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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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.
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.
US regulators set public workshop on benefits, challenges, and unintended consequences of making REMS education program mandatory. Having a single source for education is also being evaluated. Agency has previously been concerned that a mandatory program might require a restricted distribution system.