The U.S. Department of Justice levied the largest criminal fine in U.S. history against Pfizer after accusing the drug company of such things as creating false doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages and wining and dining doctors — including sending sent them on exotic trips — all to get them to prescribe its drugs.

The government claims that Pfizer promoted prescription drugs, such as the pain killer Bextra, as treatments for medical conditions different than those the drugs had been approved by the U.S. Food and Drug Administration. The use of drugs for off-label medical conditions is fairly routine but drug companies are prohibited from marketing drugs for uses that have not been approved by the FDA.

According to the press release by the DOJ:

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.

Pharmacia and Upjohn, a Pfizer subsidiary, entered an agreement to plead guilty to one count of felony misbranding over the promotion practices for Bextra (i.e., not Pfizer).  Bextra is a Cox-2 inhibitor pain medication that was pulled from the U.S. market due to the risk of heart attack, stroke and death.

Other inappropriate drug promotions involved the nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal health care programs, some of which will be shared among the states.

Best tidbit:  Former sales manager Thomas Farina, who is doing six-month of hard home confinement with an electronic ankle bracelet for his role in the case referred to his team as “the Highlanders” — a reference to a movie and TV show about a cult of immortals living secretly among us who must kill or be killed. Farina signed his emails, “There can be only one,” a reference to the motto of the show.

Highlighting that the new Administration is serious about cutting expenses, Associate Attorney General Tom Perrelli noted that:

Because health care fraud is such a significant problem for the public and the federal [budgets], the Justice Department and HHS recently invigorated our longstanding partnership in fighting health care fraud, by launching the Health Care Fraud Enforcement Action Team – or HEAT – earlier this year. This working task force is led by key senior-level leadership in both agencies and has already increased coordination and intelligence data sharing between the agencies and has secured indictments charging dozens of defendants with health care fraud offenses.

In an earlier announcement that helped distract attention from the settlement — and to show it can still obtain world domination — Pfizer announced plans to acquire Wyeth for $68 billion, which is expected to close before the end of the year.

Related posts:

1. Pfizer Plans to Introduce Generic Zoloft – Will Teva have Another Bad Day?
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3. Are any COX-2 inhibitors safe? The FDA does an about-face on Bextra

Cardizem LA (diltiazem) is a long-acting drug and part of a group of drugs called calcium channel blockers, which work by relaxing the muscles of your heart and blood vessels. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. In 2003, an administrative inquiry reported that Biovail planned to offer doctors $1,000 to write 15 prescriptions for Cardizem LA, then complete a report on each patient.

Under the terms of the agreement, Biovail Pharmaceuticals, Inc. (BPI), would plead guilty to charges relating to making payments to induce purchasing or ordering of Cardizem(R) LA in 2003 and would pay $24.6 million to fully settle this matter.  As part of the agreement, Biovail expects to get full releases for all matters related to the DOJ’s investigation.

The agreement eliminates any criminal liability for Biovail Corporation arising from this matter, and preserves the Company’s ability to conduct business in the United States. Without this agreement, the Company was at risk of being excluded from doing business with any health program sponsored by the U.S. federal government. The agreement is subject to approval at a court hearing.

Cardizem LA had $10.2 million in revenue in the first quarter, down 57 percent from $23.9 million a year earlier. In December, the company agreed to pay $138 million to settle a securities fraud class-action suit brought by investors who claimed the company’s officers and directors lied about the effectiveness of Cardizem LA when it was introduced in 2003.

This comes as many groups are starting to ban give aways to doctors. Earlier, Vanderbilt Medical Center and Stanford joined other institutions in banning gifts, meals and toys from drug reps as part of a new conflict of interest policy. The policy, to be phased in by July 1, will also preclude most employees from accepting free meals.

See more about Biovail’s previous administration under former Chairman and CEO Eugene Melnyk where the Securities and Exchange Commission charged the corporation and its former CEO, former CFO, and two current senior executives with engaging in a number of fraudulent accounting schemes and making a series of misstatements to analysts and investors.  (see complaint here)

See also: NIH Scientist Could Get Prison and $100K Fine

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