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The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.

In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency authority, a judge ruled that the FDA does not have authority to regulate tests developed by clinical laboratories.

The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.

The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.

While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers.

Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.

Danimer Scientific, Inc. (NYSE: DNMR) (“Danimer” or the “Company”) today announced it is expanding its collaboration with Chevron Phillips Chemical (“CPChem”) to explore development and commercialization of cast extrusion films, blown extrusion films, injection molded parts and rotational molded parts using Rinnovo™ polymers produced in a loop slurry reactor process.