OBJECTIVE: In January 2004, the Food and Drug Administration (FDA) proposed guidelines for the brief summary section of prescription drug direct-to-consumer advertisements. In particular, they mentioned regarding the current consumer unfriendly format which caused information overload and the overall suboptimal usefulness of the brief summaries and requested feedback to improve it. The objective of this study was to develop and evaluate brief summary formats which would be favorable for consumers and to provide practical implementation of FDA's suggestions. METHODS: A randomized within subjects study was conducted to compare effectiveness of four (2 pre-existing and 2 experimental) brief summary formats. All four formats contained the same information appearing in the brief summary for the prescription drug Pravachol®. A pre-validated reliable survey instrument was administered to students enrolled in the college of pharmacy in second year (N=70) and third year (N=77), to test the effectiveness of formats developed on ease of use, attitude towards formats, and satisfaction towards formats. RESULTS: Multivariate analysis of variance test conducted on the data (N=147), indicated significant positive effect of experimental brief summary format on all measured variables (Wilk's lambda, p<0.001). Individual analysis of variance tests on mean scores for the four formats followed by post-hoc Scheffe test revealed that currently existing formats had the lowest scores with respect to ease of use, attitude towards formats and satisfaction with formats as compared to experimental formats developed. CONCLUSION: The educational potential of the brief summaries may not be served if consumers do not attempt to read them due to their poor design and low readability formats. The FDA should consider these findings and provide clear guidelines to the industry to improve information and format of brief summaries which may improve the expected outcomes associated with these summaries as information sources for consumers.