Eli Lilly Faces FDA Scrutiny While Doubling Down on Manufacturing Expansion

Eli Lilly finds itself navigating regulatory challenges as the U.S. Food and Drug Administration takes issue with the pharmaceutical giant’s marketing approaches for its blockbuster weight-loss and diabetes medications. Despite this regulatory pressure, the company is responding with a bold countermove: a massive $5 billion manufacturing investment that signals confidence in its long-term growth trajectory.

This week, the FDA issued a formal warning letter criticizing Eli Lilly’s promotional strategies for Mounjaro and Zepbound. The regulatory body alleges the company employed misleading advertising that omitted crucial safety information in direct-to-consumer campaigns. According to the FDA, Lilly failed to adequately highlight potential risks including thyroid C-cell tumors, while also downplaying other serious side effects such as pancreatitis and hypoglycemia.

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