Legal and Ethical Issues in Medical Sales Free Essay Example, 2500 words

Off-label use can be defined as the use of drugs by doctors for purposes other than those approved by the FDA. It has become evident from various studies that a considerable proportion of patients are subjected to off-label use. This is so because doctors are free to prescribe any legally marketed device for uses other than the ones allowed by the FDA. This is so because Section 906 of the Federal Food, Drug, and Cosmetics Act points out that the Act does not interfere with the authority of a healthcare practitioner to prescribe or administer any legally marketed device for any condition or disease within legitimate health care practitioner-patient relationship (FDA, n.d). Thus, as a study by Kesselheim, Mello Studdert (2011) from the Brigham and Women s Hospital, Boston, points out, there is widespread off-label marketing of medicines in the US which cannot be controlled under the existing laws. The study identified three methods of off-label marketing. They are the expansion of d rug use to unapproved diseases, expansion of drug use to unapproved disease subtypes, and expansion of drug use to unapproved dosing strategies that often involve higher doses. We will write a custom essay sample on Legal and Ethical Issues in Medical Sales or any topic specifically for you Only $17.96 $11.86/page