November 28, 2022
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FDA's agenda in limbo as Biden's nominee stalls in Senate

Senate confirms Biden’s FDA pick despite political divisions

WASHINGTON — The Senate narrowly confirmed President Joe Biden’s pick to steer the Meals and Drug Administration on Tuesday pushing previous a thicket of political controversies that threatened to derail what was initially anticipated to be a straightforward affirmation.

The 50-46 vote means Dr. Robert Califf, a heart specialist and outstanding medical researcher, will once more lead the highly effective regulatory company, which he briefly headed throughout the finish of President Barack Obama’s administration.

The FDA hasn’t had a everlasting chief in additional than a yr despite enjoying a central function within the COVID-19 response effort, reviewing the vaccines, medicine and checks used to combat the pandemic.

Califf now inherits a raft of opinions and selections pending on the company, which regulates a number of multibillion-dollar industries, together with prescription and over-the-counter medicine, medical units, tobacco merchandise and most meals.

Califf’s to-do checklist additionally consists of particular commitments he’s made to Senate lawmakers to clinch the job. Specifically, he has vowed to shortly launch a complete evaluate of opioid painkillers like OxyContin, which helped set off the worst drug epidemic in U.S. historical past after their FDA approval within the Nineteen Nineties.

Sen. Joe Manchin, D-W.V., urged senators to oppose Califf, saying he bears “a great deal of responsibility” for lots of the drug overdose deaths which have occurred within the years since his first stint as FDA commissioner. Throughout his 11-month tenure, Califf added new warning labels to opioids and commissioned outdoors suggestions on tighten regulation of the medicine. However he was changed by President Donald Trump earlier than implementing any main modifications.

“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,” mentioned Manchin, whose dwelling state has been ravaged for many years by opioid habit and overdoses.

The White Home lengthy assumed sufficient Republicans would assist Califf to simply overcome any Democratic defections, given his sturdy assist from pharmaceutical firms and affected person teams.

However anti-abortion advocates lately launched a marketing campaign to sink his Senate vote, outraged by a latest FDA choice that eased entry to abortion capsules. Teams together with the Susan B. Anthony Checklist threatened to drag assist from any Republican senators supporting Califf.

In the long run, six Republicans joined with all however 5 Democrats in voting to verify Califf. Sen. Richard Burr, R-N.C., advocated for Califf on the Senate flooring, saying that he had not seen somebody with such a brief earlier stint on the FDA who “completed something, a lot much less the numerous negatives which were raised.”

“He has the strong company and personal sector expertise wanted to assist construct on the success of the FDA in serving to People get again to regular life with the approval of checks, vaccines and therapeutics which are bringing the pandemic to an finish,” Burr added. “He’s the leader we need today, but also for the future.”

Dr. Janet Woodcock, the FDA’s longtime drug heart director, had been serving as appearing commissioner since final January. She introduced Tuesday through Twitter that she would proceed working on the company as a principal deputy commissioner.

Greater than a yr after authorizing the primary COVID-19 vaccines, the FDA nonetheless faces a number of key selections, together with whether or not to increase their use to youngsters youthful than 5. Final week the FDA unexpectedly delayed its timeline for reviewing Pfizer’s vaccine for that age group.

FDA commissioners aren’t sometimes concerned in day-to-day scientific opinions, however they function the go-between for the company’s scientists and the White Home. That relationship has strained over the previous yr as Biden’s COVID-19 job pressure has repeatedly gotten out forward of the FDA’s methodical, scientific opinions.

Califf can even want to exchange the top of the FDA’s tobacco heart, which is weighing whether or not to ban e-cigarettes from Juul, Reynolds American and different vaping firms on account of their use by teenagers. FDA tobacco’s longtime director, Mitch Zeller, is about to retire this spring.

Califf has publicly championed the potential to avoid wasting a whole lot of hundreds of lives by embracing FDA’s authority to ban sure tobacco merchandise and components. Although the FDA has had these powers for greater than a decade, its efforts to control each conventional cigarettes and e-cigarettes have been stymied by business lawsuits.

Califf first got here to the FDA after greater than 35 years at Duke College, the place he based a contract analysis group that conducts research for lots of the world’s largest drugmakers.

Since leaving authorities he has labored as a well being coverage adviser for Google and served as a board director or adviser to greater than a half-dozen drug and biotech firms. In line with federal process, Califf agreed to resign from all of these positions and dump investments in FDA-regulated firms, in accordance with his ethics disclosures type.

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The Related Press Well being and Science Division receives assist from the Howard Hughes Medical Institute’s Division of Science Schooling. The AP is solely liable for all content material.

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