Texarkana Gazette

Senate confirms Biden’s FDA pick despite political divisions

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WASHINGTON— The Senate narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administra­tion on Tuesday pushing past a thicket of political controvers­ies that threatened to derail what was initially expected to be an easy confirmati­on.

The 50-46 vote means Dr. Robert Califf, a cardiologi­st and prominent medical researcher, will again lead the powerful regulatory agency, which he briefly headed during the end of President Barack Obama’s administra­tion.

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.

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