Opinion: How Insys undermined an FDA effort to protect the public from dangerous opioids

With the country in the throes of the opioid epidemic, the Food and Drug Administration started a risk evaluation and mitigation strategy (REMS) in 2012 to restrict prescribing of quick-absorbing fentanyl to appropriate patients. At the time, these were the most potent and riskiest opioid-based medications available. The program should have worked, but was undermined by one company, Insys, whose top executives were convicted last week of bribing doctors to prescribe this type of painkiller to people who weren’t supposed to get it.

These fast-acting fentanyl medications, also known transmucosal immediate-release fentanyl (TIRF), are taken by mouth. They were approved to treat breakthrough cancer pain. In the months after the was launched, there were large decreases in prescribing this type of fentanyl. But as we and colleagues reported in , what then followed is a cautionary tale that’s emblematic of the influence the pharmaceutical industry can have over physicians’ clinical decisions.