Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

The Orphan Drug Act of 1982 provides tax incentives and what duration of marketing exclusivity for drugs used to treat rare diseases?

1. 3 years

2. 5 years

3. 7 years

4. 10 years

The correct answer is: 3 years

The Orphan Drug Act of 1982 is designed to encourage the development of drugs for rare diseases, which often do not attract sufficient commercial interest. This legislation provides various incentives, including tax credits for qualified clinical trials and a significant period of marketing exclusivity. The correct answer, which states that the Orphan Drug Act grants 7 years of marketing exclusivity, reflects the intent of the Act to provide a sufficient incentive for manufacturers to invest in the development of treatments for rare conditions. This exclusivity means that once a drug is approved under this designation, the manufacturer has exclusive rights to market that drug for 7 years, preventing potential competitors from gaining approval for the same indication during that time. In contrast, the other durations listed do not align with the Orphan Drug Act. For instance, 3, 5, or 10 years do not represent the correct length of exclusivity as established by this legislation, which is tailored specifically to support the unique challenge of developing therapies for rare diseases.