Senate confirms Biden’s choice by FDA despite political divisions

WASHINGTON — The Senate narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administration on Tuesday, fending off 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 leading medical researcher, will once again lead the powerful regulatory agency, which he briefly led at the end of President Barack Obama’s administration.

The FDA hasn’t had a permanent head in over a year, though it has played a central role in the COVID-19 response effort, reviewing vaccines, drugs and tests used to fight it. against the pandemic.

Califf now inherits a series of pending reviews and decisions at the agency, which regulates several multi-billion 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 made to Senate lawmakers to land the job. In particular, he pledged to quickly launch a comprehensive review of opioid painkillers like OxyContin, which helped spark the worst drug epidemic in US history after they were approved by the FDA in the 1990s. .

Sen. Joe Manchin, DW.V., urged senators to oppose Califf, saying he bears “great responsibility” for numerous drug overdose deaths in the years since his first term as as Commissioner of the FDA. During his 11-month tenure, Califf added new opioid warning labels and commissioned outside recommendations on how to strengthen drug regulation. But he was replaced by President Donald Trump before implementing major changes.

“Nothing Dr. Califf has said or done has led me to believe that he will operate the FDA any differently than he did during his previous tenure,” said Manchin, whose state of origin was ravaged for decades by opioid addiction and overdoses.

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

But abortion advocates recently launched a campaign to sink her vote in the Senate, outraged by a recent FDA ruling that made abortion pills easier to access. Groups including the Susan B. Anthony List have threatened to withdraw the support of all Califf-backing Republican senators.

In the end, six Republicans joined all but five Democrats in voting to confirm Califf. Sen. Richard Burr, RN.C., defended Califf in the Senate, saying he had never seen anyone with such a short stint at the FDA who “accomplished anything, let alone the many points negatives that have been raised”.

“He has the strong agency and private sector experience needed to help build on the FDA’s success in helping Americans return to normal life with the approval of tests, vaccines and therapies that end the pandemic. “, added Burr. “He is the leader we need today, but also for the future.”

Dr. Janet Woodcock, longtime director of the FDA’s drug processing center, had served as acting commissioner since last January. She announced via Twitter on Tuesday that she would continue to work at the agency as a senior deputy commissioner.

More than a year after licensing the first COVID-19 vaccines, the FDA still faces several key decisions, including whether to expand their use to children under age 5. Last week, the FDA unexpectedly delayed its review schedule for Pfizer’s vaccine for this age group.

FDA commissioners aren’t typically involved in day-to-day scientific reviews, but they serve as an intermediary between agency scientists and the White House. That relationship has become strained over the past year as Biden’s COVID-19 task force has repeatedly outpaced the FDA’s methodical scientific reviews.

Califf will also have to replace the head of the FDA’s tobacco center, which is considering whether to ban e-cigarettes from Juul, Reynolds American and other vaping companies because of their use by teens. Longtime FDA Tobacco director Mitch Zeller is set to retire this spring.

Califf has publicly championed the potential to save hundreds of thousands of lives by adopting the authority of the FDA to ban certain tobacco products and ingredients. Although the FDA has had these powers for more than a decade, its efforts to regulate both traditional cigarettes and e-cigarettes have been thwarted 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 top 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 half a dozen pharmaceutical and biotech companies. In accordance with federal procedure, Califf agreed to resign from all of those positions and sell investments in FDA-regulated companies, according to its ethics disclosure form.

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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

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