South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What does the Orphan Drug Act of 1983 provide incentives for?

1. Development of medications for common diseases

2. Approval of high volume medications

3. Research and marketing of drugs for rare diseases

4. Regulatory compliance for pharmaceutical companies

The correct answer is: Research and marketing of drugs for rare diseases

The Orphan Drug Act of 1983 was established to encourage the development of medications specifically for rare diseases, also known as orphan diseases, which affect a small number of patients. The act provides various incentives to pharmaceutical companies to stimulate research and marketing for these drugs, including tax credits for clinical research, grants for study costs, and a seven-year period of exclusive market rights upon approval of the drug. This incentivization is critical because the limited market for rare diseases often disincentivizes companies from investing in research and development due to the high costs and low potential returns. The focus on rare diseases underlines the intention of the legislation to address unmet medical needs where no effective treatments may be available, which contrasts sharply with the broader healthcare focus on common diseases and medications. By enabling companies to recoup their investment and achieve profitability, the Orphan Drug Act plays a key role in bringing necessary treatment options to patients with these rare conditions.