Johnson & Johnson Pushed Drug for Elderly After FDA Warning

Johnson & Johnson planned to market an antipsychotic drug for unapproved uses just months after the Food and Drug Administration ordered it to stop making false claims, Bloomberg reports.

In its 2000 business plan, Johnson & Johnson and its Ortho-McNeil-Janssen Pharmaceutical unit set a goal of reaching $302 million in sales of the drug Risperdal for dimentia in geriatric patients, even though the drug wasn’t approved for this use. The business plan and related documents are part of a lawsuit filed by the state of Louisiana against the company and were released after Bloomberg filed a motion to have them unsealed.

Bloomberg reports:

Janssen sought to sell Risperdal for bipolar disorder, dementia, mood and anxiety disorders and other unapproved uses, the documents show. Sales exceeded Janssen’s expectations, according to the plans. Though Janssen predicted in 1993 it would take seven years to reach $295 million, U.S. sales hit $343 million in 1995.

Hundreds of Janssen salespeople sold to doctors, nursing homes, Veteran’s Administration facilities and jails, the records show. Marketers gave doctors materials about studies of unapproved uses for Risperdal.

Ten states have sued Johnson & Johnson over Risperdal sales, according to Bloomberg.

Four other pharmaceutical companies have paid a total of $2.5 billion to settle claims in similar cases of off-label marketing of antipsychotic drugs.

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