NEW YORK, Aug 10 (Reuters) - Johnson & Johnson (JNJ.N) said it reached an agreement related to a misdemeanor charge stemming from a federal investigation into the marketing of its Risperdal schizophrenia treatment, although some issues remain unresolved.
In its quarterly securities filing, J&J said that discussions have been ongoing to resolve criminal penalties related to the promotion of Risperdal, a onetime big-selling product for the company.
“An agreement in principal on key issues relevant to a disposition of criminal charges pursuant to a single misdemeanor violation of the Food Drug and Cosmetic Act has been reached, but certain issues remain open before a settlement can be finalized,” J&J said in the filing.
J&J said it had adjusted the amount accrued in the second quarter to cover the financial component of the proposed criminal settlement.
The U.S. government also plans to intervene in whistle-blower suits alleging “off-label” promotion of Risperdal and file a superseding complaint, J&J said in the filing. Off-label promotion refers to marketing of a drug outside of its approved uses. (Reporting by Lewis Krauskopf, editing by Gerald E. McCormick)