The United States Food and Drug Administration (FDA) will use the 10-11 July meeting to engage outside experts in a discussion of how it can better leverage existing data sources and methods to evaluate the impact of these products in the real world and what new data sources and study designs could be used to ensure the efforts result in the best possible answers to inform regulatory decision-making. FDA Commissioner Scott Gottlieb, M.D. announced the agency will host a public meeting 10-11 July in Silver Spring, Md., about abuse-deterrent opioid drugs, saying the agency needs the most reliable information possible in order to make the best regulatory decisions. Gottlieb’s announcement said he had asked his FDA colleagues “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 FDA is committed to focusing on all aspects of the epidemic, he added. “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?” They are opioid formulations with properties designed to deter abuse. “For example, some make crushing or manipulating the tablet to dissolve in liquid for injection more challenging; others combine the active opioid analgesic ingredient with drugs such as naloxone, which if snorted or injected will block the high of the opioid. This has been an important area of innovation that the FDA continues to support. However, we recognise that there is a gap in our understanding of whether these products result in a real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse. To address this need, after approval, we have required companies marketing these products to conduct studies in a way that will provide the most meaningful data possible to address this issue. But these studies are challenging to conduct, and we need the most reliable data we can get to make the best regulatory decisions. Therefore, we are taking steps to get the answers we need to inform our approach,” he explained. FDA will use the meeting to engage outside experts in a discussion of how it can better leverage existing data sources and methods to evaluate the impact of these products in the real world and what new data sources and study designs could be used to ensure the efforts result in the best possible answers to inform regulatory decision-making. The agency has posted an issues paper outlining some of the existing regulatory and public health challenges it faces.
Occupational Health & Safety News, 14 June 2017 ;http://www.ohsonline.com ;