Ex-FDA Tobacco Head Advising Company on Smoker Cessation (1)

A former head of the FDA’s tobacco center has joined the advisory board of a company developing a first-of-its-kind smoking cessation inhalation product that he says has the potential to be a “game changer” in lowering US tobacco use.

Mitch Zeller, who led the Center for Tobacco Products from March 2013 until his retirement in April 2022, is now providing policy and regulatory strategy consulting to Qnovia, Inc., a pharmaceutical company focused on inhaled therapeutics. The company is currently preparing an application to the Food and Drug Administration’s Center for Drug Evaluation and Research for a cessation therapy which, if approved, will be the first inhaled prescription therapy to help tobacco smokers quit.

Zeller’s addition to the company’s advisory board comes as the FDA aims to finalize proposed bans on menthol cigarettes and flavored cigars by August. The FDA also plans to propose a rule limiting nicotine levels in cigarettes and some other tobacco products. Zeller said access to Qnovia’s product can be one essential tool along with an administration-wide effort to provide support to those with nicotine addictions once those product standards take effect.

“Some people will be able to quit cold turkey, but a whole bunch won’t, and they will be seeking nicotine elsewhere,” Zeller said in an interview.

“The last thing that we want smokers to do if any of those policies go into effect is to simply switch to another tobacco product,” he added.

The Centers for Disease Control and Prevention describes tobacco use as the “leading cause of preventable disease, disability, and death” in the US. An estimated 40 million American adults currently smoke cigarettes, with more than 3 million middle- and high-schoolers identifying as tobacco users.

Nearly half a million Americans die prematurely due to either smoking or exposure to secondhand smoke, according to the CDC.

FDA Commissioner Robert M. Califf said in a House hearing Wednesday on the agency’s fiscal 2024 budget request that the FDA is on track to finalize the proposed menthol and characterizing flavor bans by August. He cautioned, though, that “our healthcare systems are not set up to deal with” the number of tobacco users coming off their addiction once they are no longer able to access these products.

Zeller said addressing nicotine addiction requires a more coordinated government approach that includes additional therapies available to smokers, insurance coverage for these products, and other support like counseling services and public education.

“The government has, I would say, a moral and ethical responsibility to step up its game when it comes to treatment,” he said.

‘Public Health Opportunity’

The FDA has already approved and cleared some nicotine replacement therapies, which are intended to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without the toxic chemicals included in combustible cigarettes. Prescription treatments include nicotine spray and inhalers, while OTC therapies are offered through skin patches, chewing gum, and lozenges.

Prior to leading the tobacco center, Zeller worked for a decade as a senior vice president for pharmaceutical and healthcare consulting firm Pinney Associates. Zeller said that while serving in this role, he witnessed “how ineffective” existing NRT products “were in the real world.”

“Primarily because when you deliver nicotine orally, or dermally through the patch, that delivery is really slow. By contrast, a cigarette is designed to deliver the nicotine to the brain in less than 10 seconds after one takes a puff,” he said.

A 2020 US Surgeon General report found that more than three out of five US adults who have smoked cigarettes have quit, and that while a majority attempt to quit each year, less than a third use FDA-approved cessation medications or behavioral counseling.

Now, Zeller is helping Qnovia meet the requirements for FDA approval. Qnovia’s product is a “12-week, step-down therapy” that provides smaller, measured doses of nicotine through an inhalation device, said Qnovia CEO Brian Quigley, who previously served as president and CEO of the tobacco manufacturer Altria Group.

“What I became convinced of was that this was a public health opportunity that has the potential to be a game changer when it comes to cessation and progress in reducing consumption prevalence of the most harmful tobacco products,” Zeller said.

Balancing Safety, Efficacy

Qnovia is seeking FDA approval for its cessation therapy through the FDA’s 505 (b)(2) pathway for new drug applications, which requires reports of safety and effectiveness investigations, where some of the information may come from outside studies or published literature.

Quigley said in an interview that that the company conducted its first pre-application meeting with the FDA in 2019, and has completed all safety studies associated with the product. The company hopes to begin human clinical trials by the end of this year, Quigley said.

One unique challenge in getting Qnovia’s product approved is demonstrating the safety of breathing in the therapy.

“Inhalation raises a set of questions about safety because you’re talking about pulmonary delivery that obviously are not present with gum, patch, and lozenge on the safety side,” Zeller said.

“But the flip side of that is the efficacy,” he added.

Quigley said he believes the FDA understands “the potential impact of what delivering the drug more quickly when the patient is really feeling the craving, what that can do to improving efficacy outcomes.”

Coordinated Response

But Qnovia’s therapy alone won’t be enough to reduce tobacco consumption across the US, Zeller said.

“There needs to be a whole of government approach to this,” he said. “FDA has nothing to do with reimbursement policy, so the Department of Health and Human Services needs to play a leadership role in bringing everybody together to address tobacco cessation, and look at it through every facet.”

An FDA-commissioned outside review by the Reagan-Udall Foundation found that FDA’s tobacco division lacks a clear strategy to regulate the industry and reduce harms from tobacco use. The group’s report, released in December, called for the FDA to work better with the administration “to make enforcement of the tobacco laws a government-wide priority,” especially “to address the marketing of illegal products and the risks of youth use.”

Tobacco industry and consumer groups have expressed concern on the availability of alternatives for smokers to turn to once the FDA finalizes its menthol and characterizing flavor product standards, arguing that some may turn to an illicit, unregulated market of products. The FDA has said the menthol bans would only apply to tobacco manufacturers, wholesalers, and retailers, and not individual consumers, and that any illicit market is estimated to be relatively small.

Zeller said taking on regulatory policies to limit tobacco products comes with it “the responsibility to address the need for improved products, programs, and services to help smokers quit.”

“I hope that this administration will see this as an administration-wide obligation to take a comprehensive approach to reducing tobacco use,” he added.

Michael Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. Bloomberg Law is operated by entities controlled by Michael Bloomberg.