PNS80 CONTENT ANALYSIS OF FDA WARNING LETTERS AND NOTICE OF VIOLATIONS FROM 2012-2019 USING THE ECONOMIC, CLINICAL, AND HUMANISTIC OUTCOMES (ECHO) MODEL

Abstract

The study’s purpose was to review Food and Drug Administration (FDA) issued Warning Letters (WLs) and Notices of Violation (NOVs) from 2012-2019 using economic, clinical, and humanistic (ECHO) model. Specific objectives were to (1) assess the number of WLs and NOVs issued; (2) their frequency by therapeutic areas; (3) type of communication media cited; (4) intended audience for the promotional material claims; and (5) number of ECHO claims. A content-analysis approach was used to review WLs and NOVs, obtained from the FDA website, from January 2012 until December 2019. The data collection form (DCF) was developed based on this topic’s past literature and letters from 2010, and pilot tested on letters from 2011. The letters from January 2012 to December 2019 were reviewed by three researchers using the DCF. In case of reviewer disagreement, either a fourth reviewer arbitrated or the letters were reviewed together to determine a final classification. ICD-10 codes were used for therapeutic categories in the DCF. Data were analyzed using IBM SPSS Statistics version 24.0. A total of 102 letters were analyzed. Of these, 19 (19%) were WLs and 83 (81%) were NOVs. The top two disease categories with promotional violations were ‘Diseases of the Nervous System’ (n=18; 17.6%) and ‘Neoplasms’ (n=14; 13.7%). Most commonly used promotional media were websites and sales-aid. Out of the 155 violations in 102 letters, 92 (59%) were clinical; 14 (9%) humanistic; 3 (2%) were economic; and 46 (30%) were categorized as ‘Others’. The study found misleading claims of the clinical effectiveness and risk information included in the promotional materials targeted to consumers as well as healthcare providers. Promoting reliable, evidence-based information is important for the health of the public as inadequate information could lead to irrational decision making both on consumer as well as prescriber side.