How the Supreme Court's Chevron decision will impact the FDA

The FDA's ability to make regulatory decisions could be shaken up thanks to last week's Supreme Court ruling overturning the Chevron doctrine. The 40-year-old doctrine had granted federal agencies the right to make final decisions if laws in question were vague.

"This decision is potentially going to have a destabilizing effect on the industry," one expert told STAT. "They won't have the same predictability of the regulatory system that they have now."

Among other issues, the FDA's ability to regulate laboratory-developed tests could be challenged. Labs and hospitals are already pushing back against the FDA's efforts to regulate LDTs. The agency's regulation of tobacco products, particularly vapes, is also likely to get swept up in a new round of litigation.

neurology

The new ALS Moonshot is not enough

Congress tasked the National Academies of Science, Engineering, and Medicine with penning a report on how to make ALS a "livable" disease in the next decade. But the ideas offered up just don't cut it, opines health innovator and ALS patient Bernard Zipprich. The report, he writes, "eschews cutting-edge science in favor of tepid recommendations to do more of the same, like develop better biomarkers and run a new natural history study."

Like cancer, ALS is a heterogeneous disease, and there won't be a single treatment that will help. To actually allow ALS to be a livable condition, Zipprich writes, real innovation is critical — with government and industry players working together to move the needle.

research

Mapping Alzheimer's with proteins

Tracking the proteomic changes in cerebrospinal fluid could help scientists diagnose or predict the trajectory of Alzheimer's disease, STAT's Rohan Rajeev writes. A study, published in Science Translational Medicine, profiled some 5,000 proteins in people with and without the neurodegenerative disease.

Scientists found 34 cellular processes that were highly associated with Alzheimer's disease. Two stood out in particular: glycolysis, and also the process of degrading and reprocessing proteins and organelles.

Alzheimer's

Cassava collaborator charged with defrauding NIH

A neuroscientist who served as a consultant for Cassava Sciences was indicted by a federal grand jury for allegedly defrauding the NIH in its grant applications for simufilam, its controversial Alzheimer's drug. Hoau-Yan Wang of CUNY had published key papers demonstrating simufilam's efficacy — but many outside researchers, including CUNY investigators, say that his work contained fabricated and falsified data.

The U.S. Department of Justice accused Wang of submitting $16 million in fraudulent grant applications to the NIH for himself and Cassava. A grand jury charged Wang with one count of major fraud against the U.S., two counts of wire fraud, and one count of false statements.

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