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HHS priorities pile up; the Aduhelm investigation; what to watch in 2023

 

 

D.C. Diagnosis

Happy Tuesday and happy New Year, D.C. Diagnosis readers! I hope you had a restful holiday and, if you traveled, it wasn’t with Southwest. If I missed something in the agency and policy guides below, let me know at sarah.owermohle@statnews.com

Health agencies grapple with dozens of non-Covid priorities this year

Federal health officials’ to-do list just keeps growing. So does congressional frustration.

Top health officials have promised reforms in the food, drug, and public health departments as criticism mounts over the federal response to Covid-19 and last year’s widespread baby formula shortages. While Biden appointees race to fix pandemic-exposed cracks in the the systems for mental health care, addiction treatment, and health coverage, millions of people are likely to be kicked out of Medicaid, the federal program serving low income people with few resources

There’s still no one leading the National Institutes of Health — and now the top infectious disease role is open too.

As the list of federal health priorities grows, congressional goodwill seems to wane. While lawmakers delivered wins for mental health care and more funding for the Advanced Research Projects Agency for Health, they skipped new Covid-19 funding and declined a modest ask for the HHS climate change office.

Although federal officials are resigned to their depleted coronavirus budgets, they are still concerned that new SARS-CoV-2 variants and the end of federal vaccine coverage could spell disaster if vaccines need to be updated. Again.

"Put all that all in the context of no money and little appetite [among the public] to pay attention," said a senior Biden official. "But really, the virus doesn't care."

Inside the Aduhelm investigation 

The Food and Drug Administration’s review and approval of Aduhelm, a controversial Alzheimer’s drug, was “rife with irregularities,” and an “inappropriate” level of coordination between the drugmaker, Biogen, and regulators, two House committees said last week after an 18-month investigation.

The congressional investigators faulted FDA regulators for glossing over internal disagreements about the pricey new Alzheimer’s medicine and for advocating its approval in a much broader patient population than had been studied, my colleague Rachel Cohrs wrote.

Documents obtained by the committees showed that Biogen settled on a price that was more than double what insurers and doctors had recommended for the broadest patient access, in hopes that record profits would “establish Aduhelm as one of the top pharmaceutical launches of all time.”

The findings build on STAT’s extensive reporting that first uncovered the FDA’s unusual coordination with Biogen before the drug’s approval, which House investigators cited.

Read more: Rachel joined colleagues Adam Feuerstein and Damian Garde to break down the 8 biggest takeaways from the report. Adam and Damian also dig into a trove of internal Biogen documents discussing a pricing strategy to maximize profits. 

Hospital and insurance trends to watch this year

Much like the health agencies, hospitals and health insurers are looking at a transition out of pandemic-era policies to a post-Covid shift in coverage and costs.

My colleagues Bob Herman and Tara Bannow lay out three big trends they’re watching:

  • Medicaid enrollment is set for a shake-up after the omnibus spending package allowed states to begin kicking people off their rolls on April 1, 2023, ending a pandemic freeze. The program grew 30% during the pandemic, but commercial insurers are eager to funnel Medicaid enrollees into their own taxpayer-subsidized health plans sold through the Affordable Care Act, Bob and Tara write.
  • Hospital prices could tick upward as providers deal with the end of bailout funds and a continued lag in patient care. If hospitals raise prices to stave off losses, that could translate into higher premiums for average Americans.
  • Medicare Advantage has grown to the point that a majority of seniors are in that commercial option rather than the traditional program. But that doesn’t mean they are getting a better deal or better care, Bob and Tara write. Regulators could more fiercely audit programs and outcomes this year.

Eric Lander’s next act

Eric Lander, who left the White House Office of Science and Technology Policy last February amid reports of bullying, is now leading  a new nonprofit called Science for America, STAT’s Megan Molteni reports.

The organization markets itself as a “solution incubator” for challenges including climate change, cancer, pandemic preparedness, and equity in science.

Science for America said in a July blog post that its funders include Bloomberg Philanthropies, the Emerson Collective (founded by Laurene Powell Jobs, the widow of Steve Jobs), the Ford Foundation, Gates Ventures, and Schmidt Futures. Together, they have committed $30 million over two years.

The nonprofit’s model seems to mirror efforts to stand up The Advanced Research Projects Agency for Health, which Lander helped shepherd during his time at the White House. Familiar faces include program managers from the Pentagon and energy-focused versions of the agencies, as well as former FDA Commissioner Margaret Hamburg.

What we're reading

  • New FDA guidance explains that Plan B is not an abortion pill, STAT
  • A 72-year-old congressman goes back to school, pursuing a degree in AI, The Washington Post
  • Three debates about addiction medicine to watch in 2023, STAT
  • The case for wearing masks forever, The New Yorker
  • Three years on, the pandemic — and our response — have been jolting. Here’s what even the experts didn’t see coming, STAT
  • Wegovy may help teens with obesity lose weight but isn’t a magic bullet, STAT
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Thanks for reading! More on Thursday,

Rachel Cohrs

Tuesday, January 3, 2023

STAT

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