Weekend update

David Ermer–ACA, Congress, FDA, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Congress remains on its State / District work break from Capitol Hill until September 2, 2025, roughly two more weeks.
  • The Office of Management and Budget’s reginfo.gov website remains under maintenance at 5 pm ET on Sunday.
  • STAT News reports,
    • “Novo Nordisk’s obesity drug Wegovy was cleared by U.S. regulators on Friday to treat an increasingly common liver disease, adding to the list of conditions for which the blockbuster therapy is now approved. 
    • “The Food and Drug Administration granted accelerated approval to Wegovy for patients with metabolic dysfunction-associated steatohepatitis, or MASH, with moderate to advanced liver scarring. The decision was based on Phase 3 results showing that the drug helped improve liver scarring, or fibrosis, and resolve symptoms.”

From the public health and medical research front,

  • Medscape reports,
    • “Heart disease is still the top cause of death in the US, but the types of heart disease killing people are changing, a new analysis has found. While deaths from acute conditions such as heart attacks have declined, deaths from other types of heart disease such as heart failure, hypertensive heart disease, and arrhythmias have increased.
    • “And that has important implications for primary care physicians (PCPs), who will shoulder much of the burden for caring for these patients who can survive acute threats such as a heart attack but go on to need care for chronic cardiac conditions, sometimes for decades.”
  • and
    • A significant [medical research] issue is under enrollment of women in randomized trials, meaning the percentage of women enrolled isn’t in line with the percentage of women with a particular disease in the real world — so signals that indicate an adverse event are not picked up. From a systems perspective, women do not clear drugs through their kidneys as quickly as men, and women maintain a higher blood concentration of the medication. “Women may be overmedicated,” Neurologist Irving Zucker and others wrote in a 2020 analysis of 86 medications.
    • “This can lead to adverse events (AEs). And they do.
    • “Women experience adverse drug reactions nearly twice as often as men, yet the role of sex as a biological factor in the generation of [these reactions] is poorly understood,” Zucker wrote in that study, published in the journal Biology of Sex Differences, which showed that pharmacokinetics “strongly linked” sex differences in adverse drug events.”

From the U.S. healthcare business front,

  • Beckers Payer Issues informs us,
    • “Mountain Health Co-Op, which insures more than 11,000 people in Wyoming, is exiting the state at the end of 2025, Cowboy State Daily reported Aug. 14. 
    • “Mountain Health CEO Blair Fjeseth told the news outlet that several factors contributed to the decision, but the high cost of healthcare was a top reason.” * * *
    • “The company was one of three insurers available on the ACA’s healthcare exchange in Wyoming, according to the report. 
    • “Mountain Health will continue to offer plans in Montana and Idaho, according to the report.” 
  • MedTech Dive lets us know,
    • “Philips said Thursday [August 14] that it will invest more than $150 million to expand manufacturing in the U.S. of AI-enabled technologies.
    • “The investment includes expanding manufacturing and research and development at a site in Reedsville, Pennsylvania, that makes AI-enabled ultrasound systems. The addition is expected to bring 24,000 more square feet of manufacturing space and 40,000 square feet of warehouse space. 
    • “Philips is making the investment as it expects growth in its ultrasound business and as the company works to optimize its manufacturing sites.“
  • HR Dive tells us,
    • “Regulatory requirements are combining with a cultural shift to push most U.S. companies in a recent WTW survey to adopt pay transparency practices, the consulting firm said in a press release Monday.
    • “WTW’s poll of 388 U.S.-based respondents found that 82% were either communicating, planning or considering communicating pay ranges with employees and 79% were doing so with external job candidates. However, fewer than half said they shared base pay determinations or progressions, and “even fewer” shared how pay ranges are designed or managed or shared the employee’s position within a given range.
    • “More than two-thirds of employers cited regulations as driving their pay transparency efforts, while 44% said the same of company values and culture and 41% pointed to employee expectations. These are signs of a “broader cultural shift” around communicating pay, Lindsay Wiggins, WTW’s North America pay equity co-leader, said in the release.”