The Opioid Is In The Mail?
The US Postal Service is suddenly a key cog in the US public health infrastructure – but don’t expect FDA to mandate mail-back packaging on opioids right away.
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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.
The US FDA is continuing to think through mechanisms to make opioid prescriber education mandatory – either separate from or in addition to relying on its REMS authority.
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?