Opioid Policy At US FDA: Gottlieb Seeks More Activist Role To Combat Abuse
‘Dramatic action’ needed to curb opioid epidemic, commissioner-nominee says, including potentially a cross-center approach to evaluating drugs and devices for pain, and new nomenclature for formulations currently labeled as abuse deterrent.
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US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.
A plurality of the questions from the Senate HELP Committee at Stephen Hahn's confirmation hearing to head the US FDA focused on drug development issues, despite the time lawmakers spent discussing the agency's regulation of e-cigarettes.
Company will cease manufacturing the extended-release oxymorphone formulation immediately and will not ship existing finished product after Sept. 1; decision to pull the opioid from the market heads off a fight with FDA, which sought withdrawal due intravenous abuse liability.