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Controlled Drugs

FDA announces review of opioid approval process

The US Food and Drug Administration (FDA) has said it will review its approach to approvals of new opioid analgesics in light of the ongoing opioid crisis in the United States.

In a statement, Scott Gottlieb, commissioner of the FDA, said it was “re-evaluating how we consider both the individual and public health impacts of new opioids as they are reviewed for approval”.

In October 2018, the US government granted the FDA new authority to require studies evaluating the efficacy of opioids; the ability to require opioids to be sold in special packaging that allows the drugs to be safely disposed; and new powers to issue a mandatory recall order for any controlled substance.

The latest FDA press announcement, issued on 2 November 2018, followed its controversial approval of Dsuvia, a sublingual formulation of the extremely potent synthetic opioid sufentanil.

In October 2017, US president Donald Trump declared the nation’s opioid crisis a public health emergency rather than a national emergency, which would have called for the allocation of federal funding.

Gottlieb said: “We’re also re-evaluating how we consider both the individual and public health impacts of new opioids as they are reviewed for approval.

“To that end, I’ve asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals; one that provides a transparent process to delineate clearly, eventually in new guidance, how we intend to consider the benefits and risks of these products in the context of this crisis.”

Outlining the forthcoming guidance, Gottlieb said it would question whether the approval of another opioid would “create added risks for diversion, accidental overdose, abuse and misuse” and whether any benefits would “outweigh the risks”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205699

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