Biotech - STAT

Biotech - STAT

At the risk of defying what has become common wisdom, laying a lot of blame for the opioid crisis at the feet of FDA is misguided. They approve drugs, including their indication. They review promotional content to ensure it stays in label. They did their job – the indication was narrow and I have to believe the promotional content reflected the label. Blame for the behavior of the Insys marketing and sales team and company management lies with the company and the individuals. Some of that behavior would have been discovered in due time, but FDA needs secondary sources and hard evidence to act on this sort of behavior. I’m not saying FDA is blameless, but calling them out here feels inappropriate. (And no, I do not nor have I ever worked for FDA.)



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