Maker of oral fentanyl spray Subsys faces investigation for alleged off-label marketing practices

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by Jim Orr

Record profits from the fentanyl sublingual spray Subsys have raised concerns from investigators that sales of the drug are being fueled by off-label prescriptions from doctors. Under Food and Drug Administration guidelines, Subsys and other fentanyl products are only intended for use among patients with severe, chronic pain such as cancer patients.

The Subsys fentanyl spray was approved by the FDA in 2012. Although the drug was intended for only a small segment of the population, the drug has earned record sales for its manufacturer, Insys Therapeutics, during the two years that Subsys has been on the market, sending share prices for the drugmaker soaring by more than 270%.

But investigators believe that the surprising profits generated by Subsys may be caused by doctors who prescribe the drug “off-label” for uses that were not approved by the FDA. According to a study by Symphony Health, a company that analyzes prescription drug trends, just 1% of Subsys prescriptions were written by oncologists. The study found that about half of prescriptions for Subsys were writing by pain management specialists, while the rest were written by general practitioners, neurologists, dentists, podiatrists, and doctors in other medical specialties unrelated to cancer treatment.

Investigators believe that Insys may have violated FDA rules through an advertising campaign that heavily marketed Subsys to doctors for unapproved uses. While doctors can legally prescribe drugs to their patients as they see fit, drug companies are prohibited by law from advertising their products to physicians for uses that have not been approved by the FDA.

Insys revealed in December 2013 that the company was under investigation by the Office of the Inspector General for potential violations of federal law. The company received a subpoena from federal investigators which ordered it to turn over documents related to its sales and marketing practices.

Federal Officials Raise Concerns About Risks of Oral Fentanyl Products

The FDA and other federal officials have already taken action to prevent off-label abuse of other oral fentanyl products. In 2008, the drugmaker Cephalon was forced to pay $425 million in fines related to the illegal off-label promotion of Actiq, the fentanyl lollipop, and other drugs marketed by the company. Cephalon sought FDA approval for another oral fentanyl product, a dissolving pill called Fentora, but was denied by the agency after reports surfaced that it was already being widely prescribed by doctors to non-cancer patients.

Pharmaceutical experts say that concerns about the off-label prescription of Subsys are especially troubling because of the highly addictive—and highly deadly—nature of the drug’s active ingredient, fentanyl. Fentanyl is about 80-100 times more powerful than morphine, meaning that even a small amount of the drug can be deadly for patients who have not already developed a tolerance for opioids. Officials also worry that the widespread of prescription of oral fentanyl products like Subsys may also contribute to the abuse of these products by patients or by individuals who suffer from opioid addiction.

Off-Label Prescribing Practices Contribute to Fatal Fentanyl Overdoses

Despite the efforts of federal investigators to limit the off-label promotion of fentanyl products such as Subsys, thousands of patients have died because of an overdose caused by this dangerous drug. Many of these deadly fentanyl overdoses occurred because patients were given too much fentanyl by their doctors or because they were given the drug despite the fact that they were not eligible to use fentanyl under FDA guidelines.

Fentanyl products can also be deadly when they are prescribed in combination with other drugs that suppress the central nervous system. The interaction between fentanyl and other CNS depressant medications can lead to a combined drug overdose, which can cause respiratory depression and death.

If you or a loved one have been the victim of a fentanyl overdose, you may be eligible to file a lawsuit and seek compensation for your injuries. The lawyers at Heygood, Orr & Pearson will work hard to ensure that your legal rights are fully protected so that you or your loved one receive the outcome in your case that you deserve.

The lawyers at our firm have successfully resolved more fentanyl lawsuits than all other law firms in the United States—combined. These cases include a verdict of $5.5 million in a Florida case involving the death of a man who died while wearing a fentanyl patch, and a verdict resulting in payment of more than $21 million for the death of another fentanyl patient in Illinois.

To receive a free legal consultation about your case and find out whether you may be eligible to file a fentanyl lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and submitting some brief information about your case.