Too often we hear from pharmaceutical companies that they see the benefits of social media, but they are resistant to adopting it because of an underlying fear about the legal risks, which are typically associated with Adverse Event Reporting (AER). In a heavily regulated industry and with millions of conversations happening online – from blogs and forums to Twitter and Facebook – it’s a logical fear for pharma companies to assume they are opening themselves up to problems.
But let’s look a little closer. As pharma companies know, 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: