Regulating Off-Label Prescribing
Scholars and practitioners debate whether and how to regulate off-label drug use.
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
Scholar argues that FDA should adopt an evidenced-based approach to regulating drug manufacturers’ speech.
Marketing Formerly Dangerous Drugs
Two scholars find that the removal of FDA health warnings prompts an increase in drug marketing.