Analysis Group Experts Publish Commentary on the Potential Interplay of Social Media with the FDA’s Adverse Event Reporting System
May 25, 2017
In an article titled "Learning From Social Media For Adverse Event Reporting," published on Law360, a team from Analysis Group's Health Care Practice explores issues surrounding the use of unstructured postings from social media in the context of pharmacovigilance. Pharmacovigilance involves identifying and evaluating signals from a variety of data sources in order to monitor the safety of pharmaceutical and biotechnology products. The monitoring takes place based on real-world use, after a product has gone through the clinical trials required for approval by the Food and Drug Administration (FDA).
In their Law360 article, Managing Principal Mei Sheng Duh, Vice President Brian Ellman, Managing Principal Marc Van Audenrode, Managing Principal Paul Greenberg, and President Pierre Cremieux discuss results from a recent Analysis Group study that compared information available from AskaPatient.com, a patient support group website, with reports from the FDA's Adverse Event Reporting System (FAERS). The results of the study, originally presented in the article "Can social media data lead to earlier detection of drug-related adverse events?" (Pharmacoepidemiology & Drug Safety), point to a higher incidence of younger patients and those with less severe adverse events reporting in social media compared with FAERS. The authors describe opportunities and limitations that follow from these findings, in particular, as they pertain to drug safety litigation.