Pfizer to Plead Guilty to Illegal Marketing

Pfizer Inc. agreed to pay $430 million and plead guilty to criminal charges for illegally marketing an epilepsy drug for unapproved uses, U.S. prosecutors said Thursday.

The company’s Warner-Lambert division promoted the drug, Neurontin, for uses it had no scientific evidence to support and even in cases when the drug was shown to be ineffective, prosecutors said.

For example, the company promoted Neurontin for treating bipolar disorder, even though a study showed that a placebo worked as well as or better than the drug for the manic-depressive illness.

“Warner-Lambert’s promotional efforts were a highly organized and deliberate attempt to circumvent federal restrictions on marketing,” Associate Atty. Gen. Robert McCallum said.

The $240-million criminal portion of Pfizer’s payment is the second-largest criminal fine for a healthcare fraud case, McCallum said. In 2001, TAP Pharmaceuticals, a venture of Abbott Laboratories Inc. and Takeda Chemical Industries Ltd. agreed to pay $290 million over charges it illegally marketed a prostate cancer drug.

Pfizer will pay the rest of the $430 million in civil fines to be shared by state and federal agencies.

The Justice Department and the attorneys general of all 50 states agreed to the Neurontin settlement with Pfizer.

The case originated from a lawsuit filed in late 1996 by whistle-blower David Franklin, who had worked for Warner-Lambert before it was acquired by Pfizer in 2000.

Franklin said the company used a variety of schemes to illegally pump up sales of Neurontin, which remains one of Pfizer’s biggest sellers, with 2003 sales of $2.7 billion.

Under federal regulations, companies may market and promote drugs only for uses approved by the Food and Drug Administration, although doctors can prescribe drugs to treat other illnesses.

Pharmaceutical companies have been increasingly scrutinized by regulators for “off-label” marketing.

Pfizer said “the allegations and conduct pertain solely to Warner-Lambert practices” before it was acquired by Pfizer.

Pfizer shares fell 31 cents Thursday to $35.40 on the New York Stock Exchange.