Marketing Drugs For Off Label - 892 Words

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as â€Å"off-label use† (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that. For example, Vedula (2012) notes that FDA guidelines state pharmaceutical companies can use peer-reviewed articles to publicize evidence of a drug’s effectiveness for off-label uses, as long as a number of conditions are met—perhaps the most essential of which is that â€Å"the information disseminated must not be false or misleading.† However, Vedula continues, there is no unyielding regulation that all research findings have to be published. Therefore, a compa ny can still choose to selectively disseminate favorable findings. His article concludes that there is now a copious amount of evidence that suggests selective reporting of study results, based on the strength and direction of findings, is performed extensively by the pharmaceutical industry. The fruits of this devious labor are plain to see. For instance, Tamiflu is a drug that governments around the world have spent billions of dollars amassing—almost in a panic—in hopes that it could alleviate the morbidity influenza (JeffersonShow MoreRelatedOff Label Promotion : Profitable Health Jeopardizing Act Of Defiance1103 Words   |  5 PagesOff-label promotion: profitable health jeopardizing act of defiance or costly freedom of speech? INTRODUCTION Over the years there is the discussion on the nature of off-label promotion. Promotion for an unapproved by the Food and Drug Administration usage of a drug, medical device or biologic is prohibited by the 1938 Food, Drug and Cosmetics Act, and subjects the product to the misbranding provisions. On the other hand, off-label promotion is deemed to be a constitutional right protected by theRead MoreThe Utilization Of Prescription Drug1332 Words   |  6 Pagesprescription drug has increased in recent times. The availability of these medications has resulted in the treatment of numerous infections and ailments. These drugs alleviate chronic pain, depression and anxiety, sleep apnea, and much more. For an efficient health system, the main goal is to provide quality health care to all patients. However, over the years, there have been many legal and health controversies over drugs and the effects that they have on the body. The process of prescription drug startsRead MoreMedical Fraud214 0 Words   |  9 Pagesmy paper. Understanding the topic of medical fraud and off labeling is important, especially for consumers who participate in the use of prescription drugs. It is imperative to understand what your doctor is prescribing and knowing the specific uses of said drug. Off labeling may occur and recognizing this fact will only benefit a wise consumer and make them aware of the risks of using a drug that was prescribed for a uses not on the label. This topic is especially important during the time of newRead MoreMarketing Approval For Medicinal Products Essay1353 Words   |  6 Pagesdifferent countries to make available new therapy for their patients, who have unmet needs. The USA, UK and Japan are offering an accelerated marketing approval for the medicinal products. USA: USFDA is offering a Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review options to expedite the medicinal products approval. 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As the Food and Drug Administration Progresses it had became a reliable source for Americans .President Theodore Roosevelt signed the Food, Drug, and Cosmetic Act in 1938 to provide the publicRead MoreInternational Drug Monitoring For The Thalidomide Disaster Detected1301 Words   |  6 PagesINTRODUCTION Pharmacovigilance (PV or PhV) , also known as Drug Safety, is defined as the science and activities relating to the detection, collection, assessment, monitoring, understanding and prevention of adverse effects (AEs) or any other drug-related problem. World health organization (WHO) established its programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. The aims of PV are to enhance patient care and patient safety in relation to the useRead MoreMerck : An Ethical And Socially Responsible Drug Manufacturer1453 Words   |  6 PagesQuestion 1 Merck was known as an ethical and socially responsible drug manufacturer. Back in 1950, George W. Merck, CEO, said, â€Å"We try never to forget that medicine is for the people. It is not for the profits† (Lawrence Weber, 2014). Merck was also known for research and innovation in developing new drugs as well as their philanthropic efforts. This was a company that had built its success on a solid reputation of being an ethical and socially responsible organization. The Vioxx case is evidenceRead MoreChipman Union Inc. Odor Eater Socks1487 Words   |  6 Pagesand athletic socks, which were sold to the retail/ distribution channels unbranded as private label merchandise. By early 1980, CU’s market share was estimated at 10% of units and 11% of factory sales. The distribution channel of CU was also wide spread. In 1979, over 90% of its production was sold to 33 retail chains of which only 3 accounted for around 60% of the volume. 1% each was sold to food and drug stores and catalog show rooms. About 1.5% of the volume was even exported. Bryan Hagen; PresidentRead MoreCase Study: Procter Gamble Business Strategy786 Words   |  4 Pagesproducer of various everyday household goods. Over the many years of manufacturing, marketing, and distributing products, the company developed many business strategies and adjusted them accordingly when needed. The first strategy Procter Gamble used was to have mass production of goods out of their hometown, Cincinnati. Then they would have a group of smaller, independent companies handle the manufacturing, marketing and distributing of those products. During this time, the 1960’s, this way had workedRead MoreAnalysis of Will Smiths Party Starter801 Words   |  4 Pagesserious. There was the impression or hope that things will get better. Soon, corporate record labels started to repackage rap music as it gained in popularity. The business minded executives were looking to create a wider appeal by erasing hip-hops historic function. Hip-hop became a business. Rap music was a valuable commodity. In the 1980s, the music was sold back to the streets through marketing ploys such as videos and Top 40 charts. With the rise of rap, a sub-genre called gangsta rap