Pharma Industry News Weekly Recap: August 25, 2022

The promise and uncertainty of healthcare in the metaverse
August 24, 2022 / Metaverse / HIPAA – There have been more than 400 healthcare patents filed in the metaverse as people look to the virtual reality platform to improve the healthcare industry, yet the platform is still underdeveloped, Politico reported Aug. 24. According to IFI Claims, a Connecticut company that tracks intellectual property, IBM, Microsoft, Medtronic, Siemens and Chinese telehealth firm Ping An have filed for healthcare patents in the metaverse, but experts say the metaverse’s place in healthcare is still vague. Read on Berkshire Hospital Review >>

FDA’s adcomm process needs reform, researchers say
August 22, 2022 / FDA / Regulation – Reforms are needed to make the US Food and Drug Administration’s (FDA) advisory committee process more consistent and transparent, according to three researchers from the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School. The researchers propose that FDA issue guidance spelling out how it decides whether to convene an advisory committee and committing to seeking advisory committee input for certain types of regulatory decisions, such as accelerated approvals. They also call on the agency to publish in advance the questions it will ask advisory committees to consider and to standardize some of the questions related to approval or authorization of products. Finally, the researchers ask FDA to commit to publicly explaining its reasoning when rejecting the advice of an advisory committee. Read on Regulatory Focus >>

FDA clears Insulet Omnipod 5 for children two years and older
August 22, 2022 / Insulet / Type 1 Diabetes / Omnipod 5 – Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes.
Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, the company presented data supporting the use of Omnipod 5 in young children, with the platform significantly improving time in range and reducing HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months of use. Read on Drug Delivery Business >>

FDA says it’s making recruitment strides, but problems with overseas inspections persist
August 22, 2022 / FDA / Inspections / Human Resources – Amid pandemic-fueled delays to the FDA’s manufacturing inspection work, staffing issues have emerged as another sticking point for the regulator. While the agency seems to have made good progress on hiring in the past 12 months—even picking up a few lessons courtesy of COVID-19—there’s still much work to be done, especially when it comes to agents overseas. As of Monday, the FDA had 56 open job postings on USAjobs.gov, a significant drop from the 416 vacancies the agency had listed on the website about a year ago. The listings run the gamut from physician posts and consumer safety roles to those for program analysts, statisticians and regulatory counsel. Read on Fierce Pharma >>

Regulatory considerations to keep pace with innovation in digital health products
August 19, 2022 / Digital Health Products / Regulatory / Medical Devices – Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation. Read on Nature.com >>