Pfizer Inc. formally pleaded guilty in Boston yesterday to charges that its Warner-Lambert subsidiary violated federal law by promoting unapproved uses for one of its drugs.
As part of a settlement with the government, Pfizer agreed last month to plead guilty to two counts of violating the Food, Drug and Cosmetic Act and to pay $430 million in fines.
Pfizer acknowledged Warner-Lambert, a company that it bought in 2000, spent hundreds of thousands of dollars to promote off-label uses for the anti-seizure drug Neurontin.
Martin Teicher, vice president of Warner-Lambert Co., entered the guilty plea. James P. Rouhandeh, an attorney for the company, noted that Teicher had no involvement in any of the illegal marketing activities.
Pfizer has repeatedly said that the activity alleged in a whistleblower's lawsuit and charged by prosecutors occurred years before it bought Warner-Lambert. The case began in 1996, when employee David Franklin sued Parke-Davis and its parent, Warner-Lambert, alleging it used an illegal marketing plan to drive up sales of Neurontin in the 1990s. At the time, Neurontin was approved only as an epilepsy drug, but 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.
Franklin's suit alleged the publicity plan included paying doctors to put their names on ghostwritten articles about Neurontin.