Law Commons^™

A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan

Faculty Publications

Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …