ABSTRACT
Consumers, although they may not realize it, live the effects of the Drug Price Competition and Patent Term Restoration Act of 1984, known commonly as the Hatch-Waxman Amendments (also known as the Waxman-Hatch Amendments, or simply the Amendments)(1) every day. The primary effect of the Amendments was to create the abbreviated new drug application (ANDA) process, which established an administrative mechanism for rapid clearance of generic drugs by allowing shortened
applications to be filed with the U.S. Food and Drug Administration (FDA). In these days of rapidly escalating health care costs, especially medicines, the result has been to give consumers less expensive versions of the medications they need to maintain their health. The passage of the Drug Price Competition and Patent Term Restoration Act of 1984 signified Congress’s attempt to strike a balance between the need for pharmaceutical innovation and less expensive drugs. This balance has not always been preserved, however.
