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Jeff Shuren’s FDA legacy: Bringing stability to device regs
The contents of Jeff Shuren‘s from his long tenure as head of Food and Drug Administration Center for Radiological Resources and Health — which my colleague Lizzy Lawrence reported on last month — has left the medical device world stunned and hard to imagine an institution without him.
Shuren has led CDRH since 2009, with key charges to gain the medical device industry and public trust. Experts say he’s succeeded more than the industry, including by making the medical device regulatory labyrinth more predictable, but not as much as the public — especially as dangerous products continue to slip through the cracks, like with Philips sleep apnea machines recalls in 2021.
Lizzy interviewed many of Shuren’s colleagues, patient advocates and device industry leaders about her time at the FDA: they paint a picture of a seasoned lawyer who persevered in the policy of the Washington administration. Read more.
FDA’s digital health advisory committee launches
Elsewhere in the regulatory agency, the FDA’s first advisory committee for digital health already has a list of industry experts, and its first meeting is scheduled for Nov. 20-21. Members, drawn mainly from academic institutions including Emory, University of Washingtony and these University of Rochester, will take on issues related to AI-enabled medical devices. Among the members are Jessica Jacksonwho created the field of moral health Therapy is for Everyone, Yaniv Kerememergency medicine doctor at Kaiser Permanente Medical Center Redwood City, and go University of Kentucky College of Medicine‘s Melissa Denise Clarkson, a patient advocate. Composed of 9 core voting members, the committee’s mission is to advise the FDA on digital health issues and regulations.
The FDA has also appointed a group of private sector leaders to represent the interests of the digital health industry on the committee sometimes as non-selective members: That includes. 7wireVentures Lee Shapiro and several managers from Abbott, Medtronic and Boston Science.
Study points to dangers of over-the-counter weight loss drugs
As websites selling weight-loss drugs proliferate, my colleague Katie Palmer highlights a groundbreaking new study in JAMA Network Open that laments the dangers of the so-called drugs is “combined”, and illegal online pharmacies that completely violate the doctor’s procedure. The researchers are University of California San Diego and go University of Pécs Hungary determined that semaglutide ordered from illegal sources contained more of the drug than was prescribed, and in one case, showed signs of possible contamination during production.
“It’s a very risky business, going online and buying this product,” UCSD studies Tim Mackey, who wrote the study together, he told Katie. “Just because it’s available online, and can be sold without a prescription, doesn’t mean it’s real. Read more.
Hims & Hers beats Wall Street expectations, raises earnings outlook
While other virtual care businesses continue to stumble (even with new leadership Teladoc’s body recent earnings showed a drop in revenue and adjusted terms, as well as a new impairment charge) all eyes are on the consumer-facing businesses squeezing the GLP-1 market. Among them are Home and Homewhich reported 155,000 new subscribers and active members of almost two million people. Revenue exceeded $315 million in the second quarter, up 52% from the same period last year. “Early weight loss management program can provide long-term benefits: The introduction of combined GLP-1s including semaglutide can drive revenue higher if consumer demand, and HIMS is able to supply enough product, exceeds
expectations,” Leerink Partners analysts wrote in a note to investors.
The board rejects 23andMe’s CEO’s plan for privacy
A special committee within the genetic testing giant 23 and meThe board of directors rejected the proposal from the co-founder and CEO Anne Wojcicki considering it a secret, STAT’s Matt Herper reports. To a In a letter published late last week, the board decided that Wojcicki’s proposal did not provide a premium to the current stock price and did not include commitments from other investors, among other obstacles. the rest.
“Our expectation after months of work was for you to provide a fully funded, fully functional, efficient proposal that is beneficial to our non-member shareholders,” the committee wrote. However, it gave him “more limited time to submit a revised proposal that meets our expectations.” Read on Again.
HHS posts notice on Change Healthcare hack
A cyberattack alert has appeared the Department of Health and Human Services The Office of Civil Rights portal last week nearly six months after the devastating Change Healthcare ransomware attack that halted payment processing across the healthcare industry; The change was reported in mid-July, according to HHS. Among the interesting facts: UnitedHealth Property Change confirms the number of people affected by the crisis
However, HHS said that 500 is the minimum threshold for posting a notice on its portal, and that the Amendment is still measuring the total number involved.
A UnitedHealth spokesperson told Brittany that the review is still in its final stages, but Change has begun notifying affected people. The data so far is “consistent with prior information from a large portion of affected Americans,” the spokesperson said in a statement, “and the OCR report may be updated as necessary upon completion of the review.”
Where can cost-effectiveness analyzes be lacking?
A new review led by Medicaid– the introduction of health technology Waymark‘s co-founder Sanjay Basu raises an interesting health policy question: Are cost-effectiveness analysis models often used to justify policy decisions, excluding groups that are already excluded?
Proving its cost effectiveness is the foundation of Waymark’s success – a community-based healthcare company backed by investors such as Andreessen Horowitz and health plan partners, so perhaps it’s no surprise that leadership is carefully examining the traditional way of demonstrating value.
In their analysis, the authors suggest that design factors may reduce the demonstrated cost savings and adjusted life years for certain disadvantaged populations, making interventions less likely. work. Read more and let me know what you think.
What we read
- Politics is taking back the best meth addiction treatment tool, STAT
- Researchers think AI could help predict heart disease risk, BBC
- Inside one company’s AI technology for protein design, Genetic Engineering & Biotechnology News
- Improving data tools for clinical research, JAMA
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