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FDA issues guidance on development of generic abuse-deterrent opioids

Nov. 21, 2017 2:00 PM ET|By: Douglas W. House, SA News Editor

In a statement, FDA Commissioner Scott Gottlieb, M.D. says the agency is taking steps to help drug makers develop approvable generic opioid medications that incorporate abuse-deterrent characteristics.

Acknowledging that premium pricing is playing a key role in hindering market penetration of the 10 abuse-deterrent opioids OK'd so far, he says the new guidance includes recommendations on the type of studies needed to demonstrate that a generic version is no less abuse-deterrent (non-inferior) than the branded product.

Other initiatives include refining the review process to make it more efficient and predictable and a flexible adaptive approach to the evaluation and labeling of abuse-deterrent opioids that includes new tools for expediting the process. New review policies include updated guidance aimed at helping generic drug makers who meet with the agency to clarify the FDA's expectations early in the development process and to discuss relevant issues before filling applications.

The FDA is also assessing the effectiveness of currently marketed abuse-deterrent opioids in the field.