FDA Called Lax in Curbing Use of Powerful Class of Opioids

The drugs were approved for cancer patients, but have been prescribed to patients with migraine and back pain, a New York Times investigation reveals.

A class of drugs for cancer patients experiencing “breakthrough pain,” (sudden and sharp onrushes of pain despite the use of standard round-the-clock pain medications), have been prescribed to patients with back pain and migraine, putting them at high risk for addiction, a New York Times investigation says.  

The drugs contain fentanyl, a narcotic up to 50 times stronger than heroin and 100 times stronger than morphine and include Actiq and Fentora, made by Cephalon, and Subsys, made by Insys Therapeutics. The drugs are called T.I.R.F.s (for transmucosal immediate-release fentanyl).

But in what’s being described as a fox guarding the hen house blunder, the FDA in 2011 charged a consortium of drug companies making the products with regulating their use. TheTimes looked at approximately 5,000 pages of documents that researchers at Johns Hopkins University obtained through the Freedom of Information Act. They showed widespread off-label prescribing of the drugs that the FDA did not intervene to prevent. 

Andrew Kolodny, MD, an opioid policy researcher at Brandeis University, told the newspaper that “if any opioids were going to be tightly regulated, it would be these. They had the fox guarding the hen house, people were getting hurt—and the FDA sat by and watched this happen.”

Janet Woodcock, MD, the director of the Center for Drug Evaluation and Research at the FDA, told the newspaper that “the information we have isn’t very good, but it seems to indicate people who aren’t cancer patients are getting this and people who aren’t opioid tolerant are getting this.”

About 115 people in the United States die every day from overdosing on opioids, according to the National Institute on Drug Abuse.

In December 2011, the FDA created a safety program overseeing the use of T.I.R.F.s. “The program required doctors to undergo training for prescribing T.I.R.F.s and to sign a form saying they understood that prescribing to other patients can be dangerous,” the Times reports. “To administer the program, the consortium hired McKesson, a large national distributor that supplies drugs, including T.I.R.F.s, to pharmaceutical retailers.”

McKeeson released a statement in the wake of the investigation saying that it was just doing its job as a third-party administrator and that it was following requirements “developed jointly by the manufacturers and the FDA with ultimate approval resting with the FDA. McKesson administers the program according to these FDA requirements.”