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Subsys Off Label

Subsys and Off-Label Marketing Concerns

Subsys is a fentanyl pain killer that is administered via a spray under the patient’s tongue. Subsys was approved by the FDA in 2012 as a treatment for break-through pain in cancer patients who are already undergoing 24 hour opiod pain treatment. Insys, the manufacturer of Subsys, is currently under investigation by the Department of Health and Human Services for violating the federal law forbidding pharmaceutical companies from marketing their products to doctors for anything other than the approved treatment.

Subsys (Fentanyl) is a member of the opiod family of pain medications. Opiods relieve moderate to severe pain by blocking the perception of pain in the central nervous system. Subsys is about 80 to 100 times more potent than morphine, and thus can be a very addictive and dangerous drug.

The FDA, recognizing the powerful nature of the drug, recommended that Subsys only be prescribed by oncologists and pain specialists and that these doctors enroll in and undergo training in a restricted distribution program called the Transmucosal Immediate-Release Fentanyl (TIRF) Access program. This program is designed to properly educate physicians as to the specifics of safely using and prescribing Subsys.

Since its approval, Subsys has earned tremendous sales topping $100 million. The incredible surge in the use of Subsys has raised red flags about how the Insys Sales Force has marketed the drug. While doctors are legally allowed to prescribe drugs for uses other than that which the FDA approved, pharmaceutical companies are not legally permitted to market their drugs for off label (or non-FDA approved) uses.

A recent study regarding the prescriptions of Subsys found that only 1% of prescriptions were written by oncologists. Nearly half of all Subsys prescriptions were written by neurologists, physical medicine doctors, rehabilitation specialists and even oral surgeons – doctors that often have very little to do with cancer treatment.

The disparity between how the drug has been prescribed and how it was approved by the FDA has lead to investigations into the marketing practices of Insys. Allegations are that the company aggressively marketed Subsys to doctors for use outside of cancer treatment. The sales force was also financially incented to sell higher doses of Subsys, which is an unusual compensation plan when dealing with such powerful pain killers. Such sales practices could be very dangerous to the end patient as fentanyl pain medications carry high chances of misuse, dependence and overdose. Patients and doctors need to be fully informed as to the uses and risks of the powerful narcotic, Subsys.

Using a drug like Subsys for a purpose other than for which it was clinically tested and approved could have some serious health consequences such as breathing problems and overdoses. If you or a family member had suffered harm while using Subsys, then you may want to contact an attorney who is familiar with pharmaceutical litigation. An attorney can assist you in navigating your way through the legal process. Brett H. Oppenheimer, a Kentucky lawyer, would like to discuss your potential case with you and help you through this difficult time.

Contact Brett online to to schedule a free consultation.

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