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PRESCRIPTION FOR TROUBLE: Drugmakers pushing risky off-label uses on physicians, Detroit Free Press:"Milton Cole, a 71-year-old man in generally good health, was complaining of chest pains. A battery of cardiac tests couldn't pinpoint the problem. To blunt the pain, Murray gave his patient a prescription and some free samples of the drug. The drug Murray prescribed was Prozac, a popular antidepressant that isn't approved by the U.S. Food and Drug Administration for treating chest pain. Murray later said he had no idea that experts have debated for years whether Prozac causes suicide. Thirteen days after that visit to the doctor, on June 28, 2001, Cole's wife, Amby, found him hanging from a beam in a back room of their shop."


Medicare scrutinizing off-label uses for medicine, By Christopher Rowland, Globe Staff, 2/10/2004:"Federal administrators who run the Medicare program have begun to closely scrutinize the off-label use of prescription drugs, using clinical reviews to determine which prescriptions will get into the hands of American consumers and which won't. The move is part of a pattern of growing influence for the Medicare agency, called the Centers for Medicare and Medicaid Services, or CMS. By conducting more clinical reviews of its own to decide whether to pay for drugs, it is adopting activities that previously had been the exclusive domain of the Food and Drug Administration. Off-label uses of drugs, meaning they are used in treatments not approved by the FDA, are common in US healthcare. Medicare has traditionally covered these prescriptions based on a doctor's judgment. But the agency is beginning to demand evidence of health benefits in response to expensive cutting-edge treatments, more off-label prescribing, and marketing abuses by drug companies."


Litigation Threatens Off-Label Pharmaceutical Sales,"Because a few companies have egregiously violated FDA rules and regulations in marketing their drugs for off-label uses, spoiling it for the majority, the pharmaceutical industry is on a collision course with the Federal False Claims Act (FCA) that may jeopardize its $13 billion in annual, off-label pharmaceutical sales. In addition to what has already been filed, expect an increasing number of qui tam lawsuits and crippling fines against specific companies, as well as unwanted government regulation--unless industry leaders develop standards to curb abuses. The FCA is the U.S. Government's most powerful and most utilized tool to fight fraud. The FCA was originally enacted by Congress in 1863, as a response to widespread abuses by government contractors against the Union Army during the Civil War. The Act was scarcely used in the interim years until 1986, when Congress enacted amendments to the Act which strengthened the law and increased monetary awards."
210 12th Avenue South Nashville, TN 37203
Phone: 615.385.4131 Fax: 615.385.4979 Toll Free: 888.293.9675


Off Label Prescriptions, Marketplace - Canada's Investigative Consumer Program:"As many as 40 per cent of prescriptions are 'off label' There's no Canadian figure, but the American Medical Association estimates as many as 40 per cent of all prescriptions are for "off label" uses. That can be good news for drug companies, who don't have to pay the costly toll for the long road to approval. In Vancouver, clinical pharmacologist Dr. Tom Perry wonders what's driving Topamax sales. He's studied the drug closely. "I haven't found reasons to prescribe it to my own patients." Perry consulted on the Dana McCartney case. He thinks 'I haven't found reasons to prescribe it to my own patients.' Dr Tom Perry, clinical pharmacologist Topamax is over-prescribed."


Off-label Prescriptions Call Fda Role Into Question, National Center for Policy Analysis:"The problem of "drug lag" is widely recognized. It requires almost nine years for the Food and Drug Administration (FDA) to approve a new drug in the United States. However, "off-label" use is a good illustration of a less-regulated market in drugs. Off-label refers to the use by doctors of FDA-approved drugs for purposes other than those approved by the agency. Off-label use is so high that most hospital inpatients receive at least one approved drug for reasons other than those for which it was approved. Through the use of off-label prescriptions, doctors successfully determine the efficacy of drugs on their own and build up a community of knowledge. For example: Aspirin, used for decades as a pain reliever, was also used to reduce the mortality rate among heart attack victims for years before the FDA sanctioned its use for that purpose. Doctors tested the theory that stomach ulcers were caused by bacteria through off-label prescriptions for antibiotics. Mitomycin, approved for gastric and pancreatic cancers, was found to be useful in treating lung, bladder, breast and cervical cancers as well."
12770 Coit Rd., Suite 800 - Dallas, TX 75251-1339 - 972/386-6272 - Fax 972/386-0924
655 15th St. N.W., Suite 375 - Washington, DC 20005 - 202/628-6671 - Fax 202/628-6474


FAQ on off-label prescribing, Obesity Meds and Research News:"Definition of off-label prescribing. Off-label use is the prescribing of a medication in a different dose, for a longer duration of time, or for a different medical indication than recommended in the prescribing information. Although the Food and Drug Administration (FDA) approves a drug for a specific indication, the physician has discretion to prescribe it as indicated above, or in combination with other medications in the treatment of patients. In 1998, the agency proposed an amendment to the FDA Modernization Act that allows dissemination of information by manufacturers about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company files a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use."
PO Box 19316, Alexandria, VA 22320-0316
Telephone: 703/966-5513
Fax: 703/960-7462


Off-Label Prescribing of Drugs Calls FDA Role into Question by Scott Esposito, Pittsburgh Tribune-Review:""Off-label" prescriptions are uses of FDA-approved drugs for purposes other than those approved by the agency. For example, aspirin, approved by the FDA as a pain killer, was used to reduce the mortality rate among heart attack victims for years before the FDA sanctioned that use of it. In his recent study of off-label prescriptions in The Independent Review (Summer 2000), "Assessing the FDA via the Anomaly of Off-Label Drug Prescribing," economist Alex Tabarrok shows that the rate of off-label prescribing is so high that most hospital patients receive at least one drug off label. Through the use of off-label prescriptions, doctors successfully determine the efficacy of drugs on their own and build up a community of knowledge. For example, when it was theorized that stomach ulcers were caused by bacteria, doctors tested this theory through the off-label prescription of antibiotics. As doctors discovered and shared information regarding the efficacy of antibiotics against stomach ulcers, amoxicillin and tetracycline were found useful in the treatment of ulcers without any FDA intervention."


Off-Label Use of Prescription Drugs, USPharmacist:"For years it has been accepted policy that physicians may prescribe, and pharmacists may dispense, FDA-approved prescription-only drugs for purposes other than those listed in the FDA-approved package insert. This has been accepted practice only if the off-label use was generally recognized as acceptable in the scientific community (usually as evidenced by peer-reviewed publications addressing the off-label use) and the off-label use does not constitute "experimentation."1 When all of these conditions are met, the FDA position has been that it will not take action against prescribers or pharmacists."
USPharmacist C.E.TM, Inc., Jobson Publishing
1515 Broad Street Bloomfield, NJ 07003
(973) 954-9300 Fax (973) 954-9302


Off-Label Prescriptions : Medicines prescribed for purposes other than their manufactured design - November 2, 2003,"A three-part investigative series by Knight Ridder Newspapers has found that patients nationwide are being harmed as doctors routinely prescribe drugs in ways the Food and Drug Administration has never approved as safe and effective. The study, based on a sample of top-selling drugs, found that the number of off-label prescriptions has nearly doubled in five years. The Knight Ridder analysis released today is perhaps the most comprehensive ever done of off-label prescribing. The series by investigative reporters Alison Young and Chris Adams is based on interviews with patients, doctors, researchers and drug companies, and the review of thousands of records from lawsuits, government hearings and regulatory actions, medical records and scientific studies. The complete results will run over the next three days in Knight Ridder newspapers across the country."




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Last updated by Andrew Lopez, RN on Thursday, January 28, 2010

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