Late last year, Bristol-Myers Squibb (BMS) settled with the government to resolve allegations that spanned several states that it improperly promoted a schizophrenia treatment for uses not approved by the United States Food and Drug Administration (FDA).
The agreement, with a whopping forty-two states (including California, New York, and Texas) and the District of Columbia, focuses on charges that BMS promoted Abilify (an anti-psychotic drug) for use in children and elderly patients with dementia and Alzheimer’s disease. The FDA approved Abilify in 2002 for treating schizophrenic adults. Since then, it has since approved various forms of the drug for other uses. When the alleged improper marketing occurred, such uses were not approved by the FDA. In 2006, Abilify received a “black box” warning stating that it could increase the risk of death for dementia patients.
The states further alleged that BMS misrepresented risks that the drug posed to patients, such as weight gain and metabolic side effects, violating consumer protection laws.
The agreement prohibits BMS 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.
“Drug companies should not market their drug for off-label uses or make claims that are not supported by scientific evidence,” New York Attorney General Eric T. Schneiderman said. “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.”
“We allege that Bristol-Myers Squibb improperly marketed this drug to encourage prescriptions to children and seniors and misled the public about its safety for those populations,” said Massachusetts Attorney General Maura Healey. “Companies cannot use deceptive practices and unfair marketing to increase their sales at the expense of patients’ health and well-being.”
The settlement allows each state to receive hundreds of thousands of dollars, with some getting over $1 million. For example, New York will receive $788,774, Texas will rake in $1 million from the settlement and California will come away with $1.3 million. The only eight states that were not part of the settlement, and therefore will receive no part of the settlement funds, were Alaska, Idaho, Mississippi, New Mexico, South Carolina, Utah, Virginia, and Wyoming.
The settlement will finally lay to rest over a decade of allegations about Abilify marketing. In 2015, a United States judge tossed federal court claims that BMS and its Abilify partner, Otsuka, paid kickbacks to boost prescriptions of the drug. Similar to this state settlement, that whistleblower suit cited promotions to pediatric psychiatrists as evidence of off-label marketing. At the time, the judge allowed the whistleblowers to pursue claims that BMS fired them to retaliate for their off-label accusations.
This settlement follows a 2007 settlement at the federal level, where the company agreed to pay $515 million to settle an off-label investigation involving Abilify, along with other drugs.
BMS notes that it has not marketed the drug since 2013 and did not admit to any wrongdoing and denied all allegations against it.