FDA Law Blog -- On Tuesday, April 19, 2011, after years of debate and several public meetings, FDA released the final Risk Evaluation and Mitigation Strategy (“REMS”) it will require for all extended-release opioid medications. The final REMS was issued as part of the White House’s multi-agency plan to reduce prescription drug abuse. FDA has been working on a class-wide opioid REMS since at least February 2009, when it invited sponsors of extended-release opioid products to a private meeting. Seventeen months later, in July 2010, FDA released its draft of a REMS for extended-release opioid products.
