Department of Pharmaceutical and Biomedical Sciences, University of Georgia, 250 West Green Street, Athens, GA, 30602, USA.
Pharmaceutical and Medical Devices, Engineering Systems, Inc, Norcross, GA, USA.
Ther Innov Regul Sci. 2020 Sep;54(5):1123-1133. doi: 10.1007/s43441-020-00129-z. Epub 2020 Feb 24.
Warning Letters issued by the Food and Drug Administration's Bioresearch Monitoring (BIMO) Program provide insight into data integrity issues and other research misconduct in the premarket side of the pharmaceutical industry. The objectives of this study were to understand the common compliance issues for clinical investigators, institutional review boards, sponsors of clinical studies, good laboratory practice laboratories, and bioequivalence studies and to see how compliance has changed over time.
Warning letters and closeout letters issued by the BIMO program between US fiscal years 2007-2018 were analyzed by categorizing regulatory violations into violation themes. Inspections during the same time period were analyzed based on the assigned inspection classification.
A combined total of 300 warning letters were analyzed as a part of this study. The most common violations found in all warning letter categories included failing to follow and maintain procedures and poor documentation practices. Inspection results show that overall the percentage of Official Action Indicated results has decreased over time, while the percentage of No Action Indicated results has increased.
Although the number of warning letters has decreased over the past decade and inspection results have been improving, there are still significant data integrity and other regulatory compliance issues found in the premarket side of the pharmaceutical industry. It is unclear if the reduction of warning letters is due to improved compliance in the industry or other factors unrelated to compliance.
美国食品和药物管理局生物研究监测（BIMO）计划发布的警告信提供了对制药行业上市前数据完整性问题和其他研究不端行为的深入了解。本研究的目的是了解临床研究者、机构审查委员会、临床研究赞助商、良好实验室规范实验室和生物等效性研究的常见合规问题，并观察合规情况随时间的变化。
通过将监管违规行为归类为违规主题，对 BIMO 计划在 2007 年至 2018 年财政年度发布的警告信和结案信进行了分析。同时根据分配的检查分类对同期的检查进行了分析。
作为本研究的一部分，共分析了 300 封警告信。在所有警告信类别中发现的最常见违规行为包括未能遵循和维护程序以及文件记录不良。检查结果表明，总体而言，一段时间以来，有官方行动指示结果的百分比有所下降，而无行动指示结果的百分比有所增加。
尽管过去十年警告信的数量有所减少，检查结果也有所改善，但制药行业上市前仍存在严重的数据完整性和其他监管合规问题。目前尚不清楚警告信数量的减少是由于行业合规性的提高还是与合规性无关的其他因素。
