NEW YORK (AdAge.com) -- Pharmaceutical giant Pfizer agreed today to pay $2.3 billion to settle the largest fraudulent-health-care-marketing case in the history of the Department of Justice.
The settlement stems from government charges that Pfizer falsely marketed and promoted four of its drugs -- pain medication Bextra, anti-epilepsy drug Lyrica, infection drug Zyvox and schizophrenia medication Geodon. It also alleged that Pfizer paid kickback money to physicians to prescribe nine of the drug company's other medications.
The government accused Pfizer of marketing Bextra off label for several uses and dosages that the U.S. Food and Drug Administration declined to approve for safety reasons. It charged that from 2002 through April 2005, Pfizer used false and misleading claims of safety and efficacy to promote Bextra for unapproved uses and for dosages above the approved level.
Pfizer unit Pharmacia & Upjohn, which manufactured Bextra until it was pulled from the market by Pfizer in 2005, agreed to plead guilty to one criminal count of violating the U.S. Food, Drug and Cosmetic Act for misbranding the pain reliever.
The resolution includes $1.3 billion in criminal fines and forfeiture -- the largest fine ever imposed in a U.S. criminal prosecution -- and $1 billion in combined federal and state civil False Claims Act settlements. The federal share of the civil settlement is $668,514,830, and the state Medicaid share is $331,485,170.
'Corporate integrity' a priority
In a statement, New York-based Pfizer said: "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 so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect from a leading worldwide company dedicated to healing and better health. ... Corporate integrity is an absolute priority for Pfizer, and we will continue to take appropriate actions to further enhance our compliance practices and strengthen public trust in our company."
The Justice Department said Pfizer's marketing team positioned Bextra for acute pain, surgical pain and other unapproved uses; created sales materials and messages to promote Bextra for those uses; and commissioned market research to test its sales materials and confirmed those unapproved messages.
In the civil portion of the case, the government said Pfizer violated the federal False Claims Act by making claims that led to purchases by Medicare and other federal health-care programs. That was done by touting Bextra, Geodon, Zyvox and Lyrica for uses not approved by the FDA; making and disseminating "unsubstantiated and false representations" about the safety and efficacy of Bextra, Geodon, Zyvox and Lyrica; and paying kickbacks, it said, to health-care providers to induce them to prescribe the four drugs. It also charged the company with paying kickbacks to goose prescriptions of nine other drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec.
"This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare," said Tony West, assistant attorney general for the civil division of the Department of Justice, in a statement released by the department.
"When manufacturers undermine the FDA's rules, they interfere with a doctor's judgment and can put patient health at risk," said Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. "The public trusts companies to market their drugs for uses that the FDA has approved and trusts that doctors are using independent judgment."