Word: label
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Dates: during 2000-2009
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Prescription for Restraint Drugmakers take heat for pushing their products' off-label uses...
...Greyhound to Canada to buy the same medicine for less. But just for a moment, put yourself in the shoes of pharmaceutical executives who last week attended a conference in Boston on the latest practice to tarnish their trade: the sale and illegal marketing of drugs for "off label" uses not approved by the FDA. "Rarely has a conference been more timely," warned James Dillon, a partner at Foley Hoag, the Boston-based law firm that sponsored the event. Prosecutors and regulators are circling, the executives were told. Would-be whistle-blowers are collecting promotional materials, saving e-mails, taping...
...recent cases involving off-label sales of prescription drugs, Neurontin and Paxil, are rekindling debate about whether drugmakers are generating profits at the expense and health of consumers. Since 2001, pharmaceutical companies have paid the U.S. government more than $2 billion to resolve charges of fraudulent sales and marketing tactics (including a record $875 million that TAP Pharmaceutical Products paid as a settlement in 2001 over kickback schemes to get doctors to prescribe its prostate-cancer drug Lupron). Almost every major firm is now being investigated. Says T. Reed Stephens, a former federal prosecutor who brought several cases against...
Prescribing drugs for off-label uses is nothing new, nor is it illegal. Doctors have been doing it for decades to treat rare diseases, pediatric disorders (for which medicines are often not specially approved) and various cancers. By some estimates, more than half of all oncology patients are treated with at least one off-label drug as part of their chemotherapy regimen. And many doctors see the practice as life-saving science. Statins, for example, were initially approved to lower cholesterol but are now heavily prescribed (and blessed by regulators) to prevent heart attacks and stroke. Says Dr. Cary Gross...
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