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The Food and Drug Administration and Eli Lilly have permitted a single individual to receive retatrutide — Lilly's highly anticipated obesity drug candidate — through the FDA's compassionate use program, according to a scoop by STAT News journalist Lizzy Lawrence.
The arrangement grants one patient access to the experimental therapy outside the standard clinical trial process, immediately raising the question of who obtained that exclusive slot and how.
What Compassionate Use Actually Means The FDA's compassionate use program — formally called expanded access — allows patients with serious or life-threatening conditions to receive investigational drugs before those drugs have cleared the full regulatory approval process.
The program exists specifically for situations where no comparable approved treatment is available and where a physician and the FDA agree that the potential benefit justifies the risk of an unapproved therapy.
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