Document Type

Article

Publication Date

2018

Abstract

Reform of the Hatch-Waxman generic drug framework is in the air. Changes in how the U.S. Food and Drug Administration (FDA) implements the law, as well as changes to the law itself, are under serious consideration. These policymaking discussions are taking place against a backdrop of shared assumptions about the origins and nature of the original Hatch-Waxman legislation-assumptions that this Article claims are wrong.

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