OR WAIT 15 SECS
Pharma companies need a clear online policy that addresses employee obligations, monitoring guidelines, and engagement roles.
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.
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.
Social media monitoring should be encouraged, and policies should address the method of monitoring, and what is done with the results (from a pharmacovigilance perspective). In putting patients first, we need to overcome fear of these reports being "discoverable" by plaintiffs. In the future, a manufacturer is likely to learn first of additional potential drug indications (and real-world risks that did not surface in trials) via the Internet.
Monitor Always, Not Once In the pharmaceutical industry, many marketers equate social-media monitoring with conducting a one-time market research project. The results are analyzed and used to guide decisions and messaging, then the study is placed in a binder next to the one from last year's sales meeting. However, social media is fluid, and challenges and opportunities are perpetual. This morning's "tweet" can be tonight's CNN story, and social media is an opportunity to address problems before they start.
Ensure Legal and Medical Oversight Monitoring research should be done with oversight to ensure the methodology is appropriate, reporting obligations are upheld, and legal and regulatory guidance is followed on discoveries that might have labeling implications. Companies need to determine how widely they'll search, and technology can make it a lot easier than attorneys believe.
Report All Adverse Events It's extremely rare that a serious adverse event (AE) can be reported with information garnered from social media monitoring. However, in the rare instances where manufacturers identify and document instances of recurring AEs or off-label use, it should make some good-faith efforts to correct the information or encourage the individual to report the AE via existing reporting channels.
Don't Try to Be Perfect Lawyers are legitimately concerned that evidence of monitoring could create an FDA expectation that the manufacturer is obliged to read and respond to all social media–generated information. That is obviously impossible, and FDA will not soon demand that manufacturers read and report on the entire Internet. However, if an issue is identified and ignored, "We didn't know it was happening because we didn't use the Internet" would be a poor defense. You can expect FDA to take action against companies for not updating labels based on evident side effects that are well-documented online, or not correcting off-label mentions on sites like Wikipedia.
Pharmaceutical firms are not in the business of publishing or hosting social media, and can't do so objectively given regulatory constraints. As a result, marketers should not look to host social media, but to reach customers via prevailing social media sites, and using tools such as paid and earned media (ads and PR influence).
Set Guidelines to Avoid Mistakes or Apathy Marketing should have clear policies on advertising around social media, similar to advertising in print or television. If ads are placed adjacent to condition-specific information, they should be unbranded—not "reminder" ads. Otherwise, the media agency should inform the brand of the taste/tone of the site where it runs the ad.
Revise Review Processes and Develop a 911 Plan For good reasons, manufacturers maintain thorough and somewhat lengthy review processes. However, the process by which ads are approved cannot facilitate the timely handling of some events in social media. Some matters need rapid attention and resolution. For example, the manager of one major airline's Twitter presence knows exactly what he would tweet if one of the company's planes crashed.
Know Who Matters Social media engagement requires individuals who are accountable not just to journalists but also to everyday people who have an influential voice online. This doesn't mean an employee needs to read and reply to every Twitter or YouTube video tagged with the company's or its product's name. But if an individual with a large social media following has a legitimate inquiry or problem, it may merit the speed and attention otherwise reserved for investment or media inquiries.
Kevin Nalty is the founder of Nalts Consulting. He can be reached at Kevin@naltsconsulting.com