TRENDS IN FDA DRUG PROMOTION ENFORCEMENT LETTERS OVER A TEN-YEAR PERIOD
Author(s)
Zagrodney K1, Sheikhan T2, Sheikhan NY3, Pinto AM3, Witek T1
1University of Toronto, Toronto, ON, Canada, 2University College London, London, UK, 3McMaster University, Hamilton, ON, Canada
OBJECTIVES: The Office of Prescription and Drug Promotion (OPDP), a division of the U.S. Food and Drug Administration (FDA), routinely evaluates pharmaceutical product promotion to ensure truthful, balanced, and accurate promotion. When an ad violation is discovered, OPDP responds through the issuance of enforcement letters to the company responsible. We provide a descriptive review of such letters over the period 2005-2015 and provide categorical analysis based on company revenue. METHODS: Information extracted from publicly available enforcement letters included the type of enforcement letter (warning letter vs. untitled), violation-type category (e.g. risk minimization), promotional material venue (e.g. brochure), and intended audience for the promotional material (consumer vs. provider). Global pharmaceutical revenue was recorded for each company via public sources or direct contact. RESULTS: A lower frequency of letters were issued in the last five years of observation, with warning letters as a particular rarity. Websites were the most common venue cited, with a high in 2009 of 41.46% of letters referencing website materials. Insufficient reporting of risk information was the most frequent violation over the ten years. Throughout the observation period, providers were the intended audience for the majority of violative promotions. From 2007-2011, large companies received the most letters; with very small companies predominating from 2013-2015. CONCLUSIONS: This research highlights trends of FDA regulatory enforcement letters from 2005-2015. Risk minimization was the most frequent violation. The decreased frequency of letters in the second half of our observation period may reflect either OPDP resource levels directed at compliance, a more compliant industry, or both. The maintained trend for website violations over the last seven years observed reflects its mainstream presence in drug promotion. The higher proportion of smaller companies with violative promotions may reflect suboptimal internal competencies and experience with compliant promotion or aggressive promotion with acquired legacy products.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP59
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care
Topic Subcategory
Approval & Labeling, Health Care Research, Pricing Policy & Schemes
Disease
Multiple Diseases