FDA Social Media Guidance: Four years in the making
Four years have passed since the first hearing about the use of social media for medical marketing. A year has passed since the releasing of information about social media guidance for medical companies (unsolicited requests). Thus, it is time for the “real deal” to emerge. The FDA has finally released a comprehensive guidance on this topic (hurrah!).
The good news (1): Medical devices firms are off the hook (for now). However, while only covering drugs and biologics at this stage, medical devices firms need to stay attentive to the pulse of the industry, implementing in their social media guidelines whatever is appropriate.
The good news (2): Firms are only responsible for the content that they create or influence. Sounds trivial, right? But the fact of the matter is that pharma firms were hesitant to engage in social media because of the undefined boundaries of responsibility and accountability.
This guideline doesn’t answer all of the questions or address all of the shortcomings, but it is a start.
About the FDA social media (draft) guidance
Titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” this 10-page guidance draft is intended to describe the FDA’s current thinking about how manufacturers, packers, and distributors should act with regards to the use of interactive promotional media for their FDA-approved products.
The guide stipulates the responsibility of a manufacturer regarding promotional content. Promotional content is not limited to the material prepared and promoted by the pharma company on its own; indeed, it extends to companies operating on its behalf, as well. Accountability is determined according to the level of influence or control over the product’s promotional activity or communication in whole or in part.
The guidance is short yet comprehensive. It covers the use of interactive promotional media, which includes modern social media tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts) that medical firms use to promote drugs or biologics.
Which interactive promotional media requires postmarketing submissions?
All materials used for promoting a product on sites that the medical company owns and influences are required to be submitted to the agency. Firms are responsible for submitting materials to the FDA, even in instances in which the influence is limited in scope, such as in cases where it collaborates with publishers on editorials, previews, and so forth (UCG means User Generated Content).
If a firm only provides financial support and has no influence on the site, then it has no obligation to submit the promotional materials to the FDA. Additionally, if it is merely providing promotional materials to a third-party site but does not direct the placement of the promotion within the site and has no other control or influence on that site, the firm is responsible only for the content it places there and, thus, is responsible only for submitting to the FDA any promotional content that was disseminated on that site.
Firm responsibility of an employee-generated content or an agent who is acting on behalf
A firm is responsible for the content generated by its employees or any agents acting on behalf of the firm who promote the firm’s product. This includes a medical science liaison or paid speaker (for example, a key opinion leader) acting on the firm’s behalf, as well as comments on a third-party site about the firm’s product. The firm is responsible for the content that its employee or agent provides. A firm is also responsible for the content on a blogger’s site if the blogger is acting on behalf of the firm.
This is only the beginning
All in all, the guidance relays how a drug manufacturer would do in the offline arena and extends it to marketing in the interactive healthcare social media environment. The main issue here for a firm is the need to have a tighter control over its marketing. While in the past, it was the firm’s marketing communications department that had the monopoly over the company’s medical marketing materials, now, each employee—or individual even partially sponsored by the company—is potentially a creator and distributor of promotional content. This is obviously more difficult for the medical firm to control.