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Full-Text Articles in Law
Making The Modern American Legislative State, William J. Novak
Making The Modern American Legislative State, William J. Novak
Book Chapters
The essays in this volume are dedicated to two propositions. First, most generally, they aim to reinvigorate scholarly interest in the subject of legislation and bring a new level of analytical sophistication to the study of the legislature. Second, they are committed to looking at legislation developmentally, that is, legislation not as the simple static textual output of a law-drafting body, but as a dynamic social and political process-a living and breathing human activity with a distinct time dimension involving a complex pattern of beginnings, evolutions, maturations, mutations, emendations, and, of course, endings. These propositions nicely intersect with recent themes …
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Book Chapters
This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …
Midnight Rulemaking And Congress, Nina A. Mendelson
Midnight Rulemaking And Congress, Nina A. Mendelson
Book Chapters
This chapter focuses on Congress, our most democratic federal institution. Congress is generally responsible for defining the authorities possessed by the administrative state, and congressional oversight is key to holding agencies accountable for their actions. Midnight rulemaking also has the potential to increase congressional engagement. Two commentators have recently argued that relative inattention from Congress can facilitate midnight rulemaking, because Congress may meet less frequently during the lame duck period and there is no “repeat player” relationship between the outgoing president and the Congress. To the contrary, however, Congress retains considerable formal power to respond to and override presidential decisions, …