Finally: An FDA (Draft) Guidance for Social Media in Medical Marketing

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FDA Social Media Guidance: Four years in the making About the FDA social media (draft) guidance Which interactive promotional media requires postmarketing submissions?Firm responsibility of an employee-generated content or an agent who is acting on behalf This is only the beginning

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.

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).

Example 1: A firm provides on its product website an online forum that gives users the opportunity to post comments about the use of its product. In this case, the firm is responsible for submitting to FDA the product website to meet the postmarketing submission requirements because the firm created, owns, or operates the website.

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.

Example 2: A firm does not have any control of, or influence on, information on an independent third-party site but chooses to promote its product on this site (e.g., by providing specific promotional content such as firm-initiated UGC). In this situation, to meet postmarketing submission requirements, the firm is responsible for submitting to FDA the promotional content it provided to the site.

Example 3: A firm makes suggestions on the placement of its promotional messages on an independent third-party site. Because the firm influenced the placement of its promotion within the third-party site, the firm is responsible for submitting to FDA the promotion, along with the surrounding pages, to adequately provide context to facilitate the review of the third-party site, in order to fulfill the postmarketing submission requirements.

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.

Example 4: A sales representative acting on behalf of a firm posts comments about the innovative release mechanism of the firm’s product on an independent third-party site. Because the sales representative is acting on behalf of the firm, the firm is responsible for submitting the comments to FDA to meet the postmarketing submission requirements.

Example 5: A representative of a firm, such as a blogger paid by the firm, maintains a blog about the firm’s product. The firm is responsible for submitting the blog to FDA to meet the postmarketing submission requirements. FDA recommends that a firm be transparent in disclosing its involvement on a site by clearly identifying the UGC and communications of its employees or third parties acting on behalf of the firm. This could be achieved by inclusion of the firm’s identifier (e.g., name or logo) as part of the communication. However, a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, on behalf of, or prompted by the firm in any particular). FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards, and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.

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.