Over the last few years, companies that manufacture pharmaceutical drugs have been paying hefty fines. These companies include:
- Allergan ($600 million)
- AstraZeneca ($520 million)
- Bristol-Myers Squibb ($515 million)
- Eli Lily ($1.4 billion)
- Forest Laboratories ($313 million)
- Pfizer ($2.3 billion)
Many of the charges against these companies involved fraud, and now, Novartis joins the ???club.???
The New York Times reported on September 30, 2010 that federal prosecutors alleged people working for Novartis paid illegal kickbacks to a number of health care providers. These kickbacks took the form of payments for serving as a speaker and serving on advisory boards, as well as providing entertainment, meals and travel.
However, according to the New York Times, the only charge that Novartis pleaded guilty to was a charge for mislabeling. The total amount Novartis paid to settle the civil and criminal charges is $422.5 million, which included a criminal fine amounting to $170 million and a criminal forfeiture of $15 million (of note, this forfeiture is for Novartis Pharmaceuticals which is a subsidiary in the United States).
Similar to some of the other companies listed above, Novartis engaged in illegal promotions of their products; this practice is often referred to as ???off-label marketing.??? As an example, Novartis promoted a drug called Trileptal (oxycarbazepine) to psychiatrists for treating bipolar disorder and neuropathic pain, when this drug is indicated (and approved) for treating seizures.
Generally speaking, physicians are ???free??? (legally permitted) to use drugs that have been approved by the U.S. Food and Drug Administration (FDA) for any purpose; however, pharmaceutical companies such as Novartis are prohibited from promoting drugs for off-label use ??? such as in situations where the FDA has not reviewed the data and approved a drug for a particular use.
According to information released by the prosecutors, the upper management at Novartis had approved this sort of marketing of their products for a period from July of 2000 to June of 2004.