FDA对超说明书用药促销监管的思考

FDA's administration of off-label drug use

本文通过介绍美国超说明书用药界定及超说明书用药促销现状,分析FDA对超说明书用药促销监管的政策演变、目前的监管范围和监管措施,得出FDA对制药企业合法性促销条件要求逐步放宽,对违法促销企业的惩罚力度不断加大,并且FDA的监管机制与医药市场整体环境相配套,以期对我国超说明书用药促销的监管提供借鉴与启发,促进合理用药。

The definition and current situation of off-label drug use promotion in America were introduced and the policy development, the administrative range and the administrative methods were analyzed. The authors find out that the legal promotion conditions of pharmaceutical companies required by FDA are loosened ; FDA＇s pun- ishments inflicted on pharmaceutical companies that illegally promote off-label drug use are strengthened; and FDA＇s administrative mechanism matches with the medical and pharmaceutical market environment. The author hopes that we can draw some experiences to improve rational drug use in China.