FDA Responds to Lawmakers Demanding Black Box Warnings on Prescription Opioids

By John Lavitt 09/08/15

The agency told Congress that the warnings are under "consideration." How long until they act?


The FDA has responded to a request by Congressional lawmakers to require black box warnings on all prescription opioids. In the face of the painkiller abuse and overdose epidemic that continues to plague the entire country, Congress wants the FDA to reconsider the policy of only requiring such black box warnings on extended release opioids. Instead, they believe the black box warning exemption for immediate release prescription opioids should be revised. The goal is to require all prescription opioid painkillers to prominently display the black box warning on their packaging.

Bipartisan leaders of the House Energy & Commerce Committee sent the August 12 letter to the FDA. Committee Chairman Rep. Fred Upton (R-Mich.), ranking member Frank Pallone (D-N.J.), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-Pa.), and ranking member Diana DeGette (D-Colo.) requested the information. The letter was released on September 2, when the FDA posted their response. In detailed answers to each question posed by the lawmakers, the FDA explained their position. They remarked that a citizen petition to require the black box warnings for immediate-release opioids was already under “active consideration.”

On the issue of black box warnings, the FDA suggests new information has led the agency to reconsider the policy exempting IR opioids. The agency points to data in a 2014 petition filed by Purdue Pharma that shows comparable risks for misuse and abuse with both IR and ER formulations. In regards to Risk Evaluation and Mitigation Strategies (REMS), the FDA admitted that the metrics, data sources, and methodologies for assessing those strategies is still evolving.

For example, the 2015 REMS assessment was the first to include prescriber knowledge surveys. The assessment is still under review with a focus on discovering whether specific milestones for prescriber training had been achieved. The FDA supports mandatory education for prescribers as a component of risk management for all opioids. Such strategies were specifically highlighted in the 2011 Prescription Drug Abuse Prevention Plan.

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Growing up in Manhattan as a stutterer, John Lavitt discovered that writing was the best way to express himself when the words would not come. After graduating with honors from Brown University, he lived on the Greek island of Patmos, studying with his mentor, the late American poet Robert Lax. As a writer, John’s published work includes three articles in Chicken Soup For The Soul volumes and poems in multiple poetry journals and compilations. Active in recovery, John has been the Treatment Professional News Editor for The Fix. Since 2015, he has published over 500 articles on the addiction and recovery news website. Today, he lives in Los Angeles, trying his best to be happy and creative. Find John on Facebook, Twitter, and LinkedIn.