FBI Seeks Subsys Users As Criminal Investigation Over Sales Tactics, Additions, Continues

Federal investigators are asking patients who were prescribed the fentanyl spray Subsys to come forward, as part of an ongoing investigation into criminal charges against the drug manufacturer, who the government and a number of plaintiffs allege bribed doctors to prescribe the powerful and addictive pain killer off-label, when there was no medical need for the drug. 

The Federal Bureau of Investigations (FBI) has released a questionnaire for users of Subsys, seeking information as part of an on-going investigation, which has resulted in a number of arrests of former executives of Insys, the manufacturer of the fentanyl spray.

Earlier this month, one former company manager, Elizabeth Gurrieri, plead guilty to wire fraud conspiracy in connection with the investigation. She is the second company employee to plead guilty to charges related to Subsys sales.

Since the beginning of the year, a number of Subsys lawsuits have been filed in a number of state courts, claiming that the company mislead patients and bribed doctors to increase sales of the drug.

The pharmaceutical company’s marketing practices have been under investigation since December 2013.

The Department of Health and Human Services Office of Inspector General (DHHS-OIG) began investigating Insys, the manufacturer of Subsys, for possible illegal off-label marketing of the drug, after it catapulted past the $100 million sales mark despite being introduced with limited approval for cancer patients suffering from severe pain.

Subsys is a spray form of fentanyl, which is a painkiller that is considered 100 times more powerful than heroin. If an individual overdoses on fentanyl, it can result in severe and life-threatening injuries.

The broad sales of Subsys raised suspicions, because the FDA approved the new drug in 2012, with recommendations that only oncologists and pain specialists prescribe the drug. Those doctors also had to undergo special training before being allowed to prescribe the drug, and patients have to sign an agreement that they understand the risks involved as part of a Subsys Risk Evaluation and Mitigation Strategy (REMS).

Following a 270% increase in sales over just a year, it appeared that only 1% Subsys sales are by oncologists, about half are from pain specialists, and the rest of the prescriptions are issued by doctors, dentists and even podiatrists who appear to be using the drug off-label.

While doctors are permitted to prescribe any approved medication for whatever purposes they see fit, it is illegal for pharmaceutical companies to promote their drugs for applications that have not been approved by the FDA after establishing that it is safe and effective for that use.

Claims against the company include personal injury and wrongful death lawsuits indicating that sales reps were specifically told to push doctors to sell the powerful painkiller to patients who were not fighting cancer because those patients could live longer and they could increase their dosage. One sales representative who has turned whistleblower has said the company’s view of patients was to “[G]et them high, and hope they don’t die.”

The tactics also allegedly included bribes and kickbacks to doctors who boosted sales.

Insys has insisted that the actions are in the company’s past and that it is trying to improve its corporate culture, focus on patient safety, and that it has purged employees linked to questionable activities.

However, it is expected that the number of Subsys lawsuits will continue to grow as more patients step forward and the FBI investigation continues.