STAT Plus: FDA rejects bid for a moratorium on opioid approvals as scrutiny of the agency heats up

As public health officials struggle to address the ongoing opioid crisis, the Food and Drug Administration has rejected a petition filed by a consumer advocacy group calling for the agency to impose a moratorium on the approval of any new or reformulated opioids.

In arguing for the moratorium, Public Citizen maintained last March that the FDA displayed “dangerously deficient oversight” and that none of more than two dozen opioids approved between 2009 and 2015 provided benefits that outweighed the risks. As noted at the time the petition was filed, two drugs — Opana ER and Dsuvia — were singled out as examples.

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