FDA’s Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis According the Office of the Inspector General

The Office of the Inspector General for Health and Human Services (OIG) issued a comprehensive review of the effectiveness of the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) for certain opioid-based drugs. Transmucosal immediate-release fentanyl (TIRF) drugs and extended-release/long-acting (ER/LA) opioids are two major classes of opioids that pose serious risk of addiction, abuse, and overdose. In 2011 and 2012, the FDA approved the REMS for TIRF drugs and the REMS for ER/LA opioids, respectively. The two REMS are intended to mitigate risks of abuse and misuse while maintaining access to these two classes of opioids.

The OIG determined that the FDA struggled to measure the effectiveness of the REMS for TIRF drugs and for ER/LA opioids in mitigating the misuse of opioids. For the REMS for TIRF drugs, OIG found data in the assessments suggesting that the manufacturers were not meeting all their goals and also found the data for some of the REMS goals to be inadequate.

The OIG report made the following recommendations for the FDA to improve these two opioid REMS:

  • Use new TIRF REMS patient registry to monitor for known areas of risk, such as inappropriate conversions (i.e., switching a patient between different TIRF drugs inappropriately) and off-label prescribing;
  • Strengthen the REMS for opioid analgesics (the successor to the REMS for ER/LA opioids) by requiring training for prescribers;
  • Enhance its REMS assessment review process by completing its reviews in a timely fashion and seeking information on inappropriate prescribing trends from FDA’s Office of Prescription Drug Promotion; and
  • Seek additional authority to ensure that manufacturers are held accountable when appropriate.

OIG reports are typically a harbinger for imminent enforcement action. Pharmacies and manufacturers are well advised to review their policies and procedures related to REMS programs and compliance with those programs. Pharmacies need to pay particular attention to both the use of state-mandated prescription monitoring programs and to review medical necessity for these highly dangerous and addictive medications. Manufacturers need to assure compliance with REMS applicable to their products and be prepared for increased FDA enforcement.

How Frier Levitt Can Help

Frier Levitt maintains a team of clinician-attorneys, including several Pharm. D.s, that have extensive experience with REMS programs, including enforcement actions related thereto.  Contact Frier Levitt to speak with an attorney today.