lizzy's device digest
Jeff Shuren's FDA legacy: Bringing stability to device regs
The news of Jeff Shuren's departure from his long-held role as head of the Food and Drug Administration's Center for Devices and Radiological Health — which my colleague Lizzy Lawrence reported exclusively last month — has left the medical device world stunned and struggling to imagine the agency without him.
Shuren has led CDRH since 2009, with key charges of earning the medical device industry and the public's trust. Experts say he's been more successful with industry, including by making the regulatory labyrinth for medical devices more predictable, but not as much with the public — especially as risky products continue to slip through the cracks, like the Philips sleep apnea machines recalled in 2021.
Lizzy interviewed a dozen of Shuren's former colleagues, patient advocates and device industry leaders about his time at the FDA: they paint a picture of a seasoned regulatory advocate who patiently navigated Washington's bureaucratic maze. Read more.
adcoms
Digital health advisory committee takes shape
Elsewhere at the regulatory agency, the FDA's first advisory committee for digital health is now staffed up with a roster of industry experts, and its first meeting is slated for Nov. 20-21. Members, drawn heavily from academic institutions including Emory, Washington University and the University of Rochester, will take up issues related to generative AI-enabled medical devices. Among members is Jessica Jackson, who founded behavioral health site Therapy is for Everyone, Yaniv Kerem, an emergency medicine doctor at the Kaiser Permanente Redwood City Medical Center, and the University of Kentucky College of Medicine's Melissa Denise Clarkson, an expert in patient advocacy. Made up of 9 core voting members, the committee's goal is to advise the FDA on digital health issues and regulations.
FDA has also identified a pool of private sector leaders to represent the digital health industry's interests on the committee occasionally as non-voting members: That includes 7wireVentures' Lee Shapiro and several executives from Abbott, Medtronic and Boston Scientific.
telehealth
Study points to risks for weight loss drugs without prescriptions
As sites hawking weight loss drugs online proliferate, my colleague Katie Palmer highlights an urgent new study in JAMA Network Open sounding the alarm about the risks of so-called "compounded" medicines, and some illegal online pharmacies skipping the prescription process entirely. Researchers at the University of San Diego and the University of Pécs in Hungary concluded that semaglutide ordered from illegal sites contained significantly more of the drug than labeled, and in one case, showed signs of a potential bacterial contamination during manufacturing.
"It's just a very, very risky business, going online and buying this product," UCSD's Tim Mackey, who co-authored the study, told Katie. "Just because it's online and it's accessible and it can be sold without a prescription, does not mean it's authentic." Read more.
Hims & Hers beats Wall Street expectations, raises revenue outlook
As some virtual care businesses continue to stumble (despite new leadership Teladoc's latest earnings demonstrated declining revenue and missed targets, as well as as a fresh impairment charge) all eyes are on direct-to-consumer businesses crowding the GLP-1 market. Among them is Hims & Hers, which reported 155,000 net new subscribers and a total active membership of almost 2 million people. Revenue topped $315 million in the second quarter, up 52% from the same period last year. "Early weight loss management program could provide long-term gains: The launch of compounded GLP-1s including semaglutide could drive revenue upside if customer demand, and HIMS' able to supply enough product, exceeds
expectations," Leerink Partners analysts wrote in a investor note.
boardroom drama
23andMe board rejects plan to take company private
A special committee within genetic testing giant 23andMe's board of directors rejected an offer from co-founder and CEO Anne Wojcicki to take it private, STAT's Matt Herper reports. In a letter made public late last week, the board determined that Wojcicki's proposal didn't offer a premium to the current stock price and didn't include commitments from other investors, among other hurdles.
"Our expectation after months of work was that you would submit a fully-financed, fully-diligenced, actionable proposal that is in the best interests of the non-affiliated shareholders," the committee wrote. Still, it offered her "a limited amount of additional time to submit a revised proposal in line with our expectation." Read more.
Cybersecurity
HHS posts notice on Change Healthcare hack
A cyberattack notification has appeared on the Health and Human Services Department Office for Civil Rights data breach portal last week just about six months after Change Healthcare's devastating ransomware attack that brought payment processing across the health care industry to a halt; Change filed the report in mid-July, according to HHS. Among interesting details: UnitedHealth property Change pegs the number of affected individuals at 500 — a shocking departure from from UnitedHealth CEO Andrew Witty's previously estimated "1/3 of all Americans."
Still, HHS said 500 is the minimum threshold for posting a notice on its portal, and that Change is still determining the total number affected.
A UnitedHealth spokesperson told Brittany that the review is still ongoing and in its final stages, but Change has already begun to notify affected individuals. The data so far "is in line with earlier information of a substantial proportion of Americans being impacted," the spokesperson said in a statement, "and the OCR report can be updated if needed at the completion of the review."
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