DC dis­trict court sides with FDA af­ter Ipsen sued over block­buster's clas­si­fi­ca­tion as a drug

The US Dis­trict Court for the Dis­trict of Co­lum­bia hand­ed the FDA a rare court win on Mon­day af­ter Ipsen sued the agency, ar­gu­ing that the FDA erred in its de­ci­sion to reg­u­late its block­buster so­mato­statin ag­o­nist So­mat­u­line De­pot (lan­reotide) as a drug, rather than a bi­o­log­ic.

The court large­ly de­ferred to FDA’s ex­per­tise, not­ing that the agency’s de­ci­sion “to an­a­lyze just lan­reotide ac­etate (which is re­spon­si­ble for So­mat­u­line De­pot’s ther­a­peu­tic ef­fect) and not the nan­otubes (which are not) was un­am­bigu­ous­ly cor­rect. But even if the FDA’s reg­u­la­tions were am­bigu­ous on this point, the Court would de­fer to the FDA’s in­ter­pre­ta­tion as rea­son­able.”

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