FDA’s regulation of prescription drug product promotion extends both to promotional activities that are carried out by the firm itself, and to promotion conducted on the firm’s behalf. In determining whether the firm is accountable for a communication about its product(s), the Agency considers whether the firm or anyone acting on its behalf is influencing or controlling the product promotional activity or communication in whole or part. Firms may have a variety of options for how much control they exert over activities that utilize interactive promotional media, regardless of whether the promotional activity occurs on firm-sponsored or third-party venues. For example, a firm may promote its products throughproduct websites, discussion boards, chat rooms, or other public electronic forums that it maintains and over which it has full control. In addition, third-party sites (i.e., websites and other venues that are either entirely independent of a firm’s control and influence, or not fully controlled by a firm) may promote a firm’s products.
As part of the postmarketing reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), application holders are required to submit all promotional labeling and advertising pieces at the time of initial dissemination
of the labeling and at the time of initial publication of the advertisement for a drug. However, for some interactive
promotional media, submission “at the time of initial dissemination” may pose a challenge for firms, particularly when these
media communicate information that is displayed in real time. While “at the time of initial dissemination” does not refer to submissions on a weekly, monthly, or other routine schedule, FDA intends to exercise its enforcement discretion
under certain circumstances due to the high volume of information that may be posted within short periods of time using interactive promotional media that allow for real-time communications. If a firm submits interactive promotional media in the manner described in this draft guidance, FDA intends to exercise enforcement discretion regarding the regulatory requirements for postmarketing submissions related to promotional labeling and advertising.