Federal regulations and federal agencies (Program) (Supervisor) November 4, Federal regulations and federal agencies Off-label drugs are drugs that are prescribed and are used for purposes that are different from labeled applications or for recommended groups of patients. Even though such applications are legal, the Food and Drug Administration as well as government care plans discourage them. This discussion argues that it should be illegal for a pharmaceutical company to promote off-labeled drugs because of government policies against it and because of its potential harm. Off labeled drugs may be helpful to patients if prescribed for the patients’ best interest and in a scientific based way that minimizes potential harm to the patients.
Probability of harm is however, greater if such labels are not based on scientific evidence and such uninformed applications should be illegalized. Most of off-labeled drug usage is however not supported by scientific evidence (Dresser & Frader, 2009) and the uninformed approach, especially when such usage exposes patients to adverse drug side effects, requires legal control. According to Ahuja, and with respect to children alone, off label drugs could lead to “jaundice, ” “seizures and cardiac arrests, ” “withdrawal symptoms, ” and “staining teeth” (2005, p.
98). Such effects suggest that the government should be effective in its role of ensuring public health by illegalizing off-labeled drugs, especially prescriptions whose safety have not been proven by scientific evidence. The fact that the Food and Drug Administration and government’s Medicare and Medicaid plan discourage use of off label drugs is also an indicator of the applications threat to good health and warrants illegalization (Ausness, 2008). Off-label drugs should therefore be illegalized and pharmaceutical companies should not promote it because of their possible adverse effects, widespread uninformed prescriptions, and existence of policies against prescription and usage of off labeled drugs.
ReferencesAhuja, G. (2005). Drug injury: Liability, analysis, and prevention. Tucson, AZ: Lawyers & Judges Publishing Company. Ausness, R. (2008). “There’s danger here, Cherie! ”: Liability for promoting and marketing of drugs and medical devices for off-label use. University of Kentucky College of Law. Retrieved from: http: //uknowledge. uky. edu/law_facpub/46/. Dresser, R. & Frader, J. (2009). Off-labeled prescribing: A call for heightened professional and government oversight.
The Journal of Law, Medicine & Ethics 37(3): 476-486.