FDA's delayed guidance throws PR curveball

The Food and Drug Administration's decision earlier this week to once again postpone the release of social media guidelines comes as little shock to PR pros.

The Food and Drug Administration's decision earlier this week to once again postpone the release of social media guidelines comes as little shock to PR pros.

Although PR execs say that they sympathize with the bureaucratic obstacles the FDA faces, they also stress that by continuing to delay the release of social media guidelines the FDA may hamper the ability of public relations executives to provide proper counsel for their highly regulated clients that want to enhance their social media marketing.

The FDA was scheduled to release the guidelines in December, but stated at the time that it would delay the release of the first draft guidance until Q1 of 2011. Now that's been indefinitely put on hold.

“No one is terribly surprised that there's been a delay,” says Mark Senak, SVP and partner at Fleishman-Hillard, who is in charge of the agency's healthcare practice. “The [FDA] has layers and layers of bureaucracy to send the guidelines through, so some of it is out of their control.”

He added: “That said, this is a doable task. The Internet has been around since 1996 and people [in PR] have been waiting a long time for the [guidelines]. It's hard for the industry to proceed without the guidelines.”

For now, PR pros will have to continue to apply existing FDA regulations on how drug companies promote their products via print and broadcast outlets to their social media initiatives.

But here's the rub: traditional media outlets carry monologues by marketers, whereas social media networks á la Twitter and Facebook involve multiple conversations among marketers, consumers, patients, and patient advocacy groups.

John Bell, global MD of Ogilvy's 360º Digital Influence, says he did not think the latest delay is an indication that the FDA is “de-prioritizing” social media guidelines, but he does sense some foot-dragging.

“I'm afraid what's causing the delay at the FDA is the agency wants to deliver very detailed information of the exact mechanics of how digital marketing and social media executions must work versus the principals of that we as marketers should follow,” says Bell who, as then-president of the Word of Mouth Marketing Association, testified at the FDA's hearings on social media in November 2009. “If that's the road they're going down, it may be another year until we see something.”

Bell added that he would prefer if the FDA followed the Federal Trade Commission's lead. The FTC Guides on social media, which took effect in December 2009, delineate how the FTC intends to apply its existing powers “prohibiting deceptive and unfair business practices to nontraditional consumer-generated media, such as blogs and social networking sites.”

“It's a matter of giving marketers and communicators the guiding  principles - with examples - and letting the marketplace show how they can be precisely applied today and in the technology platforms of tomorrow,” Bell says.

In a statement, the FDA said it did not have a timeframe for when it will release the guidelines. An FDA spokesperson added that the DDMAC's (Division of Drug Marketing, Advertising, and Communications) “objective in protecting the public health is to ensure that consumers and healthcare professionals receive accurate, balanced, and non-misleading information about prescription drugs.”

Jeff Chester, executive director of The Center for Digital Democracy, says he urged the FDA to delay the release of the guidelines. The Department of Health and Human Services, which governs the FDA, “is trying to figure out what to do about [social media marketing], and is under tremendous pressure from the industry to create new rules,” Chester says. “But the FDA is weary of a race to the bottom.”

Gil Bashe, EVP and practice director of healthcare at Makovsky & Co., says he does not see the delay as detrimental to the PR field. “The FDA is starting to appreciate how complex social media is,” he says. “Would the agency want to come up with guidelines that take a more reactionary approach and are more restrictive? Of course, not. Patients need this medium.”

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