美国面向消费者处方药广告的监管机制研究

付洁; 王岳

doi:10.6039/j.issn.1001-0408.2025.22.02

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美国面向消费者处方药广告的监管机制研究

药事管理 | 更新时间：2025-11-25

- 美国面向消费者处方药广告的监管机制研究
- Research on the regulatory framework for direct-to-consumer prescription drug advertising in the United States
- 中国药房 2025年36卷第22期页码：2760-2765
- 作者机构：
  
  北京大学医学人文学院，北京　100191
- 作者简介：
  
  博士研究生。研究方向：医药卫生政策与制度史、卫生法。E-mail：2311110254@stu.pku.edu.cn
  教授，博士生导师，博士。研究方向：卫生政策与卫生法学、应急管理、医学人文与医患关系。E-mail：wangyues@pku.edu.cn
- 基金信息：
  
  国家卫生健康委委托项目
- DOI：10.6039/j.issn.1001-0408.2025.22.02
  中图分类号： R95
- 收稿：2025-06-05，
  
  修回：2025-10-29，
  
  录用：2025-10-31，
  
  纸质出版：2025-11-30
- 稿件说明：
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付洁,王岳.美国面向消费者处方药广告的监管机制研究 ^Δ[J].中国药房,2025,36(22):2760-2765.

FU Jie,WANG Yue.Research on the regulatory framework for direct-to-consumer prescription drug advertising in the United States[J].ZHONGGUO YAOFANG,2025,36(22):2760-2765.
付洁,王岳.美国面向消费者处方药广告的监管机制研究 ^Δ[J].中国药房,2025,36(22):2760-2765. DOI： 10.6039/j.issn.1001-0408.2025.22.02.

FU Jie,WANG Yue.Research on the regulatory framework for direct-to-consumer prescription drug advertising in the United States[J].ZHONGGUO YAOFANG,2025,36(22):2760-2765. DOI： 10.6039/j.issn.1001-0408.2025.22.02.

摘要

目的

探讨美国面向消费者（DTC）处方药广告的监管机制，以期为我国药品广告监管体系的完善提供借鉴。

方法

采用文献研究法，系统分析美国《联邦食品、药品和化妆品法案》及相关监管指南，梳理其基于风险平衡理念的监管框架与执行机制。

结果

美国FDA构建了分类监管与严格事后追责双轨并行的监管路径。在事前环节，FDA依据信息披露程度将DTC处方药广告划分为产品声明广告、提醒广告及求助广告3类，并实施差异化标准以平衡信息流通与风险控制。在事后环节，FDA建立了民事高额罚金、行政矫正与刑事追责相结合的多元责任体系，对违法广告相关行为形成了有效威慑。

结论

美国DTC处方药广告监管机制在保障商业自由与公共健康方面提供了重要经验。我国可参考其风险平衡逻辑，在立法中融合分类监管的灵活性与多元责任的刚性，以期在保障公众用药安全的同时，促进医药市场的健康发展。

Abstract

OBJECTIVE

To explore the regulatory framework for direct-to-consumer （DTC） prescription drug advertising in the United States， in order to provide reference for the improvement of China’s pharmaceutical advertising regulatory system.

METHODS

By utilizing the literature research approach， this study systematically analyzed the

Federal Food， Drug， and Cosmetic Act

， along with relevant regulatory guidelines. Its regulatory framework and enforcement mechanisms grounded in the principle of risk-benefit balance were elucidated.

RESULTS

The FDA had established a dual-track regulatory approach that combined categorized supervision with stringent post-market accountability. In the pre-market phase， DTC prescription drug advertisements were classified into three categories，i.e. product claim advertisements， reminder advertisements， and help-seeking advertisements，based on the extent of information disclosure. Differentiated standards were implemented to balance information dissemination and risk control. In the post-market phase， a multi-faceted liability system was established， combining substantial civil fines， administrative corrective measures， and criminal prosecution to effectively deter illegal advertising practices.

CONCLUSIONS

The regulatory mechanism for DTC prescription drug advertising in the United States offers valuable experience in balancing commercial freedom and public health. China can draw on its risk-balance rationale by integrating the flexibility of categorized supervision with the rigidity of a multi-faceted liability system in its legislation， aiming to safeguard public medication safety while promoting the healthy development of the pharmaceutical market.

关键词

Keywords

references

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