Yang Y Tony, Chen Brian
Food Drug Law J. 2014;69(1):39-51, ii.
Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.
社交媒体营销是药品直接面向消费者广告的下一个前沿领域,但却是监管行动的未知领域。随着社交媒体使用的爆炸式增长,以及制药公司利用社交媒体营销机会的能力不断提高,美国食品药品监督管理局(FDA)迫切需要发展自身监测和参与社交媒体营销的能力。为应对FDA可能采取的行动,制药公司的营销、法规合规和法律人员必须密切合作,设计出对FDA关切敏感的举措。本文将探讨FDA关于社交媒体广告的法规现状、其历史渊源、实施面临的挑战以及可能的未来发展方向。