Eli Lilly Sues to Block FDA Interpretation of Biological Product

Eli Lilly & Co. is seeking to block the FDA’s decision to designate its obesity medicine, retatrutide, as a drug instead of a biological product.

The Food and Drug Administration’s determination that Eli Lilly’s product is “neither a protein nor analogous to a protein and is therefore not a biological product” is arbitrary and capricious, the drugmaker wrote in a complaint Tuesday in the US District Court for the Southern District of Indiana.

Congress gave the agency the authority under the Public Health Service Act to regulate biological products, which includes “proteins” and products “analogous” to proteins that are “applicable ...