Opioids

Study: FDA, drugmakers let opioid misuse slide

Oxycodone pain pills. Photo: John Moore/Getty Images

Federal regulators and fentanyl manufacturers didn't take action when it became clear that highly potent fentanyl products were being inappropriately prescribed to as many as half of the patients taking them, according to a new study in the Journal of the American Medical Association.

How it works: The type of fentanyl in question is approved by the Food and Drug Administration only for adult cancer patents who have already built up a tolerance to less potent opioids.

FDA blasts McKesson for not monitoring opioid shipments

A pile of oxycodone pills.
Oxycodone pills. Photo: John Moore/Getty Images

The FDA has sent a warning letter to McKesson, alleging the drug distributor broke federal law by not responding to notifications from pharmacies that drugs were tampered with while in McKesson's possession — including instances where oxycodone pills were stolen and replaced with "illegitimate" medications. FDA commissioner Scott Gottlieb said the alleged violations were "simply unacceptable."

Why it matters: Drug wholesalers like McKesson face a lot of legal liability for their role in the opioid epidemic, and now the FDA is threatening legal action if the companies don't prove they are rectifying their oversight of painkiller shipments. McKesson said it has been in touch with the FDA and is "in the process of providing additional procedural detail and documentation."

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