Federal prosecutors have slapped Pfizer with the largest criminal fine in U.S. history. This is part of a $2.3 billion settlement in fines for the illegal promotions of drugs that have influenced doctors with free golf, massages and resort gatherings.
The pharmaceuticals giant is pleading guilty to promoting its withdrawn arthritis painkiller Bextra to doctors for unapproved uses and is paying to settle other claims over its marketing of nine other drugs. Bextra, which was withdrawn in 2005 after being linked to an increased risk of heart attacks and strokes, was among several drugs Pfizer promoted to doctors for unapproved uses.
The government said Pfizer also paid kickbacks to market a host of well-known drugs that include: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec.
It signals that the Department of Justice plans to come down hard on firms as it seeks to claw back money to reduce the cost of the U.S. state-run health insurance schemes Medicare and Medicaid.
Claims have also been settled that were inappropriate payments made to doctors. As part of the settlement Pfizer will submit to a five-year compliance regime overseen by the U.S. government.
Regulators such as the Food and Drug Administration in the U.S. carefully set out what claims can be made for every drug and control the exact wording of the drug’s label. Companies promoting products for unapproved uses face large fines. However, doctors can prescribe drugs whenever they think they may be effective, even if the precise use has not been officially sanctioned.
This “off-label” use can be a big contributor to drug-company revenue, particularly from recently launched products.
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