Seeking Guidance On Abuse-Deterrence: Sponsors Fall Short, Congress Urges Action
This article was originally published in RPM Report
Congressional appropriators are urging FDA to move quickly to finalize guidance on abuse deterrence claims for opioids—and to take the next step and prohibit marketing of products that don’t deter abuse. FDA says the science isn’t there yet, and two sponsors join the list of those who have failed to clear the hurdle.
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Spending agreement includes $137 more for FDA—most from user fee increases previously enacted. Still, discretionary budget does go up for FDA, albeit at the cost of a rider demanding final action on abuse-deterrent formulation guidance by June.
Pfizer got its first abuse-deterrent claim for its pain therapy Embeda. But it has also ended an agreement to develop another potential abuse-deterrent pain drug.
FDA could get relief this autumn from a year of political controversy stemming from the approval of Zohydro, thanks to two abuse-deterrent hydrocodone applications in the works from Purdue and Zogenix.