Over 2 decades, the FDA consistently approved new opioids based on studies lacking critical safety and efficacy data

Over the past 2 decades, data submitted to the U.S. Food and Drug Administration (FDA) for new opioid approvals has lacked critical safety and efficacy information. During this timeframe, the FDA approved opioids on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations, excluding patients who did not tolerate the drug. Findings from a cross-sectional analysis are published in Annals of Internal Medicine.

Per capita use of opioids in the U.S. remains at epidemic levels and far exceeds that of other countries. Overdose rates are at an all-time high, mainly due to heroin and fentanyl use, but most users of those illicit drugs report that their first opioid was a prescription drug. Given the role that prescription opioids have played in driving the epidemic, the regulatory activities of the FDA have been scrutinized. Little is known about the evidence required by the FDA for new approvals of opioid analgesics.

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