Califf Says Opioid Labeling Changes, Withdrawals Still Possible
The US FDA commissioner also suggests the pain medications along with marijuana products should be regulated differently than other drugs.
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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.
Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.