FDA proposes change to rule on off-label drug use

The FDA has issued a proposed rule that clarifies when drugmakers are required to update their drug labels to reflect off-label use, STAT reported.

Off-label drug use occurs when a drug is used to treat something other than what it is FDA-approved to treat. Physicians are allowed to prescribe a drug for any purpose, but courts have ruled that drugmakers can only advertise off-label uses if the information provided isn't misleading.