A US senator is urging federal agencies to limit the use of a prescription version of the powerful painkiller fentanyl, going so far as to say the government may be helping to fuel the ongoing opioid epidemic by failing to more aggressively police its use.
Edward Markey, a Massachusetts Democrat, sent letters Tuesday to the heads of two federal agencies in response to a STAT article detailing the death of a 32-year-old woman who overdosed on the prescription form of fentanyl called Subsys. The drug, which is sold by Insys Therapeutics, is approved only for use in cancer patients suffering from sharp bouts of previously untreatable pain.
The woman, Sarah Fuller, who overdosed while taking Subsys, did not have cancer. She was prescribed the drug “off-label” for chronic neck and back pain stemming from two automobile accidents as well as painful fibromyalgia, according to her family. The government insurer, Medicare, paid $250,544 for a 15-month supply of Subsys prescribed to Fuller, billing records show.
“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,” Markey wrote to Andy Slavitt, the acting administrator for the Centers for Medicare and Medicaid Services.
Medicare is paying for “tens of millions of dollars in Subsys prescriptions that may have also led to the overdose deaths of people who should never have received the drug in the first place,” Markey wrote. Medicare paid $30 million for Subsys in 2013 and then $97 million just a year later in 2014, according to Markey’s letter.
A Medicare spokesman said the agency would respond directly to the senator.
The senator said he was concerned prescription use of fentanyl may be adding to the country’s opioid problem. Much of the fentanyl abused in the United States is produced illicitly in China and then funneled into the country by Mexican drug cartels. It has quickly replaced heroin and other prescription painkillers as the leading cause of fatal opioid overdoses in some regions of the country.
“Fentanyl prescribed by physicians, and in many instances paid for by Medicare, now appears to be contributing to the epidemic,” Markey wrote.
He alleged that Insys has “aggressively and illegally pushed this off-label prescribing” of Subsys.
Insys did not return messages requesting comment.
Markey also wrote to Robert Califf, the commissioner of the Food and Drug Administration, to urge that agency to “reign in any improper and dangerous marketing and promotion of off-label use” of Subsys.
He asked the FDA to provide him with any steps it has taken in response to Insys’s off-label marketing of Subsys.
An FDA spokeswoman said the agency would respond to the senator after reviewing his letter. She added the agency is “deeply concerned about the opioid epidemic” and working on a number of steps that are part of the FDA’s opioid action plan.
Subsys, which is sprayed under the tongue, is part of a special FDA program designed to mitigate the risk of prescription fentanyl products. Doctors cannot prescribe Subsys unless they are enrolled in that program and successfully pass a test about the appropriate use of the drug and the risks of it being abused.
Markey asked Califf how the off-label use of Subsys was consistent with the agency’s program designed to limit the abuse of prescription fentanyl. He also asked Medicare to provide him with more information, including whether the agency is taking any steps to make sure it is not paying for any inappropriate prescribing of Subsys.
While doctors are allowed to prescribe drugs for off-label conditions, drug makers aren’t permitted to promote medications for these purposes. Insys, based in Chandler, Ariz., is under investigation by several state attorneys general and federal prosecutors for the marketing of Subsys, according to disclosures made by the company. An Insys sales rep in Alabama and a nurse in Connecticut have pleaded guilty to federal kickback charges related to off-label Subsys prescribing.
In the case of Fuller, her father said an Insys sales representative was present in the doctor’s office when his daughter was first prescribed Subsys.
Sarah Fuller started on the drug in January 2015. She was delivered 30-day supplies to her house by FedEx. She died on March 25. A toxicology report detected fentanyl in her blood at 15 to 20 times the therapeutic level and well above rates considered lethal.
Subsys is the only brand-name drug Insys sells. In 2011, the year before it hit the marketplace, Insys was operating at a loss with no reported revenue. Last year, company revenues were $330 million, and it reported a profit of $58.5 million.