March 19, 2013 – Although the FDA has not yet issued its long-awaited social media guidance for the biopharma industry, whatever guidelines it drafts on this topic are likely to be informed by the staff guidance document issued last week by the Federal Trade Commission (FTC). The FTC’s new guidance, “.com Disclosures,” revises an FTC document issued in 2000 and, essentially, advises advertisers that online ad claims must be “clear and conspicuous” and that it is the message, not the medium that defines compliant ads. According to the guidance, “cyberspace is not without boundaries, and deception is unlawful no matter what the medium.”

“The FTC has led the way on these issues and continues to do so. Clearly, the FDA will recognize the leadership here and likely move forward similarly. I’m optimistic that we will see similar guidance soon from FDA’s Office of Prescription Drug Promotion,” noted John Kamp, Executive Director, Coalition for Healthcare Communication.

The updated FTC guidance emphasizes that consumer protection laws apply equally to marketers across all media, “whether delivered on a desktop computer, a mobile device, or more traditional media such as television, radio, or print,” according to an FTC press release. The FTC stated that if disclosures are needed to prevent an online ad claim from being deceptive or unfair, they must ensure that these disclosures are clear and conspicuous “on all devices and platforms that consumers may use to view the ad.”

As an article in The Wall Street Journal noted, “That means making room for full disclosure even in a 140-character tweet on Twitter. The agency suggested that marketers could flag Twitter ads by including ‘Ad:’ (three characters) at the beginning of the post or the word ‘sponsored’ (nine characters).” The FTC also clarified in the new guidance that disclosures should be “as close as possible” to the relevant claim,” which is a revision from the 2000 guidance, which called for disclosures to be “near, and when possible, on the same screen.”

Indeed, when practical, the FTC would like advertisers to incorporate relevant limitations and qualifying information into the underlying claim, rather than have a separate disclosure qualifying the claim. Where that is not possible, the agency continued to caution advertisers that they should avoid using hyperlinks

for disclosures and that “required disclosures about serious health and safety issues are unlikely to be effective when accessible only through a hyperlink.”

The FTC’s hyperlink restrictions could very likely be adopted by the FDA. Industry attorney Arnie Friede, a former FDA associate chief counsel, told Pharmalot.com that “the FDA can certainly hang its hat on this language to say that even the FTC rejects disclosures via hyperlink of important health and safety information, e.g., ‘fair balance’ information.”

The FTC also asks marketers to avoid “conveying such disclosures through pop-ups, because they are often blocked” and states that if a disclosure is necessary to prevent an advertisement from being deceptive, unfair or otherwise violative of a Commission rule, and it is not possible to make the disclosure clearly and conspicuously, “then that ad should not be disseminated. This means that if a particular platform does not provide an opportunity to make clear and conspicuous disclosures, then that platform should not be used to disseminate advertisements that require disclosures.”

In the final analysis, the FTC concludes, “the ultimate test is whether the information intended to be disclosed is actually conveyed to consumers.”

Silverman, Ed; “Will FDA Emulate FTC Online Ad Guidance?” Pharmalot.com (March 13, 2013).