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Eisai’s lobbying muscle, cannabis in Kansas, and FDA’s first vape company fines

February 23, 2023
Reporter, D.C. Diagnosis Writer

Good morning, and happy Thursday! To start your morning on a heartwarming note, read this blog post about the HHS Photographer to the Secretary (a job title I did not know existed) departing after 32 years. And sign up to see HHS Secretary Xavier Becerra himself, interviewed by my co-author Sarah Owermohle, at our upcoming STAT event on March 7, and send your burning questions to rachel.cohrs@statnews.com.

dicareLobbying 

Eisai beefs up its lobbying

Eisai is gearing up for a fight in Washington over access to its newly FDA-approved Alzheimer's treatment, Leqembi. Right now, the medicine falls under a restrictive Medicare coverage policy developed based on data from a different drug that didn't appear to work as well. (Perhaps you remember Aduhelm.) 

So Eisai is bringing on Roberti Associates Consulting, which also reps Amgen and BIO, per a lobbying disclosure. Eisai's lobbying overall has steadily increased since the beginning of 2022, when the company itself re-registered to lobby after a two-year hiatus. The company spent between $300,000 and $530,000 each quarter that year. All the company's disclosures from last year mentioned lobbying on Medicare coverage of Alzheimer's drugs. 

One of the two other outside firms registered to lobby for Eisai is run by Steve Ricchetti, the brother of a prominent White House official. He's worked with Eisai since 2015. (Ricchetti, you'll remember, just lost his lobbying contract with PhRMA last month.) 


states

Say "cannabis in Kansas" five times fast

THCNicholas Florko/STAT

When my co-worker Nick Florko asked about cannabis products at a vape shop in Topeka, Kansas, the employee working the register had one question: "Do you have pain, or are you trying to get f—- up?"

He found a variety of cannabis products for sale, even though Kansas is one of just a handful of states where possession of marijuana is still a crime. To get around those laws, merchants are selling quasi-legal products containing slightly tweaked versions of marijuana to skirt the laws.

Nick breaks down the trend of making slight tweaks to the chemical structure of cannabis to make it technically legal in states like Kansas, and why public health officials are worried about it. Read more.


tobacco

FDA issues first-ever fines to vape makers

The FDA for the first time fined four companies that ignored warnings to stop selling unapproved vapes, Nick reports.

Two of the companies the FDA fined, VapEscape and Great American Vapes, were listed in an October STAT investigation into vape companies ignoring the FDA's orders. 

The FDA frequently issues fines, but it had not before this week issued any to vape makers for selling illegal products. The announcement comes a week after Sen. Dick Durbin (D-Ill.) chastised the commissioner for his "lack of urgency" on the issue. Get the full story on the historic move here.



Congress

Gingko leading congressional commission draws conflict of interest concerns

Congress in 2021 created a new, 12-person commission to advise the U.S. government on keeping the nation's biotech industry competitive and capable of serving national security needs. It was also supposed to be an "independent" commission, but some government watchdogs are concerned its members aren't exactly impartial, my colleague Jason Mast reports

Ginkgo Bioworks CEO Jason Kelly will chair the panel while maintaining his position at Ginkgo and a roughly 6% stake in the company, currently valued at over $100 million. He's not the only corporate executive on the board, but Ginkgo is unusually dependent on government contracts. The biotech commission will have access to classified and other non-public information, which creates further concerns.

Read the full story with experts' takes on the panel, and the other companies involved.


health tech

As the FDA doubles down on AI tool regulation, industry says "not so fast"

Health tech companies are in a tizzy. After years of letting companies roll out software tools to guide patient care with little oversight, the FDA is taking a tougher stance, my colleague Lizzy Lawrence writes.

In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the change. Earlier this month, the Clinical Decision Support Coalition filed a petition asking the FDA to withdraw its final guidance on the subject, arguing regulators are overstepping their bounds. "Truthfully, the result is that more products are regulated," said Bethany Hills, a partner at DLA Piper who advises FDA-regulated device companies. "That's hard for folks to digest."

Read more on the battle between the AI tool industry and FDA here.

A version of this item appeared in STAT's free, twice-a-week Health Tech newsletter. Subscribe here.


drug pricing

Friday news dump, CBO edition

Some eagle-eyed sources pointed out that the Congressional Budget Office quietly released a new slide deck late last week, providing more details about the impact of the drug pricing provisions of the Inflation Reduction Act. Remember they're just projections, but here are few interesting takeaways:

  • CBO expects HHS will be able to obtain prices lower than the statutory maximum price in negotiations with drugmakers
  • It says net prices for negotiated drugs will decrease by 50% on average
  • Drugmakers may be able to reduce the rebates they give to insurers to mitigate the effects of penalties for raising prices faster than inflation

More around STAT
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What we're reading

  • Dutch group sues AbbVie for human rights violations stemming from Humira pricing, STAT
  • U.S. plans to allow Medicaid for drug treatment in prisons, Associated Press
  • Experts weigh in on potential health hazards posed by chemicals in Ohio train derailment, STAT
  • A wealthy 'anti-woke' activist joins the 2024 presidential field, The New York Times

Thanks for reading! More next week,


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