US FDA Needs ‘More Streamlined’ REMS Enforcement Authority, Inspector General Says
Additional power would allow the agency to punish 'simple' REMS violations and improve administration of risk management programs, according to a new report looking at FDA's oversight of opioids.
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Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.