The FDA's just-released draft social media guidance has been more than four years in the making but finally looks to offer industry some substantial direction on its use of digital media.

Given that the US regulator's November 2009 hearing on “using the internet and social media tools” encompassed such burning digital issues of yesteryear as Google Sidewiki, it's fair to say the guidance wasn't exactly rushed through.

Following up on that hearing the FDA yesterday set out its position on 'interactive promotional media', that is “tools and technologies that often allow for real-time communications and interactions”.

These tools and technologies, it explains, include blogs, microblogs social networking sites, online communities, live podcasts, which pharma uses to promote its drugs.

The long-awaited draft guidance was, the US regulator said, issued in response to “stakeholder requests for specific guidance on FDA's current views on how manufacturers … can fulfil regulatory requirements for post-marketing submissions of interactive promotional media for their FDA-approved products”.

Its 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 recognises that in other cases they possess certain unique technological features and offer novel presentation and content features”.

In terms of what it covers, the FDA said it will only examine product communications that use interactive technologies which are subject to “substantive influence by firms that market the product, therefore triggering post-marketing submission requirements”.

The FDA's social media recommendations

• Firms are responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm
- Such product promotional communications may include firm-sponsored microblogs (eg Twitter), social networking sites (eg Facebook) and the firm's blogs

FDA example: 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 … because the firm created, owns, or operates the website

• Under certain circumstances, firms are responsible for promotion on third-party sites
- Companies are responsible for such promotion if they have any control or influence on the third-party site, even if that influence is limited in scope

FDA example: A firm collaborates, or has editorial, preview, or review privilege, then it is responsible for its promotion on the site; but if it only provides financial support and has no other control or influence on that site, then the firm is not responsible for information on a third-party site

• 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 are responsible for content generated by its employees, or any agents, acting on their behalf who promote the firm's products

FDA example: If an employee or agent of a firm, such as a medical science liaison or paid speaker (eg key opinion leader) acting on the firm's behalf, comments on a third-party site about the firm's product, the firm is responsible for the content.

The regulator also said it wanted to receive all user-generated contact (UGC) that falls within its recommendations for interactive promotional media.

But the guidance does acknowledge the need for a practical process that addresses “the potential volume of real-time information that is continuously posted and shared through various interactive promotional media platforms”.

Consequently it suggests that, once a month, companies should submit an updated listing of all non-restricted (non-password protected) sites for which it is responsible, or in which it remains an active participant, and that include interactive or real-time communications.

Once finalised the guidance will represent the FDA's current thinking on fulfilling the regulatory requirements for post-marketing submissions of interactive promotional media for drugs.

It will then add to a growing body of digital guidance from the FDA that so far covers off-label information on social media and a tailored approach to mobile app regulation.

• Read: The Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

• Read: supplementary information on the FDA's social media guidance

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