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Pfizer pleads guilty to promoting drug for off-label use

Compliance Monitor, May 19, 2004

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Pfizer Inc. became an industry example last week when it plead guilty to promoting its anti-seizure drug for off-label use.

On May 13, it agreed to settle criminal and civil charges and pay fines of more than $430 million for charges that its Warner-Lambert unit promoted non-approved uses for Neurontin, according to an Associated Press report.

The settlement includes a $24.6 million payment for whistleblower David Franklin, who filed the original lawsuit in 1996.

Under the agreement released May 13 at a Department of Justice press conference, Pfizer acknowledged Warner-Lambert spent hundreds of thousands of dollars to promote non-approved uses for Neurontin. It said it paid physicians large fees for speaking engagements and flew them to expensive resorts under the guise of educational trips.

According to the office of the Attorney General in California, the settlement requires Warner-Lambert to pay $38 million to resolve deceptive marketing allegations. It will also pay $392 million to resolve federal and state investigations of Medicaid fraud, illegal kickbacks, and submitting false claims to obtain public funds.

The $392 million includes a $240 million fine for violating the Food, Drug and Cosmetic Act. In addition, the company will pay $152 million to the states to settle the Medicaid fraud allegations. The Medicaid fraud portion of the settlement will become final upon approval by the states.

Pfizer also agreed to sign a corporate integrity agreement (CIA) for the monitoring of future marketing practices. To view the CIA, click here.

According to a statement on the Pfizer Web site, "The underlying allegations and related investigations originated in 1996, well before Pfizer's acquisition of Warner-Lambert in 2000. The allegations and conduct pertain solely to Warner-Lambert practices."

To read the press release from the California Attorney General, click here.

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