Monitoring Social Media
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
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.
Engaging in Social Media
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
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