ABSTRACT
The regulatory scheme for approval of generic drugs changed in April 1984 with the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman or Waxman-Hatch Act (1). The Act was intended to balance the interests of consumers, the brand-name/(innovator) pharmaceutical industry, and the generic drug industry to ‘‘make available more low cost generic
drugs [and] to create a new incentive for increased expenditures for research and development of certain products which are subject to pre-market approval’’ (2). In fewer than 20 years since enactment of the statute, generic drugs increased from 19 to 47% of prescriptions filled for pharmaceuticals and even in 1994 accounted for savings to consumers of $8-10 billion (3).
