Research on the regulatory framework for direct-to-consumer prescription drug advertising in the United States
- VernacularTitle:美国面向消费者处方药广告的监管机制研究
- Author:
Jie FU
1
;
Yue WANG
1
Author Information
1. School of Medical Humanities，Peking University，Beijing 100191，China
- Publication Type:Journal Article
- Keywords:
prescription drug advertising;
regulatory mechanism;
direct-to-consumer advertising
- From:
China Pharmacy
2025;36(22):2760-2765
- CountryChina
- Language:Chinese
-
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.
