Like college students cramming for a mid-term exam, the pharmaceutical industry became frantic last November preparing for FDA's hearing on digital marketing and social media. And the heat is turning up again as we prepare for the spring FDA docket submissions. But in truth this exercise has been somewhat anticlimactic, with FDA doing little more than asking sometimes uninformed questions as Rx social media gurus mostly talking to themselves and offering shameless self-promotion.
Waiting for FDA to provide useful guidance in this area, of course, would be as constructive as holding your breath while driving through Norway's 15-mile Lærdal Tunnel. FDA guidance on social media will remain, perhaps, like electronic medical records or mobile advertising: an elusive promise that's always just "one year away."
Meanwhile, social media efforts have become disruptive to an already disoriented industry, and Big Pharma has both hands tied behind its back. A simple search of online consumer dialogue shows that the industry's silence in "conversational" media is perceived as covert, dishonest, uncaring, even reckless.Manufacturers are performing a complex dance that includes marketing, legal, regulatory, and public relations. Few have concrete private or public policies on sites like Facebook, YouTube, Twitter, Google's SideWiki, or Wikipedia. Instead the industry has become dependent on a government agency that understands less about the true dynamics of emerging media than we do about the inner workings of Capitol Hill.
Interpretation is Key
As far as social media go, pharma is going to have to write its own rulebook. A DDMAC Handbook to Social Media is not going to appear any time soon, but that's not the most important piece of the puzzle. What the industry really needs is a set of manufacturers' guidelines shaped strictly by FDA laws.
Pharma has lost sight of something more critical than being compliant. We need to be relevant and honor social media's unwritten rules. Ignoring these will not only waste time and money, it can be more damaging to a manufacturer's reputation than an FDA letter.
There is, however, some good news: The pharmaceutical sector is neither the first nor the last regulated industry to struggle with the nuances of social media. The automotive industry was not eager to read about passenger-side airbags failing to deploy, but eventually it developed an approach to monitoring and engaging in social media that placated nervous attorneys and senior executives.
Social media will become just as much a way of life as eBusiness did in 2000. A good first step toward integration is to see what existing guidelines might be applicable. For instance: If the public relations department is responsible for ongoing media monitoring and outreach, then it is likely already engaging with prominent bloggers, who are often former media writers; if your market research team is responsible for data collection, it might oversee ongoing social-media monitoring and analysis; if a medical affairs group is answering product inquiries, it might be responsible for ensuring the company's medications are accurately represented on Wikipedia, which is often the first Google result for a search on a pharmaceutical brand.
A solid policy will address at least three key areas: employee rights and obligations, monitoring guidelines, and engagement processes/roles, including the following practices:
» Allow employees the free speech they're permitted by law. If the employee isn't identified by his or her employer, it shouldn't matter whether they have their own photo Web site, cooking blog, Facebook profile, or YouTube videos
» If an employee identifies her employer, she should first gain approval from management or the public affairs department, just as if she were speaking at a conference
» The Internet is not a refuge from confidentially and "code of conduct" obligation to our employers
» HR policies should encourage "common sense" and training and education should help employees see the implications of what might otherwise appear as trivial.