Regulatory System for the Pharmaceutical Company’s Drug Promotional Activities by the US FDA: Toward the Establishment of a Monitoring System for Drug Advertising in Japan

Abstract

As the pharmaceutical company’s promotional activities sometimes communicate false or misleading information ultimately detrimental to the health of consumers/patients, the establishment of a third-party regulatory system for new drug promotional activities is necessary. This study explores the possibilities for such a system in Japan, by considering, as an example, the US Food and Drug Administration’s (FDA) existing regulatory system for the pharmaceutical company’s promotional activities. In this study, the current status of drug advertising violations in the USA was analyzed, based on a review of warning letters and untitled letters issued by the FDA. At the FDA, expert examiners in every medical field and specialty effectively review enormous quantities of specialized promotional materials. To counter violations in settings where surveillance is difficult, e. g. clinics and meetings, the FDA targets on-site health care practitioners through its Bad Ad Program, which incorporates both educational and violation-reporting capabilities. As violations in American electronic media have recently been on the rise, the monitoring of information on social media, e. g. Facebook, will become increasingly important.