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
Nicholas Florko/STAT
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