FDA’s Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis

Date Issued

Friday, September 25, 2020

Submitting OIG

Department of Health & Human Services OIG

Other Participating OIGs

Department of Health & Human Services OIG

Agencies Reviewed/Investigated

Department of Health & Human Services

Components

Food and Drug Administration

Report Number

OEI-01-17-00510

Report Type

Inspection / Evaluation

Agency Wide

Yes

Number of Recommendations

Questioned Costs

Funds for Better Use

Open Recommendations

This report has 4 open recommendations.

Recommendation Number	Significant Recommendation	Recommended Questioned Costs	Recommended Funds for Better Use
6602	No	$0	$0
FDA should use the new TIRF REMS patient registry to monitor for known areas of risk, such as inappropriate conversions and off-label prescribing.
6603	No	$0	$0
FDA should strengthen the REMS for opioid analgesics (the successor to ER/LA opioids) by requiring prescriber training.
6604	No	$0	$0
FDA should enhance its REMS assessment review process.
6605	No	$0	$0
FDA should seek additional authority to ensure that manufacturers are held accountable when appropriate.