By Peter Marcus, DENVER DAILY NEWS
Colorado scored $3.5 million after drug giant Pfizer Inc plead guilty to a criminal charge related to promotion of a now-withdrawn pain medicine and several other drugs.
The total multi-state settlement was for more than $2.3 billion, including a $1.3 billion criminal fine and a $1 billion civil payment.
The world’s largest drugmaker plead guilty to charges related to its pitching Bextra and 12 other medicines to patients and doctors for unapproved uses.
“These settlements are a significant recovery for the State of Colorado,” said Colorado Attorney General John Suthers. “These settlements underline that Colorado and its peer states will not tolerate off-label marketing schemes that place a drain on the heath care our states provide for the neediest of our residents and expose patients to potentially serious side effects from drugs that are not being prescribed as approved.”
The settlement makes Pfizer a repeat offender after in 2004 the drug giant plead guilty to an earlier criminal charge of improper sales tactics and practices.
Colorado will receive the $3.5 million as part of two settlements — $2.8 million as part of the $1 billion Medicaid multi-state settlement and $705,000 as part of a $33 million non-Medicaid multi-state settlement.
Pfizer promoted Bextra for unapproved medical conditions and dosages, and promoted the drug Geodon for pediatric and adolescent patients for whom the FDA had only approved the drug for the treatment of schizophrenia and manic or mixed episodes of bipolar disorder in adults, to name a couple of the details of the settlement.
The federal settlement includes a $1.3 billion criminal fine related to methods of selling Bextra, which was withdrawn from the market in 2005 over safety concerns. Pfizer acquired Bextra in its 2003 purchase of Pharmacia Corp.
The two companies used advisory boards, consultant meetings and provided travel to lavish resorts to improperly promote Bextra to doctors and made misleading claims about the drug’s safety and efficacy, the federal government said. The companies also paid kickbacks to persuade doctors to prescribe the drugs.
“We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls,” Amy Schulman, Pfizer’s general counsel, said in a prepared statement.
The settlement marks the largest Medicaid pharmaceutical settlement in history, topping the $1.42 billion Eli Lilly and Co settlement earlier this year for off-label sales of its Zyprexa schizophrenia drug.
Pfizer said it will pay $503 million to resolve practices involving Bextra, $301 million related to its schizophrenia drug Geodon, $98 million for Zyvox and about $50 million for its blockbuster Lyrica used to treat nerve pain and seizures.
The $33 million non-Medicaid settlement is in addition to the $2.3 billion federal fine; it aims to resolve state civil consumer fraud allegations with 42 states and the District of Columbia related to promotions of Geodon.
Six whistleblowers will be rewarded with more than $102 million under the False Claims Act. John Kopchinski, a former sales representative who exposed Pfizer’s Bextra marketing tactics, will be paid more than $51.5 million.
Pfizer will be required to adhere to five more years of the government’s compliance program as a result of the plea. Due to the 2004 case, the drug giant has already been under federal supervision for the past five years.
The company will be required to post on its Web site information about payments to doctors such as travel, and set up a system for doctors to report questionable conduct by Pfizer’s representatives.
Pfizer shares fell 10 cents, or 0.6 percent, to close at $16.28 on the New York Stock Exchange.
Distributed by Colorado Capitol Reporters