In 2012, the US Department of Justice brought a series of charges, both civil and criminal, against the London-based pharmaceutical conglomerate GlaxoSmithKline. Those charges were eventually resolved in the largest settlement for alleged health care fraud in US history: $3 billion.
Of at least six civil and criminal charges brought against GlaxoSmithKline, the company ultimately pleaded guilty to three of the criminal charges.
US Charges Filed Against GlaxoSmithKline: Paying Doctors To Promote Drugs “Off-Label”
This was, of course, big news, as were the actual charges filed against the company. Federal prosecutors alleged that GSK had promoted a number of different drugs to physicians for unapproved, or “off-label,” uses.
But the government’s allegations also involved members of the medical community.
The United States claimed that GlaxoSmithKline had paid health care providers to promote products for unapproved uses to other doctors. Before we continue, note that no doctors were charged with criminal or civil violations during this case; GlaxoSmithKline was the only defendant.
Unlawful Promotion Of Paxil For Unapproved Indications
The first charge to which GSK pleaded guilty involved Paxil, which is used to treat forms of depression, anxiety disorders and posttraumatic stress disorder.
The United States alleged that GlaxoSmithKline had “unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use.”
Compensating Medical Professionals For Promoting Drugs “Off-Label”
The US also claimed that GSK “sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended.”
This theme, paying members of the medical community to deliver presentations extolling the virtues of “off-label” uses, is one that would recur throughout the United States’ criminal and civil allegations.
Millions For Doctors Who Promoted Wellbutrin Off-Label
In their second criminal charge, the DOJ alleged that GlaxoSmithKline had “paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wellbutrin for these unapproved uses.”
During 2012, Wellbutrin was FDA approved only for the treatment of Major Depressive Disorder. The United States claimed that GSK had paid health care providers to promote the drug “off-label” for “weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses.”
Prosecuting “Off-Label” Promotion: The False Claims Act & The Food, Drug & Cosmetic Act
While the development of relationships, even financial ones, between pharmaceutical manufacturers and physicians, nurses and other health care professionals is not strictly illegal, it becomes unlawful when those doctors make “false or misleading” claims about a drug’s safety or efficacy.
The federal government often considers these unlawful practices a form of “misbranding,” and it was to charges of “misbranding” that GlaxoSmithKline ultimately pleaded guilty in 2012. In order to understand why the government would consider “off label” promotion in this way, we’ll have to turn to two federal statutes that government prosecutors commonly use to charge pharmaceutical companies for unlawful business practices.
In the Justice Department’s own press release, we find a simple definition of “off-label” promotion, as it is laid out in the Food, Drug & Cosmetic Act of 1938:
“Under the provisions of the Food, Drug & Cosmetic Act, a company in its application to the FDA must specify each intended use of a drug. After the FDA approves the product as safe and effective for a specified use, a company’s promotional activities must be limited to the intended uses that FDA approved. In fact, promotion by the manufacturer for other uses – known as ‘off-label uses’ – renders the product ‘misbranded.’ “
In its case against GlaxoSmithKline, the US government employed these provisions, which make it “illegal for drug companies to introduce into the marketplace drugs that the company intends will be used ‘off-label,’ i.e., for uses or at doses not approved by the FDA.”
Defrauding Government Insurance Programs
The government also uses another legal argument to prosecute charges of “misbranded” pharmaceuticals.
The False Claims Act makes private individuals and companies legally liable for defrauding programs run by the government. Since Medicare, Medicaid and several other health insurance programs are operated by the government, and funds from those programs allegedly paid for many of the prescriptions that had been promoted for “off-label” purposes, the US Department of Justice claimed that GlaxoSmithKline had defrauded its public health care programs.
This argument, that the kickbacks paid to health care professionals for promoting and prescribing drugs for off-label purposes had “caused false claims to be submitted to federal health care programs,” was used in relation to the government’s charges regarding Zofran and its allegedly “off-label” promotion as a safe and effective morning sickness treatment.
Alleged Kickbacks To Medical Professionals
Among the government’s civil charges, one involved the promotion of several different drugs, including Zofran, for “off-label non-covered uses.” The government claimed that GlaxoSmithKline had even paid kickbacks to physicians who prescribed those drugs.
GSK continues to deny all of the government’s civil claims, including those filed in relation to Zofran. Citing a desire to “avoid the delay, expense, inconvenience and uncertainty of protracted litigation,” the company agreed to pay an additional $2 billion to resolve its civil liabilities. For perspective, GSK is the sixth largest pharmaceutical company in the world with annual revenues over $23 billion.
How Common Is Off-Label Promotion?
Since GlaxoSmithKline’s settlement was reached in 2012, two other pharmaceutical manufacturers have been charged for promoting drugs “off-label” under the False Claims and Food, Drug & Cosmetic Acts.
Amgen Promotes Drug For Doses FDA Had Already Rejected
On December 19, 2012, the Department of Justice announced that “biotechnology giant” Amgen Inc. had pleaded guilty to unlawfully selling an anemia drug, Aranesp, “with the intention that it be used at off-label doses that the FDA had specifically considered and rejected, and for an off-label treatment that the FDA had never approved.”
As in GlaxoSmithKline’s case, Amgen also agreed to pay a significant sum ($612 million) to resolve multiple civil claims, allegations that the company continues to deny. The United States’ charges included:
- “promot[ing] Aranesp and two other drugs that [Amgen Inc.] manufacturered, Enbrel and Neulasta, for off-label uses and doses that were not approved by the FDA and not reimbursable by federal insurance programs”
- “offer[ing] illegal kickbacks to a wide range of entities in an effort to influence health care providers to select its products for use, regardless of whether they were reimbursable by federal health care programs or were medically necessary”
Johnson & Johnson Promotes Schizophrenia Drug Off-Label As Treatment For Dementia In Nursing Homes
Less than a year later, on November 4, 2013, “global health care giant” Johnson and Johnson agreed to pay over $2.2 billion to resolve federal allegations that its subsidiaries had promoted several drugs for unapproved uses, and paid “millions of dollars in kickbacks” to Omnicare Inc., the “nation’s largest pharmacy specializing in dispensing drugs to nursing home patients.”
Specifically, the United States claimed that Johnson and Johnson had promoted its drug Risperdal, FDA approved only for the treatment of schizophrenia, to Omnicare and “its hundreds of consultant pharmacists” as an “active intervention program” for dementia patients.
Using the False Claims Act, the Department of Justice argued that these kickbacks “caused Omnicare to submit false claims to federal health care programs.”