Former FDA tobacco head: Smokers need a new tool to quit

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Apr 04, 2023 View in browser   By Katherine Ellen Foley and David Lim Driving the Day Pharma company Qnovia wants the FDA to approve its RespiRx nicotine-replacement device (above) as a drug product. | Qnovia INHALED PRESCRIPTION TO QUIT SMOKING — Roughly a year after Mitch Zeller retired as the head of the FDA’s Center for Tobacco Products in 2022, he joined the advisory board of Qnovia, a young pharma company focused on developing inhaled therapies, last month. The first order of business for the well-respected former regulator? Advising the company on getting the first inhaled smoking cessation device approved by the FDA as a drug product. “Here’s the reality: We’ve plateaued,” Zeller told Prescription Pulse. “We’re doing a great job at preventing kids from becoming new smokers, but when it comes to existing adult smokers, almost all of whom are addicted, we need something new. We need something innovative.” Unlike nicotine gum or patches, Qnovia’s product, dubbed RespiRx, allows users to inhale nicotine, but it is not an e-cigarette, explained Brian Quigley, Qnovia’s CEO and former head of Altria’s smokeless tobacco division. Roughly 40 million smokers will try — and fail — to quit this year, according to the CDC. Quigley blames a lack of effective smoking-cessation tools. While neither Zeller nor Quigley described their product as a game-changer, it could well be if it’s successful. RespiRx weans users off nicotine over time by having a preset number of nicotine doses available throughout the day. E-cigarettes appeal to smokers looking to quit because they provide the same hit of the addictive stimulant nicotine but without harmful tobacco smoke. Smokers often prefer vapes to nicotine replacement patches or gum because they provide immediate nicotine delivery, similar to the way cigarettes do. But most smokers who switch to e-cigarettes never truly overcome their nicotine addiction — they just use a new, albeit less harmful, product. Vapes are also regulated as tobacco products — which must only prove to the FDA that they are not harmful to adults and not likely to draw in kids. Qnovia will seek approval as a medical product regulated by the agency’s Center for Drug Evaluation and Research. The company must demonstrate RespiRx is safe and effective through rigorous clinical testing. Qnovia expects to file an investigational new drug application for RespiRx this year, which would allow the company to begin clinical trials. Qnovia aims to complete the trials by 2025 when it will file for approval. The FDA’s approval process could then take another 10 months unless the agency reviews RespiRx on an accelerated pathway. If approved, it would be Qnovia’s first product to hit the market. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Attending the World Vaccine Congress this week in Washington? Make sure to say “hi” to Katherine and Future Pulse reporter Carmen Paun, who will both be reporting in person. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with David, who explores the implications of the FTC’s decision to tell biotech company Illumina to dissolve its acquisition with Grail, a multicancer early-detection test company. Listen to today’s Pulse Check podcast In the Courts The FTC has mandated that Illumina dissolve its acquisition of Grail, the maker of multicancer tests like the one shown above. | Business Wire ILLUMINA ORDERED TO UNWIND GRAIL DEAL — On Monday, the Federal Trade Commission ordered DNA-sequencing company Illumina to unwind its acquisition of Grail, a multicancer early-detection test company, finding the deal is likely to substantially reduce competition for research, development and commercialization of cancer tests in the U.S. Illumina said it would appeal the decision, which reverses a September ruling by the FTC’s Chief Administrative Law Judge D. Michael Chappell that the acquisition would not negatively impact the nascent multicancer diagnostics market. Antitrust concerns are also bogging down the deal in the European Union. Proxy battle: Wall Street has some issues, too. Activist investor Carl Icahn argues Illumina’s board took “ill-advised (and frankly inexplicable) actions” related to the acquisition of Grail and is seeking three seats at the company’s 2023 shareholders’ meeting — which has not been set yet. Illumina is urging shareholders to vote against Icahn’s board nominees, arguing they “have no relevant healthcare or genomics expertise on paper.”   JOIN POLITICO ON 4/5 FOR THE 2023 RECAST POWER LIST: America’s demographics and power dynamics are changing — and POLITICO is recasting how it covers the intersection of race, identity, politics and policy. Join us for a conversation on the themes of the 2023 Recast Power List that will examine America’s decision-making tables, who gets to sit at them, and the challenges that still need to be addressed. REGISTER HERE.     Around the Agencies CMS GIVES INSURERS A WIN — CMS said late Friday it will phase in Medicare Advantage payment adjustments — reviled and heavily lobbied against by the insurance industry — over three years, blunting the immediate impact to payers’ bottom lines. The decision will give insurers more money next year than CMS proposed in February. The agency expects the fiscal 2024 rate announcement to result in a 3.3 percent increase in payments to Medicare Advantage plans relative to fiscal 2023 compared with the 1 percent the agency initially proposed. CMS Administrator Chiquita Brooks-LaSure told reporters the government is confident the Medicare Advantage market would “remain strong” despite the payment changes and predicted premiums would remain stable and supplemental benefits would be generous. “The MA market is highly competitive and has seen rapid growth over the past several years,” Brooks-LaSure told reporters. “Enrollment in MA has doubled in the last decade, and any reduction in benefits would be decisions made by companies, not because of CMS policies.” Drug Pricing PFIZER SHRINKS DISCOUNTED XELJANZ ACCESS — Effective May 1, Pfizer will limit the number of pharmacies that can distribute a pricey blockbuster drug to treat autoimmune conditions through a federal program that discounts prices for low-income patients, Katherine reports. Hospitals will be permitted to contract with only one external pharmacy in addition to their in-house pharmacy to distribute Xeljanz — which earned Pfizer $1.8 billion in 2022 — through the so-called 340B program. The 30-year-old program provides cheaper drugs to hospitals and clinics that serve low-income patients. Without insurance, Xeljanz costs between $2,000 and $3,000 a month. Pfizer said the move comes as a result of hospitals abusing the 340B program. But participating 340B hospitals, which will have to pay drugmakers more for Xeljanz than they’re paying now, say that pharma company restrictions on drugs harm patients. Eye on the FDA MAIL-BACK ENVELOPES FOR OPIOIDS MANDATED — The FDA said it will require makers of outpatient opioid pain relievers to include envelopes for patients to safely dispose of any unused pills, Katherine reports. The requirement, which the agency expects to go into effect next year, aims at curbing opioid misuse. “These efforts will not only increase convenient disposal options for many Americans, but also reduce unfortunate opportunities for nonmedical use, accidental exposure, overdose and potential new cases of opioid use disorder,” FDA Commissioner Robert Califf said in a statement Monday. ADVISERS TO DISCUSS OTC BIRTH CONTROL — The FDA said it will gather independent experts who focus on nonprescription drugs and obstetrics, reproductive and urologic drugs to discuss HRA Pharma’s bid for approval of an over-the-counter birth control pill. The meeting is set for May 9 and 10. If approved, HRA Pharma’s pill, called Opill, would be the first daily hormonal birth control sold without a prescription. Easier access to birth control has been a top demand of activists and the Biden administration since the leaked draft decision of the Supreme Court to overturn Roe v. Wade, which the court did last year. Quick Hits Abortion-rights activists are split over what limits to impose on ballot initiatives that would protect abortion access in red or purple states, POLITICO’s Alice Miranda Ollstein and Megan Messerly report. For Kaiser Health News, Christina Saint Louis reports that rural Minnesota residents still face barriers to receiving substance use treatment despite the state’s program overhaul. Document Drawer CMS has quietly disclosed that fewer Medicare Part B drugs — 20 instead of the 27 announced in March — will have lower coinsurance payments starting in April due to provisions in the Inflation Reduction Act that target drugs whose price hikes outpace the annual inflation rate. Rep. Buddy Carter (R-Ga.), along with Elissa Slotkin (D-Mich.), Chrissy Houlahan (D-Pa.), and Gus Bilirakis (R-Fla.), have announced the launch of a bipartisan domestic pharmaceutical manufacturing caucus.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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