Firms waiting for FDA to issue guidance on how best to use social media for marketing and promotion can look instead at existing regulations both in and outside the agency, experts said recently.

They may have no choice. Attendees at the April 6 Food and Drug Law Institute annual conference were reminded that draft guidance for use of social media was due in 2010 and then the 2011 first quarter, and that the wait continues.

What is more, regulators may never fully keep up with the rapidly changing online environment anyway, said Jeffrey Wasserstein, a director at the law firm Hyman, Phelps & McNamara.

"FDA regulations are already outdated. If they issue a guidance it will be stale about two weeks after it's issued," Wasserstein said. "There is absolutely no way they can keep up with the changing technology. [But] there are legitimate ways to use social media tools."

FTC Offers Some Answers…

The Federal Trade Commission Act prohibits deceptive or unfair acts or practices that occur in commerce, and the agency last year released updated guides about how the provision applies to endorsements and testimonials. FTC staff attorney Stacey Ferguson said those revisions can be applied to social media.

Key changes require disclosure of: when an advertiser has paid for a study touted in an ad, the sponsorship of a study, and when an author paid for products he or she is reviewing.

Those same requirements apply to social networking sites, which are often used by advertisers to reach targeted audiences, Ferguson said. For example, truth-in-advertising rules still apply to viral and stealth marketing, blogs, blog advertising and social network sites such as Facebook.

"The FTC Act does not change," she said.

Still, some updates accommodate the changing technology. Bloggers, for example, must now disclose when they are paid or receive a free product (Also see "FTC Testimonial Guide Moves Past "Results Not Typical," Enters Blog Era" - Pink Sheet, 12 October, 2009.).

"Advertisers have to monitor bloggers and take steps to halt publication of any deceptive things when discovered," Ferguson said.

…And FDA Gives Clues In Past Actions

FDA deserves credit from moving away from relative inaction a few years ago, when it simply noted that "it's not the medium, it's the message" concerning the venue for companies' advertising and marketing, said Jeffrey Senger, former FDA acting chief counsel and deputy chief counsel.

"This is huge and getting huger. FDA is aware of that and is up to the minute, itself, using social media in a number of ways," said Senger, a partner at Sidley Austin.

He added he is confident that FDA will come out with thorough draft guidance after working with an unusually high amount of interested parties.

"This is a tricky issue," Senger said. "A lot of constituencies are interested in it. If FDA is doing its job right, as I am sure they are, they are trying to coordinate within the community of regulated entities as well as within the government."

Senger argued that FDA has offered clues about its enforcement thinking with past actions. FDA, for example, determined in 2009 that advertising links for drugs posted on Google violated advertising rules, in part because they lacked risk information, the established generic product name "and in some cases broadened the indication."

Still, he added, FDA has much to consider in shaping guidance. The task includes addressing questions such as how to govern Twitter's 140 character limit, or Google links with 70 character limits in text and 25 character limits in the title, with little room to include sufficient text to easily satisfy existing rules.

Another expected FDA decision area: How to guide corporate behavior in chat rooms, where employees could record comments anonymously.

"FDA has said if you pay for the ad or pay somebody who is responsible for the ad, you are responsible for the ad," Senger said. "But what if it is a chat room? What if you pay for the chat room but don't pay anybody who posts on it? The medium must be dealt with and FDA is starting to do so."

FDA's proposed guidance for use of social media has been under discussion since at least 2009. In early 2010, the agency also solicited feedback from industry about best practices for marketing and promotion using social media such as Facebook, Twitter and YouTube (Also see "FDA Officials Offer Pointers For Navigating Social Media Pitfalls" - Pink Sheet, 24 May, 2010.).

By Mark Hollmer

Social Media Marketing Guidance Available In Existing Regs, Experts Say

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