Misbranding drugs leads to Pfizer paying $1.3 billion in criminal fines

October 19, 2009

Natural News

By Mike Adams

In the largest criminal fine ever levied against any drug company in the world, a unit of U.S.-based Pfizer, Inc. was sentenced to pay $1.3 billion in criminal fines and revenue forfeiture. It’s all part of a $2.3 billion settlement announced by the Justice Department. The case centers around Pfizer’s criminal “off-label marketing” of four drugs, including the painkiller Bextra. After whistleblowers filed lawsuits in three states, the U.S. Justice Department took an interest in the case and prosecuted Pfizer for criminal acts.

In the settlement, Pfizer admitted to a felony crime and agreed to pay $2.3 billion in fines and other fees. The investigation of Pfizer reportedly turned up evidence that Pfizer engaged in kickback payments to doctors for nine drugs, including Viagra and Lipitor.

Part of the reason the penalty against Pfizer was so large is because the company was considered a “repeat offender” in promoting drugs for unapproved uses (which is a violation of federal law).

Off-label marketing makes a mockery of modern medicine

So-called “off-label” marketing of drugs is rampant in the pharmaceutical industry. Although the FDA, drug companies and many conventional doctors claim the drug industry is guided by a “gold standard” of scientific scrutiny, the truth is that pharmaceuticals are routinely marketed and prescribed for health conditions for which they have never even been studied… much less actually approved by the FDA. The fact that this continues today makes a mockery of any “scientific credibility” the pharmaceutical industry claims to possess.

Drug companies take advantage of this gaping hole in regulatory oversight by getting their drugs approved by the FDA for one health condition, then heavily promoting it for numerous unrelated conditions. A drug approved for high blood pressure, for example, could be openly marketed for diabetes or Alzheimer’s disease even though there is no evidence whatsoever showing the drug to be either safe or effective for such conditions.

The same is true with the intended demographics of pharmaceuticals: Drug companies often get their drugs approved for adults, then they market those drugs to children even though the drugs have never been tested with children.

The result is a pharmaceutical industry that appears to be highly regulated, but isn’t. Virtually any drug can be pushed for any disease for almost any reason — all with virtually no oversight by the FDA. In fact, in this Pfizer case, even with the Justice Department filing criminal charges against Pfizer, the FDA has stood by and done absolutely nothing to prevent such actions from being repeated in the future by Pfizer or another drug company.

Click here for full report from Natural News

Pfizer to Pay Record $2.3B Penalty Over Promotions

September 2, 2009

Associated Press

By Devlin Barrett

Pfizer Inc., the world’s largest drug maker, will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions, the Justice Department announced Wednesday.

The department said the $2.3 billion settlement included a $1.2 billion criminal fine, the largest criminal fine in U.S. history. The agreement also included a criminal forfeiture of $105 million.

“Combating health care fraud is one of this administration’s top priorities,” Associate Attorney General Thomas Perelli said in announcing the settlement. He said it illustrates ways the department “can help the American public at a time when budgets are tight and health care costs are rising.”

The overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules.

The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different than those the drugs had been approved for by federal regulators.

Use of drugs for so-called “off-label” medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration.

A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding.

“These agreements bring final closure to significant legal matters and help to enhance our focus on what we do best – discovering, developing and delivering innovative medicines to treat patients dealing with some of the world’s most debilitating diseases,” said Amy W. Schulman, senior vice president and general counsel of Pfizer.

Authorities said Pfizer’s salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

Justice officials discussed details of the deal at a news conference with FBI, federal prosecutors, and Health and Human Services Department officials.

In financial filings in January, the company had indicated that it would pay $2.3 billion over allegations it had marketed the pain reliever Bextra an possibly other drugs for medical conditions different than their approved use. The settlement announced Wednesday also covered Pfizer’s promotions of three other drugs: Geodon, an anti-psychotic, Zyvox, an antibiotic, and Lyrica, an anti-epileptic.

Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal healthcare programs. Some of that money will be shared among the states: New York, for example, will receive $66 million, according to the state’s attorney general, Andrew Cuomo.

“Pfizer ripped off New Yorkers and taxpayers across the country to pad its bottom line,” Cuomo said. “Pfizer’s corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company’s drugs for patients in taxpayer-funded programs.”

Pfizer spokesman Chris Loder confirmed Wednesday that the $2.3 billion charge to the company’s earnings had been taken in the fourth quarter of 2008.

“No additional charge to the company’s earnings will be recorded in connection with this settlement,” he said.

In her statement, Schulman 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,” she said, “and we will continue to take appropriate actions to further enhance our compliance practices and strengthen public trust in our company.”

When Pfizer originally disclosed the settlement figure, it also announced plans to acquire rival Wyeth for $68 billion. That deal, which would bolster Pfizer’s position as the world’s top drug maker by revenue, is expected to close before year’s end.

Shares of Pfizer were up 9 cents at $16.47 in early trading Wednesday.

Click here for the full report from the Associated Press