Perspective: Should Japan’s Regulatory Reviewers Have Immunity From Lawsuits?
Posted 01 September 2010 | By
Regulatory agency reviewers of new drugs and medical devices sometimes face difficulty making decisions on approvals because of ambiguous data from multiple sources such as bench testing, preclinical examinations and clinical studies. Often, review decisions come down to judgment calls, opening up the risk for a lawsuit. To address this problem, reviewers at the US Food and Drug Administration (FDA) are generally immune from lawsuits; however, reviewers at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan are not. This article explores whether immunity from lawsuits is crucial for reviewers at all regulatory agencies.