chapter  4
42 Pages

Generic Drug-Approval Process: Hatch–Waxman Update

WithMarc S. Gross, Jay Lessler, S. Peter Ludwig, Amanda L. Vaught

OVERVIEW OF GENERIC DRUG-APPROVAL PROCESS UNDER HATCH-WAXMAN The regulatory scheme for approval of generic drugs changed in April 1984 with 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). Since enactment of the statute, generic drugs have increased from 19% of prescriptions in 1984 to 67% in 2007 and, in 1998, accounted for savings to consumers of $8 to 10 billion (3).