Youth e-cig use hits decade low, survey says

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

Sep 06, 2024 View in browser   By Lauren Gardner and David Lim With Carmen Paun and Erin Schumaker Driving The Day Rates of teenage vaping have dropped over the past year. | Steven Senne/AP NEW VAPE LOWS — The FDA and the CDC on Thursday touted the latest National Youth Tobacco Survey results as a public health win, with e-cigarette use among middle and high schoolers falling 25 percent over the past year to reach its lowest level in a decade. But public health advocates say the burden is now on the FDA to ensure illegal vapes — and flavorful nicotine pouches sold in small tins — marketed to kids are kept out of their hands. “The most effective strategy to avoid a lifetime of nicotine addiction is preventing young people from ever picking up a tobacco product, so I am encouraged by the progress in this declining rate of e-cigarette use by children,” Sen. Dick Durbin (D-Ill.), a vocal anti-smoking advocate and critic of the agency’s tobacco work, said in a statement. “But FDA is at a crossroad — and faces real tests of its ability to regulate and enforce the law against illegal vapes that target children.” Clear the shelves: To Durbin and groups like the American Heart Association, the agency and the Justice Department must do more to eliminate the backlog of premarketing applications for tobacco products and yank all unauthorized vape products from the market. Brian King, director of the FDA’s Center for Tobacco Products, indicated more operations to prevent illegal vape shipments are in the works after pointing to interagency partnerships over the last year that have resulted in product seizures and fines against manufacturers and retailers. A looming threat? Despite the positive numbers, anti-tobacco groups remain concerned about the allure of nicotine pouches to children. Youth use of those products remains under 2 percent, but booming sales and the availability of myriad flavors worry advocates. “Nicotine pouches have the same characteristics that made e-cigarettes so appealing to young people, including kid-friendly flavors, heavy promotion on social media and being easy to hide,” said Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids. Luis Pinto, a spokesperson for tobacco giant Reynolds, said the brand is committed to preventing underage use of tobacco and nicotine products. “Our mission is simple: Transition adult smokers to potentially reduced-risk alternatives,” he said. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Based on reader reaction to Wednesday’s newsletter, we have many Swifties among us. Reach out and send tips and preferred Taylor eras to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM). In Congress The FDA is investigating whether tampons contain metals that can pose a risk to users. | Rich Pedroncelli/AP FDA TO STUDY TAMPON SAFETY — The FDA is commissioning an independent review of possible adverse health effects from normal tampon use following congressional pressure and a recent study that suggested they may expose women to metal. “I’m pleased that FDA is taking action to help us better understand the issue of metals in tampons, and I am going to keep pushing to make sure we are taking all the steps we need to keep women safe and healthy,” Sen. Patty Murray (D-Wash.) said Thursday. The FDA’s device center is also launching a study to examine how much metal might be released by tampons in normal use — a step it says will enable a risk assessment “based on a worst-case scenario of metal exposure.” Results will be released following peer review. “All studies have limitations, and the FDA observes that while the study found metals in some tampons, the study did not test whether metals are released from tampons when used,” an FDA spokesperson said in an email. “It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use.” Industry Intel WEEKLY INSULIN RACE — Eli Lilly reported positive Phase III results Thursday from studies of its once-weekly insulin candidate for people with diabetes, nearly two months after the FDA rejected another company’s weekly injection. Lilly said the studies, which followed people with adult type 2 diabetes who either were new insulin users or had switched from daily injections, showed the participants experienced A1C reduction similar to that seen in daily insulin use. Companies like Lilly and Novo Nordisk — also a competitor in the GLP-1 market — argue that weekly insulin shots would be easier for patients to manage, lowering the risk of nonadherence and the negative health outcomes that can result from missing doses. The FDA rejected Novo’s application to sell a weekly insulin shot to patients with type 1 diabetes in July. Those patients depend on daily injections to survive, and agency staff had flagged elevated cases of hypoglycemia, or low blood sugar, in study participants with type 1 diabetes. LYKOS EXEC STEPS DOWN — Lykos Therapeutics CEO Amy Emerson is leaving the company less than a month after the FDA rejected its application to offer the psychedelic drug MDMA, also known as ecstasy, as a treatment for post-traumatic stress disorder. Emerson led the firm, once the front-runner in the race to win FDA approval for a psychedelic, for nearly a decade. After the rejection, Lykos cut 75 percent of its staff. What's next? The FDA is holding a public meeting today on treatments for post-traumatic stress disorder, including psychedelics, that will include a panel on efforts to accelerate their use for mental health treatment. Pharma Worldwide PRODUCING PARTNERSHIPS — The company behind the world’s first chikungunya vaccine is working to partner with manufacturers in regions that have experienced disease outbreaks but don’t yet have access to the shot, its CEO told POLITICO. French vaccine maker Valneva is working with Brazil’s Butantan Institute, a government-owned vaccine manufacturer, to produce the shot once it’s approved there, CEO Thomas Lingelbach said, which he expects to happen by early 2025. The South American country reported a quarter million cases of chikungunya this year and 161 deaths. The mosquito-transmitted viral infection is typically mild but can cause debilitating, long-term muscle pain. The partnership, in which Valneva produces drug substance in Scotland and then ships it to Brazil where production is completed, will serve as a model for other collaborations meant to provide access to the vaccine in countries where the chikungunya virus is endemic, he said. Valneva is also working on a partnership with at least one Asia-based manufacturer to produce the shot for India, Lingelbach said.  Why it matters: While no reports of locally acquired chikungunya cases in the U.S. since 2019 have been reported, the virus is a major health problem in the Americas. A recent study warned that climate change — and a large population in North America and Europe with no immunity to the virus — may lead to future epidemics. The FDA approved the Valneva vaccine in November, while the European Medicines Agency approved it last spring. Research Corner GLP-1 POPULATION WITH PRIVATE INSURANCE — More than 57 million adults under 65 with private health insurance could be eligible for GLP-1 drugs under current FDA indications, a KFF analysis found. That represents 42 percent of adults under 65 with private insurance plans. “Non-elderly adults who are obese make up the largest share of those clinically eligible in the private insurance market: 45.8 million people or 80% of those indicated as possibly eligible in the private market are obese, of which 41.8 million people are indicated based on obesity alone,” the KFF research states. Document Drawer The FDA announced an Oct. 10 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss Stealth BioTherapeutics’ application for an injection to treat Barth syndrome, a rare genetic disorder that results in an enlarged and weakened heart. WHAT WE'RE READING Roughly 2,000 pharmaceutical manufacturing plants have not had surveillance inspections since before the Covid-19 pandemic, including 340 in India and China, The Associated Press’ Matthew Perrone and Nicky Forster report. Alaska’s Republican governor, Mike Dunleavy, vetoed a bill to expand access to birth control by forcing insurers to cover up to a year’s supply, The Associated Press’ Becky Bohrer and Gene Johnson report.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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