Under the agreement, Bristol-Myers Squibb will pay 43 states and the District of Columbia a total of $19.5 million and implement marketing, sales, disclosure and other reforms aimed at avoiding recurrence of the conduct at issue. New Jersey is to receive a total payment of $468,661 under the settlement.

Abilify is an atypical antipsychotic drug approved by the federal Food and Drug Administration (FDA) for treatment of various mental-health-related conditions. It was approved for treatment of schizophrenia in adults in November 2002 and, since then, has been approved for numerous other conditions, including certain bi-polar disorder diagnoses.

A multi-state investigation focused on the drug’s marketing, however, found that Bristol-Myers Squibb improperly promoted Abilify for off-label uses – uses not approved by the FDA. In addition, the investigation found that Bristol-Meyers Squibb made unsubstantiated product claims about Abilify by minimizing and misrepresenting the risks associated with the drug, and improperly incentivized its sales staff to generate off-label prescriptions.

“When it comes to the marketing of prescription drugs, anyone who makes misleading or unfounded statements, minimizes or fails to disclose associated dangers and aggressively promotes a product for unapproved uses is betraying the public trust and, potentially, putting consumers at risk,” said Attorney General Porrino.
 “We are committed to ensuring that drug manufacturers market and promote their products responsibly, and that they do so in accordance with state and federal law,” Porrino said.

The class of drugs to which Abilify belongs – atypical antipsychotics – were first marketed in the 1990s. Upon their introduction, it was believed they might be used as long-term treatment for schizophrenia without posing the same risks as first-generation anti-psychotics. Specifically, experts thought that atypical anti-psychotics would be less likely to produce side-effect movement disorders known as extrapyramidal symptoms or EPS.

However, Abilify can cause EPS, including akathisia (motor restlessness) and a condition known as tardive dyskinesia or TD. In addition, the drug can cause adverse reactions such as stroke in elderly patients with dementia-related psychosis, hyperglycemia and other severe conditions. The packaging for Abilify also contains a “black box warning” referencing possible increased mortality in elderly patients with dementia-related psychosis when taking anti-psychotic drugs.

Under the multi-state settlement announced today, Bristol-Myers Squibb is banned for a period of five years from promoting Abilify for off-label use. The company also is banned for five years from numerous other actions including:

• Compensating health care providers for merely attending a promotional activity for Abilify

• Rewarding health care providers with grants based on their prescribing habits

• Allowing non-scientifically trained company personnel to offer opinions about, or to summarize, off-label information

• Using medical education grants – including Continuing Medical Education (CME) grants – or any other type of grant to promote Abilify

• Providing samples of Abilify to health care providers whose clinical practices are inconsistent with Abilify’s FDA-approved label

Among actions required by Bristol-Myers Squibb under the settlement, the company must disclose Abilify’s risks-related boxed warning in all promotional materials. It also must have systems and controls in place to ensure that financial incentives do not spur the improper promotion, sales and marketing – including off-label promotion – of Abilify.

The agreement also requires that Bristol-Myers Squibb:

• Refrain from making unsubstantiated safety or efficacy comparisons between Abilify and another product

• Present risk information concerning Abilify clearly and conspicuously when promoting the drug

• Disclose payments to speakers and consultants related to Abilify

• Review and modify, if necessary, the call plans of company sales and marketing personnel who promote Abilify to ensure that they promote the drug only for FDA-approved uses

• Create and maintain records concerning unsolicited requests for off-label information about Abilify, as well as information provided to the requestor

In addition to adult schizophrenia, Abilify has been approved by the FDA for use in treating other conditions including schizophrenia in adolescents (ages 13-to-17) and acute treatment of manic and mixed episodes associated with Bipolar I Disorder in both adults and pediatric patients (ages 10-to-17.) The drug also has been approved for treatment of Tourette’s syndrome and irritability associated with autistic disorder in pediatric patients.

The multi-state investigation – approved by 43 participating states and the District of Columbia and carried out by an executive committee of 10 states -- began in 2009 and involved the review of thousands of documents, as well as interviews with former Bristol-Myers Squibb sales personnel.

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