US FDA May Seek Legal Authority To Require Superiority Tests For Future Opioids
Commissioner Califf testifies at budget appropriations hearing that the agency may ask Congress to give it authority to require a new opioid drug application to show superiority to opioids on the market.
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US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.
The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.
Sponsors would be required to furnish patients with pre-paid envelopes to mail back unused opioid medications for disposal. Comments on FDA's proposal could follow industry concerns about burden on health care system voiced when the idea was floated in 2018.