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Around the nation: FDA proposes new limits on nicotine


FDA has proposed a new rule limiting the amount of nicotine in cigarettes and certain other tobacco products to reduce the risk of addiction, in today's bite-sized hospital and health industry news from California, Maryland, and New Jersey. 

  • California: Earlier this month, Transcarent announced plans to acquire the health benefits platform Accolade in a deal valued at $621 million. According to Fierce Healthcare, Transcarent will finance the deal through a fully committed equity financing by General Catalyst and 62 Ventures. The deal is expected to close in the second quarter of 2025, after which Accolade will become a privately held company. "By integrating our recently introduced generative AI-powered WayFinding and comprehensive care experiences with Accolade's advocacy, expert medical opinions, and primary care, we have a solution that finally makes it easy to access high-quality health and care and deliver lower costs for the people who pay for care – employers, and all of us," said Transcarent CEO Glen Tullman, adding that the acquisition was a "perfect fit" for the company. (Landi, Fierce Healthcare, 1/8)
  • Maryland: FDA has issued a proposed rule to significantly reduce the amount of nicotine in cigarettes and certain other tobacco products. The proposed rule, which has been several years in the making, would cap the maximum nicotine level in cigarettes and certain other combusted tobacco products at 0.7 mg/g of tobacco. According to FDA, reducing the amount of nicotine in each cigarette from 10 to 15 mg to below 0.7 mg would help make cigarettes less addictive. If the rule is finalized, the United States would be the first country in the world to place a strict limit on nicotine. "Reducing nicotine levels in cigarettes will be a watershed moment in public health by helping addicted smokers quit and by preventing young people from starting smoking," said F. Joseph McClernon from Duke University School of Medicine. "The policy will save millions of lives, trillions of dollars in healthcare costs, and countless suffering from tobacco-related disease." FDA is taking public comments on the proposed rule through Sept. 25. The agency also plans to seek input from its Tobacco Products Scientific Advisory Committee. (Lou, MedPage Today, 1/15)
  • New Jersey: Last week, Johnson & Johnson (J&J) announced plans to buy Intra-Cellular Therapies in a deal worth $14.6 billion. Through the acquisition, J&J will gain access to Intra-Cellular drug Caplyta, which has been approved to treat schizophrenia and bipolar-related depression. Intra-Cellular has also asked U.S. regulators to approve the drug to be used in combination with regular antidepressants to treat major depressive disorder. J&J will also pick up an experimental drug called ITI-1284, which is currently in Phase 2 studies for anxiety and Alzheimer's-related psychosis. "This unique opportunity to add Intra-Cellular Therapies to our Innovative Medicine business demonstrates our commitment to transforming care and advancing research in some of today's most devastating neuropsychiatric and neurodegenerative disorders," said J&J CEO Joaquin Duato. (Joseph, STAT+ [subscription required], 1/13)

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