Opioid REMS Hearing Features Top-Level FDA Team – But No Manufacturers
FDA’s most recent public meeting to explore better approaches to managing prescription opioids marked the public debut of its new Opioid Steering Committee. The issue has top management attention at FDA – but the hearing didn’t include any industry speakers.
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Pharma firms might avoid paying for national opioid prescription monitoring database because state systems already talk to each other, although current operations still need some upgrades.
Whether to require physician education, when to limit the doses prescribed to patients, and how to weigh societal abuse potential in approvals are the initial questions for the Opioid Policy Steering Committee.
The strange politics of prescription drug importation legislation in the US are on display again, this time in the context of the FDA user fee reauthorization bill. Including the topic in the bill is a ‘big deal’ – but probably makes imports less likely.