OBJECTIVE To assess both the accuracy of scientific data presented in print pharmaceutical advertisements and the compliance of these advertisements with current Food and Drug Administration (FDA) standards. METHODS Cross-sectional survey. METHODS Each full-page pharmaceutical advertisement (n = 109) appearing in 10 leading medical journals, along with all available references cited in the advertisement (82% of the references cited were available) were sent to three reviewers: two physicians in the relevant clinical area who were experienced in peer review and one academic clinical pharmacist. Reviewers, 95% of whom responded, were asked to evaluate the advertisements using criteria based on FDA guidelines, to judge the educational value and overall quality of the advertisements, and to make a recommendation regarding publication. RESULTS In 30% of cases, two or more reviewers disagreed with the advertisers' claim that the drug was the "drug of choice." Reviewers felt that information on efficacy was balanced with that on side effects and contraindications in 49% of advertisements but was not balanced in 40%. Reviewers agreed with advertisements' claims that the drug was safe in 86% of the cases but judged that headlines in 32% of the advertisements containing headlines misled the reader about efficacy. In 44% of cases, reviewers felt that the advertisement would lead to improper prescribing if a physician had no other information about the drug other than that contained in the advertisement. Fifty-seven percent of advertisements were judged by two or more reviewers to have little or no educational value. Overall, reviewers would not have recommended publication of 28% of the advertisements and would have required major revisions in 34% before publication. CONCLUSIONS In the opinion of the reviewers, many advertisements contained deficiencies in areas in which the FDA has established explicit standards of quality. New strategies are needed to ensure that advertisements comply with standards intended to promote proper use of the products and to protect the consumer.