Drug labels

Off-Label Drug Use Liability

Off-Label Drug Use Liability

Scholar argues that FDA approval should not save drug makers from state-law claims arising from off-label use.

Regulating Speech About a Drug’s Off-Label Uses

Regulating Speech About a Drug’s Off-Label Uses

Scholar argues that FDA should adopt an evidenced-based approach to regulating drug manufacturers’ speech.

Marketing Formerly Dangerous Drugs

Marketing Formerly Dangerous Drugs

Two scholars find that the removal of FDA health warnings prompts an increase in drug marketing.