- The Washington Times - Thursday, September 3, 2009

In what authorities called the largest criminal fine in history, pharmaceutical giant Pfizer Inc. has agreed to pay $1.3 billion, plus $1 billion in civil penalties, for peddling drugs to treat conditions for which the federal government had not approved the medications.

Pfizer, the world’s biggest drugmaker, gave doctors free resort trips, including golf games and massages, for meetings at which the drug company’s “marketing machine” would push doctors to prescribe medications for non-approved purposes, authorities said.

“When a drug is marketed or promoted for nonauthorized, so-called off-label uses, any use not approved by the [Food and Drug Administration] — as was the case here — public health may be at risk,” Associate Attorney General Tom Perrelli said during a news conference Wednesday announcing the settlement. “And there’s a real danger for patients that the medical providers who prescribed the medicine … don’t have full information about the drug’s risks and benefits.”

The settlement focused mainly on Pfizer’s promotion of Bextra, an anti-inflammatory drug pulled from the market in 2005 for safety reasons.

Authorities said Bextra had been approved in 2001 for only three ailments — uterus pain and two forms of arthritis. Pfizer had asked for FDA approval to have Bextra prescribed to treat all types of pain, but the FDA refused because of concerns about it causing blood clots in the heart.

But Pfizer marketed the drug as a general pain reliever anyway, though it remains unclear how many patients fell ill as a result.

“I think whether or not it harmed patients was not the focus of the investigating,” Mr. Perrelli said. “So it wasn’t something that was simply part of our inquiry.”

Similarly, authorities said, doctors who prescribed the drug were not investigated.

“We regret certain actions taken in the past,” Amy W. Schulman, senior vice president and general counsel of Pfizer, said in a statement, “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.”

As part of the agreement, the Department of Health and Human Services will monitor Pfizer’s marketing more closely for five years.

The agreement also called for Pfizer subsidiary Pharmacia & Upjohn Co. to plead guilty to a felony for misbranding Bextra. As a result of that plea, Pfizer must pay a criminal fine of nearly $1.2 billion, the largest criminal fine ever imposed in the United States, while Pharmacia & Upjohn must forfeit $105 million.

Pfizer also has agreed to pay $1 billion in civil penalties for illegally marketing and giving kickbacks to doctors who prescribed Bextra and three other drugs — Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug.

Attorney General Eric H. Holder Jr. recused himself from the case because his former law firm had represented Pfizer.

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