Content Analysis of FDA Warning Letters to Manufacturers of Pharmaceuticals and Therapeutic Biologicals for Promotional Violations

Abstract

Manufacturers of pharmaceuticals use advertising and promotion as key marketing activities to foster the success of their products. These activities, however, have to comply with FDA regulations; failure to do so results in FDA enforcement actions such as issuance of warning letters and notices of violation. The purpose of this study is to critically evaluate the content of FDA letters to manufacturers for promotional violations. Two judges formally trained in content analysis procedures critically evaluated the content of publicly available letters from 2000 to 2006. A total of 249 letters described 806 violations from 107 manufacturers. Media most frequently cited in letters were print (n −67), sales aids (n = 42), and television (n = 39). Violations were most frequently related to lack of fair balance (n = 131), misleading claims of efficacy (n = 102), misleading superiority claims (n = 92), and omission of risk information (n = 89). Inter-rater reliabilities between the two judges were exceptional, ranging from 0.89 to 1.00. The marketing of prescription drugs has a significant impact on the medication use process. Managed care policymakers and pharmacists should remain abreast of promotional strategies and claims, particularly those deemed problematic by the FDA, which may spur requests for additional information, prescriptions, or formulary status changes for the drugs promoted.