Telehealth
Hims offers Zepbound
Earlier this week, Hims and Hers Health announced it was now offering prescriptions for Eli Lilly's obesity drug Zepbound, which is a little amusing because of how much time and money Hims has spent railing against big pharma. But where a number of telehealth companies are providing access to vials of the branded drug through official partnerships, this appears to be something else. Lilly was quick to disavow any formal ties between the companies, adding that Zepbound "can be prescribed by any licensed healthcare professional."
The more notable news is that Hims has delivered on its promise to offer generic liraglutide, an earlier generation GLP-1 drug that was approved in 2010 to treat diabetes. FDA approved the first generic in December. Hims is marketing the drug on its website for weight loss treatments, noting in a disclaimer that it "may be prescribed off-label for weight loss at a healthcare provider's discretion."
With the boom in popularity of GLP-1 drugs, telehealth companies have raced to cash in. While Lilly's tirzepatide, the scientific name for Zepbound, and Novo Nordisk's semaglutide (aka Ozempic/Wegovy) were in short supply, companies like Hims could legally market copies of the drugs produced by compounding pharmacies. With the drugs off the FDA's shortage list, they'll have to stop. As Hims seeks to keep offering care, generics and selling the name-brand drugs are alternatives. The company continues to prescribe compounded versions of semaglutide at different doses than the FDA-approved drug.
Relatedly: Lilly this week sued two compounding pharmacies for falsely marketing "personalized" doses of tirzepatide.
medical devices
Experts brief lawmakers on device cybersecurity risks
Brittany Trang writes: On Tuesday, a House of Representatives subcommittee held a hearing on medical device cybersecurity, motivated by the discovery earlier this year of a backdoor to a patient monitoring device that led to an IP address at a Chinese university. At a high-level, Republicans asked expert witnesses about device security and if the U.S. needs to be worried that China will use medical devices to disrupt the healthcare system. Democrats asked about the cuts to HHS, FDA, and NIH.
Kevin Fu, a professor at Northeastern University and previously the acting director of medical device cybersecurity at FDA's devices center, fielded many of the questions about the regulator's ability to handle medical device cyberattacks or reports of vulnerabilities while losing employees as part of the mass firing at HHS. He said that the team was a "skeleton crew" during his tenure a few years ago.
"If you lose one, you're probably going to have a much harder time responding to simultaneous threats, which seem to be a natural course of the future," he said. "If you lose two, we might just not have a response."
During the hearing, Healthcare Sector Coordinating Council executive director for cybersecurity Greg Garcia also brought up a proposal his industry group had sent to the Trump administration regarding the wildly unpopular proposed update to the HIPAA security rule, which governs health care cybersecurity minimums. HSCC's cybersecurity working group advised "that the Administration suspend any further consideration of the [HIPAA Security update] as written." Instead, Garcia wants the industry to be able to negotiate what's in the rule — particularly about how prescriptive the government is about how to achieve tight security.
"They give us the what, we give them the how, and then we decide which of these set of controls that we've agreed upon ought to be mandatory," he told STAT in an interview. "That's my nirvana."
health IT TEFCA contractor still funded, despite fears
Also from Brittany: As we reported last month, the health IT world is anxiously waiting to see what happens to TEFCA, the government-supported national health information sharing framework, in the new administration. There are rumors that the government ended its contract with the Sequoia Project to coordinate TEFCA — or that it might.
An alarming piece of evidence cropped up: An HHS webpage titled "Ending Wasteful Spending" itemizes the TEFCA contract on a list of cancelled contracts. But multiple sources familiar with the situation told STAT that the contract is ongoing and that TEFCA is proceeding as normal for now. It's unclear how the list was compiled or if it's at all indicative of future cancellations. (Let us know what you know.)
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