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.”

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER