Pfizer completes $2.3-billion settlement with US DOJ over marketing practices

Pfizer stated Wednesday that it completed a previously announced $2.3-billion legal settlement with the US Department of Justice (DOJ) regarding past marketing practices involving the COX-2 inhibitor Bextra (valdecoxib) and other drugs. The DOJ indicated that the agreement is the largest healthcare fraud settlement in the department's history.

The settlement resolves other federal investigations into the alleged past off-label promotion of Zyvox (linezolid), Geodon (ziprasidone) and Lyrica (pregabalin), as well as allegations concerning certain payments to physicians involving these and nine other Pfizer drugs, the company said. Pfizer general counsel Amy Schulman commented completion of the settlement brings "final closure to significant legal matters." She added: "We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures."

As part of the agreement, the company noted that it will pay a $1.3-billion criminal penalty related solely to Bextra, and that its subsidiary, Pharmacia & Upjohn, will plead guilty to one criminal count related to the promotion of the drug. The remainder of the $2.3 billion will consist of civil payments, including approximately $503 million to resolve civil allegations concerning past promotional practices related to Bextra, as well as about $301 million for Geodon, $98 million for Zyvox, and $50 million for Lyrica, Pfizer indicated. The company denied all the civil allegations in the lawsuit with the exception of "certain improper actions" related to the promotion of Zyvox.

Also as part of the settlement, Pfizer remarked that it entered into a corporate integrity agreement (CIA) with the US Department of Health and Human Services that institutes certain new measures and requires the drugmaker to continue maintenance of a corporate compliance programme for a period of five years. Under the CIA, Pfizer said it will "engage an independent review organisation that will help the company assess and evaluate its promotional and product-related business functions."

The DOJ explained that whistleblower lawsuits triggered its investigation, and added that "six whistleblowers will receive payments totalling more than $102 million from the federal share of the civil recovery."

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