What is one of the purposes of the Drug Price Competition and Patent Term Restoration Act of 1984?

One of the main purposes of the Drug Price Competition and Patent Term Restoration Act of 1984 is to streamline the generic drug approval process. This legislation was designed to encourage the development and marketing of generic drugs by providing a pathway for generic manufacturers to obtain approval more efficiently. It established an abbreviated New Drug Application (ANDA) process, which allowed manufacturers to demonstrate that their generic formulations are bioequivalent to the brand-name drugs without having to conduct extensive clinical trials.

By doing so, the Act aimed to increase market competition, thereby lowering drug prices for consumers while still providing a degree of patent protection for original drug manufacturers. This balance seeks to promote both innovation in drug development and accessibility to lower-cost medication options through generics. The outcome has been an overall enhancement of the availability of affordable medications in the market.