The Drug Price Competition and Patent Term Restoration Act of 1984 is designed to facilitate what process?

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, was specifically designed to accelerate the approval process for generic medications. One of its key components is the establishment of an abbreviated new drug application (ANDA) process, which allows manufacturers to seek approval for a generic version of a drug without having to conduct the extensive clinical trials typically required for new drugs. This legislation balances the need for innovation in drug development—by providing patent term extensions to brand-name manufacturers to compensate for their costs incurred during the lengthy approval process—with the need to increase the availability and affordability of medications through the introduction of generic options. Thus, the act directly supports the entry of cheaper alternatives into the market, which is crucial for maintaining a competitive pharmaceutical landscape.