J&J unit Scios pleads guilty to misbranding Natrecor, paying $85 million fine

Scios, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has pleaded guilty tto a misdemeanor violation of the Food, Drug and Cosmetic Act (FDCA) for introducing into interstate commerce its heart failure drug, Natrecor (nesiritide), for a use that was not approved by the Food and Drug Administration the Justice Department announced.

The district court also sentenced Scios to pay an $85 million criminal fine in accordance with the plea agreement between the company and the US government. Sales of Natrecor peaked at $400 million a year, but have since declined to below $100 million.

In 2001, the FDA approved Natrecor for “the intravenous treatment of patients with acutely decompensated congestive heart failure [CHF] who have dyspnea [shortness of breath] at rest or with minimal activity.” The approved labeling for Natrecor did not list any other use, and the drug was not approved by FDA for any other use.