WASHINGTON, D. C. – Attorney General Karl A. Racine announced today that the District and 42 states have reached a $19.5 million settlement with Bristol Myers Squibb Company to resolve allegations that the drug maker misled consumers and doctors about the antipsychotic drug Abilify and improperly marketed it for uses not approved by the Food and Drug Administration (FDA). The District, along with nine states, led this investigation and is set to receive $386,425.00 of the total settlement.
“Ensuring that drug companies follow the law is vitally important to protecting the health and safety of all Americans,” said Attorney General Racine. “Any company that misleads consumers should be held accountable, but this is especially true here, where wrongdoing including deceptive and unlawful marketing practices put District residents at risk.”
Abilify is the brand name for the drug aripiprazole, which was originally approved by the FDA for the treatment of schizophrenia in 2002 and has since been approved for several additional uses. However, the complaint filed by Attorney General Racine in D.C. Superior Court today alleges that Bristol Myers Squibb promoted Abilify for uses for children and for elderly patients with symptoms of dementia and Alzheimer’s disease -- despite a lack of FDA approval for these uses. Bristol Myers Squibb also allegedly made false and misleading representations of Abilify’s risks, including of metabolic and weight-gain side effects.
- Requires Bristol Myers Squibb to modify its marketing practices;
- Prohibits the company from making any false, misleading or deceptive claims in promoting Abilify or related drugs;
- Prohibits Bristol Myers Squibb from making any claim about the safety or efficacy of an atypical antipsychotic drug compared to other drugs when claims are unsupported by evidence;
- Prohibits the company from promoting this type of drug for any off-label use;
- Limits financial incentives the drug company can offer to sales representatives and healthcare providers;
- Prohibits the dissemination of information that may promote off-label use of Abilify; and,
- Bars Bristol Myers Squibb from other practices affecting off-label promotion of its products.
The settlement must still be approved by the D.C. Superior Court.
Consumers with complaints about pharmaceuticals or other consumer products should alert the Office of the Attorney General’s Consumer Protection Hotline at (202) 442-9828, send an e-mail to firstname.lastname@example.org, or submit an online complaint on OAG’s website.