2 November 2018 - The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is a public health priority for the FDA.
The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain. As part of these considerations, there’s been an important and robust public debate leading up to the regulatory decision on Dsuvia that merits a response.
I want to take this opportunity to address some of the concerns that were raised, and more broadly, how I believe the FDA should consider the approval of new opioid pain medications that can help fill targeted medical needs.