The person said Monday that under the deal, Johnson & Johnson will retain its ability to sell products to federal health programmes including Medicare, while the agreement will resolve US prosecutors' investigations into the company. According to The Wall Street Journal, the settlement had been delayed by disagreements between federal prosecutors, as well as Johnson & Johnson's efforts to ensure that the wording of the deal protects it from potential lawsuits blaming Risperdal for serious side effects in children. Bloomberg noted that the settlement doesn’t end claims brought by several states, including Louisiana and South Carolina.
US authorities have been probing Risperdal sales practices since 2004, including allegations that Johnson & Johnson marketed the drug for unapproved uses, such as for treating elderly patients with dementia and for children before the FDA first approved paediatric uses in 2006. The source additionally noted that the agreement would settle investigations into the drugmaker's promotion of another schizophrenia drug Invega (paliperidone) and the congestive heart failure therapy Natrecor (nesiritide), as well as end a probe into whether the company awarded kickbacks to Onmicare to increase sales of its products to patients in nursing homes.
The deal follows an agreement by GlaxoSmithKline last year to pay $3 billion in penalties to settle claims, amongst others, that it illegally marketed Avandia (rosiglitazone). In 2009, Pfizer reached a $2.3-billion settlement with the Department of Justice concerning its marketing of Bextra (valdecoxib) and other therapies.(Ver)