Policy & Practice

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require physicians and surgeons to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association (CMA)opposes the legislation. In a statement, the CMA said existing law is enough because physicians can be held liable for not disclosing risks. Off-label use often saves lives, the statement said. The bill would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Mary Ellen Schneider


Next Article: