FDA IG to Probe Opioid REMS, Drug Supply Chain Tracing

The FDA inspector general will look into whether the agency is holding opioid manufacturers accountable for meeting the risk evaluation and mitigation strategies goals designed to curtail addiction and abuse, the IG announced.

The IG also will examine how well drugs can be traced from dispenser back to manufacturer, per the Drug Supply Chain Security Act, the inspector general’s office said in posting its work plan.

Reports of both investigations are expected in 2019.