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- Off-label_use abstract "Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most study of off-label use centers on prescription drugs. Off-label use is generally legal unless it violates specific ethical guidelines or safety regulations, but it does carry health risks and differences in legal liability. A leading example of how regulatory agencies approach off-label use is provided by the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). CDER reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.The FDA approves a drug for prescription use, and continues to regulate the pharmaceutical industry's promotional practices for that drug through the work of the Office of Prescription Drug Promotion (OPDP, formerly the Division for Drug Marketing, Advertisement and Communication (DDMAC). The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates. Actiq, for example, is commonly prescribed off-label even though it is a Schedule II controlled substance. While it would be legal for a physician to independently decide to prescribe a drug such as Actiq off-label, it is illegal for the company to promote off-label uses to prescribers. In fact, Cephalon, the maker of Actiq, was fined for illegal promotion of the drug in September 2008. Under the Food, Drug, and Cosmetic Act (FDCA) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing a drug for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. Manufacturers are now able to provide medical practitioners with publications on off-label uses of a drug, in response to an unsolicited request. In 2004, the federal government and whistleblower David Franklin reached a $430 million settlement in Franklin v. Parke-Davis to resolve claims that Warner-Lambert engaged in off-label promotion of Neurontin in violation of the FDCA and the False Claims Act. At the time, the settlement was one of the largest recoveries against a pharmaceutical company in U.S. history, and the first off-label promotion settlement in U.S. history.".
- Off-label_use wikiPageExternalLink fda-to-drug-companies-off-label-use-ok.
- Off-label_use wikiPageExternalLink Demonaco,%20Ali,%20Evh%20Off%20Label%20drug%20WP.pdf.
- Off-label_use wikiPageExternalLink article.asp?articleID=240&issueID=21.
- Off-label_use wikiPageExternalLink offlabel_11.
- Off-label_use wikiPageExternalLink abstract?CRETRY=1&SRETRY=0.
- Off-label_use wikiPageID "1550394".
- Off-label_use wikiPageRevisionID "599702584".
- Off-label_use hasPhotoCollection Off-label_use.
- Off-label_use subject Category:Ethically_disputed_business_practices.
- Off-label_use subject Category:Pharmacology.
- Off-label_use type Abstraction100002137.
- Off-label_use type Act100030358.
- Off-label_use type Activity100407535.
- Off-label_use type EthicallyDisputedBusinessPractices.
- Off-label_use type Event100029378.
- Off-label_use type Practice100410247.
- Off-label_use type PsychologicalFeature100023100.
- Off-label_use type YagoPermanentlyLocatedEntity.
- Off-label_use comment "Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most study of off-label use centers on prescription drugs. Off-label use is generally legal unless it violates specific ethical guidelines or safety regulations, but it does carry health risks and differences in legal liability.".
- Off-label_use label "Niet-geregistreerd gebruik".
- Off-label_use label "Off-Label-Use".
- Off-label_use label "Off-label use".
- Off-label_use label "Off-label".
- Off-label_use label "Pozarejestracyjne stosowanie leków".
- Off-label_use label "Uso fuera de indicación".
- Off-label_use label "Офф-лейбл".
- Off-label_use sameAs Off-Label-Use.
- Off-label_use sameAs Uso_fuera_de_indicación.
- Off-label_use sameAs Off-label.
- Off-label_use sameAs 오프라벨.
- Off-label_use sameAs Niet-geregistreerd_gebruik.
- Off-label_use sameAs Pozarejestracyjne_stosowanie_leków.
- Off-label_use sameAs m.059nl8.
- Off-label_use sameAs Q119697.
- Off-label_use sameAs Q119697.
- Off-label_use sameAs Off-label_use.
- Off-label_use wasDerivedFrom Off-label_use?oldid=599702584.
- Off-label_use isPrimaryTopicOf Off-label_use.