ABSTRACT

The display of efficacy and risk information in direct-to-customer promotional labelling and advertisements is a complicated problem. On the one hand, customers have a right to accurate and unbiased information regarding the advantages and disadvantages of prescription medications. Pharmaceutical businesses, on the other, have the right to market their goods in an honest and non-misleading manner. The United States Food and Drug Administration has released guidelines; this guideline is an invaluable resource for companies creating direct-to-consumer advertisement materials for prescription medications. However, a variety of possible conflicts of interest may occur as a result of these recommendations. Conflicts might occur from the pharmaceutical sector, advertisements corporations, or the organizations themselves. It is critical to resolve these possible conflicts of interest to provide customers with accurate and unbiased information regarding the benefits and loss of prescription medications. The regulatory requirements for conveying this information on labelling and advertisements will be discussed in this study. The presentation will also cover the possibility of ethical conflict in the context of these principles, as well as how to handle such conflicts. The paper will conclude with guidelines for regulatory affairs professionals who are in charge of ensuring that their company's labelling and advertisements are legally compliant. Keywords: Promotional Material, Control Group, Effective, Prescription Drug, Data
Publication date: 01/07/2024

https://ijbpas.com/pdf/2024/August/MS_IJBPAS_2024_8259.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.8.8259