August 10th, 2011
Johnson & Johnson to Settle Charge Over Drug's Marketing
The New York Times
Johnson & Johnson reached an agreement in principle to settle a misdemeanor criminal charge related to the marketing of its antipsychotic drug Risperdal, the company said in a regulatory filing on Tuesday.
Prosecutors have been investigating the company’s Risperdal sales practices since 2004, including accusations that it marketed the drug for unapproved uses, Johnson & Johnson said in its quarterly filing.
“Discussions have been ongoing in an effort to resolve criminal penalties under the Food, Drug and Cosmetic Act related to the promotion of Risperdal,” Johnson & Johnson said. “Certain issues remain open before a settlement can be finalized.”
The agreement in principle on the criminal charge is on a single misdemeanor violation of the Food, Drug and Cosmetic Act, the company said.
The Justice Department and the United States attorney in Philadelphia “are continuing to pursue both criminal and civil actions,” the company said.
Johnson & Johnson said it had adjusted the accrued amount in the second quarter of 2011 to cover the financial component of the proposed criminal settlement, but did not disclose an amount for the reserve.
The company said it was also in negotiations to settle civil investigations related to the marketing of Risperdal and another drug, Invega. It said it was not sure a settlement could be reached on those claims.