Drug Advertising Violations: A Longitudinal Trend Analysis of FDA Enforcement Letters from 2005 to 2019.

These trends are of value for industry and regulators alike in refining policy to ensure fair, balanced and meaningful information in pharmaceutical promotion. The frequency of violation letters has decreased in recent years; however, smaller companies have increasingly received the majority of letters. Small firms must increase their compliance around informing drug risk potential with balanced safety information across all promotional venues. Specifically, these findings are useful for pharmaceutical companies to direct educational efforts to promotional staff and their advertising agencies, especially regarding online advertising.