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U.S. joins FCA suit against drug company accused of off-label marketing

By Phillips & Cohen LLP

The U.S. Dept. of Justice announced that it has joined two whistleblower suits against drug manufacturer Scios Inc. and its parent company, Johnson & Johnson Inc. The suits, brought under the qui tam provisions of the False Claims Act, allege that the companies engaged in off-label marketing of the drug Natrecor.

Drug manufacturers are required to specify the intended use of a drug in their application for approval from the Food and Drug Administration. They are prohibited from promoting the use of the drug for other purposes.

Medicare does not cover drugs used for off-label uses unless such off-label use is established to be medically necessary. The suit alleges that the federal health care programs paid substantial amounts for the off-label use of Natrecor.

Full post as published by False Claims Act - Qui Tam on February 19, 2009 (boomark / email).