FDA releases draft social media submission guidance

Four years after the FDA began drafting guidance on the use of social media, they publish directions on how digital media submissions to the FDA should be made. Following the hearing on social media in 2009, FDA published new guidance on submitting ‘interactive promotional media’ yesterday. Interactive promotional media includes tools and technologies such as blogs, social networking sites, online communities and forums, live podcasts which allow for real-time communication and interactions. These tools may be used by pharma companies for promoting its drugs. The guidance notes that “although some interactive promotional media are substantially similar in presentation and content to certain traditional promotional media, such as print media, FDA recognizes that in other cases they possess certain unique technological features and offer novel presentation and content features”. The FDA has said that it will only examine product communications that use interactive tools and technologies which are subject to “substantive influence by firms that market the product, therefore triggering post-marketing submission requirements”. Some of the social media recommendations by the FDA are:

• Firms are responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm. Examples of these sites are firm-sponsored microblogs (e.g. Twitter), social networking sites (e.g. Facebook) and the firm's blogs.
• Under certain circumstances, firms are responsible for promotion on third-party sites.
• A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm's product.

Companies should submit updated lists, once a month, of all non-restricted (non-password protected) sites for which it is responsible or on which it is still an active participant, including interactive and real-time communication. All private user-generated contact (UGC) which falls within the recommendations of the guidelines for interactive promotional media is to be sent to the regulator. The finalized version of the FDA’s guidance will represent the current thinking of the FDA on the regulatory requirements for submitting post-marketing interactive promotional media relating to pharmaceutical medicines.