What does the Drug Price Competition and Patent-Term Restoration Act facilitate?

The Drug Price Competition and Patent-Term Restoration Act, commonly referred to as the Hatch-Waxman Act, primarily facilitates a streamlined approval process for generic drugs. This legislation was enacted to promote the availability of low-cost generics while balancing the interests of brand-name drug manufacturers and encouraging innovation in the pharmaceutical industry.

The act created an abbreviated new drug application (ANDA) process that allows generic drug manufacturers to demonstrate that their product is bioequivalent to the brand-name drug, rather than requiring them to conduct extensive clinical trials to prove safety and efficacy. This significantly reduces the time and cost associated with bringing generic drugs to market, thereby facilitating competition and lowering drug prices for consumers.

Through this streamlined approval process, the act has successfully increased the number of generic medications available, contributing to market competition and making essential medications more accessible and affordable for patients. The focus of the act is on fostering this competition in the pharmaceutical marketplace by accelerating the entry of generics, which is why this is the correct answer.