Twitter’s limit of 140 characters per tweet makes it difficult to share what’s for dinner, let alone the risks associated with a prescription drug. Current guidelines set by the Food and Drug Administration specify that drug advertisements must be accompanied by adverse effect warnings. However, the extreme space constraints on social media sites mean pharmaceutical companies have to avoid advertising altogether—or do it illegally.
Before April 2, 2009, the FDA was silent about the laws that drug companies were breaking on the web. But during that one day, it issued fourteen warning letters—more than it usually issues in three months. The offenders were all online drug ads, specifically sponsored links, which offer a short blurb about the product with a link to the product’s website. The FDA requested that the companies take their ads down immediately because they did not list medical risks or, in some cases, suggested unapproved uses. Requests from the FDA aren’t friendly: companies that ignore the agency risk being dragged into court, fined or even prosecuted.
The current FDA guidelines treat broadcast, print, and online media identically, but that may soon change. Shelly Burgess, an FDA spokeswoman, says that the agency plans to publish guidelines about Internet and social media promotion of regulated medical products before the end of 2010.
For now, many drug companies abide by what has come to be known as the “one click rule” to address safety concerns. These “one-click” ads contain a link to the insert label, where the adverse effects are listed. The consumer can get the information easily, if he or she clicks it. But the one click rule is not a rule at all. Instead, it’s a voluntary attempt by pharmaceutical companies to reconcile social media with drug ads. The FDA has issued warning letters even to companies that follow the rule.
Other drug companies, though, aren’t trying to follow any rules—official or not. They are undaunted by the FDA’s warnings and are continuing to use social media without even linking directly to adverse effect warnings, according to John Mack, president of VirSci Corporation, a private consulting and publishing company that specializes in pharmaceutical marketing compliance. Rather than having risks one click away, some ads require a click and then a scroll to the bottom of the page, where a viewer then has to follow another link to get the warnings. “Industry is probably trying to ride this wave” of unregulated social media, says Mack. As services like Twitter and Facebook keep growing, companies feel increasingly compelled to use them to interact directly with consumers or to market their brands. “They’re falling all over themselves to get into the game. If you’re not in it, you can’t win it,” says Mack, who is also a blogger at Pharma Marketing Blog. But with looming FDA regulations, “that game will soon be over.”
However, Jim Lefevere, a commercial marketer in the health care industry, doubts that the highly anticipated guidelines will actually solve the current problem. “I think that there is some false hope in the industry and expectation that the FDA will provide clear-cut guidelines,” he says. The new guidelines will most likely only emphasize old FDA goals: information in a drug ad must be balanced, and adverse effect warnings must be readily visible and available. Lefevere, who also blogs at The Digital Strategist, explains that because media technologies for advertising are always changing, the FDA doesn’t want to have to scramble to keep up with each innovation. Instead, he says, the agency will focus on how drug ads are presented, not where they’re presented.
Advertising shouldn’t even be the primary way drug companies use social media, according to Silja Chouquet, the owner and CEO of whydot GmbH, an agency specializing in social media consulting, coaching and training. She believes drug companies should more actively engage in social media to build stronger relationships with their audiences. “Attracting followers on Twitter is perceived as a token of trust by the community,” she says, and is “not an invitation to use Twitter as a one-way broadcast channel.”
Lefevere agrees: Drug companies must build their social media strategies around the needs of patients. “If you start with the patient perspective,” he comments, “then it gives you the opportunity to provide valuable information to help that person manage their issue, talk to their doctor more effectively, or connect them to others like them, where they may share, learn and engage.”