Public Citizen Strikes Out In Call For Opioid Approval Moratorium After Recent Win
Petition was consumer advocacy group's first request for halt to approval of an entire drug class; Public Citizen has gotten full and partial approval of other recent petitions.
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Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.
Citizen petition seeks review of all marketed opioids; agency is considering whether new opioids should have comparative benefit over existing drugs.