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Sep 3, 2009 11:15 PM | 9
Pfizer executives have again promised to play by the rules after a record-setting $2.3 billion settlement announced Wednesday for fraudulent drug marketing, and the upshot could be a windfall of millions of dollars for state Medicaid programs.
The pharma giant Pfizer agreed to settle the pending lawsuits about wrongful marketing claims for Bextra (an anti-inflammatory), Geodon (an anti-psychotic), Lyrica (an anti-epileptic) and Zyvox (an antibiotic), all of which the company was pushing doctors to prescribe "off label"—for conditions for which the drugs had not been approved. It had also been accused of incentivizing doctors for prescribing these drugs for unapproved uses via kickbacks.
Under the False Claims Act, the encouragement of off label uses—those that the U.S. Food and Drug Administration (FDA) has not okayed—is illegal. Claims for reimbursement through Medicaid for these un-condoned uses were not ultimately accepted, setting off problems for both patients and the government.
"Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by healthcare providers, and costs the government billions of dollars," Tony West, an assistant attorney general for the Civil Division, said at a press conference, the Los Angeles Times reported.
Representatives from Pfizer assert that the company has cleaned up its act, despite having faced similar allegations for fraudulently marketing Neurontin (an anti-epileptic drug) in 2004. "The reasons to trust Pfizer are because…the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner," Amy Schulman, Pfizer's general counsel told The New York Times.
Much of the payout will be going back to the states and into the Medicaid programs. Illinois, for example, should get $11.3 million, much of which will go to its Medicaid program, and $1.3 million of which it will be used help to strengthen consumer protection, reported the Chicago Tribune.
A separate Pfizer settlement yesterday, for questionable marketing of the drug Geodon, will send $33 million to 42 states and the District of Columbia, welcome funds in tight times.
The six whistleblowers who tipped off investigators to the wrongdoing—five Pfizer employees and a doctor—will split $102 million of the settlement.
One of the whistleblowers, John Kopchinski, a former Pfizer sales rep and Gulf War vet said in a statement, "In the Army I was expected to protect people at all costs…At Pfizer I was expected to increase treatments at all costs, even when sales meant endangering lives," Reuters reported.
Image courtesy of Marc Smith via Flickr
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9 Comments
Add CommentOh if you only knew what else was going on within these companies!
Reply | Report Abuse | Link to thisWell 2.3 Billion is just a drop in the bucket compared to what they made by off label marketing. It won't stop them from doing it again in the future.
So, let's see. The off label uses worked. Pfizer didn't force a doctor anywhere to actually prescribe a drug off label, even though they worked off label.
Reply | Report Abuse | Link to thisBut, some bureaucrat decides that off label is BAD, and blam. Instant taxation by litigation AND doctors are now disincentivized from using medication as effectively.
This, people, is a classic example of why government health care will be a disaster.
Oh, these terrible drug companies. They actually have the gall to make money be allieviating human suffering.
Reply | Report Abuse | Link to thisThank God we have the FDA to slow down the approval of lifesaving drugs and devices.
Expendable assets anyone? Good to know that we are looked at as just another drop in the bucket by giant corporations. It is sad that money and greed trump everything else in this country!
Reply | Report Abuse | Link to thisI feel like the lab rat they tested these drugs on.
Reply | Report Abuse | Link to thisYou have a system problem. Until a short time ago a sales rep could not even give the doctor published scientific papers on off label use. I know in some cases a drug has valid off label use but the company has no incentive to do the clinical studies because of cost and the cost recovery time before generics hit the market. Also, even if the doctor has valid medical justification to use a drug off label some insurance companys and goverment programs will not pay for the drug
Reply | Report Abuse | Link to thisI have a poorly understood and uncommon diagnosis and off label uses are pretty much the only thing available to me. I've already lost medications that helped me function on a daily basis and it seems to be getting worse. I was injured serving in the Army and because someone has decided off-label equals evil, I can't get the medication I need to take care of my family. Conveniently the ones they refuse to pay for are the more expensive ones. Even with multiple letters from my doctor I've had no luck in getting the right meds back.
Reply | Report Abuse | Link to thisLyrica is the sucessor to Neurontin which went generic several years ago. Both are widely used effectively, off label, for neuropathic pain. The assertion that either is a danger to the user when used off label is simply wrong. The FDA should look elsewhere to expend its resources although I doubt other defendents will provide so lucrative a settlement. Drug companies can be vilified for many reasons but not this one.
Reply | Report Abuse | Link to thisHow much of that settlement went to legal fees?
Reply | Report Abuse | Link to this