South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the purpose of the Orphan Drug Act enacted in 1983?

1. To regulate dietary supplements

2. To encourage drug development for rare diseases

3. To provide guidelines for drug marketing

4. To establish drug safety regulations

The correct answer is: To encourage drug development for rare diseases

The Orphan Drug Act, enacted in 1983, was specifically designed to encourage the development of therapies for rare diseases, which affect fewer than 200,000 individuals in the United States. By providing incentives such as tax credits, grants, and a seven-year period of market exclusivity for manufacturers who develop orphan drugs, the Act aims to stimulate investment and interest in the development of medications that would otherwise be less appealing to pharmaceutical companies due to the limited patient population. This legislative framework ensures that even drugs intended for smaller market segments can be developed, ultimately improving access to treatment for individuals with rare conditions. In contrast, the other options listed do not align with the primary focus of the Orphan Drug Act. The regulation of dietary supplements, drug marketing guidelines, and drug safety regulations are all managed under different legislative frameworks and agencies, such as the Dietary Supplement Health and Education Act and various provisions under the Federal Food, Drug, and Cosmetic Act. The specific aim of the Orphan Drug Act stands out as focused on addressing the needs related to rare diseases and conditions, thus making the second option the most appropriate and relevant choice.