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Jeff Shuren’s FDA legacy: Bringing stability to device regulations
The message from Jeff ShurenResignation from his long-standing position as head of the The Food and Drug Administration Center for Devices and Radiological Health — which my colleague Lizzy Lawrence reported exclusively last month — has left the medical device world stunned, and it’s hard to imagine the agency without him.
Shuren has led the CDRH since 2009 and has made a point of gaining the trust of the medical device industry and the public. Experts say he has been more successful with the industry, including by making the medical device regulatory labyrinth more predictable, but not as successful with the public – especially as risky products continue to slip through the cracks, such as the Philips sleep apnea devices recalled in 2021.
Lizzy interviewed a dozen of Shuren’s former colleagues, patient advocates and medical device industry leaders about his time at the FDA, and they paint a picture of a seasoned regulator who patiently navigated Washington’s bureaucratic labyrinth. Read more.
FDA Digital Health Advisory Committee Takes Shape
Elsewhere in the regulatory agency, the FDA’s first Digital Health Advisory Committee has been filled with a roster of industry experts, and its first meeting is scheduled for November 20 and 21. The members, mostly from academic institutions, including Emory, Washington Universityy and the University of Rochesterwill address issues surrounding generative AI-supported medical devices. Members include Jessica JacksonFounder of behavioral health website Therapy is for everyone, Yaniv KeremEmergency doctor at Kaiser Permanente Redwood City Medical Center, and that University of Kentucky School of Medicine‘S Melissa Denise Clarkson, an expert in patient advocacy. The committee consists of nine core voting members and aims to advise the FDA on digital health issues and regulations.
The FDA has also identified a pool of private sector leaders to represent the interests of the digital health industry on the committee, occasionally as non-voting members: These include Lee Shapiro of 7wireVentures and several executives from Abbott, Medtronic And ^ “Boston Scientific – Publications”.
Study highlights risks of over-the-counter weight loss drugs
As websites marketing weight-loss drugs online proliferate, my colleague Katie Palmer points to an urgent new study in JAMA Network Open that raises alarm about the risks of so-called “compounded” drugs and some illegal online pharmacies that skip the prescription process entirely. Researchers at the University of California, San Diego and that University of Pecs in Hungary concluded that semaglutide ordered from illegal websites contained significantly more of the active ingredient than stated on the label and, in one case, showed signs of possible bacterial contamination during manufacturing.
“It’s just a very, very risky business to go online and buy this product,” The Tim Mackey, the study’s co-author, Katie, said. “Just because it’s online and accessible and can be sold without a prescription doesn’t mean it’s authentic.” Read more.
Hims & Hers beats Wall Street expectations and raises revenue forecast
While some virtual care companies continue to stumble (despite new leadership Teladoc The latest results showed declining revenues and missed targets as well as a new impairment charge) all eyes are on direct sales companies flooding the GLP-1 market. Among them is For her and himthe reported 155,000 new net subscribers and a total active membership of nearly 2 million people. Revenue exceeded $315 million in the second quarter, up 52% from the same period last year.”An early weight loss management program could bring long-term benefits: The introduction of compound GLP-1s including Semaglutide could increase sales if customer demand and HIMS’s ability to supply sufficient product to meet
Expectations”, Leerink Partner analysts wrote in a note to investors.
Board rejects 23andMe CEO’s plan to privatize the company
A special committee of the genetic testing giant 23andMeThe board of directors rejected an offer from the co-founder and CEO Anne Wojcicki to keep it private, reports Matt Herper of STAT. In a In a letter released late last week, the board noted that, among other hurdles, Wojcicki’s proposal did not offer a premium to the current share price and did not include commitments from other investors.
“After months of work, we expected you to submit a fully funded, carefully crafted and actionable proposal that is in the best interests of unaffiliated shareholders,” the committee wrote. Nevertheless, it offered her “a limited amount of additional time to submit a revised proposal that meets our expectations.” To read more.
HHS issues notice on Change Healthcare hack
A report about a cyber attack has appeared on The Ministry of Health and Social Affairs The Office for Civil Rights’ data breach portal was released last week, nearly six months after the devastating Change Healthcare ransomware attack that brought payment processing across the healthcare system to a halt. Change filed the report in mid-July, according to the HHS. Among the interesting details: UnitedHealth Property Change puts the number of people affected at 500 – a shocking departure from UnitedHealth CEO Andrew Witty’s earlier estimate of “a third of all Americans.”
However, the HHS stated that 500 is the minimum number to post a notice on its portal and that Change is still in the process of determining the total number of people affected.
A UnitedHealth spokesperson told Brittany that the review is still ongoing and in its final stages, but that Change has already begun notifying those affected. The data so far “is consistent with previous information that a significant proportion of Americans are affected,” the spokesperson said in a statement, “and the OCR report may be updated as needed after the review is complete.”
Where do cost-benefit analyses possibly fall short?
A new analysis led by Medicaid-focused health tech startup WaymarkCo-founder Sanjay Basu raises an interesting health policy question: Do the types of cost-effectiveness analyses often used to justify policy decisions disadvantage already marginalized groups?
Proving its own cost efficiency is at the core of Waymark’s success – the community-based healthcare company is backed by investors such as Andreessen-Horowitz and works with health insurance companies, So it’s perhaps no surprise that company leadership is taking a close look at the standard method of demonstrating value.
In their analysis, the authors point out that structural factors may limit the demonstrated cost savings and quality-adjusted life years for certain marginalized populations, making interventions appear less effective. Read on and let me know what you think.
What we read
- Politics is holding back the best remedy for treating meth addiction, STAT
- Researchers believe AI could help detect heart attack risk, BBC
- Insights into the technology of an AI company for protein design, news from genetic engineering and biotechnology
- Modernizing the data infrastructure for clinical research, JAMA