The primary challenges with adopting social media for makers of prescription products are operational. Though much is made of the absence of an explicit Food and Drug Administration
guidance on social media, we know the answer to most of the questions about the regulatory requirements for social media activity.
Making claims about a product’s benefits requires providing appropriate risk information to ensure that the claim is balanced regardless of where the claim is made – be it on Twitter, YouTube, a television commercial, or a print ad. Using the brand name requires the use of the generic name with no intervening matter, regardless of how long the brand name or generic names are or how space-limited the context. There certainly are issues that FDA guidance could address, but no further FDA guidance is likely to change these and other basic parameters.
The operational issues, however, present a different set of obstacles to marketers of prescription products. Those issues can be addressed, and makers of prescription products can engage in social media compliantly and effectively, but first they have to understand the challenges.
What are the unique challenges of social media? Three lead the list:
1. Adverse event reporting
3. FDA filing requirements
One of the five questions from the 2009 FDA hearings on social media was about adverse event reporting and how sponsors should address any Adverse Events (AEs) they come across in social media. While waiting for the FDA to deliver guidance on this issue, industry has already adopted a position. It reports adverse events that meet FDA’s definition of a reportable event, and it does so regardless of the medium where those events are uncovered. Social media is being treated as just another medium and companies have adapted their AE reporting processes to accept social media incidents. Vendors who engage in social media listening and other activities are regularly trained on a company’s AE reporting requirements.
This has proven far less apocalyptic than some feared. The incidence of AEs in social media has been far greater than a few well-known analyses predicted, but companies actively engaged in social media have not been overwhelmed. No company has yet withdrawn a social media initiative because of an excessive volume of AE reports.
The second and the third issues are closely connected. Expectations in social media are not set primarily by the makers of prescription products. The expectations for how any company, regardless of industry, will engage socially are being set by Comcast, Delta, General Motors, American Express, and other highly social enterprises. A consumer who mentions a delayed flight on their Twitter feed has become accustomed to receiving a response from the airline in minutes, and consumers expect the same from companies that make pharmaceuticals and other prescription products.
That level of responsiveness can be difficult and the idea of generating a custom response to a social media post can seem daunting. Just getting the response through the medical-legal-regulatory promotional materials review process can take several days (or weeks), and when a product is discussed the response has to be sent to the FDA before use.
Marketers already know how to deal with these challenges in their non-social media activity. Many of those interactions are scripted with a variety of appropriate responses approved and submitted to the FDA well in advance. By thinking through the most likely scenarios, developing the appropriate possible responses, and establishing a decision procedure for choosing among the options, marketers will be able to provide the same level of responsiveness as other, less regulated industries.
Understanding the challenges of social media enables marketers to overcome them and provide information to people in the channels they prefer. As social media’s importance continues to grow, makers of prescription products need to adopt these same channels and do so compliantly. Otherwise, they face the far greater risk of becoming irrelevant to people’s health discussion.