Veterans Day is being observed today because November 11 is a Saturday. Thanks for your service, vets.

From Washington, DC,

• Reuters reports,
  • “U.S. Senate Majority Leader Chuck Schumer on Thursday took a procedural step to allow the Democratic-majority chamber to pass a stopgap government funding bill before a Nov. 17 deadline to avert a partial government shutdown.”
• and
  • “U.S. House of Representatives Republicans aim to release a stopgap measure to avert a partial government shutdown [next] Saturday”
• and
  • “Moody’s on Friday lowered its outlook on the U.S. credit rating to “negative” from “stable” citing large fiscal deficits and a decline in debt affordability, a move that drew immediate criticism from President Joe Biden’s administration.
  • “The move follows a rating downgrade of the sovereign by another ratings agency, Fitch, this year, which came after months of political brinkmanship around the U.S. debt ceiling.”

• Forbes offers an overview of the situation.
  • “[T]here are 12 appropriations subcommittees that comprise the U.S. budget. The Senate has made progress on three of them, passing a bipartisan combined bill on November 1 for Agriculture; Veterans Affairs and Transportation; Housing and Urban Development.
  • “The House has so far passed bills for seven of the 12 budgetary areas, although further progress this week has stalled so far. House bills have been passed along partisan lines, and so they are unlikely to attract the necessary support within the Democratic-controlled Senate. In contrast, the Senate measures have been bipartisan.
  • “In addition, the text of the bill raising the debt limit includes automatic 1% cuts to the government’s entire budget if a full one is not passed by January 1, 2024. The intent of that measure was to incentivize relatively quick progress on the budget, rather than for the cuts to actually be implemented. Still it’s another deadline consideration in the budgetary process.”

• MedTech Dive tells us,
  • “The Federal Trade Commission is challenging patents for 17 drugs marketed by Abbvie, AstraZeneca, GSK and other pharmaceutical companies, claiming Tuesday that the intellectual property was “improperly or inaccurately listed” in a regulatory database.
  • “The notice letters are largely about products with specialized injectors or inhalers, such as Viatris’ anaphylaxis shot EpiPen and GSK’s asthma drug Advair, which rely on those devices to deliver a precise dose. The FTC said it has filed a dispute with the Food and Drug Administration seeking to have the patents removed from the database, called the Orange Book.
  • “The FTC’s action comes two months after it approved a policy statement saying the agency would “use its full legal authority” to invalidate improperly listed patents. Drugmakers are increasingly under scrutiny for creating so-called “patent thickets” that make it difficult for generic challengers to enter the market.”

From the public health and research front,

• NBC News reports,
  • “The number of kids whose caregivers are opting them out of routine childhood vaccines has reached an all-time high, the Centers for Disease Control and Prevention reported Thursday, potentially leaving hundreds of thousands of children unprotected against preventable diseases like measles and whooping cough. 
  • “The report did not dive into the reasons for the increase, but experts said the findings clearly reflect Americans’ growing unease about medicine in general.
  • “There is a rising distrust in the health care system,” said Dr. Amna Husain, a pediatrician in private practice in North Carolina, as well as a spokesperson for the American Academy of Pediatrics. Vaccine exemptions “have unfortunately trended upward with it.”
  • “The CDC report found that 3% of children entering kindergarten during the 2022-2023 school year were granted a vaccine exemption from their state. This is the highest exemption rate ever reported in the U.S.”

• The Wall Street Journal points out,
  • “If you think canceling plans is always good self-care, you might want to think again. People who keep an active social calendar not only enjoy a better quality of life—they could also stave off an early trip to the grave.
  • “Loneliness and social isolation were linked to an increased risk of death from any cause, according to new research. That includes missing out on seeing loved ones, not having weekly group activities like a book club, or just often feeling lonely.
  • “Just like we need to make time in our busy lives to be physically active, we need to make time in our busy lives to be socially active,” said Julianne Holt-Lunstad, director of the Social Connection & Health Lab at Brigham Young University, who wasn’t involved in the report.
  • “A combination of several loneliness factors could be even more harmful, the data suggested. For example, having few family and friend visits was riskier when the person also lived alone.” 

• Per Fierce Healthcare,
  • “Nearly two-thirds of specialty centers that conduct autism evaluations have wait times longer than four months, according to a new report.
  • “The report, focused on the state of pediatric autism diagnosis in the U.S., is based on a survey designed and conducted by Scott Badesch, former president of the Autism Society of America. Cognoa, maker of an FDA-approved, AI-powered diagnostic tool for autism, sponsored the study. The survey reached 111 specialty centers across the U.S., including hospitals, private practices, public health clinics, government agencies and academic entities. 
  • “Its findings underscore “how dysfunctional the current state of affairs is,” Cognoa’s CEO Sharief Taraman, M.D., told Fierce Healthcare.”

• Medscape notes,
  • “The US Food and Drug Administration has approved fruquintinib (Fruzaqla, Takeda) for the treatment of certain adults with metastatic colorectal cancer who experience disease progression during or after prior treatment.
  • “More specifically, the approval extends to adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, in some cases, an anti-EGFR therapy.
  • “In a company press release, Takeda Pharmaceuticals said the drug “is the first targeted therapy approved for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in more than a decade.”

From the U.S. healthcare business front,

• BioPharma Dive reports,
  • “Novo Nordisk plans to invest $6 billion to expand its drug manufacturing capacity as it tries to meet skyrocketing demand for its popular obesity and diabetes medicines Wegovy and Ozempic.
  • “The investment, announced by the Danish drugmaker Friday, will be spread over the next six years and builds on the company’s existing capital spending plans. Most of the money will go toward building a new plant for making active pharmaceutical ingredients, like the semaglutide protein that’s contained in both Wegovy and Ozempic.
  • “Construction, which will also add a new packaging facility, is expected to be completed in phases from the end of 2025 through 2029, Novo said. Once finished, the company expects the production site will employ 700 staff, with another 100 working at the packaging plant.”

• Per Fierce Healthcare,
  • “As cold and flu season truly sets in, major home delivery platforms are now allowing customers to purchase products using their health benefits.
  • “Both DoorDash and Instacart announced this week that they would accept payments from health savings accounts and flexible spending accounts to cover the cost of health and wellness items. In particular, according to Instacart, this rollout will make it easier for people to take full advantage of their FSAs, as funds expire at the end of each year.
  • “In addition, some may find it difficult to use their HSA or FSA cards when making purchases at retail stores. Instacart said its new integration will allow for HSA and FSA payments from all retailers on its app that offer eligible items.”

• According to the Society for Human Resource Management,
  • “According to a recent Gusto survey of over 300,000 small and midsize businesses, 30 percent of all employees in the professional services industries who get paid time off (PTO) have taken sick leave so far this year, an increase of 42 percent from 2019. 
  • “The average amount of sick time these workers have taken has increased by 15 percent since 2019 and is now 15.5 hours per year. The largest increase is among workers ages 25-34: Nearly a third (32 percent) of them have taken sick leave in 2023, compared to 28 percent of workers ages 35-54.”

• AHIP announced,
  • AHIP joined with four other leading healthcare organizations to announce the Common Health Coalition: Together for Public Health.
  • The Common Health Coalition is focused on translating the hard-won lessons and successes of the COVID-19 pandemic response into actionable strategies that will strengthen the partnership between our healthcare and public health systems. The Coalition is the product of a joint commitment to public health made in March 2023 by founding members AHIP, the Alliance of Community Health Plans, the American Hospital Association, the American Medical Association, and Kaiser Permanente. 
  • In early 2024, the Coalition will publish recommendations informed by technical advisory groups of subject matter experts and an advisory council of public health leaders. The recommendations will focus on 4 initial priority areas:
    • spearheading greater coordination between the public health and healthcare systems;
    • building shared, well-maintained emergency preparedness plans;
    • establishing national standards for health care data that help identify health disparities; and
    • and modernizing infectious disease detection.
  • The development of these recommendations is being facilitated by ChangeLab Solutions, a national nonprofit that uses the tools of law and policy to advance health equity.