Pfizer to Pay $2.3 Billion, Undergo Annual Reviews for Off-Label Promotion

Pfizer has agreed to a $2.3 billion settlement — the largest healthcare fraud settlement in Justice Department history — to resolve criminal and civil cases arising from the illegal promotion of several of its drugs. As a result of the investigation, the drugmaker is entering into a five-year corporate integrity agreement with the HHS Office of Inspector General that requires annual reviews of the company’s compliance program. Pharmacia & Upjohn, a Pfizer subsidiary, will plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding the anti-inflammatory drug Bextra (valdecoxib) with the intent to defraud or mislead and will pay $105 million in fines, Justice said in a press briefing Wednesday.
Drug Industry Daily