AE Reporting Often Delayed: FDA to Generate More Data? Posted January 15, 2016While social media offers the potential to make pharmas more responsive and engaged with their consumers, the lack of specific guidance from the FDA has held back industry adoption, according to conventional wisdom in the industry. IMS Health has made clear that “Pharma Should Make Better Use of Social Media To Engage Patients and Improve the Use of Medicines.” Much of the interest in social media has been on the marketing front, but there is clear need for improvement on the drug safety and pharmacovigilance side of the business, too. The fact is a significant percentage of adverse events (AEs) are not reported within the 15 days required by the FDA, according to researchers. Previous reports have highlighted the limited ability of pharmas to collect and report AE data. No wonder the FDA has engaged PatientsLikeMe in a research partnership to generate more AE data. It may also seek Google’s help in improving the availability of AE data, especially for post-marketing drugs. Is FDA taking on more responsibility for capturing AE data and creating more reports? Or is it just seeking to learn more about the quality and usefulness of existing data sets? The bottom line: it’s clear that more data can – and should – improve the completeness and accuracy of AE reporting. However, pharmas will need a strong platform and effective tools to manage the huge range of diverse and multi-sourced data.