Caleb Alexander, MD: Addressing Shortcomings in the FDA's Opioid Approval Process


An expert discusses steps the FDA can take to strengthen and make more airtight their process for approving new opioids.

In an interview with HCPLive®, Caleb Alexander, MD, discussed the US Food and Drug Administration’s (FDA) process of approving new drug applications for opioids.

The FDA plays an important role in the regulation of prescription drug, including opioids, but there are nonetheless certain gaps in this process that should be addressed.

Alexander explained that the FDA has primarily relied on “enriched” trial designs, which excludes patients who cannot tolerate the investigative product or receive little to no benefit. Therefore, the design has a fundamental flaw in that it inherently biases the results in favor of demonstrating the drug’s safety and efficacy.

He also suggested that FDA should require manufacturers to more carefully, cautiously, and systematically gather information on potential adverse events.

“On the whole, the FDA gets a lot more right than they have gotten wrong,” Alexander said. “I do think the FDA deserves credit for many of the steps they have undertaken to try to improve the safe use of opioids.”

In terms of the clinician’s role in prescribing opioids, he urged clinicians to be sure that they are informed and properly educated so they can make well-balanced judgements in this domain.

“There are many tools in the toolbox, and all too often we’ve reached for opioids at the expense of safer and more effective alternatives,” he concluded. “Fortunately, I think we are in the middle of a sea change in the way that pain is managed.”

He stressed that clinicians can certainly work to improve the quality of care in patients while reducing overreliance on opioids.

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