US FDA Considering Opioid Mail-Back Envelope Mandate, But Industry Has Heard This Before
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.
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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.
The move should increase the visibility of the FDA’s wide-ranging, and widely criticized, opioid epidemic response.
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.