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Pfizer Fined Record Civil Penalties over Off Label Marketing of Drugs

The world’s largest pharmaceutical company, Pfizer Inc., has agreed to pay record civil and criminal penalties amounting to $2.3 billion, over allegations that it promoted four of its medications for off label purposes.

The penalties were announced by the Justice Department this week. The penalties include $1.2 billion in criminal fines, which is the largest criminal fine in US history, as well as a criminal forfeiture of $105 million. The total penalties are the largest paid by a drug maker for violations of federal rules. The allegations against Pfizer are that the company promoted four prescription drugs for purposes not approved by the Food and Drug Administration. The four drugs include the painkiller Bextra, the anti psychotic Geoden, antibiotic Zyvox and anti epileptic Lyrica.

Under the terms of the settlement, the company will pay $1 billion to compensate federal healthcare programs, like Medicare and Medicaid. According to authorities, Pfizer representatives created fake doctor requests for medical information in order to able to send unsolicited information to physicians about unapproved uses of these drugs. According to New York attorney general Andrew Cuomo, the company aggressively marketed these four drugs for off label uses. Doctors were sent on exotic holidays, and were wooed with gifts to goad them into prescribing the drugs for purposes not approved by the FDA, for patients covered by federal healthcare programs like Medicare.

Doctors are not prohibited from prescribing a drug for off label purposes. In fact, doctors often make use of medical research to prescribe medications for purposes that have not received approval from the Food and Drug Administration. However, pharmaceutical companies are not allowed to market these drugs for off label uses. When the Food and Drug Administration approves a drug, it does so after evaluating the benefits and risks from a particular drug. The drugs are tested and evaluated under various health conditions, before being approved. A drug may be useful for other purposes that have not been approved by the FDA. However, in these cases, the agency has not evaluated the risks of the drug, verses the benefits. Therefore, patients who take the drug may be exposed to side effects and dangerous reactions, because the drug has not been evaluated and approved for this condition.

However, as California personal injury lawyers often see, that doesn’t stop pharmaceutical companies from continuing to push doctors and physicians to prescribe drugs for conditions not approved by the FDA. The more number of conditions a particular drug can be prescribed for, the higher profits. Over the past few years, several companies have been punished for their aggressive promotion of unapproved drugs. This year, Eli Lilly was also fined hefty penalties, for aggressive off labeling marketing of Zyprexa. That drug was not approved for people with dementia and other age-related mental illnesses, but Eli Lilly representatives went ahead and pushed physicians to prescribe the drug for dementia and depression patients.  The drug increased the risk of death in patients who took Zyprexa, compared to those who didn’t.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of pharmaceutical liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

The Reeves Law Group is not acting as legal counsel for any party in the matters discussed in this posting.

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