Statement from FDA Commissioner on opioid drugs with abuse-deterrent properties

Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction. The FDA is committed to looking at all facets of this complex issue and collaborating on various approaches, as there are no simple answers to reverse this epidemic. In my prior communication, I noted that one of these approaches would be asking the public, through various forums, to share additional steps and information that the FDA should consider in addressing these challenges. Today, we are announcing a public meeting that seeks a discussion on a central question related to opioid medications with abuse-deterrent properties: do we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic? These products – opioid formulations with properties designed to deter abuse – are each intended to deter abuse by particular routes (like snorting or injecting), depending on the drug.  For example...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news