FDA to Hold Public Hearings on Big Pharma's Social-Media Use

Drug Makers, Agencies Frustrated by Lack of New Guidelines for Web 2.0

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NEW YORK (AdAge.com) -- The U.S. Food and Drug Administration will hold a two-day public hearing in November on how pharmaceutical companies use the web and social-media tools to market their products, the first step in a long overdue process that will finally establish guidelines for how drug makers proceed in a Web 2.0 world.

The industry is embracing the news, despite the newfound regulatory heavy hand the FDA has shown under the Obama administration. "It's about time," said an executive for one top-five pharmaceutical company who asked not to be identified. "Any guidance at all is better than having no guidance, which is what we have right now."

Regulatory guidelines are now sorely lacking for direct-to-consumer spending by pharmaceutical companies using internet media. While overall DTC spending fell to $4.7 billion in 2008, a 10.6% drop according to TNS Media Intelligence, internet spending by drug makers zoomed 36% to $137 million -- a modest output, but, again, a figure that was likely hampered by a lack of regulation and a fear of FDA retribution. It also does not account for web video, social media and other forms of marketing being increasingly embraced by the industry.

The FDA published its intent to hold hearings on Nov. 12-13 in Washington in the Federal Register. "This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools," part of the notice read.

The FDA hasn't addressed the issue of pharma advertising on the web since 1996 and its notice in the Federal Register seems to acknowledge that. "The continually evolving nature of the internet, including Web 2.0 and social-media tools, as well as their expansion to applications such as mobile technology, have raised questions and concerns over how to apply existing regulations to promotion in these newer media. FDA is evaluating how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer technologies," the notice read. "Although the agency believes that many issues can be addressed through existing FDA regulations, special characteristics of Web 2.0 and other emerging technologies may require the agency to provide additional guidance to the industry on how the regulations should be applied."

The dilemma of not having regulatory guidelines for marketing via such tools as Twitter, Facebook, blogs and websites, came to a head in April of this year when the FDA sent warning letters to 14 companies for search-engine ads that the FDA said violated regulations regarding presentation of fair balance. The industry countered that the regulations requiring disclosure of risk information in print and broadcast ads should not be applied to internet ads that only contain 12 words on Google ads, or 140 characters on Twitter.

Three months later, Pfizer VP of Worldwide Communications Ray Kerins expressed his frustrations over not being able to use social media, telling a conference audience, "Twitter for us is an opportunity. I mean, I consider it a newsfeed. It's as big as a newswire, as far as I'm concerned." Mr. Kerins did not respond by press time to a request for a follow-up comment.

"Right now there's been no definition of what can be done and what can't be done," said Mark Senak, senior VP at Fleishman Hillard and author of the blog Eye on FDA. "Regulation over social media has been taking place by warning letter rather than by standards that people can adhere. Certainly, the industry has been inhibited and lagged behind less-regulated industries in the use of social media, and that's hurt pharmaceuticals because that's how people are building their brands these days."

Ad agencies that specialize in health-care marketing say the hearings, and the likely implementation of set guidelines, are welcome news for pharma companies that, inherently, are already conservative by nature and have avoided doing much in the social media realm for fear of an FDA warning letter.

But Bill Drummy, CEO of New York-based Heartbeat Digital, said the FDA needs to careful when distinguishing social media from traditional media. "I don't view social networking as primarily an advertising vehicle at all," Mr. Drummy said. "It's about value exchange, creating communities of interest, and is not about a traditional advertising space. Those who use it that way do not fare well. It clearly has marketing capabilities, but it has to be looked at in different ways. Clearly it's both [advertising and informational]. Websites can provide information including fair balance, but they're also trying to encourage people to try their product. So new rules are definitely in order here."

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