Assessing Potential Drug Safety Issues for a Major Pharmaceutical Company

Recent major fines levied against pharmaceutical companies in connection with drug safety issues, and the increased scope of mass tort lawsuits involving branded pharmaceuticals and generics, point to the need for pharmaceutical companies to develop comprehensive Risk Evaluation and Mitigation Strategy (REMS). A team from Analysis Group's Health Care Consulting practice has been assisting client GlaxoSmithKline to design and execute a post-marketing, long-term epidemiology study to evaluate the safety of ezogabine (Potiga), which is used to treat partial onset seizures in epilepsy patients 18 and older. The Analysis Group team is led by Managing Principal and Chief Epidemiologist Mei Sheng Duh, M.P.H., Sc.D. Results from the study will be used to devise a REMS strategy and will be shared with the FDA. Dr. Duh serves on the drug safety expert panel for the Foundation for the National Institutes of Health's Observational Medical Outcomes Partnership. She is also a guest lecturer in the Department of Epidemiology at Harvard School of Public Health.