Off-Label Use
Prescribing an approved drug for a condition, population, or dosage not included in its approved labelling. Off-label prescribing is legal and common — semaglutide was widely prescribed off-label for weight management before receiving its separate obesity indication. Manufacturers cannot promote off-label uses.
Technical Context
Off-label prescribing is legal because physicians have clinical freedom to prescribe based on their medical judgement, even for uses not in the approved labelling. However, manufacturers cannot promote off-label uses (promotion is limited to approved indications per FDA/EMA regulations). The distinction between physician prescribing and manufacturer promotion is legally significant: Novo Nordisk could not promote Ozempic (semaglutide, approved for diabetes) for weight loss before Wegovy received its separate weight management approval — but physicians could and did prescribe Ozempic off-label for weight management based on clinical evidence. Off-label prescribing is estimated at 10-20% of all prescriptions. Insurance reimbursement for off-label use varies. Liability protections for prescribers exist when off-label use is supported by evidence.