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

Yam Limbu, Montclair State University
Christopher McKinley, Montclair State University
Valerio Temperini, Marche Polytechnic University


This study examined over-time differences in the nature and frequency of Food and Drug Administration warning and untitled letters issued to pharmaceutical companies. Across a 12-year time frame, results indicate that frequency of letters and specific violations rose steadily from 2005 to 2010 but have since fallen dramatically. When infractions do occur, they continue to result from the omission or lack of risk information, misleading/false claims, omission of material facts, and labeling issues. In addition, the findings show that violations occur most frequently on brochures, sales aids, corporate websites, and print ads, with the proportion of violations on Internet media rising consistently over-time. Overall, while these findings offer encouragement to those wary of deceptive marketing practices, given the increased proportion of violations within digital marketing platforms coupled with the rare, yet consistent tendency of companies to misrepresent product risk and/or efficacy information, continued focus must be given to consumer education initiatives.