PHP34 - An analysis of warning letters issued to Pharmaceutical companies regarding misleading Health outcomes claims 2009-2013

Abstract

While analyses of FDA warning letters issues to pharmaceutical companies for misleading promotional outcomes claims have been published for 1997-2008 (Stewart 2002; Salas 2008; Covington, 2009; Yang 2010; Chatterjee, 2012; Neumann 2012), there are no published analyses to date that specifically identify the focus of promotional claim violations from 2009-2013. Warning letters for promotional materials issued by the FDA to pharmaceutical manufacturers from 2009-2013 were downloaded and assessed by two investigators for misleading claims broadly classified clinical, quality of life (QoL), and economic. Clinical claim violations were then stratified according to the following categories: unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims categories included unsubstantiated and/or health-related (HRQoL). Economic claim categories included cost superiority/ savings of one drug compared to another. In the 5-year study period, 178 letters containing 655 violations for 204 drugs across multiple therapeutic areas were issued by the FDA all of which were clinical. Most often multiple violations for >1 drug were contained in a single letter. On average, ~36 warning letters were issued per year. Omission of risk information was the most frequently violation claim (29.0%) followed by unsubstantiated/overstatement of efficacy claims (24.76%), and broadening of indication (11.6%). There were no misleading QoL, or economic claims issued. Warning letters were primarily directed to manufacturers of oncology (17.5%), psychiatry (9.6%), cardiovascular (9.6%), and pain (8.8%) products. Approximately half (49.5%) of claims contained promotional materials directed to physicians. We found that misleading clinical outcome claims, specifically omission of risk information and inaccurate efficacy, formed the majority of the promotional violations. Compared to the preceding 6 years (2003-2008), substantially more FDA warning letters were issued (65 vs 178) possibly indicating greater surveillance by the FDA of pharmaceutical promotional materials 2009-2013.