In an Inside Health Policy article entitled “Onus On States, Not FDA, To Curb Opioid Abuse, Sources Say,” CLAAD’s Executive Director Michael C. Barnes discusses the role of the U.S. Food and Drug Administration (FDA) in the opioid abuse epidemic. He notes that the risk evaluation and mitigation (REMS) program, which falls under the FDA’s purview, remains an effective way to ensure that opioid medications’ benefits outweigh their risks. “The FDA has responsibility and takes responsibility for ensuring that when those medications are in the hands of healthcare consumers that the risks are adequately managed,” Mr. Barnes said. “If you look at the express authority that Congress granted to the FDA through the [Food and Drug Administration Amendments Act] then you see that REMS, for example, is a great way for the FDA to be able to ensure that a medication is used appropriately and that the risks to third parties are adequately mitigated.”
He further states that the Agency is not entirely to blame for the opioid abuse epidemic because, ultimately, the problem has health safety and professional contexts to it, which are regulated by the states. “We can’t just look to the FDA because the FDA operates under limited authority under federal interstate commerce power,” he said.
You can read the full article here.