The overlooked public health issue that could make or break Biden’s new drug regulator

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Robert Califf, who President Biden nominated this month to lead the FDA, is being looked to by forces from all sides as someone who can reboot the agency’s Center for Tobacco Products

11/27/2021 07:00 AM ESTThe next head of the Food and Drug Administration takes over an agency that studiously avoided answering one of the most pressing public health questions for over a decade: how to regulate the expansive tobacco product market.

With cigarette sales up for the first time in 20 years, over 10 percent of high schoolers vaping regularly and tobacco-related diseases killing nearly half-a-million Americans every year, the agency faces a pivotal moment when it could be forced to confront those hard-lined, regulatory decisions. “FDA’s been a bit of a piñata really since Gottlieb left, so they’ve kind of left it to the career staff there to figure out priorities,” said a senior tobacco industry official with experience of CTP reviews who requested anonymity due to the agency’s ongoing review of their products. “They’ve just gotten battered by everybody.”

“[CTP has] a tremendous workload and a tough time prioritizing,” said a former senior FDA official familiar with the inner workings of CTP, who requested anonymity because they are not authorized to discuss the matter. “It’s not the sexiest answer, but it's very true. You kind of [have] to go in and help them focus.”

A federal judge in California earlier this month said that if the FDA does not issue a proposed rule on ending the sale of menthol-flavored cigarettes by April, the court could consider it an unreasonable delay under federal law. “All of these decisions have reached the point where agency action will either propel the issue forward or everyone will be disappointed about the failure of the agency to use its authority,” Myers said.

 

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Oh-My-GodOmniabsolute=Universe's-Gravity: Hence, all of the Head-of-a-Government's ORGANIZATION will take an envelope under the TABLE$$$$$. (FYI, duh & now you know)

Cool. Will they start to actually administer food or drugs?

There is no greater joy than having financial stability and a life free of debts, that’s why I keep tweeting about RussellHodge_ he's for transparency and trust 💯

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