Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, ON, Canada.
Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, ON, M5T 3M6, Canada.
Pharmaceut Med. 2021 Jan;35(1):31-38. doi: 10.1007/s40290-020-00370-9. Epub 2021 Jan 16.
In the United States, all pharmaceutical promotional activities must comply with regulatory standards set by the Food and Drug Administration (FDA); failure to comply may lead to receiving an FDA enforcement letter. Letters include details of the specific advertisement in violation, as well as the action that is required by the company to rectify the non-compliant promotion.
The aim of this study was to determine trends in enforcement letters from the FDA to parties responsible for pharmaceutical promotion violations from 2005 to 2019.
A longitudinal trend analysis was conducted of FDA enforcement letters sent to pharmaceutical companies from 2005 to 2019 (n = 318). Publicly available enforcement letters released by the Office of Prescription Drug Promotion were accessed and analysed online through the Center for Drug Evaluation and Research, a part of the FDA. Variables analysed included number of letters by year, violation categories, venues, intended audience, drug age and company revenues. Publicly available revenue was the major source for company revenue information.
The total number of enforcement letters significantly decreased over time. Violations concerning risk information were significantly more prevalent than all other violation categories. Online promotional materials were most frequently cited. Proportionally, larger companies received the majority of letters in earlier years of observation, and smaller companies in later years (2013-2019).
These trends are of value for industry and regulators alike in refining policy to ensure fair, balanced and meaningful information in pharmaceutical promotion. The frequency of violation letters has decreased in recent years; however, smaller companies have increasingly received the majority of letters. Small firms must increase their compliance around informing drug risk potential with balanced safety information across all promotional venues. Specifically, these findings are useful for pharmaceutical companies to direct educational efforts to promotional staff and their advertising agencies, especially regarding online advertising.
在美国，所有药品促销活动都必须符合食品和药物管理局（FDA）设定的监管标准；不遵守规定可能会收到 FDA 执行信函。信中包含违规具体广告的详细信息，以及公司为纠正违规促销而必须采取的行动。
本研究旨在确定 2005 年至 2019 年 FDA 对负责药品促销违规行为的各方发出的执法信趋势。
通过对 2005 年至 2019 年（n=318）向制药公司发出的 FDA 执法信进行纵向趋势分析。通过 FDA 的药物评估和研究中心在线访问并分析了处方药物促销办公室发布的公开执法信。分析的变量包括按年发出的信件数量、违规类别、地点、目标受众、药物年龄和公司收入。公开收入是公司收入信息的主要来源。
执法信总数随时间显著减少。涉及风险信息的违规行为明显比所有其他违规类别更为普遍。在线促销材料最常被引用。在观察的早期年份，较大的公司收到了大多数信件，而在后期年份（2013-2019 年）则是较小的公司收到了大多数信件。
这些趋势对于行业和监管机构都具有价值，可以完善政策，确保药品促销中公平、平衡和有意义的信息。近年来，违规信的频率有所下降；然而，较小的公司越来越多地收到了大多数信件。小公司必须增加其在通过平衡所有促销场所的安全信息来告知药物风险潜力方面的合规性。具体而言，这些发现对于制药公司来说非常有用，可以指导促销人员及其广告代理商开展教育工作，特别是在网络广告方面。
