Law Commons^™

Medical Product Information Incentives And The Transparency Paradox, Daniel R. Cahoy

Indiana Law Journal

Recent allegations that essential safety and efficacy information is often suppressed by medical product manufacturers or poorly evaluated by regulators have led to calls for greater information transparency. The public is justifiably concerned that its ability to conduct an informed risk-benefit assessment of drugs and medical devices is compromised. Several changes have already been made to federal regulatory law and medical research policy to mandate greater disclosure and more changes are being considered. However, it is possible that these measures may backfire by enhancing significant tort-based economic disincentives for generating new information.I n other words, greater disclosure requirements could, paradoxically, …