Академический Документы
Профессиональный Документы
Культура Документы
New York State alone getting $66 million. Only South Carolina chose not to participate in the settlement. As news of the riches earned by whistle-blowers spread through the industry in recent years, scores of fraud cases have been filed by former drug sales representatives using a Civil War-era law that pays a bounty for fraud alerts. The cases charge that illegal drug marketing cost the federal Medicare and Medicaid program millions. Under the agreement with the Justice Department, Pfizer will pay a $1.3 billion criminal penalty related to Bextra and $1 billion in civil fines related to other medicines. In addition, a Pfizer subsidiary, Pharmacia and Upjohn, will plead guilty to violating the Food, Drug and Cosmetic Act for its promotion of Bextra. The company has agreed to sign another corporate integrity agreement that requires senior company executives to annually certify legal compliance and mandates that Pfizer post on its Web site many of its payments to doctors. Consumer advocates heaped scorn on Pfizer and said that illegal marketing was still common in the drug industry. Consumers should ask their doctor whether the medication being prescribed is F.D.A.-approved for their condition, advised Lisa Gill, editor of Consumer Reports Best Buy Drugs. If a drug is not approved for their condition, patients should press their doctors to explain their reasoning for the drugs use. Almost every major drug maker has been accused in recent years of giving kickbacks to doctors or shortchanging federal programs. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would more vigorously prosecute doctors as well. Dr. Scott Gottlieb, a top F.D.A. official in the Bush administration who now consults for drug makers, said that government prosecutors were increasingly criminalizing what reasonable people might argue is a reasonable exchange of important clinical information between drug companies and doctors. Bextra was approved in 2001 by the Food and Drug Administration to treat arthritis and menstrual cramps. The drug was not approved for the treatment of acute pain, nor was it shown to be any more powerful than ibuprofen. But Pfizer instructed its sales representatives to tell doctors that the drug could be used to treat acute and surgical pain and at doses well above those approved, even though the drugs dangers which included kidney, skin and heart risks increased with the dose, the government charged. The drug was withdrawn in 2005 because of its risks to the heart and skin. Mr. Loucks, the prosecutor, accused Pfizer of aggressive marketing tactics. Among other things, Pfizer did the following: Pfizer invited doctors to consultant meetings, many in resort locations. Attendees expenses were paid; they received a fee just for being there, he said. Such weekend getaways for doctors are still common throughout the drug and medical device industries. Top Republican officials rarely publicized drug marketing cases or appeared during news conferences about them. Eli Lilly agreed to pay $1.4 billion over its marketing of Zyprexa, an antipsychotic, in January, before President Obama took office. The announcement was made by prosecutors in Philadelphia. Ms. Sebeliuss decision to make the Pfizer announcement in Washington suggests that the political environment for the pharmaceutical industry has become more treacherous despite the industrys commitment to save the government $80 billion as part of efforts to change the health care system.