Finally, this study has profound implications for health policy. In the United States, transmission of information on written prescriptions occurs in 4 ways (William Shrank, MD, MSHS, personal communication; 16 October 2006). The first is the label affixed to the bottle, the focus of the current study. The U.S. Food and Drug Administration (FDA) and state boards of pharmacy jointly regulate the content—but not the format—of this label. Not surprisingly, practices within and among states vary. Second, pharmacies voluntarily provide consumer medication information in the form of nonstandardized, privately developed information leaflets delivered with most filled prescriptions. Consumer medication information is entirely unregulated and is often of poor quality. Third, package inserts, which are heavily regulated by the FDA, are intended for the use of the prescribing physician, are rarely delivered with prescriptions, and offer little benefit to patients (10). It is the prescribing physician, in his or her capacity as a “learned intermediary” between the drug manufacturer and the patient, who ultimately is accountable for successfully transmitting information about prescription medications. However, physician communication of basic prescription information to patients is notoriously spotty, and physicians do not seem to make a greater effort to communicate with less educated patients (11). Finally, in the past decade, the FDA has required the development of patient-directed medication guides for particularly high-risk medications (often those with “black box warnings”). In a recent study of a representative sample of such guides, none met federal readability recommendations, and nearly all were unsuitable for the average user (12). Nonetheless, the FDA's action to require medication guides at least provides a regulatory template within which we can operate as we develop more effective strategies to ensure effective and consistent prescription communication.