A mandated safety program regulators rely on to minimize opioid abuse and misuse is not “well suited” to quickly address the ongoing crisis across the U.S. And the shortcomings reflect a lack of cooperation from opioid makers that made it difficult for the Food and Drug Administration to assess key data, according to a new federal government report.
At issue are REMS, or risk evaluation and mitigation strategy programs, which the FDA requires companies to develop when the agency approves a new medicine that may pose a safety risk. When the FDA decides a REMS program is necessary, drug makers must devise a program to provide physician and patient education, sometimes monitor distribution, and send the agency regular assessments.
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