Literacy demands of product information intended to supplement television direct-to-consumer prescription drug advertisements

The US Food and Drug Administration (FDA) allows television direct-to-consumer (DTC) prescription drug advertisements that do not fully disclose drug risks if the ads include "adequate provision" for dissemination of the drug's approved labeling. This requirement can be met in part by referring consumers to multiple text sources of product labeling. This study was designed to assess the materials to which consumers were referred in 23 DTC television advertisements. SMOG assessments showed that the average reading grade levels were in the high school range for the main body sections of the materials and college-level range for the brief summary sections. The Suitability Assessment of Materials (SAM) instrument identified specific difficulties with the materials, including content, graphics, layout, and typography features. Stronger plain language requirements are recommended. Health care providers should be aware that patients who ask about an advertised drug might not have the full information required to make an informed decision. (C) 2003 Published by Elsevier Ireland Ltd.