To Combat Opioid Epidemic, King, Colleagues Urge FDA to Require Risk Management Strategies for All Prescription Opioids

Statement

Today, U.S. Senator Angus King (I-Maine) joined several of his colleagues in urging the U.S. Food and Drug Administration (FDA) to require the implementation of risk management strategies for all prescription opioids to reduce the possibility of addiction. Currently, the FDA only requires certain opioids to implement a Risk Evaluation and Mitigation Strategy (REMS) to help ensure patients who are prescribed the drug do not experience adverse side effects such as addiction. Immediate-release opioids are not subject to a REMS despite the fact that they make up 91 percent of all opioids prescribed. In a letter today, Senator King urged the FDA to require immediate-release opioids be subject to a REMS.

"We are writing to request that FDA use its authority to require immediate-release (IR) opioids be subject to a Risk Evaluation and Mitigation Strategy (REMS)," Senator King and his colleagues wrote to the FDA. "In 2012, we saw a drop in painkiller prescribing rates, and not surprisingly, a subsequent drop in prescription drug deaths for the first time since the 1990s. The clear link between opioid prescribing practices and the acceleration of this pernicious epidemic, along with the damage from opioid misuse and abuse to individuals, families, communities, and our nation as a whole cannot be overstated. We understand that battling the misuse and abuse of prescription drugs on our society is a task that requires a long-term and comprehensive approach. We also understand that FDA will play an immensely important role in achieving this ambitious but necessary goal of putting a stop to opioid abuse, misuse, and death in this country."

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