FDA’s balancing act on baby products

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Jan 03, 2024 View in browser   By Lauren Gardner and David Lim Driving the Day The FDA's approval of a smart bassinet and a wearable pulse oximeter for newborns could spur makers of similar gadgets to apply for authorization. | Issouf Sanogo/AFP via Getty Images THE FUTURE OF ‘SAFE SLEEP’? Two popular high-tech gadgets for parents of newborns — Happiest Baby’s SNOO and Owlet’s Dream Sock — received the FDA’s so-called de novo authorization — which establishes new medical-device product classes — in 2023 that could pave the way for competitors to pursue the agency’s stamp on their items. The “smart” bassinet and the wearable pulse oximeter are intended to keep infants on their backs and monitor heart rate and oxygen levels, respectively, while they sleep. Though the FDA approvals don’t include indications to prevent sudden infant death syndrome and other unexplained deaths, some pediatric experts worry parents will infer they do and feel compelled to buy the pricey devices — or unwittingly think the products are safe for engaging in practices like sharing beds or placing toys and blankets in a baby’s sleep space, which the American Academy of Pediatrics warns create unsafe environments for infants. The FDA’s entrée into the connected baby device market underscores the delicate balance the agency must strike between authorizing products that meet its safety standards and setting limits on how they can be advertised, even though consumers might have their own perceptions of what the items can and can’t do. “When you’re telling parents this is something that’s FDA-approved, you want to do everything you can for your baby, and you’re led to believe you must do this to be a good parent,” said Alison Jacobson, executive director and CEO of the nonprofit First Candle, an education and grief support organization focused on sudden unexplained infant deaths. Future goals: Happiest Baby and Owlet plan to collect data on their devices that could potentially support indications for SIDS prevention. The companies’ CEOs said the FDA’s approvals lend legitimacy to the reams of data they submitted to the regulator, and they reject arguments that their products could foster unsafe sleep practices. “I think that’s assuming that parents are going to drive more recklessly if they have a car seat,” said Owlet co-founder and CEO Kurt Workman. For now, the SNOO’s and the Dream Sock’s status as first-in-class medical device products means that competitors will likely seek to follow suit with FDA authorizations, said Jeff Gibbs, an FDA lawyer at Hyman, Phelps & McNamara. And even though parents may read into what the agency approvals mean with respect to SIDS, he said, “that’s not the company’s responsibility.” IT’S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. And welcome to 2024! Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim). In Congress The FDA is staring down two government funding deadlines. | Sarah Silbiger/Getty Images FDA FUNDING WATCH — Of federal health agencies, the FDA is the one staring down the first of two government funding deadlines, thanks to Congress’’ staggered continuing resolution approach. And with both chambers not back in session until next week, predictions as to what will happen to the agency’s appropriations stream on Jan. 19 is anyone’s guess — though as FDA funding advocate Steven Grossman told Prescription Pulse, a new fiscal 2024 spending bill for the agency by then “is near-impossible, especially without agreement on total spending levels.” Grossman, executive director of the Alliance for a Stronger FDA, noted that President Joe Biden’s fiscal 2024 funding request for the FDA included $105 million for mandated pay raises. If appropriations remain flat for the agency, he said, the “FDA will have to absorb that amount, which effectively reduces funds available to sustain existing programs at current funding levels and will not pay for new initiatives.” Eye on the FDA GOTTLIEB WEIGHS IN ON AI — The FDA should consider carving out certain low-risk artificial intelligence devices from regulation to focus resources on high-risk use cases, Dr. Scott Gottlieb, former FDA commissioner in the Trump administration, recently wrote in JAMA Health Forum. The policy input comes as the FDA’s medical device and drug centers build on a slate of 2023 guidance documents and discussion papers on how the agency plans to oversee artificial intelligence in medical products. “One of the most challenging situations for the FDA arises when it is asked to apply a new regulation to an established industry for the first time,” Gottlieb wrote. Gottlieb, who sits on the boards of Pfizer, Illumina, Tempus and Aetion, suggested the agency consider adopting “authoritative benchmarks” that can be used to help evaluate new technologies. He also argues the agency should review AI devices through a “familiar regulatory pathway.” IN MEMORIAM — Dr. Sidney Wolfe, a consumer advocate whose work with Public Citizen compelled the FDA to pull several dangerous medicines from the market over decades, died Jan. 1. He was 86. “He inspired legions of medical students and made Public Citizen a name admired in the public health community — and feared by Big Pharma,” Robert Weissman, the group’s president, said in a statement. Advocacy by Wolfe, who launched Public Citizen’s Health Research Group with organization founder Ralph Nader in 1971, prompted 28 drugs to be pulled from the market and 10 to have their uses limited, Weissman said. The Washington Post recapped his career in an obituary. MEDICAL DEVICES NEW YEAR, LESS PAPER — The FDA’s medical device center announced Tuesday it has begun to issue electronic export documentation instead of relying on good old-fashioned paper forms. Firms will have 45 days to download or print documents through the Center for Devices and Radiological Health’s export certification application and tracking system, the agency said. WHAT WE'RE READING Zika continues to circulate, but attention and effort to combat the virus have slowed in recent years, The Atlantic’s Olga Khazan reports. Document Drawer The FDA published a draft report — required by the Consolidated Appropriations Act of 2023 — on how the agency plans and uses guidance documents. The FDA issued final guidance containing recommendations for firms reformulating drugs that contain carbomers — synthetic polymers — made with benzene. The FDA issued final guidance to help small entities comply with a new rule governing direct-to-consumer prescription drug advertisements.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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