Mohite Namosha, Funtanilla Vienica, Muzumdar Jagannath, Park Taehwan
College of Pharmacy and Health Sciences, St. John's University, Queens, NY.
Innov Pharm. 2021 Jan 13;12(1). doi: 10.24926/iip.v12i1.3420. eCollection 2021.
The study purpose was to critically review FDA-issued warning letters (WLs) and notice of violation (NOV) letters against drug companies' from 2012-2019 for economic, clinical, and humanistic (ECHO) claims made in pharmaceutical promotional materials. Specific objectives were to assess the, (1) number of WLs and NOV issued; (2) frequency of WLs and NOV by therapeutic areas; (3) type of communication media cited in WLs or NOV; (4) intended audience for the claims in promotional materials for which the WLs and NOV were issued; and (5) number of WLs and NOV for ECHO claims.
The quantitative content analysis approach was employed to review WLs and NOVs, obtained from the FDA website, from January 2012-December 2019. A data abstraction form was created based on the published literature on this topic and assessment of the content of WLs and NOVs for 2010. This form was pilot tested on letters issued in 2011. The researchers discussed any unclear question or information presented in the letters. The letters were reviewed three researchers. If there was disagreement between the reviewers, either a fourth reviewer arbitrated on the disagreement or the letter(s) were discussed by the researchers to determine a final classification. ICD-10 codes were used for therapeutic categories in the data collected form. Descriptive statistics, Kappa statistics for interrater reliability, and Cochrane-Armitage test were performed 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. Majority of these letters were issued to manufacturers of therapeutic agents for diseases of the nervous system (n=15; 14.7%) and neoplasms (n=15; 14.7%). The most commonly cited media for violation was online website (n=29; 27.1%). Out of the 153 violations in 102 letters, 92 (60.1%) were clinical; 13 (8.5%) humanistic; 2 (1.3%) 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 on prescriber side.
本研究旨在严格审查美国食品药品监督管理局（FDA）在2012年至2019年期间针对制药公司发布的警告信（WLs）和违规通知（NOV）信，这些信件涉及制药宣传材料中提出的经济、临床和人文（ECHO）声明。具体目标是评估：（1）发出的警告信和违规通知的数量；（2）按治疗领域划分的警告信和违规通知的频率；（3）警告信或违规通知中引用的传播媒介类型；（4）发出警告信和违规通知所针对的宣传材料中声明的目标受众；以及（5）针对ECHO声明的警告信和违规通知的数量。
采用定量内容分析法审查从FDA网站获取的2012年1月至2019年12月的警告信和违规通知。根据关于该主题的已发表文献以及对2010年警告信和违规通知内容的评估，创建了一份数据提取表。该表在2011年发出的信件上进行了预测试。研究人员讨论了信件中任何不清楚的问题或信息。这些信件由三位研究人员进行审查。如果评审人员之间存在分歧，要么由第四位评审人员对分歧进行仲裁，要么研究人员讨论这些信件以确定最终分类。在收集的数据表中，使用国际疾病分类第十版（ICD - 10）代码对治疗类别进行分类。使用IBM SPSS Statistics 24.0版本进行描述性统计、评分者间信度的卡方统计以及 Cochr ane - Armitage检验。
共分析了102封信。其中，19封（19%）是警告信，83封（81%）是违规通知。这些信件中的大多数是发给治疗神经系统疾病（n = 15；14.7%）和肿瘤（n = 15；14.7%）药物的制造商。最常被引用的违规媒介是在线网站（n = 29；27.1%）。在102封信中的153项违规行为中，92项（60.1%）是临床方面的；13项（8.5%）是人文方面的；2项（1.3%）是经济方面的；46项（30%）被归类为“其他”。
该研究发现，针对消费者以及医疗保健提供者的宣传材料中包含有关临床有效性和风险信息的误导性声明。推广可靠的、基于证据的信息对公众健康很重要，因为信息不足可能导致消费者和开处方者双方做出不合理的决策。
