FDA unveils global pharmacovigilance initiative

The U.S. Food and Drug Administration Center for Biologics Evaluation and Research recently launched a new initiative designed to support the Global Vaccine Safety Blueprint Project.

The initiative, called "Global Regulatory Utilization of Vaccine Safety Surveillance," was created under a CBER-World Health Organization memorandum of understanding. The goal of the initiative is to aid national centers to build their capacity to make effective regulatory decisions from vaccine safety surveillance data.

FDA CBER recently hosted a two-day training seminar entitled "Application of Pharmacovigilance to U.S. FDA Regulatory Decisions for Vaccines" in Uppsala, Sweden. The meeting, held in collaboration with the WHO and the Uppsala Monitoring Center, added to the information provided by previous WHO/UMC courses on pharmacovigilence.

At the seminar, FDA CBER Division of Epidemiology staff described the relative strengths and weaknesses of their sources and methods. Topics under discussion included vaccine passive surveillance report reviewing, data mining, safety signal hypothesis generation, interpreting controlled epidemiologic studies, reviewing reporting from manufacturers and reviewing pharmacovigilance plans.

FDA CBER DE staff also provided examples of how they use public communications and post-marketing requirements, as well as how they make regulatory decisions. They said the goal of the training initiative is to make medicines, patients and public health safer globally and domestically.