Summary

Physicians use a drug "off-label" when they prescribe a Food and Drug Administration (FDA)-approved drug for treatments other than those specified on the label. GAO testified that off-label prescribing is prevalent and presents various problems for policy-makers at different times. As it stands now, the problem is that the drug industry believes that labels overly constrain its ability to promote its products. This problem can be solved either by relying on sources in addition to the label to define appropriate promotion or by improving the process for updating the label. These two options are not necessarily mutually exclusive and both have benefits and drawbacks.