Some 60% of Americans say that when they need medical information, they turn to the Internet. At least half the group uses social networks to consult one another on symptoms, diagnoses, and treatments, according to surveys on Web behavior. Pharmaceutical companies would like to get in on the conversation, but how do these highly regulated companies twitter and friend without running afoul of federal marketing restrictions?
Nobody quite knows, including the Food & Drug Administration. So the agency held two days of hearings in November to brainstorm about social media rules for drug companies. More than 800 people signed up for the meeting, held in a room that seats half that number, and so many attendees tweeted the proceedings that one of them set up a Web page, www.fdasm.com, to collect all the comments.
Those tweets had a common theme: The FDA is taking far too long to figure out Web 2.0, while patients rush to embrace it. "Does the FDA get it?" asks Mark Senak, author of the blog Eye on FDA and a senior vice-president at public relations firm Fleishman-Hillard. If it did, "they wouldn't be having this meeting now, many, many months after it was already apparent how quickly Web communications is changing."
The FDA isn't likely to issue rules before mid-2010. That's too long to wait, drugmakers complain. Their customers crave information now, and much of what they're finding online is incorrect. Ann Moravick, president of an advocacy group, Rx4good, that helps nonprofit health groups find industry funding, agrees that "a lot of the sites patients are going to are misleading or filled with errors. There isn't any FDA monitoring at all."
The pharmaceutical industry spent $4 billion on direct-to-consumer advertising in 2008, but only 4% of that amount flowed to the Web—a tiny percentage compared with other huge advertisers, such as auto companies. Drugmakers are holding back for fear of FDA retaliation if they fail to disclose side effects properly, or if their interactions with patients are construed as off-label marketing.
Drug companies did test the waters earlier this year with display ads that popped up on Google (GOOG) and Yahoo! (YHOO) searches. Those efforts ended abruptly in April when the FDA sent letters to 14 companies, among them Eli Lilly (LLY) and Merck (MRK), demanding that the advertisers display side-effect warnings. Search ads don't have space to explain all that, so most companies abandoned the format.
True to the law of unintended consequences, the search ads that remained became less useful to consumers, according to Google. Pharmaceutical companies switched to general, disease-related search ads with no mention of drug brands, and the number of searchers who clicked on the ads for more information dropped dramatically. That's an indication, says Google, that the FDA's policy is making relevant data about drugs more opaque for patients who seek it.
Drug companies are looking for clarity on more than search ads. They want to know if it is their responsibility to sniff out and correct erroneous information about their products on such sites as Wikipedia. Are they responsible for reporting to the FDA adverse drug reactions that might come up in an online comment? And what may they say in a 140-word tweet vs. a YouTube (GOOG) video vs. an online forum? "This isn't just about selling drugs," says Craig M. Audet, vice-president of U.S. Regulatory Affairs for Sanofi-aventis (SNY). "It's about listening to patients and giving them what they want."