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Full-Text Articles in Law
The Transformative Twelfth Amendment, Joshua D. Hawley
The Transformative Twelfth Amendment, Joshua D. Hawley
Faculty Publications
This paper argues that the Twelfth Amendment represents far more than a mechanical adjustment of the electoral college. Rather, it is the constitutional text that gives us the political presidency that we know today. The Twelfth Amendment worked a major structural change in the relationship between the legislative and executive branches and for that reason bears directly on the debate over the unitary executive and the meaning of “executive power.” Specifically, presidential removal power is best justified not by the original Article II, but by the constitutional structure the Twelfth Amendment created. And the scope and definition of executive power …
A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan
A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan
Faculty Publications
Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …