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美国面向消费者处方药广告的监管机制研究
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| 篇名： | 美国面向消费者处方药广告的监管机制研究 |
| TITLE： | Research on the regulatory framework for direct-to-consumer prescription drug advertising in the United States |
| 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. |
| 期刊： | 2025年第36卷第22期 |
| 作者： | 付洁；王岳 |
| AUTHORS： | FU Jie，WANG Yue |
| 关键字： | 处方药广告；监管机制；面向消费者广告 |
| KEYWORDS： | prescription drug advertising； regulatory mechanism； direct-to-consumer advertising |
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