从FDA广告指南文件看药品广告监管

Research on the Supervision for Drug Advertising from FDA Advertising Guidance Documents

目的:介绍美国药品广告指南文件中公开药品风险信息的监管要求,为我国药品广告监管提供参考。方法:检索美国食品药品监督管理局(FDA)网站,收集整理FDA发布的药品广告指南文件,对指南文件中有关公开药品风险信息的监管要求进行分析。结果与结论:FDA要求药品广告中必须充分公开药品风险信息,注重从消费者角度整体评估药品广告有无虚假宣传或误导性;要求直面消费者的平面广告的简短摘要应当采用科学易懂的方式,集中公开药品的重点风险信息;要求有字符限制的互联网/社交媒体平台广告同样需要充分公开风险信息;鼓励企业自主更正互联网中的不实药品信息;此外,FDA对广告中药品名称、广告播出前审查、企业资助的学术和科研活动的审查制度方面的经验和做法,同样值得借鉴。

Objective： To introduce the regulatory requirements for disclosure of risk information in the guidance documents for drug advertising in the United States and to provide references for the supervision of drug advertising in China. Methods： US Food and Drug Administration（FDA） website was retrieved to collect and collate drug advertisement guidance documents issued by FDA. The regulatory requirements for disclosure of information about the drug risks in the guidance documents were analyzed. Results and Conclusion： FDA requires that drug risk information should be fully disclosed in drug advertisements. FDA focuses on the overall assessment of drug advertisements whether there is false publicity or misleading information from the perspective of consumers. The brief summary of the print drug advertisement should be scientifical and easy to understand, and focus on the key risk information of the drug. For internet/social media platform advertisings with character limit, the risk information should also be fully disclosed. Enterprises are encouraged to autonomously correct false drug information on the Internet. In addition, the FDA＇s experience and practices in the aspects of the drug names in advertisements, pre-screening of advertisements, and the review of academic and research activities funded by enterprises are also worth learning.