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A Prescription for Online Medical Confusion

What is the FDA Trying to Hide and Why?

The FDA, like all federal agencies, takes full advantage of social media. But it’s mum on what drug companies can and cannot do to get its message across on the same online media.

Are you wondering what the Food and Drug Administration is thinking about drugs? Just follow them on Twitter. And if you don’t like reading 140 characters or fewer Tweets, check out the FDA on Facebook. Don’t like Facebook? No problem. You can always use LinkedIn to see what many of their employees are talking about.

It’s really quite heartening to see a federal agency as consumer oriented as the FDA using social media platforms to communicate. In fact, virtually every federal agency that protects consumers benefits from social media as a communications tool. Check out the Federal Trade Commission (Facebook), the Securities and Exchange Commission (Twitter), the Consumer Product Safety Commission (LinkedIn), and even the White House (Facebook, LinkedIn, Twitter).

And information on some not-so-consumer-friendly federal agencies are readily available on social media. Check out the Internal Revenue Service (LinkedIn) and the Central Intelligence Agency (LinkedIn).

But the FDA is special. It operates on a double standard. What the FDA thinks is good for itself, the FDA does not think is good for the industry it regulates. Despite repeated requests from the drug industry and hearings at the FDA, the agency has failed to provide any meaningful guidance on how pharmaceutical companies are supposed to use social media in their marketing.

The agency’s silence is quite odd, particularly since social media is so widely used by consumers and could be such a rich medium for education and reporting. At last report from WebMD.com, 83.3 million unique users visit its site every month perusing more than 1.8 billion page views a quarter. In the social media space, 2,177 are connected to WebMD on LinkedIn, 52,393 like their Facebook page, and 160,240 follow WebMD on Twitter.

Just what is it then that the FDA is so afraid of? Apparently, it boils down to an issue that has preoccupied the FDA ever since the FDA reluctantly allowed direct-to-consumer (DTC) prescription drug advertising in 1985 (after having called for a two-year moratorium in 1983 after some drug companies started using print ads in 1981 and television in 1983).

The issue that has vexed the FDA is the necessary disclosure of risks associated with a drug in DTC drug advertising. To understand the evolution of this concern, let’s take a look at how the FDA’s love/hate affair with drug advertising evolved and what has led it to schizophrenia in social media.

In 1985 when the FDA officially permitted DTC prescription drug advertising, it did so despite its belief that such advertising was not in the public interest. So the FDA divinely split DTC advertising into three “buckets”: “help-seeking” advertisements (ads that describe a disease or condition without reference to treatment but that urge consumers to consult with their doctor), “reminder” advertisements (ads that name a medication but provide no information on the drug’s purpose), and “product-claim” advertisements (ads that include both the name of the drug and the condition for which is can be prescribed. No special disclosures are required for help-seeking or reminder ads.

But if a company publishes a product claim ad, the FDA requires disclosure that conveys a “fair balance” of risks and benefits that includes warnings, precautions, contraindications, and adverse events. Recalling print ads, it’s generally an entire page seemingly from the Physicians’ Desk Reference, the medical profession’s bible for drugs.

In 1997, the FDA relaxed the rules for broadcast advertising provided they disclosed where consumers could get information that would generally appear in print ads, e.g., a health care provider (for example, a doctor), toll-free telephone number, the current issue of a magazine that contains a print ad, or a Web site address.

With that background, enter social media and, in particular platforms like Facebook, LinkedIn, and Twitter, where the messages are often brief and more like teasers than actual ads. What disclosure rules should apply to those ads? Because the FDA has failed to answer that question or issue sensible guidelines, the industry, following the logic of the broadcast standards, has adopted the so-called “one-click rule” where all the disclosures are available by one click on a link in the ad.

What could be more efficient than providing full disclosure a mere click away when the same disclosures in broadcast require the consumer to seek out off line resources or a Web site? If the social media ad itself provided the Web site with a simple click, what more could be required? It all made sense and companies began marketing via the one-click rule.

Then in 2009 this logic all suddenly went into cyber-history when the FDA issued enforcement letters to 14 companies concerning Google banner ads, claiming that their failure to include risk information violated federal law. Worse, when later asked about the one-click rule, the FDA stated it “never had what some are referring to as a one-click rule.” Talk about a wake-up call!

The result was complete confusion. Why did the FDA take such a stand without warning? Wasn’t the logic of the one-click rule impeccable? Do not the social media platforms provide the most robust opportunity for disclosure immediately during the consumer’s visit?

Yet today, it appears that having all the disclosure in the world a mere click away isn’t good enough for the FDA. The result was a virtual exodus by drug companies from marketing in social media.

This has been followed by hearings but a failure to issue guidelines. Indeed, in its recently published “Strategic Priorities: 2011 – 2015,” the FDA’s only mention of social media was in the context of woman’s health, where the agency opined, “Social media tools can help meet some of [the] FDA’s communication[s] challenge. We are planning to use social networks to create a virtual community.” Could it be that the FDA has returned to its early belief that such advertising was “not in the public interest”?

Enough already. What’s good for the goose is good for the gander. It’s high time for the FDA to log on and provide drug companies — and consumers — with guidance on social media marketing.

Doug Wood, We Expert

Copyright 2011. ALM Media Properties, LLC. All rights reserved.

Reprinted from Corporate Counsel, http://www.law.com/jsp/cc/index.jsp

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admin had written 358 articles for Party of We

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