United States Joins Suits Against Scios and Johnson & Johnson

WASHINGTON – The United States has intervened in two whistleblower suits filed in the Northern District of Californiaagainst the drug manufacturer Scios Inc. and its parent company, Johnson & Johnson Inc., alleging that the companies marketed the cardiac drug Natrecor for a use not approved by the Food and Drug Administration (FDA) and caused false and fraudulent claims to be submitted to the federal health care programs, the Justice Department announced today. Such an unapproved use is also known as an "off-label" use because it is not included in the drug’s FDA approved product label. Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and