Pfizer to plead guilty to settle illegal drug marketing case

Thursday, May 13th 2004, 8:57 am

By: News On 6

BOSTON (AP) _ Pfizer Inc. has agreed to plead guilty to charges that its Warner-Lambert division flouted federal law by promoting non-approved uses for one of its drugs, a source familiar with the deal told The Associated Press.

Under the agreement to be announced Thursday by the U.S. Attorney's office in Boston, Pfizer will plead guilty to violating the Food and Drug Cosmetic Act and pay an undisclosed amount to settle the case, said the source, who spoke on condition of anonymity.

Officials for Pfizer, the world's largest pharmaceutical company, had previously said they were setting aside at least $400 million for the settlement. The Wall Street Journal reported that Pfizer will pay about $430 million in fines, citing sources familiar with the matter.

A spokeswoman for the U.S. Attorney's office declined to comment on the settlement.

The case began in 1996, when Dr. David Franklin filed a whistleblower lawsuit against Parke-Davis and its parent company Warner-Lambert, alleging it used an illegal marketing plan to drive up sales of the anti-seizure drug Neurontin in the 1990s. Pfizer bought Warner-Lambert four years ago.

The lawsuit alleged that while Neurontin was approved only as an epilepsy drug, the company promoted it for relieving pain, headaches, bipolar disorder and other psychiatric illnesses.

While doctors can prescribe drugs for any use, the promotion of drugs for these so-called ``off-label uses'' is prohibited by the Food and Drug Cosmetic Act.

Last May, federal prosecutors in Boston filed a brief in support of Franklin's lawsuit, and have since been in settlement negotiations with Pfizer to recover money the Medicaid program spent on Neurontin.

The whistleblower lawsuit alleged that the company's publicity plan for Neurontin included paying doctors to put their names on ghostwritten articles about Neurontin and to fly them to lavish resorts as ``educational'' trips. He said the company also paid doctors hefty speakers' fees as part of its promotion.

One doctor received almost $308,000 to speak at conferences about the drug.

Neurontin's sales soared from $97.5 million in 1995 to nearly $2.7 billion in 2003.