Bristol-Myers Squibb (BMS) will pay $19.5 million to 42 states and Washington, D.C., to settle claims that the company improperly marketed the antipsychotic drug Abilify. The states, including New York, Texas and California, claimed that BMS improperly promoted Abilify for use by children and certain elderly patients and also misrepresented the findings of scientific studies done on the drug, which led to a misrepresentation of the risks Abilify posed to patients, including weight gain. BMS has not marketed the drug since 2013.
The agreement prohibits the drugmaker from promoting Abilify for off-label use, making false or misleading claims about it, paying health care providers for merely attending a promotional event for the drug, using medical education grants to promote the drug and rewarding health care providers with grants based on prescribing habits, among other restrictions. New York Attorney General Eric T. Schneiderman said in a statement:
Drug companies should not market their drug for off-label uses or make claims that are not supported by scientific evidence. Consumers must be able to rely on their doctor’s advice for medication without having to worry about drug companies manipulating their advertising to promote their products at the expense of patients.
The U.S. Food and Drug Administration (FDA) approved the use of Abilify for treating schizophrenic adults in 2002, but has since approved various forms of the drug for other uses, the complaints said. BMS began to market the drug as a schizophrenia treatment in 2002, but also for a number of uses not approved by the FDA, including off-label use by children. The company also promoted Abilify for use by elderly patients with symptoms consistent with dementia and Alzheimer’s disease without first establishing whether the drug was safe or effective in such situations.
In 2006, Abilify received a “black box” warning that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. Texas Attorney General Ken Paxton said in a statement:
BMS put Texans’ lives at risk when it marketed Abilify for uses not approved by the FDA. The integrity of our health care system depends on patients and doctors being able to trust the representations made by pharmaceutical companies.
Each state received hundreds of thousands of dollars, with some getting $1 million or more. Texas will take $1 million from the settlement, while California will take $1.3 million. The eight states that were not part of the case or settlement are Alaska, Idaho, Mississippi, New Mexico, South Carolina, Utah, Virginia and Wyoming. Arkansas Attorney General Leslie Rutledge, in a statement, added these comments:
The deceitful actions by Bristol-Myers Squibb were unlawful and irresponsible. Arkansans needing antipsychotic medications have a level of trust in the companies making these drugs, and unfortunately Bristol-Myers Squibb misrepresented Abilify with their marketing practices.
The investigation underlying the settlement is related to a 2007 civil settlement between BMS and the federal government regarding Abilify and some 2008 civil Medicaid-focused settlements between the company and a number of states. The cases were filed by each state’s attorney general in state court.