DIA Global Forum
Author: Supriya Desai, Sciformix Corporation
Pharmacovigilance has grown more complex over the past decade with higher data volumes, changing regulations, rise of social media, and innovative digital advances. Whilst digital media is used by biopharmaceutical companies for patient awareness initiatives, clinical trial enrollments, and patient support programs, the use of the Internet and social media has progressed slower in Product Safety/Product Vigilance (PV). This presents the industry with opportunities to leverage social media for detection, assessment, and prevention of adverse events (AEs). Moving away from traditional systems towards more patient-centric PV models would allow swift and open communication between companies, health care providers (HCPs) and patients. However, careful evaluation and assessment of the use of social media as a PV tool is required before it becomes usual practice.
REGULATORY GUIDANCE AND FRAMEWORK
Companies operating in the social media space have a responsibility to document and follow-up on potential ADRs communicated through these forums. Good Pharmacovigilance Practices (GVP) states that marketing authorization holders (MAH) should regularly screen the Internet and/or digital media under their management, for potential reports of suspected ADRs. The frequency of screening should allow for potential valid individual case safety reports (ICSRs) to be reported to competent authorities within appropriate timeframes based on the date the information was posted (VI.C.2.2.1)(1).
The US Food and Drug Administration (FDA) product promotion guidance on social media and the internet, by biopharmaceutical and medical device companies, addresses responses to offlabel inquiries (including from digital platforms) (2), provision of benefitrisk information on digital platforms with character space limitations, e.g., Twitter(3), addressing misinformation about company products(4) and fulfillment of company post-marketing regulatory requirements for submission of “interactive promotional media” for their FDA-approved products(5). These documents are an important first step towards providing guidance for companies to develop and implement their social media strategies for PV.