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

With cigarette sales on the rise for the first time in 20 years, more than 10% of high school students vaping regularly, and tobacco-related illnesses killing nearly half a million Americans each year, the agency faces a a pivotal moment when it could be forced to face these tough regulatory decisions.

“What the CTP does or does not do over the next 24 months will determine, for most people, whether it has made the fundamental difference that was hoped for when the tobacco control law was passed,” said Matthew Myers, campaign chair. for Tobacco-Free Kids, in reference to the 2009 law that created the Tobacco Products Center.

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

Meanwhile, the agency has come under scrutiny over its authorization of coronavirus vaccines and treatments as well as the approval of a controversial Alzheimer’s disease drug. These issues are likely to remain in the foreground for the foreseeable future. But it is tobacco control that has the potential to have some of the country’s most important public health consequences.

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

“The FDA has really been a piñata since Gottlieb left, so they kind of left the career staff there to determine the priorities,” said a senior tobacco industry official with exam experience. CTP who requested anonymity because of the agency. continuous review of their products. “They just got beaten up by everyone.”

An FDA spokesperson said the agency was working on “actions to protect the public, especially young people., harm from tobacco products and looks forward to our continued work with the administration to achieve these goals. “

Industry and public health experts agree that Califf, if confirmed, has an opportunity to ease their mutual frustration with the agency by establishing a concrete agenda for tobacco regulation.

“[CTP has] a huge workload and a difficult time to prioritize, ”said a former senior FDA official familiar with the inner workings of the CTP, who requested anonymity because he is not authorized to discuss the matter. the question. “It’s not the sexiest answer, but it’s very true. You sort of [have] to get in and help them focus.

The former commissioners tried to guide the CTP, but tobacco policy hampered these efforts. Lawmakers in states where the industry operates have consistently opposed regulations that would hurt sales.

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

Regardless of the policy, Califf – who likely won’t be confirmed until January because the Biden administration missed a deadline submit documents to the Senate HELP committee – may need to act quickly as a chase series that have emerged as part of the CTP’s inaction comes to a head in the coming months. The lawsuits could force the agency to speak out on issues it has long avoided, such as whether or not to ban menthol-flavored tobacco products.

A California federal judge said earlier this month that if the FDA does not enact regulations to end the sale of menthol cigarettes by April, the court could consider it an unreasonable delay under the law. federal.

Separately, public health groups have called on a Maryland federal judge to require the agency to provide an updated timeline for the review of products from some of the largest e-cigarette manufacturers, after the FDA has passed the September deadline to do so. The FDA has made rulings on more than 98% of the nearly 6.7 million flavored products that have submitted applications for approval, but, notably, not for some of the biggest players in the industry, including Juul.

And small e-cigarette companies are appealing the FDA’s denial of their products to the courts, saying the agency failed to properly assess their claims. In recent weeks, the FDA has rescinded its own denial order for three companies – a move that puts hundreds of e-cigarette products back on the market while they wait again for a decision.

“All of these decisions have reached the point where the agency’s action will advance the problem or everyone will be disappointed with the agency’s failure to use its authority,” Myers said.

There are other issues the CTP is stuck on, even though they haven’t reached the courts yet. The agency is sitting on certain applications of tobacco products that claim to be less harmful than traditional cigarettes; one of those products, from tobacco giant RJ Reynolds, has been under FDA review for almost four years.

The agency has yet to come up with 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 expensive. addictive. Woodcock told reporters in April he was still under investigation.

Many public health experts believe the CTP wants to make regulatory changes that could dramatically reduce harm to the public – it just needs a senior commissioner in charge.

“To have a new commissioner come in and put a roadmap there – that’s first and foremost what Califf has to do,” the tobacco industry official said. CTP, he says, needs a leader’s guidance to start reducing these problems. “They’re all over the place… but the agency is quite capable of walking and chewing gum at the same time.”

Source link

About Margaret Shaw

Check Also

Support for quitting smoking

January is a popular month to quit smoking, so if you are considering quitting smoking …