Drug company to pay $45 million for misbranding AIDS drug
NEWS IN BRIEF — Posted March 18, 2013
New Jersey-based Par Pharmaceutical Companies Inc. has pleaded guilty in federal court for promoting prescription drug Megace ES for uses unapproved by the Food and Drug Administration. As part of the plea agreement, the company agreed to pay the government $45 million to resolve its criminal and civil liability, according to the Dept. of Justice.
Par CEO Paul V. Campanelli pleaded guilty March 5 to criminal misdemeanor misbranding. The company was accused of promoting Megace ES (megestrol acetate), a drug approved to treat weight loss in AIDS patient, for non-AIDS-related geriatric wasting. The drug’s labeling lacked adequate directions for treating this condition, the Justice Dept. said.
In addition to the criminal and civil resolutions, Par agreed to enter into a five-year corporate integrity agreement with the Dept. of Health and Human Services’s Office of Inspector General that requires enhanced accountability, increased transparency, and wide-ranging monitoring activities conducted by internal and independent external reviewers.