FDA pick parries questions at collegial confirmation…


WASHINGTON — President Joe Biden’s decide to guide the Meals and Drug Administration parried questions on crises starting from the COVID-19 pandemic to the opioid epidemic, throughout a Senate listening to Tuesday that appeared to bode effectively for his affirmation.

After the listening to was over, Vermont Unbiased Sen. Bernie Sanders introduced he would oppose Dr. Robert Califf’s nomination. However Well being, Training, Labor and Pensions Chair Sen. Patty Murray, D-Wash., and rating GOP Sen. Richard Burr of North Carolina each have mentioned they’d assist him.

Califf, who served briefly as FDA commissioner towards the tip of the Obama administration, promised that if confirmed he would use information to streamline the approval of COVID remedies and checks, conduct a full overview of the company’s controversial dealing with of opioid painkillers, preserve concentrate on tobacco regulation, work to make pharmaceuticals extra reasonably priced, and confront medical misinformation on social media.

A heart specialist with robust connections to the pharmaceutical trade and tutorial analysis facilities, Califf insisted that public service is his motivation for returning to the FDA. In a self-deprecating apart, he referred to himself as “a 70-year-old particular person with nothing to achieve.”

His most pointed questioning got here from Sanders, who underscored Califf’s connections to drug firms and his multimillion-dollar investments in pharma shares. “What sort of consolation are you able to give to the American folks when you may have been so carefully tied to the pharmaceutical trade your self?” demanded Sanders.

Responded Califf: “I am completely with you. The worth of prescription drugs is means too excessive on this nation.”

New Hampshire Democratic Sen. Maggie Hassan pressed Califf on the necessity to change FDA prescribing data for opioids, to raised mirror the danger of habit.

Republican Sen. Invoice Cassidy of Louisiana instructed the nominee, “I thanks to your imaginative and prescient.”

The FDA has been straining for months underneath an enormous pandemic workload at the same time as a collection of scientific disputes — together with the approval of a controversial Alzheimer’s drug — have marred its public popularity. Califf’s nomination by Biden final month was seen as a protected, regular option to information the company, which hasn’t had a everlasting chief since final January.

The FDA regulates the vaccines, medication and checks used to fight COVID-19. That is on prime of its regular duties regulating a swath of shopper items and medicines, together with pharmaceuticals, medical gadgets, tobacco and vaping merchandise.

Greater than a yr after authorizing the primary COVID-19 vaccines, the FDA nonetheless faces a string of key choices, together with whether or not to increase booster photographs to youthful teenagers and youngsters. Moreover, as researchers be taught extra in regards to the omicron variant, the FDA will play a deciding function in whether or not the photographs needs to be up to date to focus on the pressure.

FDA commissioners aren’t usually concerned in day-to-day scientific evaluations, however they function the go-between the company’s scientists and political decisionmakers within the White Home.

That relationship got here to a head this fall when the FDA’s two prime vaccine reviewers publicly opposed the Biden administration’s plan to supply boosters to all American adults. Each have since retired from the company after decades-long careers, giving Califf a possibility to decide on key replacements. Final month, the FDA in the end signed off on boosters for all adults as COVID-19 circumstances surged once more.

Califf will even assist select a brand new chief for the FDA’s tobacco middle, which is weighing whether or not to ban e-cigarettes from Juul and different vaping firms as a consequence of their dangers to teenagers.

Califf’s first stint as FDA commissioner got here after greater than 35 years at Duke College, the place he based a contract analysis group that conducts research for most 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. If confirmed, Califf would resign from all of these positions, in line with a latest federal disclosures type.

Beneath Califf in 2016, the FDA added bolstered warnings to prescription opioids and started publicly scrutinizing all new opioid drug functions. However the company has but to implement many different steps really useful by consultants, together with an general overview of whether or not the opioid painkillers pose extra dangers than advantages for society at massive.

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