Over the past 25 years, pharmaceutical companies have promoted opioid use in ways that were often neither safe, nor effective, causing significant harm on patients and consumers.

Regulatory failures made by the US Food and Drug Administration (FDA) in approving and labelling new products, including deceptive safety studies, allowed for this to reach crisis point.

This piece details FDA failures to regulate opioid manufacturers, a lack and adequate and well-controlled clinical trials, and poor management of conflicts of interest between FDA staff and industry.

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