Dr. Ed Tucker is vice president and head of pharmacovigilance operations, Global Medical Safety for Janssen Research & Development LLC, which is part of Janssen Pharmaceuticals, a Johnson and Johnson subsidiary. Janssen Pharmaceuticals itself produces pharmaceuticals for treating a wide range of diseases and disorders, including ADHD, gastroesophageal reflux disease, bipolar I disorder, schizophrenia, Alzheimer’s disease, epilepsy, pain management and a variety of other health concerns.
Tucker’s role at Janssen is to gather safety-related data to inform his company — and government regulators — about patient use of its products. His department sends Individual Case Safety Reports to national government regulatory agencies about adverse events experienced by patients using Janssen’s products, whether in clinical trials, physician-prescribed therapy, or over-the-counter purchases. Thus, it is important to his function that he communicates with patients about their use of pharmaceuticals.
Social media provides a new platform and opportunity for connecting with patients and learning about their safety concerns, questions or comments, and presents new opportunities for collecting key information. However, in such a highly regulated and sensitive area as pharmaceuticals, there needs to be extra care and vigilance in how such information is gathered, including an awareness of the legal requirements about reporting certain safety-related data.
In this interview, Tucker describes how social media is providing new opportunities in his own role as well as some of its promise for the pharmaceutical industry as a whole, and how the industry can take advantage of the potential of social media without violating safety, privacy and other regulatory restrictions.
How important is the social media business to your organization right now and what are some special challenges given your industry?
It is very important. In pharmacovigilance, we receive a lot of safety information that gives us insight into our products and the patients receiving our products. We are often one of the downstream recipients of information from other parts of the company that engage in social media activities.
One of the unintended consequences for a pharma company entering the digital media space is triggering certain regulatory requirements around the reporting of safety information.