FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

New York AG Sues Insys Alleging Illegal Off-Label Promotion, Bribery to Boost Fentanyl Drug

Feb. 7, 2018
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New York’s attorney general is suing Insys for deceptive marketing of the spray form of one of its fentanyl products, a move the state says is part of a multi-pronged strategy to address the addiction crisis.

Attorney General Eric Schneiderman claims that since its FDA approval in 2012, Insys has marketed its drug Subsys far beyond its FDA indication for cancer-related breakthrough pain. Despite the narrowness of this indication, Schneiderman’s office claims, the company has marketed the highly addictive drug to people suffering mild pain and downplayed the risk of addiction.

Moreover, Schneiderman’s office claims, Insys told its sales representatives to push higher doses of the drug, which can cost up to five times as much as the lowest-strength prescription. Sales reps also called on medical offices employing providers who had a history of being arrested for illegal opioid diversion and distribution. The company, Schneiderman claims, created a business unit specifically to obtain prior authorization from health plans for patients. The staff of this unit was trained to imply patients were suffering from cancer pain even when they were not, according to the lawsuit.

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