FDA Funding Helped By Ebola Emergency Spending, But Opioid Issue Still Rankles Appropriators
This article was originally published in RPM Report
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.
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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.
Draft guidance on abuse-deterrent opioids notes that labeling claims may be revised if abusers outwit the abuse-resistant technology; the agency’s evaluation of generic-related citizen petitions continues.
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?