福里与拉德纳律师事务所合伙人戴维·罗森在《Endpoints News》的报道《FDA严打药品直面消费者广告引发法律压力》中评论道,分享了美国食品药品监督管理局针对处方药广告采取执法行动的最新进展。
罗森表示,美国食品药品监督管理局(FDA)近期发出的警告信“确实令制药行业感到意外”,尤其这些信函并未像往常那样由FDA处方药推广办公室人员签署。
罗森评论道:“我认为目前全面禁止广告促销的可能性不大,但人们在促销活动中会更加谨慎。”
他进一步指出,若美国食品药品监督管理局(FDA)仅依据已发布的指导原则来实施广告限制,而非通过正式的规则制定程序及其配套的公示征询阶段,则可能引发诉讼。
“这确实取决于规则的限制程度,”他补充道,“但这些规则很可能也会面临某种法律挑战。”
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