The US Food and Drug Commissioner Scott Gottlieb issued a statement to further amplify on the agency's plan to address ways to combat abuse of opioid drugs, which includes an upcoming public meeting in July that will address further abuse-deterrent formulations of opioid drugs.
The Commissioner noted that the agency's new policy steps included the formation of a steering committee to examine additional regulatory and policy actions that the agency can take. This steering committee will place particular emphasis on evaluating efforts to reduce the number of new cases of addiction.
One approach noted by the Commisssioner involves asking the public, through various forums, to share additional steps and information that the FDA should consider. To that end, the FDA will be holding a public meeting on July 10 and 11, which will seek discussion on a central question related to opioid medications with abuse-deterrent properties: does the industry and the agency 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 (i.e., snorting or injecting), depending on the drug. 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," said Gottlieb. "However, we recognize 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."
At the July meeting, the FDA said it will engage external thought leaders in a discussion about how it can better leverage existing data sources and methods to evaluate the impact of these products in the real world as well as what new data sources and study designs could be developed or enhanced to ensure these efforts result in the best possible answers to inform regulatory decision-making. To make this discussion as productive as possible, the agency have made public an issues paper outlining some of the existing regulatory and public health challenges we face.
Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof, noted the Commissioner. "These drugs can still be abused, particularly orally, and their use can still lead to new addiction. Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations; and I look forward to a productive discussion on how to best tackle this challenge."