Opioid Prescribing Guidelines Put US FDA In Unfamiliar Territory

FDA has always described its role as stopping short of regulating the practice of medicine. When it comes to opioids, that is no longer the case. 

People running from dangerous pills

For decades, the US FDA has drawn a bright line when describing the limits of its regulatory authority: the agency can decide whether new medicines are permitted to be marketed and can limit the scope of claims about their intended use, but the agency does not regulate the practice of medicine.

That line has gotten more and more blurry in the context of FDA’s response to the opioid abuse crisis, where the agency has applied its Risk Evaluation & Mitigation Strategy...

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