Pfizer agrees to $2bn bill for past illicit promotional practices

Pfizer Inc has finalised an agreement with the US Department of Justice (DOJ) to settle outstanding investigations regarding the off-label promotional practices, exposed by John Kopchinski, a Pfizer sales representative in Florida who filed a whistleblower ("qui tam") lawsuit in 2003.

Under the agreement with the DOJ, Pfizer will pay a previously disclosed total of $2.3bn (Euro 1.6bn) - $1.0bn (â"šÂ¬0.699bn) in civil payments related to a number of medicines, and a $1.3bn (â"šÂ¬0.9bn) criminal penalty related only to Bextra. In addition Pfizer subsidiary, Pharmacia & Upjohn Company, Inc., will plead guilty to one criminal count of violating the US Food, Drug, and Cosmetic Act related to its past promotion of Bextra. A portion of the civil payments will be distributed to 49 states and the District of Columbia pursuant to agreements with each state's Medicaid division.

The final agreement resolves other DOJ investigations involving alleged past off-label promotional practices concerning Zyvox, Geodon and Lyrica, allegations related to certain payments to healthcare professionals involving these and nine other Pfizer medicines, and several related qui tam actions.

To resolve these other civil allegations the company will make payments of approximately $301m (e210m) for Geodon, $98m (â"šÂ¬68.5m) for Zyvox, and $50m (â"šÂ¬34.9m) for Lyrica. The settlement also includes a civil payment of approximately $48m (â"šÂ¬33.5m) to resolve allegations relating to certain payments to healthcare professionals involving nine other Pfizer medicines.

Pfizer has denied the allegations that it had marketed medicines for indications or at doses not approved by the FDA, with the exception that Pfizer acknowledges certain improper actions related to the promotion of Zyvox.

Amy Schulman, senior vice president and general counsel of Pfizer said: "These agreements bring final clore to significant legal matters and help to enhance our focus on what we do best - discovering, developing and delivering innovative medicines to treat patients dealing with some of the world's most debilitating diseases.

"We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect from a leading worldwide company dedicated to healing and better health."

As part of the DOJ settlement, Pfizer has entered into a Corporate Integrity Agreement (CIA) with the Office of Inspector General of the US Department of Health and Human Services. The CIA institutes certain new measures and requires Pfizer to maintain a corporate compliance programme for five years.

In addition, Pfizer will disclose publicly its financial relationships with physicians, medical organisations and patient advocacy groups, including investigators who conduct clinical research. It has also committed to reporting payments for conducting Phase I-IV clinical trials in addition to disclosing payments for speaking and consulting.