Document Type


Publication Date



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.



To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.