How FDA Failures Contributed to the Opioid Crisis

AMA J Ethics. 2020 Aug 1;22(1):E743-750. doi: 10.1001/amajethics.2020.743.

Abstract

Over the past 25 years, pharmaceutical companies deceptively promoted opioid use in ways that were often neither safe nor effective, contributing to unprecedented increases in prescribing, opioid use disorder, and deaths by overdose. This article explores regulatory mistakes made by the US Food and Drug Administration (FDA) in approving and labeling new analgesics. By understanding and correcting these mistakes, future public health crises caused by improper pharmaceutical marketing might be prevented.

MeSH terms

  • Analgesics, Opioid / adverse effects
  • Drug Overdose* / prevention & control
  • Humans
  • Opioid Epidemic
  • Opioid-Related Disorders* / drug therapy
  • United States
  • United States Food and Drug Administration

Substances

  • Analgesics, Opioid