The Legal And Ethical Implications Associated With Wrongful Off Label Prescribing

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I aim to explain the drug development process, to explore the legal and ethical implications associated with wrongful off-label prescribing, and provide my recommendations for reform of the pharmaceutical industry. I will consistently refer to the GlaxoSmithKline case to display the maleficent inner workings of the multinational pharmaceutical company. Glaxo was involved in the biggest health care fraud settlement in U.S. history for introducing and encouraging physicians to off-label prescribe their patients six misbranded drugs, Paxil, Wellbutrin, Advair, Lamictal, Avandia and Zofran. Kickbacks were paid to physicians that prescribed those drugs but also for the drugs Imitrex, Flovent, Lotronex, and Valtrex. Glaxo also failed to report safety data to the Food and Drug Administration (FDA) for Avandia, a diabetes drug. I find this issue to be so important because I hope to pursue a career in health law. My health policy major and relevant coursework ignited my interest in the legal issues strewn throughout our health care system. The United States Pharmacopoeia (USP) was established to set the standards for the manufacture, nomenclature, indications, and chemical characteristics of drugs and continues to do so today. In 1938, the Pure Food and Drug Act created the FDA, to ensure the, “safety, efficacy, and appropriate labeling and advertising of pharmaceutical products before approving them for sale” (Blum, 2002). Prescription drugs are developed and both pre-clinical and
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