The FDA (the US drug regulator) will make cardiac monitoring a non-negotiable requirement before approving ibogaine for veterans. Recent safety studies show ibogaine can cause heart problems, so the FDA will use formal risk management agreements to ensure hospitals monitor patients' hearts. This matters because it affects whether veterans can legally access ibogaine for PTSD and addiction through approved channels.
Recent dual cardiac safety publications give FDA a clear evidentiary basis to mandate monitoring infrastructure before any veteran-access IND proceeds. REMS programs are FDA's standard risk mitigation tool for drugs with known cardiac liability (cf. clozapine, droperidol). The political pressure from veteran advocates makes outright rejection unlikely, but cardiac data makes unmonitored approval untenable. REMS as compromise is the predictable regulatory equilibrium. Falsifiable: either a formal REMS requirement is published or it isn't by 2027-03-01.