Ipsen Biopharma Fails in Lawsuit to Reclassify Growth Hormone

The US Food and Drug Administration’s classification of Ipsen Biopharmaceutical Inc.'s growth hormone product as a drug, not a biologic, wasn’t an abuse of discretion, a federal court said.

A regulation that required the agency to determine if a product met the definition of a biologic, wasn’t ambiguous, the US District Court for the District of Columbia said. Even if it was ambiguous, the agency’s interpretation of the regulation as requiring an assessment of the active ingredient, not the finished product, was reasonable, the court also said in an opinion granting FDA summary judgment.

The decision involves a long-running dispute ...