While most CMOs believe that demonstrating social media ROI is one of their biggest challenges, pharmaceutical companies face their own unique set of issues when it comes to engaging in social media. Despite the Web being a primary source for online medical information, confusion over best practices and compliance guidelines have left many pharma marketers feeling constrained by lack of information on how to successfully monitor, engage and report Adverse Events (AE). While other business and consumer brands are diving in head first to social networks and online conversations to improve product development and customer service, among other things, the majority of pharma companies are sitting on the sidelines.
Many pharmaceutical companies realize the opportunity and would like to use social media data to better engage with their customers, but concern over potential exposure to liability for monitoring and reporting Adverse Events (AE), as required by the Food and Drug Administration (FDA), gives the industry pause from participating in a social media listening program.
There are four very specific criteria that must be met in order to constitute filing a report with the FDA. If a report does not contain all four elements, it will be returned as insufficient. The FDA’s four parameters for submitting information about adverse experiences are:
With millions of conversations happening online, this is a reasonable concern. However, it’s critical for these companies to have a better understanding of the content of those online conversations.
Given these fears, we decided to dig deeper to uncover the realities of Adverse Event Reporting (AER) to understand if the number of comments that can be classified as an AE are as common as pharma companies think? Or are companies missing out because of an unfounded fear.
Visible tracked 224 pharmaceutical brands and collected and analyzed more than 257,000 posts across social media sites during a 30-day period. Some of the key findings include:
These findings prove that AE reporting is far less common than people think, creating a safer harbor for pharmaceutical marketers who want to embrace the many opportunities that social media offers to engage with consumers and build brand reputation. It also gives them the opportunity to effectively use social media to improve AER, rather than ignore the potential upside of this new medium.
This presents an extremely low risk for pharmaceutical marketers looking to embrace social media initiatives. Social media data can be used positively to help drug makers more effectively identify potential safety issues with the product earlier in its lifecycle, minimizing the risk for a crisis and more serious patient outcomes. Social media also offers the opportunity to foster customer relationships and establish more personalized healthcare services.
So what are you waiting for? Get off the sidelines and into the game.
Speaking as the spouse of an MD who works for a pharmaceutical company tracking Adverse Events, I would suggest that 3 events a month is anything but a small problem. Not to mention the issues created by all the information that constitutes incomplete reports. While the huge promotional budgets of pharmaceutical companies may appear to be a great oppportunity for Visible and other vendors of social media monitoring services, your argument is with the FDA, not pharma. You'd be amazed how big a problem can be created for regulatory professionals by well-intentioned marketing people and their promotional impulses.