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

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The 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.

Robert Califf, who President Joe Biden nominated this month to lead the agency, is being looked to by forces from all sides as someone who can reboot the FDA’s Center for Tobacco Products, a division that has come under criticism for appearing inconsistent with its regulatory power and unwilling to challenge the largest players in the tobacco and e-cigarette industries.

“They still haven’t made a single tough decision in 10 years,” said Gregory Conley, the president of the American Vaping Association, which wants the FDA to bless e-cigarettes as an acceptable alternative for smoking for adults.

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.

“What the CTP does or doesn’t do in the next 24 months will, for most people, define whether it has made the fundamental difference that was hoped when the Tobacco Control Act was passed,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids, referring to the 2009 law that created the Center for Tobacco Products.

Califf, a cardiologist who led the FDA during the final months of the Obama administration, is Biden’s choice to replace Janet Woodcock, who has served as acting commissioner for the last 10 months.

Read full article here.

Katherine Ellen Foley – Politico – 2021-11-27.

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