Drugs

Cut Fentanyl Off-Label Use: Senator Markey to FDA

David McFarland

— 2 min read
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Sen. Ed Markey (D-MA) says FDA “must not become complicit in the growing prescription fentanyl problem this country is combating.” In a letter to FDA commissioner Robert Califf, Markey particularly referenced Insys Therapeutics’ Subsys, which was approved by FDA in 2012 only for intense and persistent cancer pain.

Markey says that Subsys was included in FDA’s Transmucosal Immediate Release Fentanyl REMS to ensure that it is used only by specially trained oncologists and pain management specialists in treating cancer patients.

“For the most part,” he wrote, “Subsys prescriptions and sales have not come in response to the needs of cancer patients. Rather, by far, Subsys is used ‘off-label.’” He cited a New York Times report that just one percent of Subsys prescriptions are written by oncologists and about half by pain specialists. The remaining prescriptions are written by a “wide range of doctors,” he says, including general practice physicians, neurologists, and even dentists and podiatrists.

Markey points out that in the year before Subsys went on the market, Insys had no reported revenue. Last year, however, it reported revenue of $330 million and a profit of $58.5 million.

“Insys has aggressively and illegally pushed this off-label prescribing,” Markey says. “Its tactics have included Insys’ targeting physicians who do not treat many cancer patients and paying its sales force higher commissions for selling higher doses of the drug.” He notes that several Insys employees have been arrested in connection with kickback schemes and other investigations are underway.

Markey asked Califf to answer these questions: 

  •          How is off-label marketing of Subsys, for neck and back pain, for example, consistent with FDA’s warning accompanying the drug?
  •          How is off-label marketing of Subsys consistent with the REMS that restricts the use of transmucosal immediate release fentanyl to managing breakthrough pain in adults with cancer who are routinely taking other opioid pain medications around-the-clock for pain?
  •          Has Insys submitted its required assessment of the Subsys REMS? If so, provide a copy. If not, why not? If Insys has submitted its assessment, has FDA completed its review of the assessment? If so, provide a copy. If not, why not?
  •          Is FDA taking any steps in responses to Insys’ patterns of aggressive and illegal off-label marketing of Subsys? If so, what is FDA doing? If not, why not?

Markey sent a similar letter to the Centers for Medicare and Medicaid Services (CMS) saying that “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.”

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