SAN FRANCISCO – California Attorney General Kamala D. Harris today announced that California, along with 42 other states and the District of Columbia, has reached a $19.5 million agreement with biopharmaceutical company Bristol-Myers Squibb over allegations that the company illegally marketed the popular atypical antipsychotic drug Abilify. Attorney General Harris secured $1.3 million of the overall settlement for California.
In 2009, California and other states launched a multistate consumer protection investigation of Otsuka America Pharmaceutical, Inc., which manufactures Abilify, and Bristol-Myers Squibb, which is largely responsible for promoting Abilify. The states’ investigation found that Bristol-Myers Squibb engaged in off-label marketing by illegally promoting Abilify for therapeutic uses for which it was not approved, such as certain pediatric uses and to treat dementia. In addition to incentivizing sales representatives to engage in off-label marketing, the investigation found that the company misled doctors and patients about the drug’s risks and side effects and misrepresented the findings of scientific studies concerning the drug in marketing messages.
“These companies endangered and compromised the health and well-being of millions of Americans in order to turn a profit,” said Attorney General Harris. “This settlement makes clear that pharmaceutical companies using deceptive and unlawful tactics to promote drugs will not be tolerated in the United States.”
Abilify is approved by the Food and Drug Administration to treat schizophrenia, bipolar disorder, major depressive disorder, and Tourette’s disorder. Abilify, known as a blockbuster drug because of its popularity, generated $5.5 billion in sales in 2014, with Bristol-Myers Squibb receiving approximately $2.02 billion of that amount.
The settlement places strict rules on how Bristol-Myers Squibb can promote and market Abilify going forward, including prohibiting the company from promoting the drug for off-label uses, compensating health care providers for promotional activities without disclosing their connection to the company, using medical grants to promote the drug, and making unsubstantiated safety or efficacy comparisons between Abilify and other products.
In addition, under the terms of the agreement, Bristol-Myers Squibb must provide only accurate and scientifically balanced information about Abilify, conspicuously disclose risks, and take clear steps to ensure it is not creating financial incentives for promotion, sales, and marketing that would violate the law.
Attorney General Kamala D. Harris has a longstanding record of prosecuting illegal and deceptive marketing and sales of prescription drugs.
In September 2016, Attorney General Kamala Harris and 35 other Attorneys General filed a lawsuit against Indivior, a British pharmaceutical company, and MonoSolRX, an Indiana pharmaceutical film technology company, for engaging in a “product-hopping” scheme to block competition to Suboxone, an opioid addiction treatment, ultimately generating almost one billion dollars in undeserved profits.
In May 2016, Attorney General Harris filed a lawsuit against Johnson & Johnson for false advertising and deceptive marketing of its surgical mesh products for women, alleging that the company neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks.
Last year, Attorney General Harris along 48 other states and the District of Columbia reached a $71 million settlement with the pharmaceutical company Amgen Inc. to resolve allegations that Amgen unlawfully promoted biologic medications Aranesp and Enbrel. California received $4.6 million from the settlement. The consent judgment required Amgen to reform its marketing and promotional practices and refrain from making deceptive or misleading claims in promoting Enbrel or any drug in the same class as Aranesp.
Attorney General Harris has also been a leader in challenging reverse payment agreements by which a branded drug company pays its rivals to not compete, which allows it to wrongfully inflate drug prices. Along with the FTC, the State of California filed the action that resulted in the U.S. Supreme Court decision in FTC v. Actavis finding that such agreements could be anticompetitive. Attorney General Harris has also authored numerous amicus briefs attacking this practice, which costs consumers billions of dollars and increases drug prices.
In addition, Attorney General Kamala Harris has worked to protect Californians’ access to high-quality, affordable health care, including reproductive health care and has defended the constitutionality of the Affordable Care Act, joining a friend-of-the-court brief in Thomas More Law Center v. Obama and repeatedly speaking out in support of health care reform.