Thursday, May 13, 2004

Pfizer Pleads Guilty to Pushing Psychiatric Use of Drugs.

Pfizer Inc. has agreed to plead guilty to charges that its Warner-Lambert flouted federal law by promoting non-approved uses for one of its drugs. Under the agreement to be announced Thursday by the U.S. Attorney's office in Boston, Pfizer, the world's largest pharmaceutical company, has agreed to plead guilty to violating the Food and Drug Cosmetic Act and pay an undisclosed amount to settle the case. Company officials had previously said they were setting aside at least $400 million for the settlement. The Wall Street Journal, citing sources familiar with the matter, reported Thursday that Pfizer will pay about $430 million in fines in one of the largest Medicaid-fraud settlements.

The case began in 1996, when microbiologist David Franklin filed a whistleblower lawsuit against Parke-Davis, and its parent company, Warner-Lambert, alleging the company ignored federal law in the 1990s with an illegal marketing plan used to drive up sales of the anti-seizure drug Neurontin. Pfizer bought Warner-Lambert four years ago. The lawsuit alleged that Parke-Davis adopted a plan to step up publicity about Neurontin's effectiveness for uses that were not approved by the Food and Drug Administration, including 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.

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