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FDA poised to change the health & wellbeing of all Americans
According to an article issued on NewsTarget.Com, the FDA is now poised to dramatically change the health and well being of all Americans. Unfortunately, they are headed in the wrong direction--straight over a cliff. The FDA is supposed to make sure drugs are safe and effective; they are mandated to protect the public. However, the top two positions at the FDA are now headed by Big Pharma representatives.
Articles & Press Releases
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Pharma Giant Schering-Plough Pleads Guilty to Criminal Conspiracy
By Jeffrey Krasner
Schering-Plough has paid $435 million in fines and pleaded guilty to criminal conspiracy charges to settle U.S. Justice Department accusations that it lied to the government about drug prices and improperly marketed cancer drugs for uses not approved by the Food and Drug Administration.
The case is the third multimillion dollar government settlement in five years for the pharmaceutical company, based in Kenilworth, New Jersey, which has annual sales of about $10 billion. Counting last week's settlement, Schering-Plough has paid about $1.3 billion in civil and criminal fines since 2002.
"In most cases of health care fraud, the conduct is driven by a bottom-line mentality," said Michael Sullivan, the U.S. attorney for Massachusetts, whose office conducted the investigation. Sullivan announced the settlement Tuesday at a press conference in Boston.
Paul McNulty, the U.S. deputy attorney general, said in a statement, "This settlement sends a clear message to the pharmaceutical industry that the Justice Department will not tolerate these deceptive and illegal marketing practices."
In terms of fines paid, the settlement is one of the largest health care prosecutions by the Justice Department. While the activities alleged by the government occurred in many locations, the investigation was run out of the Justice Department's Boston office. Michael Loucks, the first assistant U.S. attorney and a participant in the Schering-Plough investigation, has a reputation for aggressively pursuing health care fraud, and previously headed Sullivan's Health Care Fraud Unit.
"This is the last of the major U.S. attorneys' investigations that we're aware of," said Brent Saunders, Schering- Plough's senior vice president for global compliance. He said that the company still faced investigations by the U.S. Department of Health and Human Services, the Justice Department and several states into its wholesale pricing practices.
According to the government, Schering-Plough engaged in illegal sales and marketing programs for several cancer drugs. It improperly promoted Temodar for use in brain tumors and metastatic cancer, and pushed the drug Intron A for use in superficial bladder cancer and hepatitis C, the government said.
While doctors are generally free to prescribe drugs for "off-label" uses that are not specified in a drug's official Food and Drug Administration labeling, the companies that make those drugs are forbidden from marketing or promoting drugs for unapproved uses.
Temodar was approved in 1999 for a specific type of brain tumor, but the government said that Schering-Plough illegally promoted it as a treatment for other types of brain cancer for which it had not received approval.
The government also said the company paid "illegal remuneration" to doctors "to induce utilization of Temodar." For example, the company would pay doctors to serve as a "preceptor" and take a Schering-Plough sales representative around with them during their workdays. It also placed doctors on medical advisory boards that existed primarily to pay the doctors stipends and provide lavish entertainment.
The government also said that Schering-Plough awarded clinical studies to doctors based on how much Temodar they used. Such studies are often considered prestigious and can be lucrative.
The company engaged in similar behavior for the four years ending in December 2003 to promote the use of Intron A as a treatment for superficial bladder cancer, according to the Justice Department.
The government cited an illegal kickback scheme that Schering-Plough had devised for its drugs used to treat hepatitis C. For each patient starting treatment with Schering-Plough's drugs, doctors would receive up to $500.
Schering-Plough also had company- paid physician assistants work in busy doctors' offices, and paid doctors for attendance at company-sponsored events.
Schering-Plough earned $124 million in pretax profit through the illegal off- label promotion of Temodar and Intron A, the government said.
In a separate scheme, Schering- Plough overcharged the government for its allergy drug Claritin. Under Medicaid rules, drug companies have to provide their products at the best price made available to private buyers like HMOs, or health care organizations providing services to prepaid subscribers.
© Copyright 2006 The New York Times Company. All Rights Reserved.
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