FDA Oversight of Risk Evaluation and Mitigation Strategies To Address Prescription Opioid Abuse

Opioid abuse and overdose deaths are at epidemic levels in the United States. The Food and Drug Administration Amendments Act of 2007 provided the Food and Drug Administration (FDA) with the authority to require pharmaceutical companies to develop Risk Evaluation and Mitigation Strategies (REMS) when FDA determines that the risk of using a drug outweighs its benefit. Through the REMS program, FDA intends to "increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing." We will describe how FDA determined the need for opioid REMS and determine the extent to which FDA has held pharmaceutical companies with required opioid REMS accountable for REMS assessments. We will also determine the extent to which FDA has held opioid REMS sponsors accountable for REMS goals to mitigate risks of misuse, abuse, addiction, overdose, and serious complications because of medication errors.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
Completed	Food and Drug Administration	FDA Oversight of Risk Evaluation and Mitigation Strategies To Address Prescription Opioid Abuse	Office of Evaluation and Inspections	OEI-01-17-00510	2020