Should a law governing the pharmaceutical market be ethically examined based on its intent or its practical applications?

Abstract

Prescription drug prices are a top health care concern among US consumers. Although this issue is at the forefront of current policy discussions, it is not new. In 1984, the Drug Pricing Competition and Patent Term Restoration Act (colloquially, the Hatch-Waxman Act) addressed drug pricing concerns. This article argues that Hatch-Waxman properly applies utilitarian principles to complex issues of biopharmaceutical development by balancing innovation and availability. However, the statute's efficacy has been marred by so-called pay-for-delay arrangements, which disrupted that carefully constructed equilibrium. This article also argues that the 2013 US Supreme Court holding in Federal Trade Commission v Actavis, Inc appropriately restored the utilitarian balance initially achieved by Hatch-Waxman.