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

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.

During that time, the agency has faced unrelenting scrutiny over its authorization of coronavirus vaccines and treatments as well as the approval of a controversial Alzheimer’s drug. Those issues are likely to remain at the forefront for the foreseeable future. But it’s tobacco control that has the potential to have some of the most far-reaching consequences for the nation’s public health.

The agency hasn’t focused much on tobacco control since former commissioner Scott Gottlieb left in 2019. Critics say that without a committed leader, the Center for Tobacco Products has been directionless — frustrating for both industry and public health officials.

“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.”

A spokesperson for the FDA said the agency is working on “actions to protect the public, especially youth, from the harms of tobacco products and looks forward to our ongoing work with the administration to further these goals.”

Industry and public health experts agree that Califf, should he be confirmed, has an opportunity to alleviate their mutual frustration with the agency by setting a concrete agenda for tobacco regulation.

“[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.”

Past commissioners have tried to guide CTP, but the politics of tobacco stymied those efforts. Lawmakers from states with heavy industry presence have historically opposed regulation that would hurt sales.

And the White House, under both Democrats and Republicans, hasn’t always been up for the fight, leaving commissioners with little cover to make tough decisions.

Regardless of the politics, Califf — who likely won’t be confirmed until January because the Biden administration missed a deadline to submit paperwork to the Senate HELP committee — may have to act fast as a spate of lawsuits that have emerged as part of CTP’s inaction comes to a head in the coming months. These lawsuits could force the agency to decide issues it has long shied away from, such as whether to prohibit menthol-flavored tobacco products.

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.

Separately, public health groups have asked a federal judge in Maryland to require the agency provide an updated timeline for examining products from some of the largest e-cigarette makers, after the FDA blew past a September deadline to do so. The FDA has issued decisions on more than 98 percent of the nearly 6.7 million flavored products that have submitted applications for approval but, notably, not for some of the industry’s biggest players, including Juul.

And smaller e-cigarette companies are in court appealing FDA’s denial of their products, claiming the agency failed to adequately assess their applications. The FDA in recent weeks has rescinded its own denial order for three companies — a move that puts hundreds of e-cigarette products back on the market while they once again await a decision.

“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.

There are other issues that CTP has stalled on, even if they haven’t reached the courts yet. The agency is sitting on some tobacco product applications that claim to be less harmful than traditional cigarettes; one such product, from tobacco giant R.J. Reynolds, has been under FDA review for nearly four years.

The agency also has yet to propose rules that would reduce the level of nicotine in cigarettes — an initiative that has lost momentum since it was first proposed by Gottlieb in 2017. This would make cigarettes less addictive. Woodcock told reporters in April that it was still under consideration.

Many public health experts believe that CTP wants to make regulatory changes that could meaningfully reduce harm for the public — it just needs a guiding commissioner in charge.

“Having a new commissioner come in and put a road map out there — that’s first and foremost what Califf needs to do,” said the tobacco industry official. CTP, he says, needs the guidance of a leader to start chipping away at these issues. “They’re just all over the place … but the agency‘s completely capable of walking and chewing gum at the same time.”

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