Aggressive, illegal marketing activities of fentanyl drugmaker Insys Therapeutics may be contributing to opioid epidemic

Washington (October 11, 2016) – As the opioid crisis continues to rage across the country fueled in part by a precipitous rise in illicit fentanyl – a synthetic opioid that is 100 times more powerful than morphine – Senator Edward J. Markey (D-Mass.) today called for immediate action to curb the use of off-label prescription fentanyl. In letters sent today to the Centers for Medicare and Medicaid Services (CMS) and Food and Drug Administration (FDA), Senator Markey queried the agencies about their efforts to stop the explosion of off-label prescriptions of the fentanyl drug Subsys manufactured by Insys Therapeutics. Despite the FDA’s approval of Subsys only for intense and persistent cancer pain, an investigation by The New York Times found that a mere one percent of Subsys prescriptions are written by oncologists. And according to health and science publication STAT, this dramatic increase has meant that Medicare payments for Subsys prescriptions increased three-fold (from $30 million to $97 million) between 2013 and 2014. In his letters, Senator Markey points to the aggressive and illegal marketing of the drug by Insys Therapeutics, including Insys’ targeting physicians who do not treat many cancer patients and paying its sales force higher commissions for selling higher doses of the drug. 

“The FDA must not become complicit in the growing prescription fentanyl problem this country is combating,” writes Senators Markey in his letter to FDA Commissioner Robert Califf.

“By reimbursing prescriptions for improper off-label use of Subsys, CMS appears to be contributing to the opioid abuse epidemic, rewarding Insys for its wrongdoing, and costing taxpayers millions of dollars,” continues Senator Markey in the separate letter to CMS Acting Administrator Andy Slavitt.

A copy of Senator Markey’s letter to CMS can be found HERE. A copy of the letter to the FDA can be found HERE.

A copy of the CMS response can be found HERE.

A copy of the FDA response can be found HERE

In the letters to the FDA and CMS, Senator Markey requests responses to questions that include:

  • How is off-label prescribing of Subsys — for example, for neck and back pain — consistent with the FDA’s warning accompanying the drug?
  • Is the FDA taking any steps in response to Insys’ pattern of aggressive and illegal off-label marketing of Subsys? 
  • For CMS data available since Subsys went on the market in 2012, how many Subsys prescriptions for cancer patients did Medicare Part D reimburse annually, and how many were off-label?
  • Is CMS taking any steps to ensure that Medicare Part D is not reimbursing for improper off-label Subsys prescriptions that resulted from Insys’ illegal marketing tactics?
  • In light of Insys’ pattern of aggressive and illegal off-label marketing of Subsys, is CMS engaging in extra scrutiny of off-label prescriptions for Subsys presented to CMS for reimbursement? 

Senator Markey also queried the FDA about the effectiveness of its “risk evaluation and mitigation strategy” (REMS) for Subsys, which is intended to ensure that the benefits of the drug outweigh the risks of misuse, abuse, addiction, overdose, and serious complications due to medication errors.”