Feds Bring Subpoena on Bristol Myers Regarding Marketing for Abilify

Feds Bring Subpoena on Bristol Myers Regarding Marketing for Abilify

February 21st, 2012 // 1:31 pm @

Source: Pharmalot

In September 2007, Bristol-Myers Squibb agreed to settle charges of giving kickbacks to docs and overcharging the government. Among the infractions alleged by the federal and state governments was off-label promotion of its Abilify antipsychotic, and the drugmaker subsequently paid $515 million and signed a five-year corporate integrity agreement.

Could there have been a violation? Clearly, the feds have renewed their attention. Last month, the US Attorney in New York issued a subpoena to the drugmaker “requesting information related to, among other things, the sales and marketing of Abilify,” according to a filing with the US Securities and Exchange Commission (see page 102). Bristol-Myers says the impact is not possible to determine.

At the time of the settlement, Bristol-Myers was charged with directed its sales force to call on child psychiatrists and other pediatric specialists, and reps then urged physicians and other health care providers to prescribe Abilify for children. The drugmaker also was charged with creating a specialized long=term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder (back story and the CIA).

This is not the first time that Bristol-Myers has generated scrutiny since signing the CIA. As the drugmaker also noted in its SEC filing, the Delaware Attorney General wrote a letter in March 2009 to say that a multi-state coalition was investigating whether certain Abilify marketing practices violated consumer protection statutes in various states.

Abilify, by the way, is the second-biggest selling drug in the Bristol-Myers portfolio. Last year, the antipsychotic generated nearly $2.8 billion in sales, or roughly 13 percent of net sales. The only medicine to generate more revenue for the drugmaker was the Plavix bloodthinner, which rang up nearly $7.1 billion in sales.


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