Opioid Diversion, Postal Carrier Dangers Among Industry Concerns With Mail-Back Envelope Requirement
Brand and generic drug sponsors also tell the US FDA that there are environmental considerations for providing a pre-paid mail-back envelope so patients can send unused opioids for disposal.
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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.