Pfizer Controversy: Why Did The Company Pay The Biggest Fine In History?

Pfizer settled a criminal and civil liability action for the improper advertising of certain medications for $2.3 billion in 2009. It was the biggest payout ever for healthcare fraud. Pfizer settled a criminal and civil liability action over the company’s improper advertising of certain medications for $2.3 billion back in 2009. It was the biggest compensation ever paid out for healthcare fraud. The pharmaceutical company GlaxoSmithKline (GSK) settled criminal and civil charges totaling $3 billion in 2012 for illegally marketing Paxil and Wellbutrin for purposes not permitted by the Food and Drug Administration. Pfizer was hit with the highest criminal fine in history, nevertheless.

Pfizer agreed to pay a criminal fine of $1.195 billion and forfeit an additional $105 million via its subsidiary Pharmacia & Upjohn Company Inc. as part of a settlement in 2009. The amount is remains the highest criminal fine in American history.

Misbranding the anti-inflammatory medicine Bextra and advertising it for applications that the FDA “specifically rejected to authorize owing to safety concerns,” the Department of Justice said, led to the company’s guilty plea on felony counts of violating the Food, Drug, and Cosmetic Act.

In addition, Pfizer paid $1 billion to settle claims under the civil False Claims Act that the corporation fraudulently advertised four drugs: the anti-psychotic medicine Geodon, the antibiotic Zyvox, and the anti-epileptic drug Lyrica. According to the allegations made in the settlement, Pfizer bribed doctors to recommend its medications.

The FDA grants approval for medications for the limited range of purposes listed by the applicant business under the terms of the Food, Drug, and Cosmetic Act of 1938. After the FDA has determined that a medicine is safe and effective for a certain indication, the business may only promote it for that purpose. The FDA considers “off-label” usage to be “misbranded” since they are not authorized by the agency.