A Longitudinal Examination of FDA Warning and Untitled Letters Issued to Pharmaceutical Companies for Violations in Drug Promotion Standards

This study examined over-time differences in the nature and frequencyof Food and Drug Administration warning and untitled letters issuedto pharmaceutical companies. Across a 12-year time frame, resultsindicate that frequency of letters and specific violations rose steadilyfrom 2005 to 2010 but have since fallen dramatically. When infractionsdo occur, they continue to result from the omission or lack of riskinformation, misleading/false claims, omission of material facts, andlabeling issues. In addition, the findings show that violations occur mostfrequently on brochures, sales aids, corporate websites, and print ads,with the proportion of violations on Internet media rising consistentlyover-time. Overall, while these findings offer encouragement to thosewary of deceptive marketing practices, given the increased proportionof violations within digital marketing platforms coupled with the rare,yet consistent tendency of companies to misrepresent product riskand/or efficacy information, continued focus must be given to consumereducation initiatives.