Pfizer has agreed to plead guilty to a U.S. criminal charge relating to promotion of Bextra, a pain medicine that is now withdrawn from the market. The company will pay $2.3 billion to settle the allegations that it improperly marketed Bextra and 12 other medicines.

According to the U.S. Department of Justice, Pfizer’s marketing team promoted Bextra for acute pain, surgical pain and other unapproved uses, while its salesforce promoted the drug directly to doctors for those unapproved uses and dosages.

The settlement includes a $1.3 billion criminal fine related to methods of selling Bextra, which was withdrawn from the market in 2005 for safety concerns. Pfizer acquired Bextra with the buyout of Pharmacia in 2003. The settlement also includes $1 billion in civil payments related to “off-label” sales of drugs and payments to healthcare professionals. Pfizer denied all of the civil allegations, except for acknowledging improper promotions of the antibiotic Zyvox. The company announced in January that it set aside $2.3 billion to resolve allegations involving Bextra and other drugs, but did not provide further details at the time.

Pfizer said it will pay $503 million to resolve practices involving Bextra, $301 million related to its schizophrenia drug Geodon, $98 million for Zyvox and $50 million for Lyrica used to treat nerve pain and seizures.

“We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls,” said Amy Schulman, Pfizer’s general counsel. Under the new settlement, Pfizer must adhere to a specified compliance program for five more years.

The settlement is the largest to date for improper marketing of prescription drugs, Earlier this year, Eli Lilly and Co. agreed to pay $1.42 billion for off-label sales of its schizophrenia drug Zyprexa

Six whistleblowers, including John Kopchinski, a former sales representative who exposed Pfizer’s Bextra marketing tactics, sparking the government probes, will be rewarded with more than $102 million under the False Claims Act. Mr. Kopchinski’s share was expected to be more than $51.5 million.

Sign up today for Contracting & Outsourcing 2009!
contractpharma.com/2009conference