A Prescription for Change: How the Medicare Act Revises Hatch-Waxman to Speed Market Entry of Generic Drugs

Abstract:     
The author reviews the pharmaceutical industry's patenting process as it has been impacted by the Hatch-Waxman and Medicare legislation which expedite review and approval for generic follow-on drugs. The pharmaceutical industry's business model of investment in research and development to create and patent innovations in drug therapies, has proven to be successful. Evidence suggests however, that the industry overreached in prolonging the life of its drug patents to the detriment of competitors and consumers. The legislative efforts which substantially increased the availability of generics caused pharmaceutical companies to reconsider their processes as well. This article considers ways to incent innovation while benefiting the public from these innovations. The complex regulatory scheme highlights the fact that unexpected problems occur which may necessitate further legislative amendments that will provide guidance for courts where there is need for further interpretation.

Number of Pages in PDF File: 48

Accepted Paper Series