South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the primary purpose of the Drug Price Competition and Patent Term Restoration Act of 1984?

1. To increase market competition for generic drugs

2. To regulate the quality of imported pharmaceuticals

3. To enhance patent protection for original drugs

4. To decrease drug prices for consumers

The correct answer is: To increase market competition for generic drugs

The primary purpose of the Drug Price Competition and Patent Term Restoration Act of 1984, often referred to as the Hatch-Waxman Act, was indeed to increase market competition for generic drugs. This significant piece of legislation aimed to accelerate the approval process for generic medications, allowing them to enter the market sooner once a brand-name drug's patent expired. The Act established a more efficient pathway for generic manufacturers to gain approval from the FDA without the requirement to replicate the extensive testing that the original brand-name drugs underwent. By doing so, it encouraged competition by enabling multiple versions of a medication to be available, ultimately benefiting consumers through lower prices and greater access to medications. Additionally, while the Act did include provisions related to enhancing patent protection for original drugs—such as extending patent terms to compensate for time spent in the FDA approval process—its overarching goal was to promote generics. The regulation of imported pharmaceuticals and a direct decrease in consumer drug prices are not the primary focuses of the Act, even though they may be indirect outcomes of increased competition in the marketplace.