Attorney General complaints from more than 42 states led Bristol-Myers Squibb to be found guilty of off-label marketing for its best-selling antipsychotic Abilify, a multifaceted treatment for depression and bipolar disorder. The Abilify settlement requires the pharmaceutical giant to pay $19.5 million in damages.
Courts discovered the company illegally promoted Abilify for unapproved uses and minimized the drug’s risks, resulting in the massive multistate settlement.
Off-Label Marketing
After a decade of violation claims, Abilify’s manufacturers were found guilty of misrepresenting clinical data and illegally promoting the drug to pediatric and elderly patients.
In 2006, the Food and Drug Administration (FDA) released a report illustrating that Abilify could be fatal for older patients with dementia-related psychosis. Regardless of the data, Bristol-Myers Squibb prompted the prescription of Abilify to elderly patients with dementia and Alzheimer’s.
Bristol-Myers Squibb also promoted the drug to children for unapproved uses. Abilify has not been proven safe or effective for children with schizophrenia, bipolar I disorder, Tourette’s disorder, or irritability associated with autistic disorder.
Though Bristol-Myers Squibb hired Otsuka Pharmaceuticals to spearhead marketing efforts in 2012, the company is held responsible for failing to stop the illegal promotion. Representatives for the corporation deny any wrongdoing.
Multistate Abilify Settlement
The Abilify settlement puts limitations on the company’s future claim-based and financial marketing incentives involving Abilify. For five years, Bristol-Myers Squibb is banned from:
- Compensating physicians for attending Abilify promotions
- Providing research grants for physicians who prescribe Abilify
- Accepting information on off-label marketing from untrained employees
- Giving Abilify samples to physicians who treat other unapproved illness
The Abilify settlement includes 42 states, as well as the District of Columbia. The state of New Jersey will receive an award of $468,661, where the company owns six offices. Delaware’s consumer protection fund will receive $389,677, Nevada is expected to receive nearly $300,000 and Michigan has been awarded $497,151. Other states involved in the settlement include California, Arizona, Colorado and Florida.
"We are committed to ensuring that drug manufacturers market and promote their products responsibly," New Jersey Attorney General Christopher Porrino said in a statement.
Abilify’s Risks
Abilify, also known as aripiprazole, was approved by the FDA in 2002 to treat adult schizophrenia. The FDA later expanded the drug’s uses, approving it for bipolar disorder and depression.
Bristol-Myers Squibb reportedly made millions off Abilify, which quickly became a best-selling atypical antipsychotic. The drug was believed to have fewer side effects than comparatively older generation antipsychotics. In 2013, the drug made $6.4 billion alone, according to Medscape.
In May, the FDA issued another safety alert, informing doctors that Abilify can cause uncontrollable compulsions. The drug had been linked to pathological impulse issues with gambling, eating, shopping, and having sex.