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November 27, 2017

How FDA will regulate generic misuse-deterrent Rx opioids

Daily Briefing

    FDA on Tuesday released final guidance for manufacturers developing generic versions of FDA-approved misuse-deterrent opioid drugs, MedPage Today reports.

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    Analysis details

    Gottlieb highlights need for generic misuse-deterrent opioids

    FDA Commissioner Scott Gottlieb in a statement said FDA to date has approved 10 opioids with misuse-deterrent formulations "intended to make certain types of [mis]use more difficult or less rewarding." However, Gottlieb said physicians have been slow to prescribe the misuse-deterrent opioids for various reasons, including the high costs of brand-name misuse-deterrent opioids, which are "inherently more expensive than the numerous non-[misuse] deterrent formulations … available in generic formulations."

    In addition, Gottlieb said, "There can be a learning curve that comes with new technologies" and "[s]ome prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions."

    Guidance details

    The final guidance details the steps generic drugmakers should take when seeking FDA approval for generic versions of brand-name misuse-deterrent opioids.

    Gottlieb said the final guidance includes new recommendations about the studies generic drugmakers should conduct to show that their generic products are no less misuse-deterrent than their brand-name counterparts.

    Further, Gottlieb said the new guidance also will "assist generic drug developers who meet with [FDA officials] to discuss scientific and regulatory issues before submitting their applications." Gottlieb said the meetings will allow FDA "to clarify the agency's expectations early in the development process with the goal of reducing the time it takes to obtain approval."

    Gottlieb outlines additional steps to help spur development of generic misuse-deterrent opioids

    Gottlieb said the "final guidance is one piece of ... FDA's ongoing work aimed at finding solutions to combat the opioid [misuse] crisis," adding that the agency is "taking additional steps beyond the new guidance to help developers of generic [misuse-deterrent opioids] navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable."

    For example, Gottlieb said FDA is "developing … improved testing methodologies for evaluating complex features like [mis]use deterrence for both brand name … and generic opioid drug products" and "taking a flexible, adaptive approach to the evaluation and labeling of [misuse-deterrent] opioids."

    In addition, Gottlieb said FDA is developing "new tools for expediting the generic development of complex products" such as misuse-deterrent opioids and "advancing new review policies."

    Gottlieb said FDA is "focused on taking actions that reduce the scope of new [misuse] by decreasing unnecessary exposure to opioids," but also noted that the agency "must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternative."

    He added, "Until we're able to find new non-opioid forms of pain management for those who need treatment for pain, it's critical that we also continue to promote the development of opioids that are harder to manipulate and [misuse], and take steps to encourage their use over opioids that don't offer any form of [misuse] deterrence" (Frieden, MedPage Today, 11/21; Barrett, Pharmacy Times, 11/21; Kunzmann, MD Magazine, 11/21; Howell, Washington Times, 11/21; Gottlieb statement, 11/21; FDA final guidance, 11/21).

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