Rosiglitazone features in $3-billion healthcare-fraud case

July 03, 2012

Philadelphia, PA - GlaxoSmithKline has agreed to pay the government $3 billion in what is being called the largest healthcare-fraud settlement ever in the US, federal prosecutors announced yesterday [1,2]. The company has pleaded guilty to criminal misdemeanor charges, including failing to report cardiovascular side-effect data to the US Food and Drug Administration (FDA) about the diabetes drug rosiglitazone (Avandia), as well as illegally promoting off-label uses of two psychiatric drugs—p aroxetine (Paxil) and bupropion (Wellbutrin)—to physicians.

The company also has agreed to settle civil charges of promoting off-label uses of several products, paying physicians kickbacks for prescribing its drugs, making false and misleading statements about the safety of rosiglitazone, submitting false price information about its drugs to the government, and consequently underpaying Medicaid drug rebates.

The illegal promotion of paroxetine and bupropion happened in the late 1990s and early 2000s, while the failure to disclose negative safety data about rosiglitazone occurred between 2001 and 2007, according to the US Department of Justice. In that period, regular safety reports filed to the FDA and required by the agency omitted data from several postmarketing studies, including two that the company initiated at the request of the European Medicines Agency, which was worried about the drug's cardiovascular safety.

As reported by heartwire , the FDA later added two boxed warnings to rosiglitazone about the potential increased risk for congestive heart failure and MI.

In other details listed in court documents, the company helped prepare, publish, and distribute a misleading medical journal article about one of the psychiatric drugs; for another, it promoted off-label, unproven effects of a so-called "happy, horny, skinny pill." The company also paid for travel, meals, lodging, and activities such as deep-sea diving and balloon rides for physicians attending their "educational forums," and in the case of two speaker's bureau physicians, paid them upwards of $1.5 million to educate doctors at meetings in places like Jamaica and Bermuda.

Although it is legal for physicians to prescribe FDA-approved drugs for off-label uses, it is not legal for a drug manufacturer to promote such uses.

Under the criminal guilty plea, GlaxoSmithKline will pay a fine of nearly $957 million and forfeit another $43 million. The company will pay the government an additional $2 billion as part of the civil settlement, which does not constitute an admission of any liability or wrongdoing, and also agreed to a five-year "corporate integrity agreement" with the Department of Health and Human Services.

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