Last month, FDA Commissioner Scott Gottlieb, M.D. asked colleagues to identify what “additional and more forceful steps the FDA can take” to stem the opioid crisis, and a steering committee was formed to evaluate policy and regulatory action.
In a new statement this week, Gottlieb announced a public meeting, which seeks to answer if FDA has the right information to determine whether abuse-deterrent products are having their intended effects, adding that there are no simple answers to reverse 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, 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,” he said. “This has been an important area of innovation that the FDA continues to support. 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.”
Gottlieb said that FDA is requiring companies that market these products to perform studies on whether these methods work, but acknowledged the challenging nature of the studies. “…[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.”
The meeting will be held July 10-11, and will include
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Discussion from thought leaders on how the agency can better leverage existing data sources and methods to evaluate the impact of these products in the real world
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Evaluation of 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.
FDA posted an issues paper in advance of the meeting outlining some of the existing regulatory and public health challenges being faced, which states, "In evaluating the impact of opioid formulations with properties designed to deter abuse, FDA generally considers the number of dosage units dispensed to be superior to the number of prescriptions dispensed or the number of individuals receiving a prescription, because every dosage unit presents an opportunity for abuse, and the average number of dosage units per prescription may vary across opioids."
“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction,” said Gottlieb. “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.”
