richard Burr, R-N.C., advocated for Califf on the Senate floor, saying that he had not seen someone with such a short previous stint at the FDA who "accomplished anything, much less the many negatives that have been raised."

"He has the robust agency and private sector experience needed to help build on the success of the FDA in helping Americans get back to normal life with the approval of tests, vaccines and therapeutics that are bringing the pandemic to an end," Burr added. "He's the leader we need today, but also for the future."

Dr. Janet Woodcock, the FDA's longtime drug center director, had been serving as acting commissioner since last January. She announced Tuesday via Twitter that she would continue working at the agency as a principal deputy commissioner.

More than a year after authorizing the first COVID-19 vaccines, the FDA still faces several key decisions, including whether to expand their use to children younger than 5. Last week the FDA unexpectedly delayed its timeline for reviewing Pfizer's vaccine for that age group.

FDA commissioners aren't typically involved in day-to-day scientific reviews, but they serve as the go-between for the agency's scientists and the White House. That relationship has strained over the past year as Biden's COVID-19 task force has repeatedly gotten out ahead of the FDA's methodical, scientific reviews.

Califf will also need to replace the head of the FDA's tobacco center, which is weighing whether to ban e-cigarettes from Juul, Reynolds American and other vaping companies due to their use by teens. FDA tobacco's longtime director, Mitch Zeller, is set to retire this spring.

The FDA is also crafting new regulations to ban menthol cigarettes, a long-sought goal for many Democratic lawmakers and public health advocates.

Califf has publicly championed the potential to save hundreds of thousands of lives by embracing FDA's authority to ban certain tobacco products and ingredients. Though the FDA has had those powers for more than a decade, its efforts to regulate both traditional cigarettes and e-cigarettes have been stymied by industry lawsuits.

Califf first came to the FDA after more than 35 years at Duke University, where he founded a contract research organization that conducts studies for many of the world's largest drugmakers.

Since leaving government he has worked as a health policy adviser for Google and served as a board director or adviser to more than a half-dozen drug and biotech companies. In keeping with federal procedure, Califf agreed to resign from all of those positions and sell off investments in FDA-regulated companies, according to his ethics disclosures form.

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