Pfizer Subsidiary Hit With Record Fine For Misbranding Bextra

   By John Letzing 
 

Pfizer Inc. (PFE) subsidiary Pharmacia & Upjohn Co. has been sentenced to pay the largest criminal fine ever imposed in the U.S. for misbranding the pain medication Bextra, the U.S. Justice Department said late Friday.

The Pfizer unit must pay a criminal fine of just under $1.2 billion and a criminal forfeiture of $105 million, the Justice Department said in a statement.

Pfizer previously agreed to pay an additional $1 billion plus interest to settle civil allegations that it "fraudulently promoted and marketed Bextra, as well as three other drugs in its portfolio, Geodon, an anti-psychotic drug, Zyvox, an antibiotic, and Lyrica, and anti-epileptic drug," the Justice Department said.

In addition, Pfizer settled claims that it paid kickbacks to "induce physician prescribing" of the drugs.

Between roughly February 2002 through April 2005, Pharmacia & Upjohn, first in partnership with Pfizer and then as a subsidiary, "promoted the sale of Bextra for some of the very uses and dosages that the FDA had declined to approve," the Justice Department said, adding that the company also promoted Bextra with misleading claims of safety.

Pharmacia & Upjohn had sought approval from the U.S. Food and Drug Administration for uses of Bextra including acute pain, including surgical pain. However, the FDA declined to approve Bextra for those uses, based in part on safety concerns.

Shares of Pfizer fell slightly to $17.75 in late trading.

-By John Letzing; 415-439-6400; [e-mail]