Pfizer fined $2.3 billion for illegal marketing in off-label drug case

September 30, 2009

http://www.usatoday.com/money/industries/health/2009-09-02-pfizer-fine_N.htm?csp=34

By Rita Rubin, USA TODAY

In the largest health care fraud settlement in history, pharmaceutical giant Pfizer must pay $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra, the U.S. Department of Justice announced Wednesday.

Besides Bextra, the drugs were Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug. Once the Food and Drug Administration approves drugs, doctors can prescribe them off-label for any use, but makers can't market them for anything other than approved uses.

Pfizer subsidiary Pharmacia & Upjohn pleaded guilty to a felony violation for promoting off-label uses of Bextra, such as for pain relief after knee replacement surgery. At the FDA's request, Pfizer pulled Bextra off the market in April 2005 because its risks, including a rare, sometimes fatal, skin reaction, outweighed its benefits. It had been approved only for treating rheumatoid arthritis, osteoarthritis and menstrual pain.

As part of the settlement, Pfizer (PFE) will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the USA for any matter, according to the Justice Department. Pharmacia & Upjohn must pay a $105 million criminal fine.

Pfizer also has agreed to pay $1 billion in civil damages and penalties to compensate federal health-care programs for false claims submitted as a result of its marketing Bextra and the other four drugs for off-label use or at unapproved dosages.