Virtual Advisory Committees: US FDA Clears A Big Test With OxyContin Meeting
Meeting to address opioid abuse crisis was also a trial of whether FDA could conduct important public business using online-only technology.
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With the meetings available on television, access can be assured for just about everyone, and the US FDA can avoid another gut punch to its credibility.
Given inconsistent study results, robustness of the efficacy evidence is expected to be key focus of the 6 November meeting of the Peripheral and Central Nervous System Drugs Advisory Committee; review could put a December 2019 guidance on the ‘substantial evidence’ standard to the test and offer insight into the amount of flexibility the agency is willing to exercise for neurodegenerative diseases with high unmet need.
Label change is one option after US advisory committee review of Purdue’s postmarketing studies concludes reformulated OxyContin ‘meaningfully reduced abuse’ by non-oral routes, but finds there is not evidence to show such reduction via all routes or that ADF reduced risk of opioid overdose.